    [House Report 117-348]
    [From the U.S. Government Publishing Office]

    117th Congress    }                                    {     Report
                            HOUSE OF REPRESENTATIVES
     2d Session       }                                    {     117-348
    _______________________________________________________________________

    .

                        FOOD AND DRUG AMENDMENTS OF 2022

                                   ----------

                                  R E P O R T

                                     of the

                        COMMITTEE ON ENERGY AND COMMERCE

                                  to accompany

                                   H.R. 7667

    		[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

      June 7, 2022.--Committed to the Committee of the Whole House on the
                  State of the Union and ordered to be printed

                        FOOD AND DRUG AMENDMENTS OF 2022

    117th Congress    } 				        {  Report
     	                HOUSE OF REPRESENTATIVES
     2d Session       }                                     {  117-348
    _______________________________________________________________________

                        FOOD AND DRUG AMENDMENTS OF 2022

                                   __________

                                  R E P O R T

                                     of the

                        COMMITTEE ON ENERGY AND COMMERCE

                                  to accompany

                                   H.R. 7667

    	        [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

      June 7, 2022.--Committed to the Committee of the Whole House on the
                  State of the Union and ordered to be printed

                                    __________

                  	     U.S. GOVERNMENT PUBLISHING OFFICE

    29-006			     WASHINGTON : 2022

    117th Congress    } 				        {  Report
     	                HOUSE OF REPRESENTATIVES
     2d Session       }                                     {  117-348

    ======================================================================

                        FOOD AND DRUG AMENDMENTS OF 2022

                                    _______

      June 7, 2022.--Committed to the Committee of the Whole House on the
                  State of the Union and ordered to be printed

                                    _______

     Mr. Pallone, from the Committee on Energy and Commerce, submitted the
                                   following

                                  R E P O R T

                            [To accompany H.R. 7667]

        The Committee on Energy and Commerce, to whom was referred
    the bill (H.R. 7667) 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, having
    considered the same, reports favorably thereon with an
    amendment and recommends that the bill as amended do pass.

                                    CONTENTS

                                                                       Page
      I. Purpose and Summary.............................................49
     II. Background and Need for the Legislation.........................49
    III. Committee Hearings..............................................67
     IV. Committee Consideration.........................................68
      V. Committee Votes.................................................68
     VI. Oversight Findings..............................................72
    VII. New Budget Authority, Entitlement Authority, and Tax Expenditure72
    VIII.Federal Mandates Statement......................................72

     IX. Statement of General Performance Goals and Objectives...........72
      X. Duplication of Federal Programs.................................72
     XI. Committee Cost Estimate.........................................72
    XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits.....72
    XIII.Advisory Committee Statement....................................73

    XIV. Applicability to Legislative Branch.............................73
     XV. Section-by-Section Analysis of the Legislation..................73
    XVI. Changes in Existing Law Made by the Bill, as Reported...........86

        The amendment is as follows:
      Strike all after the enacting clause and insert the
    following:

    SECTION 1. SHORT TITLE.

      This Act may be cited as the ``Food and Drug Amendments of 2022''.

    SEC. 2. TABLE OF CONTENTS.

      The table of contents of 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. Definitions.
    Sec. 103. Authority to assess and use drug fees.
    Sec. 104. Reauthorization; reporting requirements.
    Sec. 105. Sunset dates.
    Sec. 106. Effective date.
    Sec. 107. 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 third-party review program.
    Sec. 207. Sunset dates.
    Sec. 208. Effective date.
    Sec. 209. Savings clause.

                   TITLE III--FEES RELATING TO GENERIC DRUGS

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

           TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

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

                TITLE V--IMPROVING DIVERSITY IN CLINICAL STUDIES

    Sec. 501. Diversity action plans for clinical studies.
    Sec. 502. Evaluation of the need for FDA authority to mandate
    postapproval studies or postmarket surveillance due to insufficient
    demographic subgroup data.
    Sec. 503. Public workshops to enhance clinical study diversity.
    Sec. 504. Annual summary report on progress to increase diversity in
    clinical studies.
    Sec. 505. Public meeting on clinical study flexibilities initiated in
    response to COVID-19 pandemic.
    Sec. 506. Decentralized clinical studies.

                       TITLE VI--GENERIC DRUG COMPETITION

    Sec. 601. Increasing transparency in generic drug applications.
    Sec. 602. Enhancing access to affordable medicines.

        TITLE VII--RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN IMPROVEMENTS

                             Subtitle A--In General

    Sec. 701. Animal testing alternatives.
    Sec. 702. Emerging technology program.
    Sec. 703. Improving the treatment of rare diseases and conditions.
    Sec. 704. Antifungal research and development.
    Sec. 705. Advancing qualified infectious disease product innovation.
    Sec. 706. Advanced manufacturing technologies designation pilot
    program.
    Sec. 707. Public workshop on cell therapies.
    Sec. 708. Reauthorization of best pharmaceuticals for children.
    Sec. 709. Reauthorization for humanitarian device exemption and
    demonstration grants for improving pediatric availability.
    Sec. 710. Reauthorization of provision related to exclusivity of
    certain drugs containing single enantiomers.
    Sec. 711. Reauthorization of the critical path public-private
    partnership program.
    Sec. 712. Reauthorization of orphan drug grants.
    Sec. 713. Research into pediatric uses of drugs; additional authorities
    of Food and Drug Administration regarding molecularly targeted cancer
    drugs.

                            Subtitle B--Inspections

    Sec. 721. Factory inspection.
    Sec. 722. Uses of certain evidence.
    Sec. 723. Improving FDA inspections.
    Sec. 724. GAO report on inspections of foreign establishments
    manufacturing drugs.
    Sec. 725. Unannounced foreign facility inspections pilot program.
    Sec. 726. Reauthorization of inspection program.
    Sec. 727. Enhancing intra-agency coordination and public health
    assessment with regard to compliance activities.
    Sec. 728. Reporting of mutual recognition agreements for inspections
    and review activities.
    Sec. 729. Enhancing transparency of drug facility inspection timelines.

          TITLE VIII--TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY
                                  IMPROVEMENTS

    Sec. 801. Prompt reports of marketing status by holders of approved
    applications for biological products.
    Sec. 802. Encouraging blood donation.
    Sec. 803. Regulation of certain products as drugs.
    Sec. 804. Postapproval studies and program integrity for accelerated
    approval drugs.
    Sec. 805. Facilitating the use of real world evidence.
    Sec. 806. Dual Submission for Certain Devices.
    Sec. 807. Medical Devices Advisory Committee meetings.
    Sec. 808. Ensuring cybersecurity of medical devices.
    Sec. 809. Public docket on proposed changes to third-party vendors.
    Sec. 810. Facilitating exchange of product information prior to
    approval.
    Sec. 811. Bans of devices for one or more intended uses.
    Sec. 812. Clarifying application of exclusive approval, certification,
    or licensure for drugs designated for rare diseases or conditions.
    Sec. 813. GAO report on third-party review.
    Sec. 814. Reporting on pending generic drug applications and priority
    review applications.
    Sec. 815. FDA Workforce Improvements.

                        TITLE I--FEES RELATING TO DRUGS

    SEC. 101. SHORT TITLE; FINDING.

      (a) Short Title.--This title may be cited as the ``Prescription Drug
    User Fee Amendments of 2022''.
      (b) Finding.--The Congress finds that the fees authorized by the
    amendments made by this title will be dedicated toward expediting the
    drug development process and the process for the review of human drug
    applications, including postmarket drug safety activities, as set forth
    in the goals identified for purposes of part 2 of subchapter C of
    chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g
    et seq.), 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. DEFINITIONS.

      (a) Human Drug Application.--Section 735(1) of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended by striking ``an
    allergenic extract product, or'' and inserting ``does not include an
    application with respect to an allergenic extract product licensed
    before October 1, 2022, does not include an application with respect to
    a standardized allergenic extract product submitted pursuant to a
    notification to the applicant from the Secretary regarding the
    existence of a potency test that measures the allergenic activity of an
    allergenic extract product licensed by the applicant before October 1,
    2022, does not include an application with respect to''.
      (b) Prescription Drug Product.--Section 735(3) of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 379g(3)) is amended--
              (1) by redesignating subparagraphs (A), (B), and (C) as
            clauses (i), (ii), and (iii), respectively;
              (2) by striking ``(3) The term'' and inserting ``(3)(A) The
            term'';
              (3) by striking ``Such term does not include whole blood''
            and inserting the following:
              ``(B) Such term does not include whole blood'';
              (4) by striking ``an allergenic extract product,'' and
            inserting ``an allergenic extract product licensed before
            October 1, 2022, a standardized allergenic extract product
            submitted pursuant to a notification to the applicant from the
            Secretary regarding the existence of a potency test that
            measures the allergenic activity of an allergenic extract
            product licensed by the applicant before October 1, 2022,'' ;
            and
              (5) by adding at the end the following:
                      ``(C)(i) If a written request to place a product in
                    the discontinued section of either of the lists
                    referenced in subparagraph (A)(iii) is submitted to the
                    Secretary on behalf of an applicant, and the request
                    identifies the date the product is withdrawn from sale,
                    then for purposes of assessing the prescription drug
                    program fee under section 736(a)(2), the Secretary
                    shall consider such product to have been included in
                    the discontinued section on the later of--
                              ``(I) the date such request was received; or
                              ``(II) if the product will be withdrawn from
                            sale on a future date, such future date when
                            the product is withdrawn from sale.
                      ``(ii) For purposes of this subparagraph, a product
                    shall be considered withdrawn from sale once the
                    applicant has ceased its own distribution of the
                    product, whether or not the applicant has ordered
                    recall of all previously distributed lots of the
                    product, except that a routine, temporary interruption
                    in supply shall not render a product withdrawn from
                    sale.''.
      (c) Skin-Test Diagnostic Product.--Section 735 of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 379g) is amended by adding at the end
    the following:
              ``(12) The term `skin-test diagnostic product'--
                      ``(A) means a product--
                              ``(i) for prick, scratch, intradermal, or
                            subcutaneous administration;
                              ``(ii) expected to produce a limited, local
                            reaction at the site of administration (if
                            positive), rather than a systemic effect;
                              ``(iii) not intended to be a preventive or
                            therapeutic intervention; and
                              ``(iv) intended to detect an immediate- or
                            delayed-type skin hypersensitivity reaction to
                            aid in the diagnosis of--
                                      ``(I) an allergy to an antimicrobial
                                    agent;
                                      ``(II) an allergy that is not to an
                                    antimicrobial agent, if the diagnostic
                                    product was authorized for marketing
                                    prior to October 1, 2022; or
                                      ``(III) infection with fungal or
                                    mycobacterial pathogens; and
                      ``(B) includes positive and negative controls
                    required to interpret the results of a product
                    described in subparagraph (A).''.

    SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

      (a) Types of Fees.--
              (1) Human drug application fee.--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 2018'' and inserting ``fiscal
                    year 2023'';
                      (B) in paragraph (1)(A), by striking ``(c)(5)'' each
                    place it appears and inserting ``(c)(6)'';
                      (C) in paragraph (1)(C), by inserting ``prior to
                    approval'' after ``or was withdrawn''; and
                      (D) in paragraph (1), by adding at the end the
                    following:
                      ``(H) Exception for skin-test diagnostic products.--A
                    human drug application for a skin-test diagnostic
                    product shall not be subject to a fee under
                    subparagraph (A).''.
              (2) Prescription drug program fee.--Section 736(a)(2) of the
            Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(2)) is
            amended--
                      (A) in subparagraph (A)--
                              (i) by striking ``Except as provided in
                            subparagraphs (B) and (C)'' and inserting the
                            following:
                              ``(i) Fee.--Except as provided in
                            subparagraphs (B) and (C)'';
                              (ii) by striking ``subsection (c)(5)'' and
                            inserting ``subsection (c)(6)''; and
                              (iii) by adding at the end the following:
                              ``(ii) Special rule.--If a drug product that
                            is identified in a human drug application
                            approved as of October 1 of a fiscal year is
                            not a prescription drug product as of that date
                            because the drug product is in the discontinued
                            section of a list referenced in section
                            735(3)(A)(iii), and on any subsequent day
                            during such fiscal year the drug product is a
                            prescription drug product, then except as
                            provided in subparagraphs (B) and (C), each
                            person who is named as the applicant in a human
                            drug application with respect to such product,
                            and who, after September 1, 1992, had pending
                            before the Secretary a human drug application
                            or supplement with respect to such product,
                            shall pay the annual prescription drug program
                            fee established for a fiscal year under
                            subsection (c)(6) for such prescription drug
                            product. Such fee shall be due on the last
                            business day of such fiscal year and shall be
                            paid only once for each such product for a
                            fiscal year in which the fee is payable.''; and
                      (B) by amending subparagraph (B) to read as follows:
                      ``(B) Exception for certain prescription drug
                    products.--A prescription drug program fee shall not be
                    assessed for a prescription drug product under
                    subparagraph (A) if such product is--
                              ``(i) a large volume parenteral product (a
                            sterile aqueous drug product packaged in a
                            single-dose container with a volume greater
                            than or equal to 100 mL, not including powders
                            for reconstitution or pharmacy bulk packages)
                            identified on the list compiled under section
                            505(j)(7);
                              ``(ii) pharmaceutically equivalent (as
                            defined in section 314.3 of title 21, Code of
                            Federal Regulations (or any successor
                            regulation)) to another product on the list of
                            products compiled under section 505(j)(7) (not
                            including the discontinued section of such
                            list); or
                              ``(iii) a skin-test diagnostic product.''.
      (b) Fee Revenue Amounts.--
              (1) In general.--Paragraph (1) of section 736(b) of the
            Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is
            amended to read as follows:
              ``(1) In general.--For each of the fiscal years 2023 through
            2027, 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 strategic hiring
                    and retention adjustment for the fiscal year (as
                    determined under subsection (c)(2));
                      ``(D) the dollar amount equal to the capacity
                    planning adjustment for the fiscal year (as determined
                    under subsection (c)(3));
                      ``(E) the dollar amount equal to the operating
                    reserve adjustment for the fiscal year, if applicable
                    (as determined under subsection (c)(4));
                      ``(F) the dollar amount equal to the additional
                    direct cost adjustment for the fiscal year (as
                    determined under subsection (c)(5)); and
                      ``(G) additional dollar amounts for each fiscal year
                    as follows:
                              ``(i) $65,773,693 for fiscal year 2023.
                              ``(ii) $25,097,671 for fiscal year 2024.
                              ``(iii) $14,154,169 for fiscal year 2025.
                              ``(iv) $4,864,860 for fiscal year 2026.
                              ``(v) $1,314,620 for fiscal year 2027.''.
              (2) Annual base revenue.--Paragraph (3) of section 736(b) of
            the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is
            amended to read as follows:
              ``(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 2023, $1,151,522,958; and
                      ``(B) for fiscal years 2024 through 2027, 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)(4)
                    or (c)(5).''.
      (c) Adjustments; Annual Fee Setting.--
              (1) Inflation adjustment.--Section 736(c)(1)(B)(ii) of the
            Federal Food, Drug, and Cosmetic Act (21 U.S.C.
            379h(c)(1)(B)(ii)) is amended by striking ``Washington-
            Baltimore, DC-MD-VA-WV'' and inserting ``Washington-Arlington-
            Alexandria, DC-VA-MD-WV''.
              (2) Strategic hiring and retention adjustment.--Section
            736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
            379h(c)) is amended--
                      (A) by redesignating paragraphs (2) through (6) as
                    paragraphs (3) through (7), respectively; and
                      (B) by inserting after paragraph (1) the following:
              ``(2) Strategic hiring and retention adjustment.--For each
            fiscal year, after the annual base revenue established in
            subsection (b)(1)(A) is adjusted for inflation in accordance
            with paragraph (1), the Secretary shall further increase the
            fee revenue and fees by the following amounts:
                      ``(A) For fiscal year 2023, $9,000,000.
                      ``(B) For each of fiscal years 2024 through 2027,
                    $4,000,000.''.
              (3) Capacity planning adjustment.--Paragraph (3), as
            redesignated, of section 736(c) of the Federal Food, Drug, and
            Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
              ``(3) Capacity planning adjustment.--
                      ``(A) In general.--For each fiscal year, after the
                    annual base revenue established in subsection (b)(1)(A)
                    is adjusted in accordance with paragraphs (1) and (2),
                    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) Methodology.--For purposes of this paragraph,
                    the Secretary shall employ the capacity planning
                    methodology utilized by the Secretary in setting fees
                    for fiscal year 2021, as described in the notice titled
                    `Prescription Drug User Fee Rates for Fiscal Year 2021'
                    published in the Federal Register on August 3, 2020 (85
                    Fed. Reg. 46651). The workload categories used in
                    applying such methodology in forecasting shall include
                    only the activities described in that notice and, as
                    feasible, additional activities that are also directly
                    related to the direct review of applications and
                    supplements, including additional formal meeting types,
                    the direct review of postmarketing commitments and
                    requirements, the direct review of risk evaluation and
                    mitigation strategies, and the direct review of annual
                    reports for approved prescription drug products.
                    Subject to the exceptions in the preceding sentence,
                    the Secretary shall not include as workload categories
                    in applying such methodology in forecasting any non-
                    core review activities, including those activities that
                    the Secretary referenced for potential future use in
                    such notice but did not utilize in setting fees for
                    fiscal year 2021.
                      ``(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)(1)(A) (the annual base
                    revenue for the fiscal year), (b)(1)(B) (the dollar
                    amount of the inflation adjustment for the fiscal
                    year), and (b)(1)(C) (the dollar amount of the
                    strategic hiring and retention adjustment for the
                    fiscal year).
                      ``(D) Publication in federal register.--The Secretary
                    shall publish in the Federal Register notice under
                    paragraph (6) of the fee revenue and fees resulting
                    from the adjustment and the methodologies under this
                    paragraph.''.
              (4) Operating reserve adjustment.--Paragraph (4), as
            redesignated, of section 736(c) of the Federal Food, Drug, and
            Cosmetic Act (21 U.S.C. 379h(c)) is amended--
                      (A) by amending subparagraph (A) to read as follows:
                      ``(A) Increase.--For fiscal year 2023 and subsequent
                    fiscal years, the Secretary shall, in addition to
                    adjustments under paragraphs (1), (2), and (3), further
                    increase the fee revenue and fees if such an adjustment
                    is necessary to provide for operating reserves of
                    carryover user fees for the process for the review of
                    human drug applications for each fiscal year in at
                    least the following amounts:
                              ``(i) For fiscal year 2023, at least 8 weeks
                            of operating reserves.
                              ``(ii) For fiscal year 2024, at least 9 weeks
                            of operating reserves.
                              ``(iii) For fiscal year 2025 and subsequent
                            fiscal years, at least 10 weeks of operating
                            reserves.''; and
                      (B) in subparagraph (C), by striking ``paragraph
                    (5)'' and inserting ``paragraph (6)''.
              (5) Additional direct cost adjustment.--Paragraph (5), as
            redesignated, of section 736(c) of the Federal Food, Drug, and
            Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
              ``(5) Additional direct cost adjustment.--
                      ``(A) Increase.--The Secretary shall, in addition to
                    adjustments under paragraphs (1), (2), (3), and (4),
                    further increase the fee revenue and fees--
                              ``(i) for fiscal year 2023, by $44,386,150;
                            and
                              ``(ii) for each of fiscal years 2024 through
                            2027, by the amount set forth in clauses (i)
                            through (iv) of subparagraph (B), as
                            applicable, multiplied by the Consumer Price
                            Index for urban consumers (Washington-
                            Arlington-Alexandria, DC-VA-MD-WV; Not
                            Seasonally Adjusted; All Items; Annual Index)
                            for the most recent year of available data,
                            divided by such Index for 2021.
                      ``(B) Applicable amounts.--The amounts referred to in
                    subparagraph (A)(ii) are the following:
                              ``(i) For fiscal year 2024, $60,967,993.
                              ``(ii) For fiscal year 2025, $35,799,314.
                              ``(iii) For fiscal year 2026, $35,799, 314.
                              ``(iv) For fiscal year 2027, $35,799,314.''.
              (6) Annual fee setting.--Paragraph (6), as redesignated, of
            section 736(c) of the Federal Food, Drug, and Cosmetic Act (21
            U.S.C. 379h(c)) is amended by striking ``September 30, 2017''
            and inserting ``September 30, 2022''.
      (d) Crediting and Availability of Fees.--Section 736(g)(3) of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended
    by striking ``fiscal years 2018 through 2022'' and inserting ``fiscal
    years 2023 through 2027''.
      (e) Written Requests for Waivers, Reductions, Exemptions, and
    Returns; Disputes Concerning Fees.--Section 736(i) of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is amended to read as
    follows:
      ``(i) Written Requests for Waivers, Reductions, Exemptions, and
    Returns; Disputes Concerning Fees.--To qualify for consideration for a
    waiver or reduction under subsection (d), an exemption under subsection
    (k), or the return of any fee paid under this section, including if the
    fee is claimed to have been paid in error, a person shall--
              ``(1) not later than 180 days after such fee is due, submit
            to the Secretary a written request justifying such waiver,
            reduction, exemption, or return; and
              ``(2) include in the request any legal authorities under
            which the request is made.''.
      (f) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 379h(k)) is amended--
              (1) in paragraph (1)(B), by striking ``during the previous
            year'' and inserting ``as determined under paragraph (2)''; and
              (2) by amending paragraph (2) to read as follows:
              ``(2) Evidence of qualification.--An exemption under
            paragraph (1) applies with respect to a drug only if the
            applicant involved submits a certification that the applicant's
            gross annual revenues did not exceed $50,000,000 for the last
            calendar year ending prior to the fiscal year for which the
            exemption is requested. Such certification shall be supported
            by--
                      ``(A) tax returns submitted to the United States
                    Internal Revenue Service; or
                      ``(B) as necessary, other appropriate financial
                    information.''.

    SEC. 104. 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), by striking ``Beginning with fiscal
            year 2018, not'' and inserting ``Not'';
              (2) by striking ``Prescription Drug User Fee Amendments of
            2017'' each place it appears and inserting ``Prescription Drug
            User Fee Amendments of 2022'';
              (3) in subsection (a)(3)(A), by striking ``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'' and inserting
            ``Not later than 30 calendar days after the end of each quarter
            of each fiscal year for which fees are collected under this
            part'';
              (4) in subsection (a)(3)(B), by adding at the end the
            following:
                              ``(v) For fiscal years 2023 and 2024, of the
                            meeting requests from sponsors for which the
                            Secretary has determined that a face-to-face
                            meeting is appropriate, the number of face-to-
                            face meetings requested by sponsors to be
                            conducted in person (in such manner as the
                            Secretary shall prescribe on the internet
                            website of the Food and Drug Administration),
                            and the number of such in-person meetings
                            granted by the Secretary.'';
              (5) in subsection (a)(4), by striking ``Beginning with fiscal
            year 2020, the'' and inserting ``The'';
              (6) in subsection (b), by striking ``Beginning with fiscal
            year 2018, not'' and inserting ``Not'';
              (7) in subsection (c), by striking ``Beginning with fiscal
            year 2018, for'' and inserting ``For''; and
              (8) in subsection (f)--
                      (A) in paragraph (1), in the matter preceding
                    subparagraph (A), by striking ``fiscal year 2022'' and
                    inserting ``fiscal year 2027''; and
                      (B) in paragraph (5), by striking ``January 15,
                    2022'' and inserting ``January 15, 2027''.

    SEC. 105. SUNSET DATES.

      (a) Authorization.--Sections 735 and 736 of the Federal Food, Drug,
    and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective
    October 1, 2027.
      (b) Reporting Requirements.--Section 736B of the Federal Food, Drug,
    and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be effective January
    31, 2028.
      (c) Previous Sunset Provision.--Effective October 1, 2022,
    subsections (a) and (b) of section 104 of the FDA Reauthorization Act
    of 2017 (Public Law 115-52) are repealed.

    SEC. 106. EFFECTIVE DATE.

      The amendments made by this title shall take effect on October 1,
    2022, 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 (21 U.S.C. 379g et seq.) shall be
    assessed for all human drug applications received on or after October
    1, 2022, regardless of the date of the enactment of this Act.

    SEC. 107. SAVINGS CLAUSE.

      Notwithstanding the amendments made by this title, part 2 of
    subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
    (21 U.S.C. 379g 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 human drug applications and supplements (as defined in such
    part as of such day) that on or after October 1, 2017, but before
    October 1, 2022, 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 2023.

                       TITLE II--FEES RELATING TO DEVICES

    SEC. 201. SHORT TITLE; FINDING.

      (a) Short Title.--This title may be cited as the ``Medical Device
    User Fee Amendments of 2022''.
      (b) Finding.--The Congress finds that the fees authorized under the
    amendments made by this title will be dedicated toward expediting the
    process for the review of device applications and for assuring the
    safety and effectiveness of devices, as set forth in the goals
    identified for purposes of part 3 of subchapter C of chapter VII of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), in the
    letters from the Secretary of Health and Human Services to the Chairman
    of the Committee on Health, Education, Labor, and Pensions of the
    Senate and the Chairman of the Committee on Energy and Commerce of the
    House of Representatives, as set forth in the Congressional Record.

    SEC. 202. DEFINITIONS.

      Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    379i) is amended--
              (1) in paragraph (9)--
                      (A) in the matter preceding subparagraph (A), by
                    striking ``and premarket notification submissions'' and
                    inserting ``premarket notification submissions, and de
                    novo classification requests'';
                      (B) in subparagraph (D), by striking ``and
                    submissions'' and inserting ``submissions, and
                    requests'';
                      (C) in subparagraph (F), by striking ``and premarket
                    notification submissions'' and inserting ``premarket
                    notification submissions, and de novo classification
                    requests'';
                      (D) in each of subparagraphs (G) and (H), by striking
                    ``or submissions'' and inserting ``submissions, or
                    requests''; and
                      (E) in subparagraph (K), by striking ``or premarket
                    notification submissions'' and inserting ``premarket
                    notification submissions, or de novo classification
                    requests''; and
              (2) in paragraph (11), by striking ``2016'' and inserting
            ``2021''.

    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 2018'' and
            inserting ``fiscal year 2023''; and
              (2) in paragraph (2)--
                      (A) in subparagraph (A)--
                              (i) in the matter preceding clause (i), by
                            striking ``October 1, 2017'' and inserting
                            ``October 1, 2022'';
                              (ii) in clause (iii), by striking ``75
                            percent'' and inserting ``80 percent''; and
                              (iii) in clause (viii), by striking ``3.4
                            percent'' and inserting ``4.5 percent'';
                      (B) in subparagraph (B)(iii), by striking ``or
                    premarket notification submission'' and inserting
                    ``premarket notification submission, or de novo
                    classification request''; and
                      (C) in subparagraph (C), by striking ``or periodic
                    reporting concerning a class III device'' and inserting
                    ``periodic reporting concerning a class III device, 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--
              (1) in paragraph (1), by striking ``2018 through 2022'' and
            inserting ``2023 through 2027'';
              (2) by amending paragraph (2) to read as follows:
              ``(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 2023  Year 2024  Year 2025  Year 2026  Year 2027
    ----------------------------------------------------------------------------------------------------------------
    Premarket Application....................................   $425,000   $435,000   $445,000   $455,000   $470,000
    Establishment Registration...............................     $6,250     $6,875     $7,100     $7,575  $8,465'';
                                                                                                                 and
    ----------------------------------------------------------------------------------------------------------------

            ''; and  (3) by amending paragraph (3) to read as follows:
              ``(3) Total revenue amounts specified.--For purposes of
            paragraph (1), the total revenue amounts specified in this
            paragraph are as follows:
                      ``(A) $312,606,000 for fiscal year 2023.
                      ``(B) $335,750,000 for fiscal year 2024.
                      ``(C) $350,746,400 for fiscal year 2025.
                      ``(D) $366,486,300 for fiscal year 2026.
                      ``(E) $418,343,000 for fiscal year 2027.''.
      (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 ``2017'' and inserting
            ``2022'';
              (2) in paragraph (2)--
                      (A) in subparagraph (A), by striking ``2018'' and
                    inserting ``2023'';
                      (B) in subparagraph (B)--
                              (i) in the matter preceding clause (i), by
                            striking ``fiscal year 2018'' and inserting
                            ``fiscal year 2023''; and
                              (ii) in clause (ii), by striking ``fiscal
                            year 2016'' and inserting ``fiscal year 2022'';
                      (C) in subparagraph (C), by striking ``Washington-
                    Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
                    Arlington-Alexandria, DC-VA-MD-WV''; and
                      (D) in subparagraph (D), in the matter preceding
                    clause (i), by striking ``fiscal years 2018 through
                    2022'' and inserting ``fiscal years 2023 through
                    2027'';
              (3) in paragraph (3), by striking ``2018 through 2022'' and
            inserting ``2023 through 2027'';
              (4) by redesignating paragraphs (4) and (5) as paragraphs (7)
            and (8), respectively; and
              (5) by inserting after paragraph (3) the following:
              ``(4) Performance improvement adjustment.--
                      ``(A) In general.--For each of fiscal years 2025
                    through 2027, after the adjustments under paragraphs
                    (2) and (3), the base establishment registration fee
                    amounts for such fiscal year shall be increased to
                    reflect changes in the resource needs of the Secretary
                    due to improved review performance goals for the
                    process for the review of device applications
                    identified in the letters described in section 201(b)
                    of the Medical Device User Fee Amendments of 2022, as
                    the Secretary determines necessary to achieve an
                    increase in total fee collections for such fiscal year
                    equal to the following amounts:
                              ``(i) For fiscal year 2025, the product of--
                                      ``(I) the amount determined under
                                    subparagraph (B)(i)(I); and
                                      ``(II) the applicable inflation
                                    adjustment under paragraph (2)(B) for
                                    such fiscal year.
                              ``(ii) For fiscal year 2026, the product of--
                                      ``(I) the sum of the amounts
                                    determined under subparagraphs
                                    (B)(i)(II), (B)(ii)(I), and
                                    (B)(iii)(I); and
                                      ``(II) the applicable inflation
                                    adjustment under paragraph (2)(B) for
                                    such fiscal year.
                              ``(iii) For fiscal year 2027, the product
                            of--
                                      ``(I) the sum of the amounts
                                    determined under subparagraphs
                                    (B)(i)(III), (B)(ii)(II), and
                                    (B)(iii)(II); and
                                      ``(II) the applicable inflation
                                    adjustment under paragraph (2)(B) for
                                    such fiscal year.
                      ``(B) Amounts.--
                              ``(i) Pre-submission amount.--For purposes of
                            subparagraph (A), with respect to the pre-
                            submission written feedback goal, the amounts
                            determined under this subparagraph are as
                            follows:
                                      ``(I) For fiscal year 2025,
                                    $15,396,600 if such goal for fiscal
                                    year 2023 is met.
                                      ``(II) For fiscal year 2026:
                                              ``(aa) $15,396,600 if such
                                            goal for fiscal year 2023 is
                                            met and such goal for fiscal
                                            year 2024 is not met.
                                              ``(bb) $36,792,200 if such
                                            goal for fiscal year 2024 is
                                            met.
                                      ``(III) For fiscal year 2027:
                                              ``(aa) $15,396,600 if such
                                            goal for fiscal year 2023 is
                                            met and such goal for each of
                                            fiscal years 2024 and 2025 is
                                            not met.
                                              ``(bb) $36,792,200 if such
                                            goal for fiscal year 2024 is
                                            met and such goal for fiscal
                                            year 2025 is not met.
                                              ``(cc) $40,572,600 if such
                                            goal for fiscal year 2025 is
                                            met.
                              ``(ii) De novo classification amount.--For
                            purposes of subparagraph (A), with respect to
                            the de novo decision goal, the amounts
                            determined under this subparagraph are as
                            follows:
                                      ``(I) For fiscal year 2026,
                                    $6,323,500 if such goal for fiscal year
                                    2023 is met.
                                      ``(II) For fiscal year 2027:
                                              ``(aa) $6,323,500 if such
                                            goal for fiscal year 2023 is
                                            met and such goal for fiscal
                                            year 2024 is not met.
                                              ``(bb) $11,765,400 if such
                                            goal for fiscal year 2024 is
                                            met.
                              ``(iii) Premarket notification and premarket
                            approval amount.--For purposes of subparagraph
                            (A), with respect to the 510(k) decision goal,
                            510(k) shared outcome total time to decision
                            goal, PMA decision goal, and PMA shared outcome
                            total time to decision goal, the amounts
                            determined under this subparagraph are as
                            follows:
                                      ``(I) For fiscal year 2026,
                                    $1,020,000 if the four goals for fiscal
                                    year 2023 are met.
                                      ``(II) For fiscal year 2027:
                                              ``(aa) $1,020,000 if the four
                                            goals for fiscal year 2023 are
                                            met and one or more of the four
                                            goals for fiscal year 2024 are
                                            not met.
                                              ``(bb) $3,906,000 if the four
                                            goals for fiscal year 2024 are
                                            met.
                      ``(C) Performance calculation.--For purposes of this
                    paragraph, performance of the goals listed in
                    subparagraph (D) shall be determined as specified in
                    the letters described in section 201(b) of the Medical
                    Device User Fee Amendments of 2022 and based on data
                    available as of the following dates:
                              ``(i) The performance of the pre-submission
                            written feedback goal shall be based on data
                            available as of--
                                      ``(I) for fiscal year 2023, March 31,
                                    2024;
                                      ``(II) for fiscal year 2024, March
                                    31, 2025; and
                                      ``(III) for fiscal year 2025, March
                                    31, 2026.
                              ``(ii) The performance of the de novo
                            decision goal, 510(k) decision goal, 510(k)
                            shared outcome total time to decision goal, PMA
                            decision goal, and PMA shared outcome total
                            time to decision goal shall be based on data
                            available as of--
                                      ``(I) for fiscal year 2023, March 31,
                                    2025; and
                                      ``(II) for fiscal year 2024, March
                                    31, 2026.
                      ``(D) Goals defined.--For purposes of this paragraph,
                    the terms `pre-submission written feedback goal', `de
                    novo decision goal', `510(k) decision goal', `510(k)
                    shared outcome total time to decision goal', `PMA
                    decision goal', and `PMA shared outcome total time to
                    decision goal' refer to the goals identified by the
                    same names in the letters described in section 201(b)
                    of the Medical Device User Fee Amendments of 2022.
              ``(5) Hiring adjustment.--
                      ``(A) In general.--For each of fiscal years 2025
                    through 2027, after the adjustments under paragraphs
                    (2), (3), and (4), if applicable, if the number of
                    hires to support the process for the review of device
                    applications falls below the thresholds specified in
                    subparagraph (B) for the applicable fiscal years, the
                    base establishment registration fee amounts shall be
                    decreased as the Secretary determines necessary to
                    achieve a reduction in total fee collections equal to
                    the hiring adjustment amount under subparagraph (C).
                      ``(B) Thresholds.--The thresholds specified in this
                    subparagraph are as follows:
                              ``(i) For fiscal year 2025, the threshold is
                            123 hires for fiscal year 2023.
                              ``(ii) For fiscal year 2026, the threshold is
                            38 hires for fiscal year 2024.
                              ``(iii) For fiscal year 2027, the threshold
                            is--
                                      ``(I) 22 hires for fiscal year 2025
                                    if the base establishment registration
                                    fees are not increased by the amount
                                    determined under paragraph (4)(A)(i);
                                    or
                                      ``(II) 75 hires for fiscal year 2025
                                    if such fees are so increased.
                      ``(C) Hiring adjustment amount.--The hiring
                    adjustment amount for fiscal year 2025 and each
                    subsequent fiscal year is the product of--
                              ``(i) the number of hires by which the hiring
                            goal specified in subparagraph (D) for the
                            fiscal year before the prior fiscal year was
                            not met;
                              ``(ii) $72,877; and
                              ``(iii) the applicable inflation adjustment
                            under paragraph (2)(B) for the fiscal year for
                            which the hiring goal was not met.
                      ``(D) Hiring goals.--The hiring goals for each of
                    fiscal years 2023 through 2025 are as follows:
                              ``(i) For fiscal year 2023, 144 hires.
                              ``(ii) For fiscal year 2024, 42 hires.
                              ``(iii) For fiscal year 2025:
                                      ``(I) 24 hires if the base
                                    establishment registration fees are not
                                    increased by the amount determined
                                    under paragraph (4)(A)(i).
                                      ``(II) 83 hires if the base
                                    establishment registration fees are
                                    increased by the amount determined
                                    under paragraph (4)(A)(i).
                      ``(E) Number of hires.--For purposes of this
                    paragraph, the number of hires shall be determined by
                    the Secretary as set forth in the letters described in
                    section 201(b) of the Medical Device User Fee
                    Amendments of 2022.
              ``(6) Operating reserve adjustment.--
                      ``(A) In general.--For each of fiscal years 2023
                    through 2027, after the adjustments under paragraphs
                    (2), (3), (4), and (5), if applicable, if the Secretary
                    has operating reserves of carryover user fees for the
                    process for the review of device applications in excess
                    of the designated amount in subparagraph (B), the
                    Secretary shall decrease the base establishment
                    registration fee amounts to provide for not more than
                    such designated amount of operating reserves.
                      ``(B) Designated amount.--Subject to subparagraph
                    (C), for each fiscal year, the designated amount in
                    this subparagraph is equal to the sum of--
                              ``(i) 13 weeks of operating reserves of
                            carryover user fees; and
                              ``(ii) 1 month of operating reserves
                            maintained pursuant to paragraph (8).
                      ``(C) Excluded amount.--For the period of fiscal
                    years 2023 through 2026, a total amount equal to
                    $118,000,000 shall not be considered part of the
                    designated amount under subparagraph (B) and shall not
                    be subject to the decrease under subparagraph (A).''.
      (d) Small Businesses.--Section 738 of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 379j) is amended in each of subsections
    (d)(2)(B)(iii) and (e)(2)(B)(iii) by inserting ``, if extant,'' after
    ``national taxing authority''.
      (e) Conditions.--Section 738(g) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 379j(g)) is amended--
              (1) in paragraph (1)(A), by striking ``$320,825,000'' and
            inserting ``$398,566,000''; and
              (2) in paragraph (2), by inserting ``de novo classification
            requests,'' after ``class III device,''.
      (f) Crediting and Availability of Fees.--Section 738(h)(3) of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)(3)) is amended
    to read as follows:
              ``(3) Authorization of appropriations.--
                      ``(A) In general.--For each of fiscal years 2023
                    through 2027, there is authorized to be appropriated
                    for fees under this section an amount equal to the
                    revenue amount determined under subparagraph (B), less
                    the amount of reductions determined under subparagraph
                    (C).
                      ``(B) Revenue amount.--For purposes of this
                    paragraph, the revenue amount for each fiscal year is
                    the sum of--
                              ``(i) the total revenue amount under
                            subsection (b)(3) for the fiscal year, as
                            adjusted under paragraphs (2) and (3) of
                            subsection (c); and
                              ``(ii) the performance improvement adjustment
                            amount for the fiscal year under subsection
                            (c)(4), if applicable.
                      ``(C) Reductions.--For purposes of this paragraph,
                    the amount of reductions for each fiscal year is the
                    sum of--
                              ``(i) the hiring adjustment amount for the
                            fiscal year under subsection (c)(5), if
                            applicable; and
                              ``(ii) the operating reserve adjustment
                            amount for the fiscal year under subsection
                            (c)(6), if applicable.''.

    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) by striking ``fiscal year 2018'' each place it appears
            and inserting ``fiscal year 2023'';
              (2) by striking ``Medical Device User Fee Amendments of
            2017'' each place it appears and inserting ``Medical Device
            User Fee Amendments of 2022'';
              (3) in paragraph (1)--
                      (A) in subparagraph (A), by redesignating the second
                    clause (iv) (relating to analysis) as clause (v); and
                      (B) in subparagraph (A)(iv), by striking ``fiscal
                    year 2020'' and inserting ``fiscal year 2023''; and
              (4) in paragraph (4), by striking ``2018 through 2022'' and
            inserting ``2023 through 2027''.
      (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 ``2022'' and inserting
            ``2027''; and
              (2) in paragraph (5), by striking ``2022'' and inserting
            ``2027''.

    SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.

      Section 514(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    360d(d)) is amended to read as follows:
      ``(d) Accreditation Scheme for Conformity Assessment.--
              ``(1) In general.--The Secretary shall establish a program
            under which--
                      ``(A) testing laboratories meeting criteria specified
                    in guidance by the Secretary may be accredited by
                    accreditation bodies meeting criteria specified in
                    guidance by the Secretary, to conduct testing to
                    support the assessment of the conformity of a device to
                    certain standards recognized under this section; and
                      ``(B) subject to paragraph (2), results from tests
                    conducted to support the assessment of conformity of
                    devices as described in subparagraph (A) conducted by
                    testing laboratories accredited pursuant to this
                    subsection shall be accepted by the Secretary for
                    purposes of demonstrating such conformity unless the
                    Secretary finds that certain results of such tests
                    should not be so accepted.
              ``(2) Secretarial review of accredited laboratory results.--
            The Secretary may--
                      ``(A) review the results of tests conducted by
                    testing laboratories accredited pursuant to this
                    subsection, including by conducting periodic audits of
                    such results or of the processes of accredited bodies
                    or testing laboratories;
                      ``(B) following such review, take additional measures
                    under this Act, as the Secretary determines
                    appropriate, such as--
                              ``(i) suspension or withdrawal of
                            accreditation of a testing laboratory or
                            recognition of an accreditation body under
                            paragraph (1)(A); or
                              ``(ii) requesting additional information with
                            respect to a device; and
                      ``(C) if the Secretary becomes aware of information
                    materially bearing on the safety or effectiveness of a
                    device for which an assessment of conformity was
                    supported by testing conducted by a testing laboratory
                    accredited under this subsection, take such additional
                    measures under this Act, as the Secretary determines
                    appropriate, such as--
                              ``(i) suspension or withdrawal of
                            accreditation of a testing laboratory or
                            recognition of an accreditation body under
                            paragraph (1)(A); or
                              ``(ii) requesting additional information with
                            regard to such device.
              ``(3) Implementation and reporting.--
                      ``(A) Pilot program transition.--After September 30,
                    2023, the pilot program previously initiated under this
                    subsection, as in effect prior to the date of enactment
                    of the Medical Device User Fee Amendments of 2022,
                    shall be considered to be completed, and the Secretary
                    may continue operating a program consistent with this
                    subsection.
                      ``(B) 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.''.

    SEC. 206. REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM.

      Section 523(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    360m(c)) is amended by striking ``2022'' and inserting ``2027''.

    SEC. 207. SUNSET DATES.

      (a) Authorization.--Sections 737 and 738 of the Federal Food, Drug,
    and Cosmetic Act (21 U.S.C. 379i; 379j) shall cease to be effective
    October 1, 2027.
      (b) Reporting Requirements.--Section 738A (21 U.S.C. 379j- 1) of the
    Federal Food, Drug, and Cosmetic Act (regarding reauthorization and
    reporting requirements) shall cease to be effective January 31, 2028.
      (c) Previous Sunset Provisions.--Effective October 1, 2022,
    subsections (a) and (b) of section 210 of the FDA Reauthorization Act
    of 2017 (Public Law 115-52) are repealed.

    SEC. 208. EFFECTIVE DATE.

      The amendments made by this title shall take effect on October 1,
    2022, 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 (21 U.S.C. 379i et seq.) shall be
    assessed for all submissions listed in section 738(a)(2)(A) of such Act
    received on or after October 1, 2022, regardless of the date of the
    enactment of this Act.

    SEC. 209. SAVINGS CLAUSE.

      Notwithstanding the amendments made by this title, part 3 of
    subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
    (21 U.S.C. 379i et seq.), as in effect on the day before the date of
    the enactment of this title, shall continue to be in effect with
    respect to the submissions listed in section 738(a)(2)(A) of such Act
    (as defined in such part as of such day) that on or after October 1,
    2017, but before October 1, 2022, were received by the Food and Drug
    Administration with respect to assessing and collecting any fee
    required by such part for a fiscal year prior to fiscal year 2023.

                   TITLE III--FEES RELATING TO GENERIC DRUGS

    SEC. 301. SHORT TITLE; FINDING.

      (a) Short Title.--This title may be cited as the ``Generic Drug User
    Fee Amendments of 2022''.
      (b) Finding.--The Congress finds that the fees authorized by the
    amendments made by 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 (21 U.S.C. 379j-41 et seq.), 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. 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 2018'' and inserting ``fiscal year 2023'';
              (2) in paragraph (2)(C), by striking ``2018 through 2022''
            and inserting ``2023 through 2027'';
              (3) in paragraph (3)(B), by striking ``2018 through 2022''
            and inserting ``2023 through 2027'';
              (4) in paragraph (4)(D), by striking ``2018 through 2022''
            and inserting ``2023 through 2027''; and
              (5) in paragraph (5)(D), by striking ``2018 through 2022''
            and inserting ``2023 through 2027''.
      (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 ``2018'' and
                            inserting ``2023'';
                              (ii) by striking ``2018'' and inserting
                            ``2023''; and
                              (iii) by striking ``$493,600,000'' and
                            inserting ``$582,500,000''; and
                      (B) by amending subparagraph (B) to read as follows:
                      ``(B) Fiscal years 2024 through 2027.--
                              ``(i) In general.--For each of the fiscal
                            years 2024 through 2027, fees under paragraphs
                            (2) through (5) of subsection (a) shall be
                            established to generate a total estimated
                            revenue amount under such subsection that is
                            equal to the base revenue amount for the fiscal
                            year under clause (ii), as adjusted pursuant to
                            subsection (c).
                              ``(ii) Base revenue amount.--The base revenue
                            amount for a fiscal year referred to in clause
                            (i) is equal to the total revenue amount
                            established under this paragraph for the
                            previous fiscal year, not including any
                            adjustments made for such previous fiscal year
                            under subsection (c)(3).''; and
              (2) in paragraph (2)--
                      (A) in subparagraph (C), by striking ``one-third the
                    amount'' and inserting ``twenty-four percent'';
                      (B) in subparagraph (D), by striking ``Seven
                    percent'' and inserting ``Six percent''; and
                      (C) in subparagraph (E)(i), by striking ``Thirty-five
                    percent'' and inserting ``Thirty-six percent''.
      (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) in the matter preceding subparagraph (A)--
                              (i) by striking ``2019'' and inserting
                            ``2024''; and
                              (ii) by striking ``to equal the product of
                            the total revenues established in such notice
                            for the prior fiscal year multiplied'' and
                            inserting ``to equal the base revenue amount
                            for the fiscal year (as specified in subsection
                            (b)(1)(B)) multiplied''; and
                      (B) in subparagraph (C), by striking ``Washington-
                    Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
                    Arlington-Alexandria, DC-VA-MD-WV''; and
              (2) by striking paragraph (2) and inserting the following:
              ``(2) Capacity planning adjustment.--
                      ``(A) In general.--Beginning with fiscal year 2024,
                    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, in
                    accordance with this paragraph, to reflect changes in
                    the resource capacity needs of the Secretary for human
                    generic drug activities.
                      ``(B) Capacity planning methodology.--The Secretary
                    shall establish a capacity planning methodology for
                    purposes of this paragraph, which shall--
                              ``(i) be derived from the methodology and
                            recommendations made in the report titled
                            `Independent Evaluation of the GDUFA Resource
                            Capacity Planning Adjustment Methodology:
                            Evaluation and Recommendations' announced in
                            the Federal Register on August 3, 2020;
                              ``(ii) incorporate approaches and attributes
                            determined appropriate by the Secretary,
                            including approaches and attributes made in
                            such report, except that in incorporating such
                            approaches and attributes the workload
                            categories used in forecasting resources shall
                            only be the workload categories specified in
                            section VIII.B.2.e. of the letters described in
                            section 301(b) of the Generic Drug User Fee
                            Amendments of 2022; and
                              ``(iii) be effective beginning with fiscal
                            year 2024.
                      ``(C) Limitations.--
                              ``(i) In general.--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 subsection
                            (b)(1)(B)(ii) (the base revenue amount for the
                            fiscal year) and paragraph (1) (the dollar
                            amount of the inflation adjustment for the
                            fiscal year).
                              ``(ii) Percentage limitation.--An adjustment
                            under this paragraph shall not exceed three
                            percent of the sum described in clause (i) for
                            the fiscal year, except that such limitation
                            shall be four percent if--
                                      ``(I) for purposes of a fiscal year
                                    2024 adjustment, the Secretary
                                    determines that during the period from
                                    April 1, 2021, through March 31, 2023--
                                              ``(aa) the total number of
                                            abbreviated new drug
                                            applications submitted was
                                            greater than or equal to 2,000;
                                            or
                                              ``(bb) thirty-five percent or
                                            more of abbreviated new drug
                                            applications submitted related
                                            to complex products (as that
                                            term is defined in section XI
                                            of the letters described in
                                            section 301(b) of the Generic
                                            Drug User Fee Amendments of
                                            2022);
                                      ``(II) for purposes of a fiscal year
                                    2025 adjustment, the Secretary
                                    determines that during the period from
                                    April 1, 2022, through March 31, 2024--
                                              ``(aa) the total number of
                                            abbreviated new drug
                                            applications submitted was
                                            greater than or equal to 2,300;
                                            or
                                              ``(bb) thirty-five percent or
                                            more of abbreviated new drug
                                            applications submitted related
                                            to complex products (as so
                                            defined);
                                      ``(III) for purposes of a fiscal year
                                    2026 adjustment, the Secretary
                                    determines that during the period from
                                    April 1, 2023, through March 31, 2025--
                                              ``(aa) the total number of
                                            abbreviated new drug
                                            applications submitted was
                                            greater than or equal to 2,300;
                                            or
                                              ``(bb) thirty-five percent or
                                            more of abbreviated new drug
                                            applications submitted related
                                            to complex products (as so
                                            defined); and
                                      ``(IV) for purposes of a fiscal year
                                    2027 adjustment, the Secretary
                                    determines that during the period from
                                    April 1, 2024, through March 31, 2026--
                                              ``(aa) the total number of
                                            abbreviated new drug
                                            applications submitted was
                                            greater than or equal to 2,300;
                                            or
                                              ``(bb) thirty-five percent or
                                            more of abbreviated new drug
                                            applications submitted related
                                            to complex products (as so
                                            defined).
                      ``(D) Publication in federal register.--The Secretary
                    shall publish in the Federal Register notice referred
                    to in subsection (a) the fee revenue and fees resulting
                    from the adjustment and the methodology under this
                    paragraph.
              ``(3) Operating reserve adjustment.--
                      ``(A) In general.--For fiscal year 2024 and each
                    subsequent fiscal year, the Secretary may, in addition
                    to adjustments under paragraphs (1) and (2), further
                    increase the fee revenue and fees under this section
                    for such fiscal year if such an adjustment is necessary
                    to provide operating reserves of carryover user fees
                    for human generic drug activities for not more than the
                    number of weeks specified in subparagraph (B) with
                    respect to that fiscal year.
                      ``(B) Number of weeks.--The number of weeks specified
                    in this subparagraph is--
                              ``(i) 8 weeks for fiscal year 2024;
                              ``(ii) 9 weeks for fiscal year 2025; and
                              ``(iii) 10 weeks for each of fiscal year 2026
                            and 2027.
                      ``(C) Decrease.--If the Secretary has carryover
                    balances for human generic drug activities in excess of
                    12 weeks of the operating reserves referred to in
                    subparagraph (A), the Secretary shall decrease the fee
                    revenue and fees referred to in such subparagraph to
                    provide for not more than 12 weeks of such operating
                    reserves.
                      ``(D) Rationale for adjustment.--If an adjustment
                    under this paragraph 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 subsection (a) publishing
                    the fee revenue and fees for the fiscal year
                    involved.''.
      (d) Annual Fee Setting.--Section 744B(d)(1) of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 379j-42(d)(1)) is amended--
              (1) in the paragraph heading, by striking ``2018 through
            2022'' and inserting ``2023 through 2027''; and
              (2) by striking ``more than 60 days before the first day of
            each of fiscal years 2018 through 2022'' and inserting ``later
            than 60 days before the first day of each of fiscal years 2023
            through 2027''.
      (e) Crediting and Availability of Fees.--Section 744B(i)(3) of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(i)(3)) is
    amended by striking ``fiscal years 2018 through 2022'' and inserting
    ``fiscal years 2023 through 2027''.
      (f) Effect of Failure to Pay Fees.--The heading of paragraph (3) of
    section 744B(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    379j-42(g)) is amended by striking ``and prior approval supplement
    fee''.

    SEC. 303. 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)(1), by striking ``Beginning with fiscal
            year 2018, not'' and inserting ``Not'';
              (2) by striking ``Generic Drug User Fee Amendments of 2017''
            each place it appears and inserting ``Generic Drug User Fee
            Amendments of 2022'';
              (3) in subsection (a)(2), by striking ``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'' and inserting
            ``Not later than 30 calendar days after the end of each quarter
            of each fiscal year for which fees are collected under this
            part'';
              (4) in subsection (a)(3), by striking ``Beginning with fiscal
            year 2020, the'' and inserting ``The'';
              (5) in subsection (b), by striking ``Beginning with fiscal
            year 2018, not'' and inserting ``Not'';
              (6) in subsection (c), by striking ``Beginning with fiscal
            year 2018, for'' and inserting ``For''; and
              (7) in subsection (f)--
                      (A) in paragraph (1), in the matter preceding
                    subparagraph (A), by striking ``fiscal year 2022'' and
                    inserting ``fiscal year 2027''; and
                      (B) in paragraph (5), by striking ``January 15,
                    2022'' and inserting ``January 15, 2027''.

    SEC. 304. SUNSET DATES.

      (a) Authorization.--Sections 744A and 744B of the Federal Food, Drug,
    and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall cease to be
    effective October 1, 2027.
      (b) Reporting Requirements.--Section 744C of the Federal Food, Drug,
    and Cosmetic Act (21 U.S.C. 379j-43) shall cease to be effective
    January 31, 2028.
      (c) Previous Sunset Provision.--Effective October 1, 2022,
    subsections (a) and (b) of section 305 of the FDA Reauthorization Act
    of 2017 (Public Law 115-52) are repealed.

    SEC. 305. EFFECTIVE DATE.

      The amendments made by this title shall take effect on October 1,
    2022, 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 (21 U.S.C. 379j-41 et seq.) shall
    be assessed for all abbreviated new drug applications received on or
    after October 1, 2022, regardless of the date of the enactment of this
    Act.

    SEC. 306. 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
    (21 U.S.C. 379j-41 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 abbreviated new drug applications (as defined in such part
    as of such day) that were received by the Food and Drug Administration
    within the meaning of section 505(j)(5)(A) of such Act (21 U.S.C.
    355(j)(5)(A)), prior approval supplements that were submitted, and drug
    master files for Type II active pharmaceutical ingredients that were
    first referenced on or after October 1, 2017, but before October 1,
    2022, with respect to assessing and collecting any fee required by such
    part for a fiscal year prior to fiscal year 2023.

           TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

    SEC. 401. SHORT TITLE; FINDING.

      (a) Short Title.--This title may be cited as the ``Biosimilar User
    Fee Amendments of 2022''.
      (b) Finding.--The Congress finds that the fees authorized by the
    amendments made by 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 (21 U.S.C. 379j-51 et seq.), 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-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally
            Adjusted; All items; Annual Index) for September of the
            preceding fiscal year divided by such Index for September
            2011.''.
      (b) Biosimilar Biological Product Application.--Section
    744G(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    379j-51(4)(B)(iii)) is amended--
              (1) by striking subclause (II) (relating to an allergenic
            extract product); and
              (2) by redesignating subclauses (III) and (IV) as subclauses
            (II) and (III), respectively.

    SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.

      (a) Types of Fees.--
              (1) In general.--The matter preceding paragraph (1) in
            section 744H(a) of the Federal Food, Drug, and Cosmetic Act (21
            U.S.C. 379j-52(a)) is amended by striking ``fiscal year 2018''
            and inserting ``fiscal year 2023''.
              (2) Initial biosimilar biological product development fee.--
            Clauses (iv)(I) and (v)(II) of section 744H(a)(1)(A) of the
            Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
            52(a)(1)(A)) are each amended by striking ``5 days'' and
            inserting ``7 days''.
              (3) Annual biosimilar biological product development fee.--
            Section 744H(a)(1)(B) of the Federal Food, Drug, and Cosmetic
            Act (21 U.S.C. 379j-52(a)(1)(B)) is amended--
                      (A) in clause (i), by inserting before the period at
                    the end the following: ``, except where such product
                    (including, where applicable, ownership of the relevant
                    investigational new drug application) is transferred to
                    a licensee, assignee, or successor of such person, and
                    written notice of such transfer is provided to the
                    Secretary, in which case such licensee, assignee, or
                    successor shall pay the annual biosimilar biological
                    product development fee'';
                      (B) in clause (iii)--
                              (i) in subclause (I), by striking ``or'' at
                            the end;
                              (ii) in subclause (II), by striking the
                            period at the end and inserting ``; or''; and
                              (iii) by adding at the end the following:
                                      ``(III) been administratively removed
                                    from the biosimilar biological product
                                    development program for the product
                                    under subparagraph (E)(v).''; and
                      (C) in clause (iv), by striking ``is accepted for
                    filing on or after October 1 of such fiscal year'' and
                    inserting ``is subsequently accepted for filing''.
              (4) Reactivation fee.--Section 744H(a)(1)(D) of the Federal
            Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a)(1)(D)) is
            amended to read as follows:
                      ``(D) Reactivation fee.--
                              ``(i) In general.--A person that has
                            discontinued participation in the biosimilar
                            biological product development program for a
                            product under subparagraph (C), or who has been
                            administratively removed from the biosimilar
                            biological product development program for a
                            product under subparagraph (E)(v), shall, if
                            the person seeks to resume participation in
                            such program, pay all annual biosimilar
                            biological product development fees previously
                            assessed for such product and still owed and a
                            fee (referred to in this section as
                            `reactivation fee') by the earlier of the
                            following:
                                      ``(I) Not later than 7 days after the
                                    Secretary grants a request by such
                                    person for a biosimilar biological
                                    product development meeting for the
                                    product (after the date on which such
                                    participation was discontinued or the
                                    date of administrative removal, as
                                    applicable).
                                      ``(II) Upon the date of submission
                                    (after the date on which such
                                    participation was discontinued or the
                                    date of administrative removal, as
                                    applicable) by such person of an
                                    investigational new drug application
                                    describing an investigation that the
                                    Secretary determines is intended to
                                    support a biosimilar biological product
                                    application for that product.
                              ``(ii) Application of annual fee.--A person
                            that pays a reactivation fee for a product
                            shall pay for such product, beginning in the
                            next fiscal year, the annual biosimilar
                            biological product development fee under
                            subparagraph (B), except where such product
                            (including, where applicable, ownership of the
                            relevant investigational new drug application)
                            is transferred to a licensee, assignee, or
                            successor of such person, and written notice of
                            such transfer is provided to the Secretary, in
                            which case such licensee, assignee, or
                            successor shall pay the annual biosimilar
                            biological product development fee.''.
              (5) Effect of failure to pay fees.--Section 744H(a)(1)(E) of
            the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
            52(a)(1)(E)) is amended by adding at the end the following:
                              ``(v) Administrative removal from the
                            biosimilar biological product development
                            program.--If a person has failed to pay an
                            annual biosimilar biological product
                            development fee for a product as required under
                            subparagraph (B) for a period of two
                            consecutive fiscal years, the Secretary may
                            administratively remove such person from the
                            biosimilar biological product development
                            program for the product. At least 30 days prior
                            to administratively removing a person from the
                            biosimilar biological product development
                            program for a product under this clause, the
                            Secretary shall provide written notice to such
                            person of the intended administrative
                            removal.''.
              (6) Biosimilar biological product application fee.--Section
            744H(a)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21
            U.S.C. 379j-52(a)(2)(D)) is amended by inserting after ``or was
            withdrawn'' the following: ``prior to approval''.
              (7) Biosimilar biological product program fee.--Section
            744H(a)(3) of the Federal Food, Drug, and Cosmetic Act (21
            U.S.C. 379j-52(a)(3)) is amended--
                      (A) in subparagraph (A)--
                              (i) in clause (i), by striking ``and'' at the
                            end;
                              (ii) by redesignating clause (ii) as clause
                            (iii); and
                              (iii) by inserting after clause (i) the
                            following:
                              ``(ii) may be dispensed only under
                            prescription pursuant to section 503(b); and'';
                            and
                      (B) by adding at the end the following:
                      ``(E) Movement to discontinued list.--
                              ``(i) Date of inclusion.--If a written
                            request to place a product on the list
                            referenced in subparagraph (A) of discontinued
                            biosimilar biological products is submitted to
                            the Secretary on behalf of an applicant, and
                            the request identifies the date the product is
                            withdrawn from sale, then for purposes of
                            assessing the biosimilar biological product
                            program fee, the Secretary shall consider such
                            product to have been included on such list on
                            the later of--
                                      ``(I) the date such request was
                                    received; or
                                      ``(II) if the product will be
                                    withdrawn from sale on a future date,
                                    such future date when the product is
                                    withdrawn from sale.
                              ``(ii) Treatment as withdrawn from sale.--For
                            purposes of clause (i), a product shall be
                            considered withdrawn from sale once the
                            applicant has ceased its own distribution of
                            the product, whether or not the applicant has
                            ordered recall of all previously distributed
                            lots of the product, except that a routine,
                            temporary interruption in supply shall not
                            render a product withdrawn from sale.
                              ``(iii) Special rule.--If a biosimilar
                            biological product that is identified in a
                            biosimilar biological product application
                            approved as of October 1 of a fiscal year
                            appears, as of October 1 of such fiscal year,
                            on the list referenced in subparagraph (A) of
                            discontinued biosimilar biological products,
                            and on any subsequent day during such fiscal
                            year the biosimilar biological product does not
                            appear on such list, then except as provided in
                            subparagraph (D), each person who is named as
                            the applicant in a biosimilar biological
                            product application with respect to such
                            product shall pay the annual biosimilar
                            biological product program fee established for
                            a fiscal year under subsection (c)(5) for such
                            biosimilar biological product. Notwithstanding
                            subparagraph (B), such fee shall be due on the
                            last business day of such fiscal year and shall
                            be paid only once for each such product for
                            each fiscal year.''.
              (8) Biosimilar biological product fee.--Section 744H(a) of
            the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a))
            is amended by striking paragraph (4).
      (c) Fee Revenue Amounts.--Subsection (b) of section 744H of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
              (1) by striking paragraph (1);
              (2) by redesignating paragraphs (2) through (4) as paragraphs
            (1) through (3), respectively;
              (3) by amending paragraph (1) (as so redesignated) to read as
            follows:
              ``(1) In general.--For each of the fiscal years 2023 through
            2027, 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 (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 strategic hiring
                    and retention adjustment (as determined under
                    subsection (c)(2));
                      ``(D) the dollar amount equal to the capacity
                    planning adjustment for the fiscal year (as determined
                    under subsection (c)(3));
                      ``(E) the dollar amount equal to the operating
                    reserve adjustment for the fiscal year, if applicable
                    (as determined under subsection (c)(4));
                      ``(F) for fiscal year 2023 an additional amount of
                    $4,428,886; and
                      ``(G) for fiscal year 2024 an additional amount of
                    $320,569.'';
              (4) in paragraph (2) (as so redesignated)--
                      (A) in the paragraph heading, by striking ``;
                    limitations on fee amounts'';
                      (B) by striking subparagraph (B); and
                      (C) by redesignating subparagraphs (C) and (D) as
                    subparagraphs (B) and (C), respectively; and
              (5) by amending paragraph (3) (as so redesignated) to read as
            follows:
              ``(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 2023, $43,376,922; and
                      ``(B) for fiscal years 2024 through 2027, the dollar
                    amount of the total revenue amount established under
                    paragraph (1) for the previous fiscal year, excluding
                    any adjustments to such revenue amount under subsection
                    (c)(4).''.
      (d) Adjustments; Annual Fee Setting.--Section 744H(c) of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(c)) is amended--
              (1) in paragraph (1)--
                      (A) in subparagraph (A)--
                              (i) in the matter preceding clause (i), by
                            striking ``subsection (b)(2)(B)'' and inserting
                            ``subsection (b)(1)(B)''; and
                              (ii) in clause (i), by striking ``subsection
                            (b)'' and inserting ``subsection (b)(1)(A)'';
                            and
                      (B) in subparagraph (B)(ii), by striking
                    ``Washington-Baltimore, DC-MD-VA-WV'' and inserting
                    ``Washington-Arlington-Alexandria, DC-VA-MD-WV'';
              (2) by striking paragraphs (2) through (4) and inserting the
            following:
              ``(2) Strategic hiring and retention adjustment.--For each
            fiscal year, after the annual base revenue under subsection
            (b)(1)(A) is adjusted for inflation in accordance with
            paragraph (1), the Secretary shall further increase the fee
            revenue and fees by $150,000.
              ``(3) Capacity planning adjustment.--
                      ``(A) In general.--For each fiscal year, the
                    Secretary shall, in addition to the adjustments under
                    paragraphs (1) and (2), further adjust 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) Methodology.--For purposes of this paragraph,
                    the Secretary shall employ the capacity planning
                    methodology utilized by the Secretary in setting fees
                    for fiscal year 2021, as described in the notice titled
                    `Biosimilar User Fee Rates for Fiscal Year 2021'
                    published in the Federal Register on August 4, 2020 (85
                    Fed. Reg. 47220). The workload categories used in
                    applying such methodology in forecasting shall include
                    only the activities described in that notice and, as
                    feasible, additional activities that are also directly
                    related to the direct review of biosimilar biological
                    product applications and supplements, including
                    additional formal meeting types, the direct review of
                    postmarketing commitments and requirements, the direct
                    review of risk evaluation and mitigation strategies,
                    and the direct review of annual reports for approved
                    biosimilar biological products. Subject to the
                    exceptions in the preceding sentence, the Secretary
                    shall not include as workload categories in applying
                    such methodology in forecasting any non-core review
                    activities, including those activities that the
                    Secretary referenced for potential future use in such
                    notice but did not utilize in setting fees for fiscal
                    year 2021.
                      ``(C) Limitations.--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), (b)(1)(B) (the dollar
                    amount of the inflation adjustment for the fiscal
                    year), and (b)(1)(C) (the dollar amount of the
                    strategic hiring and retention adjustment).
                      ``(D) Publication in federal register.--The Secretary
                    shall publish in the Federal Register notice under
                    paragraph (5) the fee revenue and fees resulting from
                    the adjustment and the methodologies under this
                    paragraph.
              ``(4) Operating reserve adjustment.--
                      ``(A) Increase.--For fiscal year 2023 and subsequent
                    fiscal years, the Secretary shall, in addition to
                    adjustments under paragraphs (1), (2), and (3), further
                    increase the fee revenue and fees if such an adjustment
                    is necessary to provide for at least 10 weeks of
                    operating reserves of carryover user fees for the
                    process for the review of biosimilar biological product
                    applications.
                      ``(B) Decrease.--
                              ``(i) Fiscal year 2023.--For fiscal year
                            2023, if the Secretary has carryover balances
                            for such process in excess of 33 weeks of such
                            operating reserves, the Secretary shall
                            decrease such fee revenue and fees to provide
                            for not more than 33 weeks of such operating
                            reserves.
                              ``(ii) Fiscal year 2024.--For fiscal year
                            2024, if the Secretary has carryover balances
                            for such process in excess of 27 weeks of such
                            operating reserves, the Secretary shall
                            decrease such fee revenue and fees to provide
                            for not more than 27 weeks of such operating
                            reserves.
                              ``(iii) Fiscal year 2025 and subsequent
                            fiscal years.--For fiscal year 2025 and
                            subsequent fiscal years, if the Secretary has
                            carryover balances for such process in excess
                            of 21 weeks of such operating reserves, the
                            Secretary shall decrease such fee revenue and
                            fees to provide for not more than 21 weeks of
                            such operating reserves.
                      ``(C) Federal register notice.--If an adjustment
                    under subparagraph (A) or (B) is made, the rationale
                    for the amount of the increase or decrease 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.''; and
              (3) in paragraph (5), in the matter preceding subparagraph
            (A), by striking ``2018'' and inserting ``2023''.
      (e) Crediting and Availability of Fees.--Subsection (f)(3) of section
    744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
    52(f)(3)) is amended by striking ``2018 through 2022'' and inserting
    ``2023 through 2027''.
      (f) Written Requests for Waivers and Returns; Disputes Concerning
    Fees.--Section 744H(h) of the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 379j-52(h)) is amended to read as follows:
      ``(h) Written Requests for Waivers and Returns; Disputes Concerning
    Fees.--To qualify for consideration for a waiver under subsection (d),
    or for the return of any fee paid under this section, including if the
    fee is claimed to have been paid in error, a person shall submit to the
    Secretary a written request justifying such waiver or return and,
    except as otherwise specified in this section, such written request
    shall be submitted to the Secretary not later than 180 days after such
    fee is due. A request submitted under this paragraph shall include any
    legal authorities under which the request is made.''.

    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)(1), by striking ``Beginning with fiscal
            year 2018, not'' and inserting ``Not'';
              (2) by striking ``Biosimilar User Fee Amendments of 2017''
            each place it appears and inserting ``Biosimilar User Fee
            Amendments of 2022'';
              (3) in subsection (a)(2), by striking ``Beginning with fiscal
            year 2018, the'' and inserting ``The'';
              (4) in subsection (a)(3)(A), by striking ``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'' and inserting
            ``Not later than 30 calendar days after the end of each quarter
            of each fiscal year for which fees are collected under this
            part'';
              (5) in subsection (b), by striking ``Not later than 120 days
            after the end of fiscal year 2018 and each subsequent fiscal
            year for which fees are collected under this part'' and
            inserting ``Not later than 120 days after the end of each
            fiscal year for which fees are collected under this part'';
              (6) in subsection (c), by striking ``Beginning with fiscal
            year 2018, and for'' and inserting ``For''; and
              (7) in subsection (f)--
                      (A) in paragraph (1), in the matter preceding
                    subparagraph (A), by striking ``fiscal year 2022'' and
                    inserting ``fiscal year 2027''; and
                      (B) in paragraph (3), by striking ``January 15,
                    2022'' and inserting ``January 15, 2027''.

    SEC. 405. SUNSET DATES.

      (a) Authorization.--Sections 744G and 744H of the Federal Food, Drug,
    and Cosmetic Act (21 U.S.C. 379j-51, 379j-52) shall cease to be
    effective October 1, 2027.
      (b) Reporting Requirements.--Section 744I of the Federal Food, Drug,
    and Cosmetic Act shall cease to be effective January 31, 2028.
      (c) Previous Sunset Provision.--Effective October 1, 2022,
    subsections (a) and (b) of section 405 of the FDA Reauthorization Act
    of 2017 (Public Law 115-52) are repealed.

    SEC. 406. EFFECTIVE DATE.

      The amendments made by this title shall take effect on October 1,
    2022, 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 (21 U.S.C. 379j-51 et seq.) shall
    be assessed for all biosimilar biological product applications received
    on or after October 1, 2022, regardless of the date of the enactment of
    this Act.

    SEC. 407. SAVINGS CLAUSE.

      Notwithstanding the amendments made by this title, part 8 of
    subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
    (21 U.S.C. 379j-51 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 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, 2017, but
    before October 1, 2022, with respect to assessing and collecting any
    fee required by such part for a fiscal year prior to fiscal year 2023.

                TITLE V--IMPROVING DIVERSITY IN CLINICAL STUDIES

    SEC. 501. DIVERSITY ACTION PLANS FOR CLINICAL STUDIES.

      (a) Drugs.--Section 505(i) of the Federal Food, Drug, and Cosmetic
    Act (21 U.S.C. 355(i)) is amended by adding at the end the following:
      ``(5)(A) In order for a new drug that is being studied in a phase 3
    study, as defined in section 312.21(c) of title 21, Code of Federal
    Regulations (or successor regulations), or other pivotal study (other
    than bioavailability or bioequivalence studies), to be exempt pursuant
    to this subsection, the sponsor of a clinical investigation of such new
    drug shall submit to the Secretary a diversity action plan.
      ``(B) Such diversity action plan shall include--
              ``(i) the sponsor's goals for enrollment in such clinical
            study;
              ``(ii) the sponsor's rationale for such goals; and
              ``(iii) an explanation of how the sponsor intends to meet
            such goals.
      ``(C) The sponsor shall submit such diversity action plan in the form
    and manner specified in the guidance required by section 524B as soon
    as practicable but no later than when the sponsor seeks feedback
    regarding such a phase 3 study or other pivotal study of the drug.
      ``(D) The Secretary may waive the requirement in subparagraph (A) if
    the Secretary determines that a waiver is necessary based on what is
    known about the prevalence of the disease in terms of the patient
    population that may use the new drug.
      ``(E) No diversity action plan shall be required for a submission
    described in section 561.''.
      (b) Devices.--Section 520(g) of the Federal Food, Drug, and Cosmetic
    Act (21 U.S.C. 360j(g)) is amended by adding at the end the following:
      ``(9)(A)(i) In order for a device in a clinical study for which
    submission of an application for an investigational device exemption is
    required to be exempt under this subsection, the sponsor of such study
    shall submit to the Secretary in such application a diversity action
    plan in the form and manner specified in the guidance required by
    section 524B.
      ``(ii) In order for a device in a clinical study for which submission
    of an application for an investigational device exemption is not
    required, except for a device being studied as described in section
    812.2(c) of title 21, Code of Federal Regulations (or successor
    regulations), to be exempt under this subsection, the sponsor of such
    study shall develop and implement a diversity action plan. Such
    diversity action plan shall be submitted to the Secretary in any
    premarket notification under section 510(k), request for classification
    under section 513(f)(2), or application for premarket approval under
    section 515 for such device.
      ``(B) A diversity action plan under clause (i) or (ii) of
    subparagraph (A) shall include--
              ``(i) the sponsor's goals for enrollment in the clinical
            study;
              ``(ii) the sponsor's rationale for such goals; and
              ``(iii) an explanation of how the sponsor intends to meet
            such goals.
      ``(C) The Secretary may waive the requirement in subparagraph (A) or
    (B) if the Secretary determines that a waiver is necessary based on
    what is known about the prevalence of the disease in terms of the
    patient population that may use the device.
      ``(D) No diversity action plan shall be required for a submission
    described in section 561.''.
      (c) Guidance.--Subchapter A of chapter V of the Federal Food, Drug,
    and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the
    end the following:

    ``SEC. 524B. GUIDANCE ON DIVERSITY ACTION PLANS FOR CLINICAL STUDIES.

      ``(a) In General.--The Secretary shall issue guidance relating to--
              ``(1) the format and content of the diversity action plans
            required by sections 505(i)(5) and 520(g)(9) pertaining to the
            sponsor's goals for clinical study enrollment, disaggregated by
            age group, sex, race, geographic location, socioeconomic
            status, and ethnicity, including with respect to--
                      ``(A) the rationale for the sponsor's enrollment
                    goals, which may include--
                              ``(i) the estimated prevalence or incidence
                            in the United States of the disease or
                            condition for which the drug or device is being
                            developed or investigated, if such estimated
                            prevalence or incidence is known or can be
                            determined based on available data;
                              ``(ii) what is known about the disease or
                            condition for which the drug or device is being
                            developed or investigated;
                              ``(iii) any relevant pharmacokinetic or
                            pharmacogenomic data;
                              ``(iv) what is known about the patient
                            population for such disease or condition,
                            including, to the extent data is available--
                                      ``(I) demographic information,
                                    including age group, sex, race,
                                    geographic location, socioeconomic
                                    status, and ethnicity;
                                      ``(II) non-demographic factors,
                                    including co-morbidities affecting the
                                    patient population; and
                                      ``(III) potential barriers to
                                    enrolling diverse participants, such as
                                    patient population size, geographic
                                    location, and socioeconomic status; and
                              ``(v) any other data or information relevant
                            to selecting appropriate enrollment goals,
                            disaggregated by demographic subgroup, such as
                            the inclusion of pregnant and lactating women;
                      ``(B) an explanation for how the sponsor intends to
                    meet such goals, including demographic-specific
                    outreach and enrollment strategies, study-site
                    selection, clinical study inclusion and exclusion
                    practices, and any diversity training for study
                    personnel; and
                      ``(C) procedures for the public posting of key
                    information from the diversity action plan that would
                    be useful to patients and providers on the sponsor's
                    website, as appropriate; and
              ``(2) how sponsors should include in regular reports to the
            Secretary--
                      ``(A) the sponsor's progress in meeting the goals
                    referred to in paragraph (1)(A); and
                      ``(B) if the sponsor does not expect to meet such
                    goals--
                              ``(i) any updates needed to be made to a
                            diversity action plan referred to in paragraph
                            (1) to help meet such goals; and
                              ``(ii) the sponsor's reasons for why the
                            sponsor does not expect to meet such goals.
      ``(b) Issuance.--The Secretary shall--
              ``(1) not later than 12 months after the date of enactment of
            this section, issue new draft guidance or update existing draft
            guidance described in subsection (a); and
              ``(2) not later than 9 months after closing the comment
            period on such draft guidance, finalize such guidance.''.
      (d) Applicability.--Sections 505(i)(5) and 520(g)(9) of the Federal
    Food, Drug, and Cosmetic Act, as added by subsections (a) and (b) of
    this section, apply only with respect to clinical investigations with
    respect to which enrollment commences after the date that is 180 days
    after the publication of final guidance under section 524B(b)(2) of the
    Federal Food, Drug, and Cosmetic Act, as added by subsection (c).

    SEC. 502. EVALUATION OF THE NEED FOR FDA AUTHORITY TO MANDATE
                        POSTAPPROVAL STUDIES OR POSTMARKET SURVEILLANCE DUE
                        TO INSUFFICIENT DEMOGRAPHIC SUBGROUP DATA.

      (a) In General.--Not later than 2 years after the date of publication
    of final guidance pursuant to section 524B(b)(2) of the Federal Food,
    Drug, and Cosmetic Act, as added by section 501(c) of this Act, the
    Secretary of Health and Human Services shall commence an evaluation to
    assess whether additions or changes to statutes or regulations are
    warranted to ensure that sponsors conduct post-approval studies or
    postmarket surveillance where--
              (1) premarket studies collected insufficient data for
            underrepresented subgroups according to the goals specified in
            the diversity action plans of such sponsors; and
              (2) the Secretary has requested additional studies be
            conducted.
      (b) Determination and Reporting.--Not later than 180 days after the
    commencement of the evaluation under subsection (a), the Secretary of
    Health and Human Services shall submit a report to the Congress on the
    outcome of such evaluation, including any recommendations related to
    additional needed authorities.

    SEC. 503. PUBLIC WORKSHOPS TO ENHANCE CLINICAL STUDY DIVERSITY.

      (a) In General.--Not later than one year after the date of enactment
    of this Act, the Secretary of Health and Human Services, in
    consultation with drug sponsors, medical device manufacturers,
    patients, and other stakeholders, shall convene one or more public
    workshops to solicit input from stakeholders on increasing the
    enrollment of historically underrepresented populations in clinical
    studies and encouraging clinical study participation that reflects the
    prevalence of the disease or condition among demographic subgroups,
    where appropriate, and other topics, including--
              (1) how and when to collect and present the prevalence or
            incidence data on a disease or condition by demographic
            subgroup, including possible sources for such data and
            methodologies for assessing such data;
              (2) considerations for the dissemination, after approval, of
            information to the public on clinical study enrollment
            demographic data;
              (3) the establishment of goals for enrollment in clinical
            trials, including the relevance of the estimated prevalence or
            incidence, as applicable, in the United States of the disease
            or condition for which the drug or device is being developed;
            and
              (4) approaches to support inclusion of underrepresented
            populations and to encourage clinical study participation that
            reflects the population expected to use the drug or device
            under study, including with respect to--
                      (A) the establishment of inclusion and exclusion
                    criteria for certain subgroups, such as pregnant and
                    lactating women and individuals with disabilities,
                    including intellectual or developmental disabilities or
                    mental illness;
                      (B) considerations regarding informed consent with
                    respect to individuals with intellectual or
                    developmental disabilities or mental illness, including
                    ethical and scientific considerations;
                      (C) the appropriate use of decentralized trials or
                    digital health tools;
                      (D) clinical endpoints;
                      (E) biomarker selection; and
                      (F) studying analysis.
      (b) Public Docket.--The Secretary of Health and Human Services shall
    establish a public comment period to receive written comments related
    to the topics addressed during each public workshop convened under this
    section. The public comment period shall remain open for 60 days
    following the date on which each public workshop is convened.
      (c) Report.--Not later than 180 days after the close of the public
    comment period for each public workshop convened under this section,
    the Secretary of Health and Human Services shall make available on the
    public website of the Food and Drug Administration a report on the
    topics discussed at such workshop. The report shall include a summary
    of, and response to, recommendations raised in such workshop.

    SEC. 504. ANNUAL SUMMARY REPORT ON PROGRESS TO INCREASE DIVERSITY IN
                        CLINICAL STUDIES.

      (a) In General.--Beginning not later than 2 years after the date of
    enactment of this Act, and each year thereafter, the Secretary of
    Health and Human Services shall submit to the Congress, and publish on
    the public website of the Food and Drug Administration, a report that--
              (1) summarizes, in aggregate, the diversity action plans
            received pursuant to section 505(i)(5) or 520(g)(9) of the
            Federal Food, Drug, and Cosmetic Act, as added by subsection
            (a) or (b) of section 501 of this Act; and
              (2) contains information on--
                      (A) for drugs, biological products, and devices
                    approved, licensed, cleared, or classified under
                    section 505, 515, 510(k), or 513(f)(2) of the Federal
                    Food, Drug, and Cosmetic Act (21 U.S.C. 355; 360e;
                    360(k); and 360(f)(2)), or section 351(a) of the Public
                    Health Service Act (42 U.S.C. 262(a)), whether the
                    clinical studies conducted with respect to such
                    applications met the demographic subgroup enrollment
                    goals from the diversity action plan submitted for such
                    applications;
                      (B) the reasons provided for why enrollment goals
                    from submitted diversity action plans were not met; and
                      (C) any postmarket studies of a drug or device in a
                    demographic subgroup or subgroups required or
                    recommended by the Secretary based on inadequate
                    premarket clinical study diversity or based on other
                    reasons where a premarket study lacked adequate
                    diversity, including the status and completion date of
                    any such study.
      (b) Confidentiality.--Nothing in this section shall be construed as
    authorizing the Secretary of Health and Human Services to disclose any
    information that is a trade secret or confidential information subject
    to section 552(b)(4) of title 5, United States Code, or section 1905 of
    title 18, United States Code.

    SEC. 505. PUBLIC MEETING ON CLINICAL STUDY FLEXIBILITIES INITIATED IN
                        RESPONSE TO COVID-19 PANDEMIC.

      (a) In General.--Not later than 180 days after the date on which the
    COVID-19 emergency period ends, the Secretary of Health and Human
    Services shall convene a public meeting to discuss the recommendations
    provided by the Food and Drug Administration during the COVID-19
    emergency period to mitigate disruption of clinical studies, including
    recommendations detailed in the guidance entitled ``Conduct of Clinical
    Trials of Medical Products During the COVID-19 Public Health Emergency,
    Guidance for Industry, Investigators, and Institutional Review
    Boards'', as updated on August 8, 2021, and by any subsequent updates
    to such guidance. The Secretary of Health and Human Services shall
    invite to such meeting representatives from the pharmaceutical and
    medical device industries who sponsored clinical studies during the
    COVID-19 emergency period and organizations representing patients.
      (b) Topics.--Not later than 90 days after the date on which the
    public meeting under subsection (a) is convened, the Secretary of
    Health and Human Services shall make available on the public website of
    the Food and Drug Administration a report on the topics discussed at
    such meeting. Such topics shall include discussion of--
              (1) the actions drug sponsors took to utilize such
            recommendations and the frequency at which such recommendations
            were employed;
              (2) the characteristics of the sponsors, studies, and patient
            populations impacted by such recommendations;
              (3) a consideration of how recommendations intended to
            mitigate disruption of clinical studies during the COVID-19
            emergency period, including any recommendations to consider
            decentralized clinical studies when appropriate, may have
            affected access to clinical studies for certain patient
            populations, especially unrepresented racial and ethnic
            minorities; and
              (4) recommendations for incorporating certain clinical study
            disruption mitigation recommendations into current or
            additional guidance to improve clinical study access and
            enrollment of diverse patient populations.
      (c) COVID-19 Emergency Period Defined.--In this section, the term
    ``COVID-19 emergency period'' has the meaning given the term
    ``emergency period'' in section 1135(g)(1)(B) of the Social Security
    Act (42 U.S.C. 1320b-5(g)(1)(B)).

    SEC. 506. DECENTRALIZED CLINICAL STUDIES.

      (a) Guidance.--The Secretary of Health and Human Services shall--
              (1) not later than 12 months after the date of enactment of
            this Act, issue draft guidance that addresses considerations
            for decentralized clinical studies, including considerations
            regarding the engagement, enrollment, and retention of a
            meaningfully diverse clinical population, with respect to race,
            ethnicity, age, sex, and geographic location, when appropriate;
            and
              (2) not later than 1 year after closing the comment period on
            such draft guidance, finalize such guidance.
      (b) Content of Guidance.--The guidance under subsection (a) shall
    address the following:
              (1) Recommendations for how digital health technology or
            other remote assessment options, such as telehealth, could
            support decentralized clinical studies, including guidance on
            considerations for selecting technological platforms and
            mediums, data collection and use, data integrity and security,
            and communication to study participants through digital
            technology.
              (2) Recommendations for subject recruitment and retention,
            including considerations for sponsors to minimize or reduce
            burdens for clinical study participants through the use of
            digital health technology, telehealth, local health care
            providers and laboratories, or other means.
              (3) Recommendations with respect to the evaluation of data
            collected within a decentralized clinical study setting.
      (c) Definition.--In this section, the term ``decentralized clinical
    study'' means a clinical study in which some or all of the study-
    related activities occur at a location separate from the investigator's
    location.

                       TITLE VI--GENERIC DRUG COMPETITION

    SEC. 601. INCREASING TRANSPARENCY IN GENERIC DRUG APPLICATIONS.

      (a) In General.--Section 505(j)(3) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the
    following:
      ``(H)(i) Upon request (in controlled correspondence or otherwise) by
    a person that has submitted or intends to submit an abbreviated
    application for a new drug under this subsection for which the
    Secretary has specified in regulation, including under section
    314.94(a)(9), title 21, Code of Federal Regulations (or a successor
    regulation), or recommended in applicable guidance, certain qualitative
    or quantitative criteria with respect to an inactive ingredient, or on
    the Secretary's own initiative during the review of such abbreviated
    application, the Secretary shall inform the person whether such new
    drug is qualitatively and quantitatively the same as the listed drug.
      ``(ii) Notwithstanding section 301(j), if the Secretary determines
    that such new drug is not qualitatively or quantitatively the same as
    the listed drug, the Secretary shall identify and disclose to the
    person--
              ``(I) the ingredient or ingredients that cause the new drug
            not to be qualitatively or quantitatively the same as the
            listed drug; and
              ``(II) for any ingredient for which there is an identified
            quantitative deviation, the amount of such deviation.
      ``(iii) If the Secretary determines that such new drug is
    qualitatively and quantitatively the same as the listed drug, the
    Secretary shall not change or rescind such determination after the
    submission of an abbreviated application for such new drug under this
    subsection unless--
              ``(I) the formulation of the listed drug has been changed and
            the Secretary has determined that the prior listed drug
            formulation was withdrawn for reasons of safety or
            effectiveness; or
              ``(II) the Secretary makes a written determination that the
            prior determination must be changed because an error has been
            identified.
      ``(iv) If the Secretary makes a written determination described in
    clause (iii)(II), the Secretary shall provide notice and a copy of the
    written determination to the person making the request under clause
    (i).
      ``(v) The disclosures required by this subparagraph are disclosures
    authorized by law including for purposes of section 1905 of title 18,
    United States Code.''.
      (b) Guidance.--
              (1) In general.--Not later than 1 year after the date of
            enactment of this Act, the Secretary of Health and Human
            Services shall issue draft guidance, or update guidance,
            describing how the Secretary will determine whether a new drug
            is qualitatively and quantitatively the same as the listed drug
            (as such terms are used in section 505(j)(3)(H) of the Federal
            Food, Drug, and Cosmetic Act, as added by subsection (a)),
            including with respect to assessing pH adjusters.
              (2) Process.--In issuing guidance as required by paragraph
            (1), the Secretary of Health and Human Services shall--
                      (A) publish draft guidance;
                      (B) provide a period of at least 60 days for comment
                    on the draft guidance; and
                      (C) after considering any comments received, and not
                    later than one year after the close of the comment
                    period on the draft guidance, publish final guidance.
      (c) Applicability.--Section 505(j)(3)(H) of the Federal Food, Drug,
    and Cosmetic Act, as added by subsection (a), applies beginning on the
    date of enactment of this Act, irrespective of the date on which the
    guidance required by subsection (b) is finalized.

    SEC. 602. ENHANCING ACCESS TO AFFORDABLE MEDICINES.

      Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 355(j)(10)(A)) is amended by striking clauses (i) through (iii)
    and inserting the following:
              ``(i) a revision to the labeling of the listed drug has been
            approved by the Secretary within 90 days of when the
            application is otherwise eligible for approval under this
            subsection;
              ``(ii) the sponsor of the application agrees to submit
            revised labeling for the drug that is the subject of the
            application not later than 60 days after approval under this
            subsection of the application;
              ``(iii) the labeling revision described under clause (i) does
            not include a change to the `Warnings' section of the labeling;
            and''.

        TITLE VII--RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN IMPROVEMENTS

                             Subtitle A--In General

    SEC. 701. ANIMAL TESTING ALTERNATIVES.

      Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    355) is amended--
              (1) in subsection (b)(5)(B)(i)(II), by striking ``animal''
            and inserting ``nonclinical tests'';
              (2) in subsection (i)--
                      (A) in paragraph (1)(A), by striking ``preclinical
                    tests (including tests on animals)'' and inserting
                    ``nonclinical tests''; and
                      (B) in paragraph (2)(B), by striking ``animal'' and
                    inserting ``nonclinical tests''; and
              (3) after subsection (y), by inserting the following:
      ``(z) Nonclinical Test Defined.--For purposes of this section, the
    term `nonclinical test' means a test conducted in vitro, in silico, or
    in chemico, or a nonhuman in vivo test, that occurs before or during
    the clinical trial phase of the investigation of the safety and
    effectiveness of a drug. Such test may include the following:
              ``(1) Cell-based assays.
              ``(2) Organ chips and microphysiological systems.
              ``(3) Computer modeling.
              ``(4) Other nonhuman or human biology-based test methods.
              ``(5) Animal tests.''.

    SEC. 702. EMERGING TECHNOLOGY PROGRAM.

      Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 201
    et seq.) is amended by inserting after section 566 of such Act (21
    U.S.C. 360bbb-5) the following:

    ``SEC. 566A. EMERGING TECHNOLOGY PROGRAM.

      ``(a) Program Establishment.--
              ``(1) In general.--The Secretary shall establish a program to
            support the adoption of, and improve the development of,
            innovative approaches to drug product design and manufacturing.
              ``(2) Actions.--In carrying out the program under paragraph
            (1), the Secretary may--
                      ``(A) facilitate and increase communication between
                    public and private entities, consortia, and individuals
                    with respect to innovative drug product design and
                    manufacturing;
                      ``(B) solicit information regarding, and conduct or
                    support research on, innovative approaches to drug
                    product design and manufacturing;
                      ``(C) convene meetings with representatives of
                    industry, academia, other Federal agencies,
                    international agencies, and other interested persons,
                    as appropriate;
                      ``(D) convene working groups to support drug product
                    design and manufacturing research and development;
                      ``(E) support education and training for regulatory
                    staff and scientists related to innovative approaches
                    to drug product design and manufacturing;
                      ``(F) advance regulatory science related to the
                    development and review of innovative approaches to drug
                    product design and manufacturing;
                      ``(G) convene or participate in working groups to
                    support the harmonization of international regulatory
                    requirements related to innovative approaches to drug
                    product design and manufacturing; and
                      ``(H) award grants or contracts to carry out or
                    support the program under paragraph (1).
              ``(3) Grants and contracts.--To seek a grant or contract
            under this section, an entity shall submit an application--
                      ``(A) in such form and manner as the Secretary may
                    require; and
                      ``(B) containing such information as the Secretary
                    may require, including a description of--
                              ``(i) how the entity will conduct the
                            activities to be supported through the grant or
                            contract; and
                              ``(ii) how such activities will further
                            research and development related to, or
                            adoption of, innovative approaches to drug
                            product design and manufacturing.
      ``(b) Guidance.--The Secretary shall--
              ``(1) issue or update guidance to help facilitate the
            adoption of, and advance the development of, innovative
            approaches to drug product design and manufacturing; and
              ``(2) include in such guidance descriptions of--
                      ``(A) any regulatory requirements related to the
                    development or review of technologies related to
                    innovative approaches to drug product design and
                    manufacturing, including updates and improvements to
                    such technologies after product approval; and
                      ``(B) data that can be used to demonstrate the
                    identity, safety, purity, and potency of drugs
                    manufactured using such technologies.
      ``(c) Report to Congress.--Not later than 4 years after the date of
    enactment of this section, 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--
              ``(1) an annual accounting of the allocation of funds made
            available to carry out this section;
              ``(2) a description of how Food and Drug Administration staff
            were utilized to carry out this section and, as applicable, any
            challenges or limitations related to staffing;
              ``(3) the number of public meetings held or participated in
            by the Food and Drug Administration pursuant to this section,
            including meetings convened as part of a working group
            described in subparagraph (D) or (G) of subsection (a)(2), and
            the topics of each such meeting; and
              ``(4) the number of drug products approved or licensed, after
            the date of enactment of this section, using an innovative
            approach to drug product design and manufacturing.
      ``(d) Authorization of Appropriations.--To carry out this section,
    there is authorized to be appropriated $20,000,000 for each fiscal year
    2023 through 2027.''.

    SEC. 703. IMPROVING THE TREATMENT OF RARE DISEASES AND CONDITIONS.

      (a) Report on Orphan Drug Program.--
              (1) In general.--Not later than September 30, 2026, 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
            summarizing the activities of the Food and Drug Administration
            related to designating drugs under section 526 of the Federal
            Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) for a rare
            disease or condition and approving such drugs under section 505
            of such Act (21 U.S.C. 355) or licensing such drugs under
            section 351 of the Public Health Service Act (42 U.S.C. 262),
            including--
                      (A) the number of applications for such drugs under
                    section 505 of the Federal Food, Drug, and Cosmetic Act
                    (21 U.S.C. 355) or section 351 of the Public Health
                    Service Act (42 U.S.C. 262) received by the Food and
                    Drug Administration, the number of such applications
                    accepted and rejected for filing, and the number of
                    such applications pending, approved, and disapproved by
                    the Food and Drug Administration;
                      (B) a description of trends in drug approvals for
                    rare diseases and conditions across review divisions at
                    the Food and Drug Administration;
                      (C) the extent to which the Food and Drug
                    Administration is consulting with external experts
                    pursuant to section 569(a)(2) of the Federal Food,
                    Drug, and Cosmetic Act (21 U.S.C. 360bbb-8(a)(2)) on
                    topics pertaining to drugs for a rare disease or
                    condition, including how and when any such consultation
                    is occurring; and
                      (D) the Food and Drug Administration's efforts to
                    promote best practices in the development of novel
                    treatments for rare diseases, including--
                              (i) reviewer training on rare disease-related
                            policies, methods, and tools; and
                              (ii) new regulatory science and coordinated
                            support for patient and stakeholder engagement.
              (2) Public availability.--The Secretary shall make the report
            under paragraph (1) available to the public, including by
            posting the report on the website of the Food and Drug
            Administration.
              (3) Information disclosure.--Nothing in this subsection shall
            be construed to authorize the disclosure of information that is
            prohibited from disclosure under section 1905 of title 18,
            United States Code, or subject to withholding under paragraph
            (4) of section 552(b) of title 5, United States Code (commonly
            referred to as the ``Freedom of Information Act'').
      (b) Study on European Union Safety and Efficacy Reviews of Drugs for
    Rare Diseases and Conditions.--
              (1) In general.--The Secretary of Health and Human Services
            shall enter into a contract with an appropriate entity to
            conduct a study on processes for evaluating the safety and
            efficacy of drugs for rare diseases or conditions in the United
            States and the European Union, including--
                      (A) flexibilities, authorities, or mechanisms
                    available to regulators in the United States and the
                    European Union specific to rare diseases or conditions;
                      (B) the consideration and use of supplemental data
                    submitted during review processes in the United States
                    and the European Union, including data associated with
                    open label extension studies and expanded access
                    programs specific to rare diseases or conditions;
                      (C) an assessment of collaborative efforts between
                    United States and European Union regulators related
                    to--
                              (i) product development programs under
                            review;
                              (ii) policies under development recently
                            issued; and
                              (iii) scientific information related to
                            product development or regulation; and
                      (D) recommendations for how Congress can support
                    collaborative efforts described in subparagraph (C).
              (2) Consultation.--The contract under paragraph (1) shall
            provide for consultation with relevant stakeholders,
            including--
                      (A) representatives from the Food and Drug
                    Administration and the European Medicines Agency;
                      (B) rare disease or condition patients; and
                      (C) patient groups that--
                              (i) represent rare disease or condition
                            patients; and
                              (ii) have international patient outreach.
              (3) Report.--The contract under paragraph (1) shall provide
            for, not later than 2 years after the date of entering into
            such contract--
                      (A) the completion of the study under paragraph (1);
                    and
                      (B) the submission of a report on the results of such
                    study to the Committee on Energy and Commerce of the
                    House of Representatives and the Committee on Health,
                    Education, Labor, and Pensions of the Senate.
              (4) Public availability.--The contract under paragraph (1)
            shall provide for the appropriate entity referred to in
            paragraph (1) to make the report under paragraph (3) available
            to the public, including by posting the report on the website
            of the appropriate entity.
      (c) Public Meeting.--
              (1) In general.--Not later than December 31, 2023, the
            Secretary of Health and Human Services, acting through the
            Commissioner of Food and Drugs, shall convene one or more
            public meetings to solicit input from stakeholders regarding
            the approaches described in paragraph (2).
              (2) Approaches.--The public meeting or meetings under
            paragraph (1) shall address approaches to increasing and
            improving engagement with rare disease or condition patients,
            groups representing such patients, rare disease or condition
            experts, and experts on small population studies, in order to
            improve the understanding with respect to rare diseases or
            conditions of--
                      (A) patient burden;
                      (B) treatment options; and
                      (C) side effects of treatments, including--
                              (i) comparing the side effects of treatments;
                            and
                              (ii) understanding the risks of side effects
                            relative to the health status of the patient
                            and the progression of the disease or
                            condition.
              (3) Public docket.--The Secretary of Health and Human
            Services shall establish a public docket to receive written
            comments related to the approaches addressed during each public
            meeting under paragraph (1). Such public docket shall remain
            open for 60 days following the date of each such public
            meeting.
              (4) Reports.--Not later than 180 days after each public
            meeting under paragraph (1), the Commissioner of Food and Drugs
            shall develop and publish on the website of the Food and Drug
            Administration a report on--
                      (A) the approaches discussed at the public meeting;
                    and
                      (B) any related recommendations.
      (d) Consultation on the Science of Small Population Studies.--Section
    569(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    360bbb-8(a)(2)) is amended by adding at the end the following:
                      ``(C) Small population studies.--The external experts
                    on the list maintained pursuant to subparagraph (A) may
                    include experts on the science of small population
                    studies.''.
      (e) Study on Sufficiency and Use of FDA Mechanisms for Incorporating
    the Patient and Clinician Perspective in FDA Processes Related to
    Applications Concerning Drugs for Rare Diseases or Conditions.--
              (1) In general.--The Comptroller General of the United States
            shall conduct a study on the use of Food and Drug
            Administration mechanisms and tools to ensure that patient and
            physician perspectives are considered and incorporated
            throughout the processes of the Food and Drug Administration--
                      (A) for approving or licensing under section 505 of
                    the Federal Food, Drug, or Cosmetic Act (21 U.S.C. 355)
                    or section 351 of the Public Health Service Act (42
                    U.S.C. 262) a drug designated as a drug for a rare
                    disease or condition under section 526 of the Federal
                    Food, Drug, and Cosmetic Act (21 U.S.C. 360bb); and
                      (B) in making any determination related to such a
                    drug's approval, including assessment of the drug's--
                              (i) safety or effectiveness; or
                              (ii) postapproval safety monitoring.
              (2) Topics.--The study under paragraph (1) shall--
                      (A) identify and compare the processes that the Food
                    and Drug Administration has formally put in place and
                    utilized to gather external expertise (including
                    patients, patient groups, and physicians) related to
                    applications for rare diseases or conditions;
                      (B) examine tools or mechanisms to improve efforts
                    and initiatives of the Food and Drug Administration to
                    collect and consider such external expertise with
                    respect to applications for rare diseases or conditions
                    throughout the application review and approval or
                    licensure processes, including within internal benefit-
                    risk assessments, advisory committee processes, and
                    postapproval safety monitoring; and
                      (C) examine processes or alternatives to address or
                    resolve conflicts of interest that impede the Food and
                    Drug Administration in gaining external expert input on
                    rare diseases or conditions with a limited set of
                    clinical and research experts.
              (3) Report.--Not later than 2 years after the date of
            enactment of this Act, the Comptroller General of the United
            States shall--
                      (A) complete the study under paragraph (1);
                      (B) submit a report on the results of such study to
                    the Congress; and
                      (C) include in such report recommendations, if
                    appropriate, for changes to the processes and
                    authorities of the Food and Drug Administration to
                    improve the collection and consideration of external
                    expert opinions of patients, patient groups, and
                    physicians with expertise in rare diseases or
                    conditions.
      (f) Definition.--In this section, the term ``rare disease or
    condition'' has the meaning given such term in section 526(a)(2) of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb(a)(2)).

    SEC. 704. ANTIFUNGAL RESEARCH AND DEVELOPMENT.

      (a) Draft Guidance.--Not later than 3 years after the date of the
    enactment of this Act, the Secretary of Health and Human Services,
    acting through the Commissioner of Food and Drugs, shall issue draft
    guidance for industry for the purposes of assisting entities seeking
    approval under section 505 of the Federal Food, Drug, and Cosmetic Act
    (21 U.S.C. 355) or licensure under section 351 of the Public Health
    Service Act (42 U.S.C. 262) of antifungal therapies designed to treat
    coccidioidomycosis (commonly known as Valley Fever).
      (b) Final Guidance.--Not later than 18 months after the close of the
    public comment period on the draft guidance issued pursuant to
    subsection (a), the Secretary of Health and Human Services, acting
    through the Commissioner of Food and Drugs, shall finalize the draft
    guidance.
      (c) Workshop.--To assist entities developing preventive vaccines for
    fungal infections and coccidioidomycosis, the Secretary of Health and
    Human Services shall hold a public workshop.

    SEC. 705. ADVANCING QUALIFIED INFECTIOUS DISEASE PRODUCT INNOVATION.

      (a) In General.--Section 505E of the Federal Food, Drug, and Cosmetic
    Act (21 U.S.C. 355f) is amended--
              (1) in subsection (c)--
                      (A) in paragraph (2), by striking ``or'' at the end;
                      (B) in paragraph (3), by striking the period at the
                    end and inserting ``; or''; and
                      (C) by adding at the end the following:
              ``(4) an application pursuant to section 351(a) of the Public
            Health Service Act.'';
              (2) in subsection (d)(1), by inserting ``of this Act or
            section 351(a) of the Public Health Service Act'' after
            ``section 505(b)''; and
              (3) by amending subsection (g) to read as follows:
      ``(g) Qualified Infectious Disease Product.--The term `qualified
    infectious disease product' means a drug, including an antibacterial or
    antifungal drug or a biological product, for human use that--
              ``(1) acts directly on bacteria or fungi or on substances
            produced by such bacteria or fungi; and
              ``(2) is intended to treat a serious or life-threatening
            infection, including such an infection caused by--
                      ``(A) an antibacterial or antifungal resistant
                    pathogen, including novel or emerging infectious
                    pathogens; or
                      ``(B) qualifying pathogens listed by the Secretary
                    under subsection (f).''.
      (b) Priority Review.--Section 524A(a) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 360n-1(a)) is amended by inserting ``of this
    Act or section 351(a) of the Public Health Service Act that requires
    clinical data (other than bioavailability studies) to demonstrate
    safety or effectiveness'' before the period at the end.

    SEC. 706. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PILOT
                        PROGRAM.

      Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act
    (21 U.S.C. 351 et seq.) is amended by inserting after section 506J (21
    U.S.C. 356j) the following:

    ``SEC. 506K. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PILOT
                        PROGRAM.

      ``(a) In General.--Not later than 1 year after the date of enactment
    of this section, the Secretary shall initiate a pilot program under
    which persons may request designation of an advanced manufacturing
    technology as described in subsection (b).
      ``(b) Designation Process.--The Secretary shall establish a process
    for the designation under this section of methods of manufacturing
    drugs, including biological products, and active pharmaceutical
    ingredients of such drugs, as advanced manufacturing technologies. A
    method of manufacturing, or a combination of manufacturing methods, is
    eligible for designation as an advanced manufacturing technology if
    such method or combination of methods incorporates a novel technology,
    or uses an established technique or technology in a novel way, that
    will substantially improve the manufacturing process for a drug and
    maintain equivalent or provide superior drug quality, including by--
              ``(1) reducing development time for a drug using the
            designated manufacturing method; or
              ``(2) increasing or maintaining the supply of--
                      ``(A) a drug that is described in section 506C(a) and
                    is intended to treat a serious or life-threatening
                    condition; or
                      ``(B) a drug that is on the drug shortage list under
                    section 506E.
      ``(c) Evaluation and Designation of an Advanced Manufacturing
    Technology.--
              ``(1) Submission.--A person who requests designation of a
            method of manufacturing as an advanced manufacturing technology
            under this section shall submit to the Secretary data or
            information demonstrating that the method of manufacturing
            meets the criteria described in subsection (b) in a particular
            context of use. The Secretary may facilitate the development
            and review of such data or information by--
                      ``(A) providing timely advice to, and interactive
                    communication with, such person regarding the
                    development of the method of manufacturing; and
                      ``(B) involving senior managers and experienced staff
                    of the Food and Drug Administration, as appropriate, in
                    a collaborative, cross-disciplinary review of the
                    method of manufacturing, as applicable.
              ``(2) Evaluation and designation.--Not later than 180
            calendar days after the receipt of a request under paragraph
            (1), the Secretary shall determine whether to designate such
            method of manufacturing as an advanced manufacturing
            technology, in a particular context of use, based on the data
            and information submitted under paragraph (1) and the criteria
            described in subsection (b).
      ``(d) Review of Advanced Manufacturing Technologies.--If the
    Secretary designates a method of manufacturing as an advanced
    manufacturing technology, the Secretary shall--
              ``(1) expedite the development and review of an application
            submitted under section 505 of this Act or section 351 of the
            Public Health Service Act, including supplemental applications,
            for drugs that are manufactured using a designated advanced
            manufacturing technology and could help mitigate or prevent a
            shortage or substantially improve manufacturing processes for a
            drug and maintain equivalent or provide superior drug quality,
            as described in subsection (b); and
              ``(2) allow the holder of an advanced technology designation,
            or a person authorized by the advanced manufacturing technology
            designation holder, to reference or rely upon, in an
            application submitted under section 505 of this Act or section
            351 of the Public Health Service Act, including a supplemental
            application, data and information about the designated advanced
            manufacturing technology for use in manufacturing drugs in the
            same context of use for which the designation was granted.
      ``(e) Implementation and Evaluation of Advanced Manufacturing
    Technologies Pilot.--
              ``(1) Public meeting.--The Secretary shall publish in the
            Federal Register a notice of a public meeting, to be held not
            later than 180 days after the date of enactment of this
            section, to discuss and obtain input and recommendations from
            relevant stakeholders regarding--
                      ``(A) the goals and scope of the pilot program, and a
                    suitable framework, procedures, and requirements for
                    such program; and
                      ``(B) ways in which the Food and Drug Administration
                    will support the use of advanced manufacturing
                    technologies and other innovative manufacturing
                    approaches for drugs.
              ``(2) Pilot program guidance.--
                      ``(A) In general.--The Secretary shall--
                              ``(i) not later than 180 days after the
                            public meeting under paragraph (1), issue draft
                            guidance regarding the goals and implementation
                            of the pilot program under this section; and
                              ``(ii) not later than 2 years after the date
                            of enactment of this section, issue final
                            guidance regarding the implementation of such
                            program.
                      ``(B) Content.--The guidance described in
                    subparagraph (A) shall address--
                              ``(i) the process by which a person may
                            request a designation under subsection (b);
                              ``(ii) the data and information that a person
                            requesting such a designation is required to
                            submit under subsection (c), and how the
                            Secretary intends to evaluate such submissions;
                              ``(iii) the process to expedite the
                            development and review of applications under
                            subsection (d); and
                              ``(iv) the criteria described in subsection
                            (b) for eligibility for such a designation.
              ``(3) Report.--Not later than 3 years after the date of
            enactment of this section and annually thereafter, the
            Secretary shall publish on the website of the Food and Drug
            Administration and 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 a report
            containing a description and evaluation of the pilot program
            being conducted under this section, including the types of
            innovative manufacturing approaches supported under the
            program. Such report shall include the following:
                      ``(A) The number of persons that have requested
                    designations and that have been granted designations.
                      ``(B) The number of methods of manufacturing that
                    have been the subject of designation requests and that
                    have been granted designations.
                      ``(C) The average number of calendar days for
                    completion of evaluations under subsection (c)(2).
                      ``(D) An analysis of the factors in data submissions
                    that are relevant to determinations to designate and
                    not to designate after evaluation under subsection
                    (c)(2).
                      ``(E) The number of applications received under
                    section 505 of this Act or section 351 of the Public
                    Health Service Act, including supplemental
                    applications, that have included an advanced
                    manufacturing technology designated under this section,
                    and the number of such applications approved.
      ``(f) Sunset.--The Secretary--
              ``(1) may not consider any requests for designation submitted
            under subsection (c) after October 1, 2029; and
              ``(2) may continue all activities under this section with
            respect to advanced manufacturing technologies that were
            designated pursuant to subsection (d) prior to such date, if
            the Secretary determines such activities are in the interest of
            the public health.''.

    SEC. 707. PUBLIC WORKSHOP ON CELL THERAPIES.

      Not later than 3 years after the date of the enactment of this Act,
    the Secretary of Health and Human Services, acting through the
    Commissioner of Food and Drugs, shall convene a public workshop with
    relevant stakeholders to discuss best practices on generating
    scientific data necessary to further facilitate the development of
    certain human cell-, tissue-, and cellular-based medical products (and
    the latest scientific information about such products) that are
    regulated as drugs under the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 301 et seq.) and biological products under section 351 of the
    Public Health Service Act (42 U.S.C. 262), namely, stem-cell and other
    cellular therapies.

    SEC. 708. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN.

      Section 409I(d)(1) of the Public Health Service Act (42 U.S.C.
    284m(d)(1)) is amended by striking ``2018 through 2022'' and inserting
    ``2023 through 2027''.

    SEC. 709. REAUTHORIZATION FOR HUMANITARIAN DEVICE EXEMPTION AND
                        DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC
                        AVAILABILITY.

      (a) Humanitarian Device Exemption.--Section 520(m)(6)(A)(iv) of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is
    amended by striking ``2022'' and inserting ``2027''.
      (b) Pediatric Medical Device Safety and Improvement Act.--Section
    305(e) of the Pediatric Medical Device Safety and Improvement Act of
    2007 (Public Law 110-85) is amended by striking ``2018 through 2022''
    and inserting ``2023 through 2027''.

    SEC. 710. REAUTHORIZATION OF PROVISION RELATED 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 ``2022'' and inserting
    ``2027''.

    SEC. 711. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
                        PARTNERSHIP PROGRAM.

      Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    360bbb-5(f)) is amended by striking ``$6,000,000 for each of fiscal
    years 2018 through 2022'' and inserting ``$10,000,000 for each of
    fiscal years 2023 through 2027''.

    SEC. 712. REAUTHORIZATION OF ORPHAN DRUG GRANTS.

      Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended--
              (1) in subsection (a)--
                      (A) by striking ``and (3)'' and inserting ``(3)'';
                    and
                      (B) by inserting before the period at the end the
                    following: ``, and (4) developing regulatory science
                    pertaining to the chemistry, manufacturing, and
                    controls of individualized medical products to treat
                    individuals with rare diseases or conditions''; and
              (2) in subsection (c), by striking ``2018 through 2022'' and
            inserting ``2023 through 2027''.

    SEC. 713. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDITIONAL AUTHORITIES
                        OF FOOD AND DRUG ADMINISTRATION REGARDING
                        MOLECULARLY TARGETED CANCER DRUGS.

      (a) In General.--
              (1) Additional active ingredient for application drug;
            limitation regarding novel-combination application drug.--
            Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act
            (21 U.S.C. 355c(a)(3)) is amended--
                      (A) by redesignating subparagraphs (B) and (C) as
                    subparagraphs (C) and (D), respectively; and
                      (B) by striking subparagraph (A) and inserting the
                    following:
                      ``(A) In general.--For purposes of paragraph (1)(B),
                    the investigation described in this paragraph is (as
                    determined by the Secretary) a molecularly targeted
                    pediatric cancer investigation of--
                              ``(i) the drug or biological product for
                            which the application referred to in such
                            paragraph is submitted; or
                              ``(ii) such drug or biological product in
                            combination with--
                                      ``(I) an active ingredient of a drug
                                    or biological product--
                                              ``(aa) for which an approved
                                            application under section
                                            505(j) under this Act or under
                                            section 351(k) of the Public
                                            Health Service Act is in
                                            effect; and
                                              ``(bb) that is determined by
                                            the Secretary to be the
                                            standard of care for treating a
                                            pediatric cancer; or
                                      ``(II) an active ingredient of a drug
                                    or biological product--
                                              ``(aa) for which an approved
                                            application under section
                                            505(b) of this Act or section
                                            351(a) of the Public Health
                                            Service Act to treat an adult
                                            cancer is in effect and is held
                                            by the same person submitting
                                            the application under paragraph
                                            (1)(B); and
                                              ``(bb) that is directed at a
                                            molecular target that the
                                            Secretary determines to be
                                            substantially relevant to the
                                            growth or progression of a
                                            pediatric cancer.
                      ``(B) Additional requirements.--
                              ``(i) Design of investigation.--A molecularly
                            targeted pediatric cancer investigation
                            referred to in subparagraph (A) shall be
                            designed to yield clinically meaningful
                            pediatric study data that is 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.
                              ``(ii) Limitation.--An investigation
                            described in subparagraph (A)(ii) may be
                            required only if the drug or biological product
                            for which the application referred to in
                            paragraph (1)(B) contains either--
                                      ``(I) a single new active ingredient;
                                    or
                                      ``(II) more than one active
                                    ingredient, if an application for the
                                    combination of active ingredients has
                                    not previously been approved but each
                                    active ingredient has been previously
                                    approved to treat an adult cancer.
                              ``(iii) Results of already-completed
                            preclinical studies of application drug.--The
                            Secretary may require that reports on an
                            investigation required pursuant to paragraph
                            (1)(B) include the results of all preclinical
                            studies on which the decision to conduct such
                            investigation was based.
                              ``(iv) Rule of construction regarding
                            inactive ingredients.--With respect to a
                            combination of active ingredients referred to
                            in subparagraph (A)(ii), such subparagraph
                            shall not be construed as addressing the use of
                            inactive ingredients with such combination.''.
              (2) Determination of applicable requirements.--Section
            505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (21
            U.S.C. 355c(e)(1)) is amended by adding at the end the
            following: ``The Secretary shall determine whether subparagraph
            (A) or (B) of subsection (a)(1) shall apply with respect to an
            application before the date on which the applicant is required
            to submit the initial pediatric study plan under paragraph
            (2)(A).''.
              (3) Clarifying applicability.--Section 505B(a)(1) of the
            Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) is
            amended by adding at the end the following:
                      ``(C) Rule of construction.--No application that is
                    subject to the requirements of subparagraph (B) shall
                    be subject to the requirements of subparagraph (A), and
                    no application (or supplement to an application) that
                    is subject to the requirements of subparagraph (A)
                    shall be subject to the requirements of subparagraph
                    (B).''.
              (4) Conforming amendments.--Section 505B(a) of the Federal
            Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended--
                      (A) in paragraph (3)(C), as redesignated by paragraph
                    (1)(A) of this subsection, by striking ``investigations
                    described in this paragraph'' and inserting
                    ``investigations referred to in subparagraph (A)''; and
                      (B) in paragraph (3)(D), as redesignated by paragraph
                    (1)(A) of this subsection, by striking ``the
                    assessments under paragraph (2)(B)'' and inserting
                    ``the assessments required under paragraph (1)(A)''.
      (b) Guidance.--The Secretary shall--
              (1) not later than 6 months after the date of enactment of
            this Act, issue draft guidance on the implementation of the
            requirements in subsection (a); and
              (2) not later than 12 months after closing the comment period
            on such draft guidance, finalize such guidance.
      (c) Applicability.--The amendments made by this section apply with
    respect to any application under section 505(i) of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 355(i)) and any application under
    section 351(a) of the Public Health Service Act (42 U.S.C. 262), that
    is submitted on or after the date that is 3 years after the date of
    enactment of this Act.
      (d) Reports to Congress.--
              (1) Secretary of health and human services.--Not later than 2
            years after the date of enactment of this Act, the Secretary of
            Health and Human Services shall submit to the Committee on
            Energy and Commerce of the House of Representatives and the
            Committee on Health, Education, Labor, and Pensions of the
            Senate a report on the Secretary's efforts, in coordination
            with industry, to ensure implementation of the amendments made
            by subsection (a).
              (2) GAO study and report.--
                      (A) Study.--Not later than 2 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 subsection (a), in the development of drugs
                    and biological products for pediatric cancer
                    indications.
                      (B) Findings.--Not later than 4 years after the date
                    of enactment of this Act, the Comptroller General 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 the findings of the study conducted under
                    subparagraph (A).

                            Subtitle B--Inspections

    SEC. 721. FACTORY INSPECTION.

      (a) In General.--Section 704(a)(1) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by striking ``restricted
    devices'' each place it appears and inserting ``devices''.
      (b) Records or Other Information.--
              (1) Establishments.--Section 704(a)(4)(A) of the Federal
            Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is
            amended--
                      (A) by striking ``an establishment that is engaged in
                    the manufacture, preparation, propagation, compounding,
                    or processing of a drug'' and inserting ``an
                    establishment that is engaged in the manufacture,
                    preparation, propagation, compounding, or processing of
                    a drug or device, or that is subject to inspection
                    under paragraph (5)(C),''; and
                      (B) by inserting after ``a sufficient description of
                    the records requested'' the following: ``and a
                    rationale for requesting such records or other
                    information in advance of, or in lieu of, an
                    inspection''.
              (2) Guidance.--
                      (A) In general.--The Secretary of Health and Human
                    Services shall issue or update guidance describing--
                              (i) circumstances in which the Secretary
                            intends to issue requests for records or other
                            information in advance of, or in lieu of, an
                            inspection under section 704(a)(4) of the
                            Federal Food, Drug, and Cosmetic Act, as
                            amended by paragraph (1);
                              (ii) processes for responding to such
                            requests electronically or in physical form;
                            and
                              (iii) factors the Secretary intends to
                            consider in evaluating whether such records and
                            other information are provided within a
                            reasonable timeframe, within reasonable limits,
                            and in a reasonable manner, accounting for
                            resource and other limitations that may exist,
                            including for small businesses.
                      (B) Timing.--The Secretary of Health and Human
                    Services shall--
                              (i) not later than 1 year after the date of
                            enactment of this Act, issue draft guidance
                            under subparagraph (A); and
                              (ii) not later than 1 year after the close of
                            the comment period for such draft guidance,
                            issue final guidance under subparagraph (A).
      (c) Bioresearch Monitoring Inspections.--
              (1) In general.--Section 704(a) of the Federal Food, Drug,
            and Cosmetic Act (21 U.S.C. 374(a)) is amended by adding at the
            end the following:
              ``(5) Bioresearch monitoring inspections.--
                      ``(A) In general.--The Secretary may, to ensure the
                    accuracy and reliability of studies and records or
                    other information described in subparagraph (B) and to
                    assess compliance with applicable requirements under
                    this Act or the Public Health Service Act, enter sites
                    and facilities specified in subparagraph (C) in order
                    to inspect such records or other information.
                      ``(B) Information subject to inspection.--An
                    inspection under this paragraph shall extend to all
                    records and other information related to the studies
                    and submissions described in subparagraph (E),
                    including records and information related to the
                    conduct, results, and analyses of, and the protection
                    of human and animal trial participants participating
                    in, such studies.
                      ``(C) Sites and facilities subject to inspection.--
                              ``(i) Sites and facilities described.--The
                            sites and facilities subject to inspection by
                            the Secretary under this paragraph are those
                            owned or operated by a person described in
                            clause (ii) and which are (or were) utilized by
                            such person in connection with--
                                      ``(I) developing an application or
                                    other submission to the Secretary under
                                    this Act or the Public Health Service
                                    Act related to marketing authorization
                                    for a product described in paragraph
                                    (1);
                                      ``(II) preparing, conducting, or
                                    analyzing the results of a study
                                    described in subparagraph (E); or
                                      ``(III) holding any records or other
                                    information described in subparagraph
                                    (B).
                              ``(ii) Persons described.--A person described
                            in this clause is--
                                      ``(I) the sponsor of an application
                                    or submission specified in subparagraph
                                    (E);
                                      ``(II) a person engaged in any
                                    activity described in clause (i) on
                                    behalf of such a sponsor, through a
                                    contract, grant, or other business
                                    arrangement with such sponsor;
                                      ``(III) an institutional review
                                    board, or other individual or entity,
                                    engaged by contract, grant, or other
                                    business arrangement with a nonsponsor
                                    in preparing, collecting, or analyzing
                                    records or other information described
                                    in subparagraph (B); or
                                      ``(IV) any person not otherwise
                                    described in this clause that conducts,
                                    or has conducted, a study described in
                                    subparagraph (E) yielding records or
                                    other information described in
                                    subparagraph (B).
                      ``(D) Conditions of inspection.--
                              ``(i) Access to information subject to
                            inspection.--Subject to clause (ii), an entity
                            that owns or operates any site or facility
                            subject to inspection under this paragraph
                            shall provide the Secretary with access to
                            records and other information described in
                            subparagraph (B) that is held by or under the
                            control of such entity, including--
                                      ``(I) permitting the Secretary to
                                    record or copy such information for
                                    purposes of this paragraph;
                                      ``(II) providing the Secretary with
                                    access to any electronic information
                                    system utilized by such entity to hold,
                                    process, analyze, or transfer any
                                    records or other information described
                                    in subparagraph (B); and
                                      ``(III) permitting the Secretary to
                                    inspect the facilities, equipment,
                                    written procedures, processes, and
                                    conditions through which records or
                                    other information described in
                                    subparagraph (B) is or was generated,
                                    held, processed, analyzed, or
                                    transferred.
                              ``(ii) No effect on applicability of
                            provisions for protection of proprietary
                            information or trade secrets.--Nothing in
                            clause (i) shall negate, supersede, or
                            otherwise affect the applicability of
                            provisions, under this or any other Act,
                            preventing or limiting the disclosure of
                            confidential commercial information or other
                            information considered proprietary or trade
                            secret.
                              ``(iii) Reasonableness of inspections.--An
                            inspection under this paragraph shall be
                            conducted at reasonable times and within
                            reasonable limits and in a reasonable manner.
                      ``(E) Studies and submissions described.--The studies
                    and submissions described in this subparagraph are each
                    of the following:
                              ``(i) Clinical and nonclinical studies
                            submitted to the Secretary in support of, or
                            otherwise related to, applications and other
                            submissions to the Secretary under this Act or
                            the Public Health Service Act for marketing
                            authorization of a product described in
                            paragraph (1).
                              ``(ii) Postmarket safety activities conducted
                            under this Act or the Public Health Service
                            Act.
                              ``(iii) Any other clinical investigation of--
                                      ``(I) a drug subject to section 505
                                    or 512 of this Act or section 351 of
                                    the Public Health Service Act; or
                                      ``(II) a device subject to section
                                    520(g).
                              ``(iv) Any other submissions made under this
                            Act or the Public Health Service Act with
                            respect to which the Secretary determines an
                            inspection under this paragraph is warranted in
                            the interest of public health.
                      ``(F) Clarification.--This paragraph clarifies the
                    authority of the Secretary to conduct inspections of
                    the type described in this paragraph and shall not be
                    construed as a basis for inferring that, prior to the
                    date of enactment of this paragraph, the Secretary
                    lacked the authority to conduct such inspections,
                    including under this Act or the Public Health Service
                    Act.''.
              (2) Review of processes and practices; guidance for
            industry.--
                      (A) In general.--The Secretary of Health and Human
                    Services shall--
                              (i) review processes and practices in effect
                            as of the date of enactment of this Act
                            applicable to inspections of foreign and
                            domestic sites and facilities described in
                            subparagraph (C)(i) of section 704(a)(5) of the
                            Federal Food, Drug, and Cosmetic Act, as added
                            by paragraph (1); and
                              (ii) evaluate whether any updates are needed
                            to facilitate the consistency of such processes
                            and practices.
                      (B) Guidance.--
                              (i) In general.--The Secretary of Health and
                            Human Services shall issue guidance describing
                            the processes and practices applicable to
                            inspections of sites and facilities described
                            in subparagraph (C)(i) of section 704(a)(5) of
                            the Federal Food, Drug, and Cosmetic Act, as
                            added by paragraph (1), including with respect
                            to the types of records and information
                            required to be provided, best practices for
                            communication between the Food and Drug
                            Administration and industry in advance of or
                            during an inspection or request for records or
                            other information, and other inspections-
                            related conduct, to the extent not specified in
                            existing publicly available Food and Drug
                            Administration guides and manuals for such
                            inspections.
                              (ii) Timing.--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 under clause (i);
                                    and
                                      (II) not later than 1 year after the
                                    close of the public comment period for
                                    such draft guidance, issue final
                                    guidance under clause (i).

    SEC. 722. USES OF CERTAIN EVIDENCE.

      Section 703 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    373) is amended by adding at the end the following:
      ``(c) Applicability.--The limitations on the Secretary's use of
    evidence obtained under this section, or any evidence which is directly
    or indirectly derived from such evidence, in a criminal prosecution of
    the person from whom such evidence was obtained shall not apply to
    evidence, including records or other information, obtained under
    authorities other than this section, unless such limitations are
    specifically incorporated by reference in such other authorities.''.

    SEC. 723. IMPROVING FDA INSPECTIONS.

      (a) Risk Factors for Establishments.--Section 510(h)(4) of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)(4)) is amended--
              (1) by redesignating subparagraph (F) as subparagraph (G);
            and
              (2) by inserting after subparagraph (E) the following:
                      ``(F) The compliance history of establishments in the
                    country or region in which the establishment is located
                    that are subject to regulation under this Act,
                    including the history of violations related to products
                    exported from such country or region that are subject
                    to such regulation.''.
      (b) Use of Records.--Section 704(a)(4) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 374(a)(4)) is amended--
              (1) by redesignating subparagraph (C) as subparagraph (D);
            and
              (2) by inserting after subparagraph (B) the following:
      ``(C) The Secretary may rely on any records or other information that
    the Secretary may inspect under this section to satisfy requirements
    that may pertain to a preapproval or risk-based surveillance
    inspection, or to resolve deficiencies identified during such
    inspections, if applicable and appropriate.''.
      (c) Recognition of Foreign Government Inspections.--Section 809 of
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e) is amended--
              (1) in subsection (a)(1), by inserting ``preapproval or''
            before ``risk-based inspections''; and
              (2) by adding at the end the following:
      ``(c) Periodic Review.--
              ``(1) In general.--Beginning not later than 1 year after the
            date of the enactment of the Food and Drug Amendments of 2022,
            the Secretary shall periodically assess whether additional
            arrangements and agreements with a foreign government or an
            agency of a foreign government, as allowed under this section,
            are appropriate.
              ``(2) Reports to congress.--Beginning not later than 4 years
            after the date of the enactment of the Food and Drug Amendments
            of 2022, and every 4 years 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 describing the findings and
            conclusions of each review conducted under paragraph (1).''.

    SEC. 724. GAO REPORT ON INSPECTIONS OF FOREIGN ESTABLISHMENTS
                        MANUFACTURING DRUGS.

      (a) In General.--Not later than 18 months after the date of the
    enactment of this Act, the Comptroller General of the United States
    shall submit to the Committee on Energy and Commerce of the House of
    Representatives and the Committee on Health, Education, Labor, and
    Pensions of the Senate a report on inspections conducted by--
              (1) the Secretary of Health and Human Services (in this
            section referred to as the ``Secretary'') of foreign
            establishments pursuant to subsections (h) and (i) of section
            510 and section 704 of the Federal Food, Drug, and Cosmetic Act
            (21 U.S.C. 360; 374); or
              (2) a foreign government or an agency of a foreign government
            pursuant to section 809 of such Act (21 U.S.C. 384e).
      (b) Contents.--The report conducted under subsection (a) shall
    include--
              (1) what alternative tools, including remote inspections or
            remote evaluations, other countries are utilizing to facilitate
            inspections of foreign establishments;
              (2) how frequently trusted foreign regulators conduct
            inspections of foreign facilities that could be useful to the
            Food and Drug Administration to review in lieu of its own
            inspections;
              (3) how frequently and under what circumstances, including
            for what types of inspections, the Secretary utilizes existing
            agreements or arrangements under section 809 of the Federal
            Food, Drug, and Cosmetic Act (21 U.S.C. 384e) and whether the
            use of such agreements could be appropriately expanded;
              (4) whether the Secretary has accepted reports of inspections
            of facilities in China and India conducted by entities with
            which they have entered into such an agreement or arrangement;
              (5) what additional foreign governments or agencies of
            foreign governments the Secretary has considered entering into
            a mutual recognition agreement with and, if applicable, reasons
            why the Secretary declined to enter into a mutual recognition
            agreement with such foreign governments or agencies;
              (6) what tools, if any, the Secretary used to facilitate
            inspections of domestic facilities that could also be
            effectively utilized to appropriately inspect foreign
            facilities;
              (7) what steps the Secretary has taken to identify and
            evaluate tools and strategies the Secretary may use to continue
            oversight with respect to inspections when in-person
            inspections are disrupted;
              (8) how the Secretary is considering incorporating
            alternative tools into the inspection activities conducted
            pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
            301 et seq.); and
              (9) what steps the Secretary has taken to identify and
            evaluate how the Secretary may use alternative tools to address
            workforce shortages to carry out such inspection activities.

    SEC. 725. UNANNOUNCED FOREIGN FACILITY INSPECTIONS PILOT PROGRAM.

      (a) In General.--The Secretary of Health and Human Services (referred
    to in this section as the ``Secretary'') shall conduct a pilot program
    under which the Secretary increases the conduct of unannounced
    surveillance inspections of foreign human drug establishments and
    evaluates the differences between such inspections of domestic and
    foreign human drug establishments, including the impact of announcing
    inspections to persons who own or operate foreign human drug
    establishments in advance of an inspection. Such pilot program shall
    evaluate--
              (1) differences in the number and type of violations of
            section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic
            Act (21 U.S.C. 351(a)(2)(B)) identified as a result of
            unannounced and announced inspections of foreign human drug
            establishments and any other significant differences between
            each type of inspection;
              (2) costs and benefits associated with conducting announced
            and unannounced inspections of foreign human drug
            establishments;
              (3) barriers to conducting unannounced inspections of foreign
            human drug establishments and any challenges to achieving
            parity between domestic and foreign human drug establishment
            inspections; and
              (4) approaches for mitigating any negative effects of
            conducting announced inspections of foreign human drug
            establishments.
      (b) Pilot Program Scope.--The inspections evaluated under the pilot
    program under this section shall be routine surveillance inspections
    and shall not include inspections conducted as part of the Secretary's
    evaluation of a request for approval to market a drug submitted under
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the
    Public Health Service Act (42 U.S.C. 201 et seq.).
      (c) Pilot Program Initiation.--The Secretary shall initiate the pilot
    program under this section not later than 180 days after the date of
    enactment of this Act.
      (d) Report.--The Secretary shall, not later than 180 days following
    the completion of the pilot program under this section, make available
    on the website of the Food and Drug Administration a final report on
    the pilot program under this section, including--
              (1) findings and any associated recommendations with respect
            to the evaluation under subsection (a), including any
            recommendations to address identified barriers to conducting
            unannounced inspections of foreign human drug establishments;
              (2) findings and any associated recommendations regarding how
            the Secretary may achieve parity between domestic and foreign
            human drug inspections; and
              (3) the number of unannounced inspections during the pilot
            program that would not be unannounced under existing practices.

    SEC. 726. 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 ``2022'' and inserting
    ``2027''.

    SEC. 727. ENHANCING INTRA-AGENCY COORDINATION AND PUBLIC HEALTH
                        ASSESSMENT WITH REGARD TO COMPLIANCE ACTIVITIES.

      (a) Coordination.--Section 506D of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 356d) is amended by adding at the end the
    following:
      ``(g) Coordination.--The Secretary shall ensure timely and effective
    internal coordination and alignment among the field investigators of
    the Food and Drug Administration and the staff of the Center for Drug
    Evaluation and Research's Office of Compliance and Drug Shortage
    Program regarding--
              ``(1) the reviews of reports shared pursuant to section
            704(b)(2); and
              ``(2) any feedback or corrective or preventive actions in
            response to such reports.''.
      (b) Reporting.--
              (1) In general.--Section 506C-1(a)(2) of the Federal Food,
            Drug, and Cosmetic Act (21 U.S.C. 356c-1(a)(2)) is amended to
            read as follows:
              ``(2)(A) describes the communication between the field
            investigators of the Food and Drug Administration and the staff
            of the Center for Drug Evaluation and Research's Office of
            Compliance and Drug Shortage Program, including the Food and
            Drug Administration's procedures for enabling and ensuring such
            communication;
              ``(B) provides the number of reports described in section
            704(b)(2) that were required to be sent to the appropriate
            offices of the Food and Drug Administration and the number of
            such reports that were sent; and
              ``(C) describes the coordination and alignment activities
            undertaken pursuant to section 506D(g);''.
              (2) Applicability.--The amendment made by paragraph (1) shall
            apply with respect to reports submitted on or after March 31,
            2023.

    SEC. 728. REPORTING OF MUTUAL RECOGNITION AGREEMENTS FOR INSPECTIONS
                        AND REVIEW ACTIVITIES.

      (a) In General.--Not later than December 31, 2022, and annually
    thereafter, the Secretary of Health and Human Services (referred to in
    this section as the ``Secretary'') shall publish a report on the public
    website of the Food and Drug Administration on the utilization of
    agreements entered into pursuant to section 809 of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 384e) or otherwise entered into by
    the Secretary in the previous fiscal year to recognize inspections
    between drug regulatory authorities across countries and international
    regions with analogous review criteria to the Food and Drug
    Administration, such as the Pharmaceutical Inspection Co-Operation
    Scheme, the Mutual Recognition Agreement with the European Union, and
    the Australia-Canada-Singapore-Switzerland-United Kingdom Consortium.
      (b) Content.--The report under subsection (a) shall include each of
    the following:
              (1) The total number of establishments that are registered
            under section 510(i) of the Federal Food, Drug, and Cosmetic
            Act (21 U.S.C. 360(i)), and the number of such establishments
            in each region of interest.
              (2)  The total number of inspections conducted at
            establishments described in paragraph (1), disaggregated by
            inspections conducted--
                      (A) pursuant to an agreement or other recognition
                    described in subsection (a); and
                      (B) by employees or contractors of the Food and Drug
                    Administration.
              (3) Of the inspections described in paragraph (2), the total
            number of inspections in each region of interest.
              (4) Of the inspections in each region of interest reported
            pursuant to paragraph (3), the number of inspections in each
            FDA inspection category.
              (5) Of the number of inspections reported under each of
            paragraphs (3) and (4)--
                      (A) the number of inspections which have been
                    conducted pursuant to an agreement or other recognition
                    described in subsection (a); and
                      (B) the number of inspections which have been
                    conducted by employees or contractors of the Food and
                    Drug Administration.
      (c) Definitions.--In this section:
              (1) FDA inspection category.--The term ``FDA inspection
            category'' means the following inspection categories:
                      (A) Inspections to support approvals of changes to
                    the manufacturing process of drugs approved under
                    section 505 of the Federal Food, Drug, and Cosmetic Act
                    (21 U.S.C. 355) or section 351 of the Public Health
                    Service Act (42 U.S.C. 262).
                      (B) Surveillance inspections.
                      (C) For-cause inspections.
              (2) Region of interest.--The term ``region of interest''
            means China, India, the European Union, and any other
            geographic region as the Secretary determines appropriate.

    SEC. 729. ENHANCING TRANSPARENCY OF DRUG FACILITY INSPECTION TIMELINES.

      Section 902 of the FDA Reauthorization Act of 2017 (21 U.S.C. 355
    note) is amended to read as follows:

    ``SEC. 902. ANNUAL REPORT ON INSPECTIONS.

      ``Not later than 120 days after the end of each fiscal year, the
    Secretary of Health and Human Services shall post on the public website
    of the Food and Drug Administration information related to inspections
    of facilities necessary for approval of a drug under subsection (c) or
    (j) of 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 fiscal 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, including--
                      ``(A) the median time for drugs described in section
                    505(j)(11)(A)(i) of the Federal Food, Drug, and
                    Cosmetic Act (21 U.S.C. 355(j)(11)(A)(i));
                      ``(B) the median time for drugs described in section
                    506C(a) of such Act (21 U.S.C. 356c(a)) only; and
                      ``(C) the median time for drugs on the drug shortage
                    list in effect under section 506E of such Act (21
                    U.S.C. 356e).
              ``(2) The median time from the issuance of a report pursuant
            to section 704(b) of such Act (21 U.S.C. 374(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,
            including the median time for each category of drugs listed in
            subparagraphs (A) through (C) of paragraph (1).
              ``(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 actions indicated to address the
            conditions or practices observed during an inspection.
              ``(4) The number of facilities that failed to implement
            adequate corrective or preventive actions following a report
            pursuant to such section 704(b), resulting in a withhold
            recommendation, including the number of such times for each
            category of drugs listed in subparagraphs (A) through (C) of
            paragraph (1).''.

          TITLE VIII--TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY
                                  IMPROVEMENTS

    SEC. 801. PROMPT REPORTS OF MARKETING STATUS BY HOLDERS OF APPROVED
                        APPLICATIONS FOR BIOLOGICAL PRODUCTS.

      (a) In General.--Section 506I of the Federal Food, Drug, and Cosmetic
    Act (21 U.S.C. 356i) is amended--
              (1) in subsection (a)--
                      (A) in the matter preceding paragraph (1), by
                    striking ``The holder of an application approved under
                    subsection (c) or (j) of section 505'' and inserting
                    ``The holder of an application approved under
                    subsection (c) or (j) of section 505 of this Act or
                    subsection (a) or (k) of section 351 of the Public
                    Health Service Act'';
                      (B) in paragraph (2), by striking ``established
                    name'' and inserting ``established name (for biological
                    products, by proper name)''; and
                      (C) in paragraph (3), by striking ``or abbreviated
                    application number'' and inserting ``, abbreviated
                    application number, or biologics license application
                    number''; and
              (2) in subsection (b)--
                      (A) in the matter preceding paragraph (1), by
                    striking ``The holder of an application approved under
                    subsection (c) or (j)'' and inserting ``The holder of
                    an application approved under subsection (c) or (j) of
                    section 505 of this Act or subsection (a) or (k) of
                    section 351 of the Public Health Service Act'';
                      (B) in paragraph (1), by striking ``established
                    name'' and inserting ``established name (for biological
                    products, by proper name)''; and
                      (C) in paragraph (2), by striking ``or abbreviated
                    application number'' and inserting ``, abbreviated
                    application number, or biologics license application
                    number''.
      (b) Additional One-Time Report.--Subsection (c) of section 506I of
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amended to
    read as follows:
      ``(c) Additional One-Time Report.--Within 180 days of the date of
    enactment of the Food and Drug Amendments of 2022, all holders of
    applications approved under subsection (a) or (k) of section 351 of the
    Public Health Service Act shall review the information in the list
    published under section 351(k)(9)(A) and shall submit a written notice
    to the Secretary--
              ``(1) stating that all of the application holder's biological
            products in the list published under section 351(k)(9)(A) that
            are not listed as discontinued are available for sale; or
              ``(2) including the information required pursuant to
            subsection (a) or (b), as applicable, for each of the
            application holder's biological products that are in the list
            published under section 351(k)(9)(A) and not listed as
            discontinued, but have been discontinued from sale or never
            have been available for sale.''.
      (c) Purple Book.--Section 506I of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 356i) is amended--
              (1) by striking subsection (d) and inserting the following:
      ``(d) Failure To Meet Requirements.--If a holder of an approved
    application fails to submit the information required under subsection
    (a), (b), or (c), the Secretary may--
              ``(1) move the application holder's drugs from the active
            section of the list published under section 505(j)(7)(A) to the
            discontinued section of the list, except that the Secretary
            shall remove from the list in accordance with section
            505(j)(7)(C) drugs the Secretary determines have been withdrawn
            from sale for reasons of safety or effectiveness; and
              ``(2) identify the application holder's biological products
            as discontinued in the list published under section
            351(k)(9)(A) of the Public Health Service Act, except that the
            Secretary shall remove from the list in accordance with section
            351(k)(9)(B) of such Act biological products for which the
            license has been revoked or suspended for reasons of safety,
            purity, or potency.''; and
              (2) in subsection (e)--
                      (A) by inserting after the first sentence the
                    following: ``The Secretary shall update the list
                    published under section 351(k)(9)(A) of the Public
                    Health Service Act based on information provided under
                    subsections (a), (b), and (c) by identifying as
                    discontinued biological products that are not available
                    for sale, except that biological products for which the
                    license has been revoked or suspended for safety,
                    purity, or potency reasons shall be removed from the
                    list in accordance with section 351(k)(9)(B) of the
                    Public Health Service Act.'';
                      (B) by striking ``monthly updates to the list'' and
                    inserting ``monthly updates to the lists referred to in
                    the preceding sentences''; and
                      (C) by striking ``and shall update the list based
                    on'' and inserting ``and shall update such lists based
                    on''.
      (d) Technical Corrections.--Section 506I(e) of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 356i(e)) is amended--
              (1) by striking ``subsection 505(j)(7)(A)'' and inserting
            ``section 505(j)(7)(A)''; and
              (2) by striking ``subsection 505(j)(7)(C)'' and inserting
            ``section 505(j)(7)(C)''.

    SEC. 802. ENCOURAGING BLOOD DONATION.

      (a) Streamlining Patient and Blood Donor Input.--Section 3003 of the
    21st Century Cures Act (21 U.S.C. 360bbb-8c note) is amended to read as
    follows:

    ``SEC. 3003. STREAMLINING PATIENT AND BLOOD DONOR INPUT.

      ``Chapter 35 of title 44, United States Code, shall not apply to the
    collection of information to which a response is voluntary, to
    solicit--
              ``(1) the views and perspectives of patients under section
            569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
            360bbb-8c) (as amended by section 3001) or section 3002; or
              ``(2) information from blood donors or potential blood donors
            to support the development of recommendations by the Secretary
            of Health and Human Services acting through the Commissioner of
            Food and Drugs concerning blood donation.''.
      (b) Clerical Amendment.--The table of contents in section 1(b) of the
    21st Century Cures Act is amended by striking the item relating to
    section 3003 and inserting the following:

    ``Sec. 3003. Streamlining patient and blood donor input.''.

    SEC. 803. REGULATION OF CERTAIN PRODUCTS AS DRUGS.

      Section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    353) is amended by adding at the end the following:
      ``(h)(1) Any contrast agent, radioactive drug, or OTC monograph drug
    shall be deemed to be a drug under section 201(g) and not a device
    under section 201(h).
      ``(2) For purposes of this subsection:
              ``(A) The term `contrast agent' means an article that is
            intended for use in conjunction with a medical imaging device,
            and--
                      ``(i) is a diagnostic radiopharmaceutical, as defined
                    in sections 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) The term `radioactive drug' has the meaning given such
            term in section 310.3(n) of title 21, Code of Federal
            Regulations (or any successor regulations), except that such
            term does not include--
                      ``(i) an implant or article similar to an implant;
                      ``(ii) an article that applies radiation from outside
                    of the body; or
                      ``(iii) the radiation source of an article described
                    in clause (i) or (ii).
              ``(C) The term `OTC monograph drug' has the meaning given
            such term in section 744L.
      ``(3) Nothing in this subsection shall be construed as allowing for
    the classification of a product as a drug (as defined in section
    201(g)) if such product--
              ``(A) is not described in paragraph (1); and
              ``(B) meets the definition of a device under section 201(h),
    unless another provision of this Act otherwise indicates a different
    classification.''.

    SEC. 804. POSTAPPROVAL STUDIES AND PROGRAM INTEGRITY FOR ACCELERATED
                        APPROVAL DRUGS.

      (a) In General.--Section 506(c) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 356(c)) is amended--
              (1) by striking paragraph (2) and inserting the following:
              ``(2) Limitation.--
                      ``(A) In general.--Approval of a product under this
                    subsection may be subject to 1 or both of the following
                    requirements:
                              ``(i) That the sponsor conduct an appropriate
                            postapproval study or studies (which may be
                            augmented or supported by real world evidence)
                            to verify and describe the predicted effect on
                            irreversible morbidity or mortality or other
                            clinical benefit.
                              ``(ii) That the sponsor submit copies of all
                            promotional materials related to the product
                            during the preapproval review period and,
                            following approval and for such period
                            thereafter as the Secretary determines to be
                            appropriate, at least 30 days prior to
                            dissemination of the materials.
                      ``(B) Studies not required.--If the Secretary does
                    not require that the sponsor of a product approved
                    under accelerated approval conduct a postapproval study
                    under this paragraph, the Secretary shall publish on
                    the website of the Food and Drug Administration the
                    rationale for why such study is not appropriate or
                    necessary.
                      ``(C) Postapproval study conditions.--Not later than
                    the time of approval of a product under accelerated
                    approval, the Secretary shall specify the conditions
                    for a postapproval study or studies required to be
                    conducted under this paragraph with respect to such
                    product, which may include enrollment targets, the
                    study protocol, and milestones, including the target
                    date of study completion.
                      ``(D) Studies begun before approval.--The Secretary
                    may require such study or studies to be underway prior
                    to approval.''; and
              (2) by striking paragraph (3) and inserting the following:
              ``(3) Expedited withdrawal of approval.--
                      ``(A) In general.--The Secretary may withdraw
                    approval of a product approved under accelerated
                    approval using expedited procedures described in
                    subparagraph (B), if--
                              ``(i) the sponsor fails to conduct any
                            required postapproval study of the product with
                            due diligence, including with respect to
                            conditions specified by the Secretary under
                            paragraph (2)(C);
                              ``(ii) a study required to verify and
                            describe the predicted effect on irreversible
                            morbidity or mortality or other clinical
                            benefit of the product fails to verify and
                            describe such effect or benefit;
                              ``(iii) other evidence demonstrates that the
                            product is not shown to be safe or effective
                            under the conditions of use; or
                              ``(iv) the sponsor disseminates false or
                            misleading promotional materials with respect
                            to the product.
                      ``(B) Expedited procedures described.--Expedited
                    procedures described in this subparagraph shall consist
                    of, prior to the withdrawal of accelerated approval--
                              ``(i) providing the sponsor with--
                                      ``(I) due notice;
                                      ``(II) an explanation for the
                                    proposed withdrawal;
                                      ``(III) an opportunity for a meeting
                                    with the Commissioner of Food and Drugs
                                    or the Commissioner's designee; and
                                      ``(IV) an opportunity for written
                                    appeal to--
                                              ``(aa) the Commissioner of
                                            Food and Drugs; or
                                              ``(bb) a designee of the
                                            Commissioner who has not
                                            participated in the proposed
                                            withdrawal of approval (other
                                            than a meeting pursuant to
                                            subclause (III)) and is not a
                                            subordinate of an individual
                                            (other than the Commissioner)
                                            who participated in such
                                            proposed withdrawal;
                              ``(ii) providing an opportunity for public
                            comment on the notice proposing to withdraw
                            approval;
                              ``(iii) the publication of a summary of the
                            public comments received, and the Secretary's
                            response to such comments, on the website of
                            the Food and Drug Administration; and
                              ``(iv) convening and consulting an advisory
                            committee on issues related to the proposed
                            withdrawal, if requested by the sponsor and if
                            no such advisory committee has previously
                            advised the Secretary on such issues with
                            respect to the withdrawal of the product prior
                            to the sponsor's request.
              ``(4) Labeling.--
                      ``(A) In general.--Subject to subparagraph (B), the
                    labeling for a product approved under accelerated
                    approval shall include--
                              ``(i) a statement indicating that the product
                            was approved under accelerated approval;
                              ``(ii) a statement indicating that continued
                            approval of the product is subject to
                            postmarketing studies to verify clinical
                            benefit;
                              ``(iii) identification of the surrogate or
                            intermediate endpoint or endpoints that
                            supported approval and any known limitations of
                            such surrogate or intermediate endpoint or
                            endpoints in determining clinical benefit; and
                              ``(iv) a succinct description of the product
                            and any uncertainty about anticipated clinical
                            benefit and a discussion of available evidence
                            with respect to such clinical benefit.
                      ``(B) Applicability.--The labeling requirements of
                    subparagraph (A) shall apply only to products approved
                    under accelerated approval for which the predicted
                    effect on irreversible morbidity or mortality or other
                    clinical benefit has not been verified.
                      ``(C) Rule of construction.--With respect to any
                    application pending before the Secretary on the date of
                    enactment of the Food and Drug Amendments of 2022, the
                    Secretary shall allow any applicable changes to the
                    product labeling required to comply with subparagraph
                    (A) to be made by supplement after the approval of such
                    application.
              ``(5) Reporting.--Not later than September 30, 2025, 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
            describing circumstances in which the Secretary considered real
            world evidence submitted to support postapproval studies
            required under this subsection that were completed after the
            date of enactment of the Food and Drug Amendments of 2022.''.
      (b) Reports of Postmarketing Studies.--Section 506B(a) of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 356b(a)) is amended--
              (1) by redesignating paragraph (2) as paragraph (3); and
              (2) by inserting after paragraph (1) the following:
              ``(2) Accelerated approval.--Notwithstanding paragraph (1), a
            sponsor of a drug approved under accelerated approval shall
            submit to the Secretary a report of the progress of any study
            required under section 506(c), including progress toward
            enrollment targets, milestones, and other information as
            required by the Secretary, not later than 180 days after the
            approval of such drug and not less frequently than every 180
            days thereafter, until the study is completed or terminated.''.
      (c) Guidance.--
              (1) In general.--The Secretary of Health and Human Services
            shall issue guidance describing--
                      (A) how sponsor questions related to the
                    identification of novel surrogate or intermediate
                    clinical endpoints may be addressed in early-stage
                    development meetings with the Food and Drug
                    Administration;
                      (B) the use of novel clinical trial designs that may
                    be used to conduct appropriate postapproval studies as
                    may be required under section 506(c)(2)(A) of the
                    Federal Food, Drug, and Cosmetic Act (21 U.S.C.
                    356(c)(2)(A)), as amended by subsection (a); and
                      (C) the expedited procedures described in section
                    506(c)(3)(B) of the Federal Food, Drug, and Cosmetic
                    Act (21 U.S.C. 356(c)(3)(B)).
              (2) Final guidance.--The Secretary shall issue--
                      (A) draft guidance under paragraph (1) not later than
                    18 months after the date of enactment of this Act; and
                      (B) final guidance not later than 1 year after the
                    close of the public comment period on such draft
                    guidance.
      (d) Rare Disease Endpoint Advancement Pilot.--
              (1) In general.--The Secretary of Health and Human Services
            shall establish a pilot program under which the Secretary will
            establish procedures to provide increased interaction with
            sponsors of rare disease drug development programs for purposes
            of advancing the development of efficacy endpoints, including
            surrogate and intermediate endpoints, for drugs intended to
            treat rare diseases, including through--
                      (A) determining eligibility of participants for such
                    a program; and
                      (B) developing and implementing a process for
                    applying to, and participating in, such a program.
              (2) Public workshops.--The Secretary shall conduct up to 3
            public workshops, which shall be completed not later than
            September 30, 2026, to discuss topics relevant to the
            development of endpoints for rare diseases, which may include
            discussions about--
                      (A) novel endpoints developed through the pilot
                    program established under this subsection; and
                      (B) as appropriate, the use of real world evidence
                    and real world data to support the validation of
                    efficacy endpoints, including surrogate and
                    intermediate endpoints, for rare diseases.
              (3) Report.--Not later than September 30, 2027, 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
            describing the outcomes of the pilot program established under
            this subsection.
              (4) Guidance.--Not later than September 30, 2027, the
            Secretary shall issue guidance describing best practices and
            strategies for development of efficacy endpoints, including
            surrogate and intermediate endpoints, for rare diseases.
              (5) Sunset.--The Secretary may not accept any new application
            or request to participate in the program established by this
            subsection on or after October 1, 2027.

    SEC. 805. FACILITATING THE USE OF REAL WORLD EVIDENCE.

      (a) Guidance.--Not later than 1 year after the date of the enactment
    of this Act, the Secretary of Health and Human Services shall issue, or
    revise existing, guidance on considerations for the use of real world
    data and real world evidence to support regulatory decisionmaking, as
    follows:
              (1) With respect to drugs, such guidance shall address--
                      (A) the use of such data and evidence to support the
                    approval of a drug application under section 505 of the
                    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
                    a biological product application under section 351 of
                    the Public Health Service Act (42 U.S.C. 262), or to
                    support an investigational use exemption under section
                    505(i) of the Federal Food, Drug, and Cosmetic Act or
                    section 351(a)(3) of the Public Health Service Act; and
                      (B) the use of such data and evidence obtained as a
                    result of the use of drugs authorized for emergency use
                    under section 564 of the Federal Food, Drug, and
                    Cosmetic Act (21 U.S.C. 360bbb-3) in such applications,
                    submissions, or requests; and
                      (C) standards and methodologies which may be used for
                    collection and analysis of real world evidence included
                    in such applications, submissions, or requests, as
                    appropriate.
              (2) With respect to devices, such guidance shall address--
                      (A) the use of such data and evidence to support the
                    approval, clearance, or classification of a device
                    pursuant to an application or submission submitted
                    under section 510(k), 513(f)(2), or 515 of the Federal
                    Food, Drug, and Cosmetic Act (21 U.S.C. 360(k),
                    360c(f)(2), 360e), or to support an investigational use
                    exemption under section 520(g) of such Act (21 U.S.C.
                    360j(g));
                      (B) the use of such data and evidence obtained as a
                    result of the use of devices authorized for emergency
                    use under section 564 of the Federal Food, Drug, and
                    Cosmetic Act (21 U.S.C. 360bbb-3), in such
                    applications, submissions, or requests; and
                      (C) standards and methodologies which may be used for
                    collection and analysis of real world evidence included
                    in such applications, submissions, or requests, as
                    appropriate.
      (b) Report to Congress.--Not later than 2 years after the termination
    of the public health emergency determination by the Secretary of Health
    and Human Services under section 564 of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 360bbb-3) on February 4, 2020, with respect to
    the Coronavirus Disease 2019 (COVID-19), the Secretary shall submit a
    report to the Committee on Energy and Commerce of the House of
    Representatives and the Committee on Health, Education, Labor, and
    Pensions of the Senate on--
              (1) the number of applications, submissions, or requests
            submitted for clearance or approval under section 505, 510(k),
            513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act
            (21 U.S.C. 355, 360(k), 360c(f)(2), 360e) or section 351 of the
            Public Health Service Act, for which an authorization under
            section 564 of the Federal Food, Drug, and Cosmetic Act (21
            U.S.C. 360bbb-3) was previously granted;
              (2) of the number of applications so submitted, the number of
            such applications--
                      (A) for which real world evidence was submitted and
                    used to support a regulatory decision; and
                      (B) for which real world evidence was submitted and
                    determined to be insufficient to support a regulatory
                    decision; and
              (3) a summary explanation of why, in the case of applications
            described in paragraph (2)(B), real world evidence could not be
            used to support regulatory decisions.
      (c) Information Disclosure.--Nothing in this section shall be
    construed to authorize the disclosure of information that is prohibited
    from disclosure under section 1905 of title 18, United States Code, or
    subject to withholding under subsection (b)(4) of section 552 of title
    5, United States Code (commonly referred to as the ``Freedom of
    Information Act'').

    SEC. 806. DUAL SUBMISSION FOR CERTAIN DEVICES.

      Section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    360c) is amended by adding at the end the following:
      ``(k) For a device authorized for emergency use under section 564 for
    which, in accordance with section 564(m), the Secretary has deemed a
    laboratory examination or procedure associated with such device to be
    in the category of examinations and procedures described in section
    353(d)(3) of the Public Health Service Act, the sponsor of such device
    may, when submitting a request for classification under section
    513(f)(2), submit a single submission containing--
              ``(1) the information needed for such a request; and
              ``(2) sufficient information to enable the Secretary to
            determine whether such laboratory examination or procedure
            satisfies the criteria to be categorized under section
            353(d)(3) of the Public Health Service Act.''.

    SEC. 807. MEDICAL DEVICES ADVISORY COMMITTEE MEETINGS.

      (a) In General.--The Secretary shall convene one or more panels of
    the Medical Devices Advisory Committee not less than once per year for
    the purpose of providing advice to the Secretary on topics related to
    medical devices used in pandemic preparedness and response, including
    topics related to in vitro diagnostics.
      (b) Required Panel Member.--A panel convened under subsection (a)
    shall include at least 1 population health-specific representative.
      (c) Sunset.--This section shall cease to be effective on October 1,
    2027.

    SEC. 808. ENSURING CYBERSECURITY OF MEDICAL DEVICES.

      (a) In General.--Subchapter A of chapter V of the Federal Food, Drug,
    and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by section 501, is
    further amended by adding at the end the following:

    ``SEC. 524C. ENSURING CYBERSECURITY OF DEVICES.

      ``(a) In General.--For purposes of ensuring cybersecurity throughout
    the lifecycle of a cyber device, any person who submits a premarket
    submission for the cyber device shall include such information as the
    Secretary may require to ensure that the cyber device meets such
    cybersecurity requirements as the Secretary determines to be
    appropriate to demonstrate a reasonable assurance of safety and
    effectiveness, including at a minimum the cybersecurity requirements
    under subsection (b).
      ``(b) Cybersecurity Requirements.--At a minimum, the manufacturer of
    a cyber device shall meet the following cybersecurity requirements:
              ``(1) The manufacturer shall have a plan to appropriately
            monitor, identify, and address in a reasonable time postmarket
            cybersecurity vulnerabilities and exploits, including
            coordinated vulnerability disclosure and procedures.
              ``(2) The manufacturer shall design, develop, and maintain
            processes and procedures to ensure the device and related
            systems are cybersecure, and shall make available updates and
            patches to the cyber device and related systems throughout the
            lifecycle of the cyber device to address--
                      ``(A) on a reasonably justified regular cycle, known
                    unacceptable vulnerabilities; and
                      ``(B) as soon as possible out of cycle, critical
                    vulnerabilities that could cause uncontrolled risks.
              ``(3) The manufacturer shall provide in the labeling of the
            cyber device a software bill of materials, including
            commercial, open-source, and off-the-shelf software components.
              ``(4) The manufacturer shall comply with such other
            requirements as the Secretary may require to demonstrate
            reasonable assurance of the safety and effectiveness of the
            device for purposes of cybersecurity, which the Secretary may
            require by an order published in the Federal Register.
      ``(c) Substantial Equivalence.--In making a determination of
    substantial equivalence under section 513(i) for a cyber device, the
    Secretary may--
              ``(1) find that cybersecurity information for the cyber
            device described in the relevant premarket submission in the
            cyber device's use environment is inadequate; and
              ``(2) issue a nonsubstantial equivalence determination based
            on this finding.
      ``(d) Definition.--In this section:
              ``(1) Cyber device.--The term `cyber device' means a device
            that--
                      ``(A) includes software, including software as or in
                    a device;
                      ``(B) has the ability to connect to the internet; or
                      ``(C) contains any such technological characteristics
                    that could be vulnerable to cybersecurity threats.
              ``(2) Lifecycle of the cyber device.--The term `lifecycle of
            the cyber device' includes the postmarket lifecycle of the
            cyber device.
              ``(3) Premarket submission.--The term `premarket submission'
            means any submission under section 510(k), 513, 515(c), 515(f),
            or 520(m).
      ``(e) Exemption.--The Secretary may identify devices or types of
    devices that are exempt from meeting the cybersecurity requirements
    established by this section and regulations promulgated pursuant to
    this section. The Secretary shall publish in the Federal Register, and
    update, as appropriate, a list of the devices and types of devices so
    identified by the Secretary.''.
      (b) Prohibited Act.--Section 301(q) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 331(q)) is amended by adding at the end the
    following:
      ``(3) The failure to comply with any requirement under section 524C
    (relating to ensuring device cybersecurity).''.
      (c) Adulteration.--Section 501 of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph
    (j) the following:
      ``(k) If it is a device subject to the requirements set forth in
    section 524C (relating to ensuring device cybersecurity) and fails to
    comply with any requirement under that section.''.
      (d) Misbranding.--Section 502(t) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 352(t)) is amended--
              (1) by striking ``or (3)'' and inserting ``(3)''; and
              (2) by inserting before the period at the end the following:
            ``, or (4) to furnish a software bill of materials as required
            under section 524C (relating to ensuring device
            cybersecurity)''.

    SEC. 809. PUBLIC DOCKET ON PROPOSED CHANGES TO THIRD-PARTY VENDORS.

      (a) In General.--
              (1) Opening public docket.--Not later than 90 days after the
            date of enactment of this Act, the Secretary of Health and
            Human Services shall open a single public docket to solicit
            comments on factors that generally should be considered by the
            Secretary when reviewing requests from sponsors of drugs
            subject to risk evaluation and mitigation strategies to change
            third-party vendors engaged by sponsors to aid in
            implementation and management of the strategies.
              (2) Factors.--Such factors include the potential effects of
            changes in third-party vendors on--
                      (A) patient access; and
                      (B) prescribing and administration of the drugs by
                    health care providers.
              (3) Closing public docket.--The Secretary of Health and Human
            Services may close such public docket not earlier than 90 days
            after such docket is opened.
              (4) No delay.--Nothing in this section shall delay agency
            action on any modification to a risk evaluation and mitigation
            strategy.
      (b) GAO Report.--Not later than December 31, 2026, the Comptroller
    General of the United States shall submit to the Committee on Energy
    and Commerce of the House of Representatives and the Committee on
    Health, Education, Labor, and Pensions of the Senate a report on--
              (1) the number of changes in third-party vendors (engaged by
            sponsors to aid implementation and management of risk
            evaluation and mitigation strategies) for an approved risk
            evaluation and mitigation strategy the Secretary of Health and
            Human Services has approved under section 505-1(h) of the
            Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(h));
              (2) any issues affecting patient access to the drug that is
            subject to the strategy or considerations with respect to the
            administration or prescribing of such drug by health care
            providers that arose as a result of such modifications; and
              (3) how such issues were resolved, as applicable.

    SEC. 810. FACILITATING EXCHANGE OF PRODUCT INFORMATION PRIOR TO
                        APPROVAL.

      (a) In General.--Section 502 of the Federal Food, Drug, and Cosmetic
    Act (21 U.S.C. 352) is amended--
              (1) in paragraph (a)--
                      (A) by striking ``drugs for coverage'' and inserting
                    ``drugs or devices for coverage''; and
                      (B) by striking ``drug'' each place it appears and
                    inserting ``drug or device'', respectively;
              (2) in paragraphs (a)(1) and (a)(2)(B), by striking ``under
            section 505 or under section 351 of the Public Health Service
            Act'' and inserting ``under section 505, 510(k), 513(f)(2), or
            515 of this Act or section 351 of the Public Health Service
            Act'';
              (3) in paragraph (a)(1)--
                      (A) by striking ``under section 505 or under section
                    351(a) of the Public Health Service Act'' and inserting
                    ``under section 505, 510(k), 513(f)(2), or 515 of this
                    Act or section 351 of the Public Health Service Act'';
                    and
                      (B) by striking ``in section 505(a) or in subsections
                    (a) and (k) of section 351 of the Public Health Service
                    Act'' and inserting ``in section 505, 510(k),
                    513(f)(2), or 515 of this Act or section 351 of the
                    Public Health Service Act''; and
              (4) by adding at the end the following:
      ``(gg)(1) Unless its labeling bears adequate directions for use in
    accordance with paragraph (f), except that (in addition to drugs or
    devices that conform with exemptions pursuant to such paragraph) no
    drug or device shall be deemed to be misbranded under such paragraph
    through the provision of product information to a payor, formulary
    committee, or other similar entity with knowledge and expertise in the
    area of health care economic analysis carrying out its responsibilities
    for the selection of drugs or devices for coverage or reimbursement if
    the product information relates to an investigational drug or device or
    investigational use of a drug or device that is approved, cleared,
    granted marketing authorization, or licensed under section 505, 510(k),
    513(f)(2), or 515 of this Act or section 351 of the Public Health
    Service Act (as applicable), provided--
              ``(A) the product information includes--
                      ``(i) a clear statement that the investigational drug
                    or device or investigational use of a drug or device
                    has not been approved, cleared, granted marketing
                    authorization, or licensed under section 505, 510(k),
                    513(f)(2), or 515 of this Act or section 351 of the
                    Public Health Service Act (as applicable) and that the
                    safety and effectiveness of the drug or device or use
                    has not been established;
                      ``(ii) information related to the stage of
                    development of the drug or device involved, such as--
                              ``(I) the status of any study or studies in
                            which the investigational drug or device or
                            investigational use is being investigated;
                              ``(II) how the study or studies relate to the
                            overall plan for the development of the drug or
                            device; and
                              ``(III) whether an application, premarket
                            notification, or request for classification for
                            the investigational drug or device or
                            investigational use has been submitted to the
                            Secretary and when such a submission is
                            planned;
                      ``(iii) in the case of information that includes
                    factual presentations of results from studies, which
                    shall not be selectively presented, a description of--
                              ``(I) all material aspects of study design,
                            methodology, and results; and
                              ``(II) all material limitations related to
                            the study design, methodology, and results;
                      ``(iv) where applicable, a prominent statement
                    disclosing the indication or indications for which the
                    Secretary has approved, granted marketing
                    authorization, cleared, or licensed the product
                    pursuant to section 505, 510(k), 513(f)(2), or 515 of
                    this Act or section 351 of the Public Health Service
                    Act, and a copy of the most current required labeling;
                    and
                      ``(v) updated information, if previously communicated
                    information becomes materially outdated as a result of
                    significant changes or as a result of new information
                    regarding the product or its review status; and
              ``(B) the product information does not include--
                      ``(i) information that represents that an unapproved
                    product--
                              ``(I) has been approved, cleared, granted
                            marketing authorization, or licensed under
                            section 505, 510(k), 513(f)(2), or 515 of this
                            Act or section 351 of the Public Health Service
                            Act (as applicable); or
                              ``(II) has otherwise been determined to be
                            safe or effective for the purpose or purposes
                            for which the drug or device is being studied;
                            or
                      ``(ii) information that represents that an unapproved
                    use of a drug or device that has been so approved,
                    granted marketing authorization, cleared, or licensed--
                              ``(I) is so approved, granted marketing
                            authorization, cleared, or licensed; or
                              ``(II) that the product is safe or effective
                            for the use or uses for which the drug or
                            device is being studied.
      ``(2) For purposes of this paragraph, the term `product information'
    includes--
              ``(A) information describing the drug or device (such as drug
            class, device description, and features);
              ``(B) information about the indication or indications being
            investigated;
              ``(C) the anticipated timeline for a possible approval,
            clearance, marketing authorization, or licensure pursuant to
            section 505, 510(k), 513, or 515 of this Act or section 351 of
            the Public Health Service Act;
              ``(D) drug or device pricing information;
              ``(E) patient utilization projections;
              ``(F) product-related programs or services; and
              ``(G) factual presentations of results from studies that do
            not characterize or make conclusions regarding safety or
            efficacy.''.
      (b) GAO Study and Report.--Beginning on the date that is 5 years and
    6 months after the date of enactment of this Act, the Comptroller
    General of the United States shall conduct a study on the provision and
    use of information pursuant to section 502(gg) of the Federal Food,
    Drug, and Cosmetic Act, as added by this subsection (a), between
    manufacturers of drugs and devices (as defined in section 201 of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) and entities
    described in such section 502(gg). Such study shall include an analysis
    of the following:
              (1) The types of information communicated between such
            manufacturers and payors.
              (2) The manner of communication between such manufacturers
            and payors.
              (3)(A) Whether such manufacturers file an application for
            approval, marketing authorization, clearance, or licensing of a
            new drug or device or the new use of a drug or device that is
            the subject of communication between such manufacturers and
            payors under section 502(gg) of the Federal Food, Drug, and
            Cosmetic Act, as added by subsection (a).
              (B) How frequently the Food and Drug Administration approves,
            grants marketing authorization, clears, or licenses the new
            drug or device or new use.
              (C) The timeframe between the initial communications
            permitted under section 502(gg) of the Federal Food, Drug, and
            Cosmetic Act, as added by subsection (a), regarding an
            investigational drug or device or investigational use, and the
            initial marketing of such drug or device.

    SEC. 811. BANS OF DEVICES FOR ONE OR MORE INTENDED USES.

      (a) In General.--Section 516(a) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 360f(a)) is amended--
              (1) in paragraph (1), by inserting ``for one or more intended
            use'' before the semicolon at the end; and
              (2) in the matter following paragraph (2), by inserting ``for
            any such intended use or uses. A device that is banned for one
            or more intended uses is not a legally marketed device under
            section 1006 when intended for such use or uses'' after
            ``banned device''.
      (b) Specific Devices Deemed Banned.--Section 516 of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 360f) is further amended by adding at
    the end the following:
      ``(c) Specific Device Banned.--Electrical stimulation devices that
    apply a noxious electrical stimulus to a person's skin intended to
    reduce or cease self-injurious behavior or aggressive behavior are
    deemed to be banned devices, as described in subsection (a).
      ``(d) Reversal by Regulation.--Devices banned under this section are
    banned devices unless or until the Secretary promulgates a regulation
    to make such devices or use of such devices no longer banned based on a
    finding that such devices or use of such devices does not present
    substantial deception or an unreasonable and substantial risk of
    illness or injury, or that such risk can be corrected or eliminated by
    labeling.''.

    SEC. 812. CLARIFYING APPLICATION OF EXCLUSIVE APPROVAL, CERTIFICATION,
                        OR LICENSURE FOR DRUGS DESIGNATED FOR RARE DISEASES
                        OR CONDITIONS.

      (a) Application of Exclusive Approval, Certification, or Licensure
    for Drugs Designated for Rare Diseases or Conditions.--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 ``same disease or condition'' and inserting ``same
            approved indication or use within such rare disease or
            condition'';
              (2) in subsection (b)--
                      (A) in the matter preceding paragraph (1), by
                    striking ``same rare disease or condition'' and
                    inserting ``same indication or use for which the
                    Secretary has approved or licensed such drug''; and
                      (B) in paragraph (1), by striking ``with the disease
                    or condition for which the drug was designated'' and
                    inserting ``for whom the drug is indicated''; and
              (3) in subsection (c), by striking ``same rare disease or
            condition'' and inserting ``same indication or use''.
      (b) Application of Amendments.--The amendments made by subsection (a)
    shall apply with respect to any drug designated under section 526 of
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regardless
    of the date on which the drug was so designated, and regardless of the
    date on which the drug was approved under section 505 of such Act (21
    U.S.C. 355) or licensed under section 351 of the Public Health Service
    Act (42 U.S.C. 262).

    SEC. 813. GAO REPORT ON THIRD-PARTY REVIEW.

      Not later than September 30, 2026, the Comptroller General of the
    United States shall submit to the Committee on Energy and Commerce of
    the House of Representatives and the Committee on Health, Education,
    Labor, and Pensions of the Senate a report on the third-party review
    program described in section 523 of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 360m). Such report shall include--
              (1) a description of the financial and staffing resources
            used to carry out such program;
              (2) a description of actions taken by the Secretary pursuant
            section 523(b)(2)(C) of the Federal Food, Drug, and Cosmetic
            Act (21 U.S.C. 360m(b)(2)(C)); and
              (3) the results of an audit of the performance of select
            persons accredited under such program.

    SEC. 814. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY
                        REVIEW APPLICATIONS.

      Section 807 of the FDA Reauthorization Act of 2017 (Public Law 115-
    52) is amended, in the matter preceding paragraph (1), by striking
    ``2022'' and inserting ``2027''.

    SEC. 815. FDA WORKFORCE IMPROVEMENTS.

      Section 714A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    379d-3a) is amended--
              (1) in subsection (a), by striking ``medical products'' and
            inserting ``products regulated by the Food and Drug
            Administration''; and
              (2) by striking subsection (d) and inserting the following:
      ``(d) Agency-wide Strategic Workforce Plan.--
              ``(1) In general.--Not later than 1 year after the date of
            enactment of the Food and Drug Amendments of 2022, the
            Commissioner of Food and Drugs shall develop and begin
            implementation of an agency-wide strategic workforce plan at
            the Food and Drug Administration, which shall include--
                      ``(A) agency-wide human capital goals and strategies;
                      ``(B) performance measures, benchmarks, or other
                    elements to facilitate the monitoring and evaluation of
                    the progress made toward such goals and the
                    effectiveness of such strategies; and
                      ``(C) a process for updating such plan based on
                    timely and relevant information on an ongoing basis.
              ``(2) Report to congress.--Not later than 18 months after the
            date of enactment of the Food and Drug Amendments of 2022, 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
            describing the plan under paragraph (1) and the status of its
            implementation.''.

                             I. Purpose and Summary

        H.R. 7667, the ``Food and Drug Amendments of 2022,''
    enables Food and Drug Administration (FDA) to continue to
    collect user fees from regulated industry to supplement
    Congressional appropriations for the premarket review and
    regulation of medical products. Specifically, the bill revises
    and reauthorizes provisions of the Prescription Drug User Fee
    Act (PDUFA), the Medical Device User Fee Amendments (MDUFA),
    the Generic Drug User Fee Amendments (GDUFA), and the
    Biosimilars User Fee Act (BsUFA) through 2027. The legislation
    also includes various provisions that will promote clinical
    trial diversity, encourage increased generic drug competition,
    preserve existing incentives for orphan drug development,
    facilitate a more resilient supply chain, and improve the
    review and regulation of medical products and the inspections
    of facilities that manufacture them.

                    II. Background and Need for Legislation

    A. User Fees

        Since 1992, pursuant to PDUFA, Congress has authorized FDA
    to collect fees from regulated industry to supplement
    Congressional appropriations. Revenues generated from these
    fees have been used on specific activities related to the
    review and regulation of medical products. FDA also commits to
    meeting certain performance goals, such as completing product
    reviews within specified timeframes. FDA's ability to collect
    such fees must be reauthorized every five years following a
    process laid out in statute that involves negotiations between
    the agency and regulated industry and recommendations provided
    to Congress. The reauthorization process allows for input by
    other interested stakeholders, including patient and consumer
    groups, and provides opportunity for broader public comment.
        Based in large part on the positive impact PDUFA had on
    expediting new drug product review times and improving related
    regulatory activities at FDA, Congress authorized FDA to
    collect medical device user fees in 2002 as part of the Medical
    Device User Fee and Modernization Act.\1\ MDUFA user fees were
    reauthorized in 2007, 2012, and 2017, along with PDUFA.
    ---------------------------------------------------------------------------
        \1\Pub. L. No. 107-250 (2002).
    ---------------------------------------------------------------------------
        Due to growing concerns from a wide range of stakeholders
    about the time it was taking FDA to review generic drug
    applications and the backlog of such applications pending at
    the agency, Congress passed the Generic Drug User Fee
    Amendments (GDUFA) in 2012 as part of the Food and Drug
    Administration Safety and Innovation Act (FDASIA).\2\ Congress
    reauthorized GDUFA user fees in 2017.
    ---------------------------------------------------------------------------
        \2\Pub. L. No. 112-114 (2012).
    ---------------------------------------------------------------------------
        As part of FDASIA, Congress also passed BsUFA in 2012 to
    authorize FDA to collect user fees from biosimilar product
    manufacturers. Congress reauthorized BsUFA in 2017.
        Each of these four user fee programs is due to expire at
    the end of this fiscal year and must be reauthorized if FDA is
    to continue collecting fees to support review programs and
    other functions of the agency. H.R. 7667 would reauthorize all
    four user fee programs through 2027. The Committee also
    considered additional policies that would improve the
    regulation of certain medical products, a number of which are
    also included in the bill.

    B. Improvements Across Product Areas

                1. Clinical Study Diversity
        Clinical studies--studies in human subjects--are
    fundamental to assessing whether medical products are safe and
    effective for a particular use and patient population.\3\ FDA
    relies on these studies to assess whether medical products meet
    applicable premarket review standards, which determines whether
    they may be marketed, as well as what uses and patient
    populations they may be approved for, what labeling, including
    warnings and contraindications is required, and whether
    additional post-market studies are warranted, among other
    considerations. These studies also inform physician decisions
    regarding diagnosis and treatment, and providers and patients
    rely on FDA's premarket review and labeling determinations in
    their medical decision-making.
    ---------------------------------------------------------------------------
        \3\U.S. Food and Drug Administration, Step 3: Clinical Research
    (www.fda.gov/patients/drug-development-process/step-3-clinical-
    research) (Jan. 4, 2018).
    ---------------------------------------------------------------------------
        Neither diseases nor medical products affect everyone the
    same way. Certain demographic groups are at higher risk of
    developing certain illnesses or conditions than others; a
    product that poses little risk or is highly effective in some
    demographic groups may pose serious risks or provide little
    benefit to others.\4\ Non-demographic factors such as co-
    morbidities can also affect outcomes. Inclusion of diverse,
    representative populations in clinical studies can enable
    identification of these differences in risk and benefit across
    subgroups before a product comes to market,\5\ which in turn
    can improve both regulatory and medical decision-making. It is
    thus critical that the participants that sponsors and
    investigators enroll in a clinical study are reflective of the
    patient population expected to use the medical product, both as
    a matter of health equity and as a matter of good science and
    medicine.\6\
    ---------------------------------------------------------------------------
        \4\House Committee on Energy and Commerce, Subcommittee on Health,
    Testimony of Dr. Ruben Mesa, Executive Director, Mays Cancer Center at
    UT Health San Antonio MD Anderson, Hearing on The Future of Medicine:
    Legislation to Encourage Innovation and Improve Oversight, 117th Cong.
    (Mar. 17, 2022) (energycommerce.house.gov/sites/
    democrats.energycommerce
    .house.gov/files/documents/Witness%20Testimony_Mesa_HE_2022.03.17.pdf).
        \5\Food and Drug Administration, Draft Guidance, Diversity Plans to
    Improve Enrollment of Participants from Underrepresented Racial and
    Ethnic Populations in Clinical Trials (April 2022) (www.fda.gov/
    regulatory-information/search-fda-guidance-documents/diversity-plans-
    improve-enrollment-participants-underrepresented-racial-and-ethnic-
    populations).
        \6\See note 4; National Academies of Sciences, Engineering, and
    Medicine, Improving Representation in Clinical Trials and Research:
    Building Research Equity for Women and Underrepresented Groups (2022)
    (nap.nationalacademies.org/download/26479).
    ---------------------------------------------------------------------------
        At present, clinical studies often lack adequate diversity.
    Individuals from Black or African American, Hispanic/Latino,
    Indigenous and Native American, Asian, Native Hawaiian and
    other Pacific Islander populations and other persons of color
    ``are frequently underrepresented in biomedical research
    despite having a disproportionate disease burden for certain
    diseases relative to their proportional representation in the
    general population.''\7\ For example, in an FDA analysis of
    nearly 300,000 people who participated in clinical studies
    between 2015 and 2019, only seven percent identified as African
    American and only 13 percent identified as Hispanic or
    Latino,\8\ despite these groups making up 13.4 percent and 18.5
    percent of the United States population, respectively.\9\ There
    are various reasons for this lack of adequate representation.
    On the sponsor side, there may be challenges to including
    subpopulations where expanding enrollment may require
    additional time or resources.\10\ On the participant side,
    barriers include lack of awareness of open studies, mistrust of
    research, financial and language barriers, and lack of
    diversity among those conducting the studies.\11\
    ---------------------------------------------------------------------------
        \7\See note 4.
        \8\Food and Drug Administration, 2015-2019 Drug Trials Snapshots
    Summary Report (www.fda.gov/media/143592/download).
        \9\Census Bureau, QuickFacts (www.census.gov/quickfacts/fact/table/
    US/PST045221) (accessed May 24, 2022).
        \10\See note 6 at 134-35.
        \11\See note 4.
    ---------------------------------------------------------------------------
        Title V of H.R. 7667 addresses both sides of this problem.
    Under section 501, the legislation requires sponsors of phase 3
    or other pivotal studies of drugs and biological products, and
    sponsors of clinical studies of devices, to develop, implement,
    and submit to FDA diversity action plans that include the
    sponsor's goals for study enrollment, a rationale for such
    goals, and an explanation of how these goals will be met.
    Section 501 also requires FDA to update its guidance to address
    sponsor diversity goals, disaggregated by age group, sex, race,
    geographic location, socioeconomic status, and ethnicity, and
    how sponsors will publicly post key information from their
    plans on their website. Building on some of the experience
    gained during the current coronavirus disease 2019 (COVID-19)
    pandemic, the legislation also requires guidance addressing
    decentralized study enrollment, including the engagement,
    enrollment, and retention of a meaningfully diverse study
    population and recommendations for sponsors to reduce burdens
    for participants through digital health technology, telehealth,
    local providers and laboratories, or other means.
        To further advance the goal of robust diverse
    participation, the legislation requires FDA to further study
    and discuss these issues. Section 502 requires FDA to evaluate
    whether there is a need for additional authorities to assure
    that sponsors conduct post-approval studies or postmarket
    surveillance in certain circumstances where premarket studies
    collect insufficient data for underrepresented subgroups.
    Section 503 requires public workshops to discuss how study
    enrollment of historically underrepresented populations may be
    increased and how participation reflective of the prevalence of
    a disease among subgroups may be encouraged, the creation of a
    docket for public comment regarding such information, and the
    publication of an FDA report on such workshops on its website.
    Section 504 requires an annual report from FDA to Congress
    summarizing the diversity action plans received, whether goals
    were met, and the reasons given why any goals were not met. The
    report also must include any postmarket studies required or
    recommended by FDA based on its existing authority and the
    premarket study lacked adequate diversity. Section 505 requires
    a public meeting regarding the clinical study flexibilities
    initiated in response to the COVID-19 pandemic, including how
    such flexibilities, such as those relating to study
    decentralization, may have affected access to studies by
    unrepresented or underrepresented populations, including racial
    and ethnic minorities, and how they may help improve clinical
    study access and diverse enrollment in the future. Finally,
    Section 506 requires FDA to issue guidance recommending how
    digital health technology or other remote assessment options
    could support decentralized clinical studies, as well as
    considerations for sponsors to minimize or reduce burdens for
    clinical study participants, thus encouraging the retention of
    a meaningfully diverse clinical population.
                2. Inspections
        The COVID-19 pandemic and an increasing reliance on drugs
    manufactured overseas has illustrated the need for updates and
    clarification with respect to FDA's inspectional authorities
    for medical products, in particular with respect to certain
    aspects of foreign inspections, bioresearch monitoring
    inspections, and inspections of records both in-person and
    remotely.
        Concerns have been raised in recent years regarding FDA's
    inspections of foreign medical product facilities, including
    with respect to its practice of preannouncing most of these
    inspections. For example, in 2019 the Government Accountability
    Office (GAO) reported:

              FDA investigators identified persistent challenges
            conducting foreign inspections, raising questions about
            the equivalence of foreign to domestic inspections. For
            example, while domestic inspections are almost always
            unannounced, FDA's practice of preannouncing foreign
            inspections up to 12 weeks in advance may give
            manufacturers the opportunity to fix problems [before
            the investigator arrives]. Investigators from FDA's
            China and India offices do conduct some unannounced
            inspections, but they are involved in a small
            percentage of inspections in these countries (27
            percent and 10 percent, respectively).\12\
    ---------------------------------------------------------------------------
        \12\House Committee on Energy and Commerce, Subcommittee on
    Oversight and Investigations, Testimony of Mary Denigan-Macauley,
    Director, U.S. Government Accountability Office, Hearing on Securing
    the U.S. Drug Supply Chain: Oversight of FDA's Foreign Inspection
    Program, Preliminary Findings Indicate Persistent Challenges with FDA
    Foreign Inspections, 116th Cong. (Dec. 10, 2019) (www.gao.gov/assets/
    gao-20-262t.pdf).

        On the other hand, FDA investigators reported some benefits
    to preannouncing foreign inspections, including avoiding
    wasting agency resources, better preparation of establishment
    records and staff, and ensuring the safety of investigators in
    the foreign country,\13\ which has become more of a concern
    during the COVID-19 public health emergency. FDA also reported
    a lack of data that would enable it to assess the relative
    merits of unannounced and preannounced inspections.\14\ GAO
    more recently reported that FDA plans to implement two pilot
    programs to help address challenges related to preannounced
    inspections and language barriers, which will include gathering
    data that can be used to evaluate differences between announced
    and unannounced inspections.\15\ However, FDA has not yet
    finalized the design of these pilots due to the COVID-19
    pandemic.\16\
    ---------------------------------------------------------------------------
        \13\Id.
        \14\Id.
        \15\Government Accountability Office, GAO-22-103611, Drug Safety:
    FDA Should Take Additional Steps to Improve its Foreign Inspection
    Program (Jan. 2022) (www.gao.gov/assets/gao-22-103611.pdf).
        \16\Id.
    ---------------------------------------------------------------------------
        H.R. 7667 addresses these issues in several ways. Section
    725 requires FDA to initiate a pilot program within 180 days of
    enactment in which FDA increases the conduct of unannounced
    surveillance inspections of foreign drug establishments,
    evaluates the differences between such inspections of domestic
    and foreign establishments, including the impact of announcing
    inspections, and posts a report of its findings and
    recommendations on the FDA website. Section 721 requires FDA to
    review its processes and practices applicable to bioresearch
    monitoring inspections in the United States and in foreign
    countries, evaluate whether updates are needed to facilitate
    consistency, and issue guidance describing the conduct of such
    inspections. Section 723 provides for FDA consideration of the
    compliance history of other FDA-regulated establishments in the
    country or region in which an establishment is located as a
    factor in establishing a schedule for risk-based inspections
    and requires a periodic assessment of whether additional
    arrangements with foreign governments pertaining to recognition
    of foreign government inspections of foreign establishments are
    appropriate. Currently, FDA has these arrangements in place
    with the European Union and the United Kingdom; however, the
    agency's inspection capabilities may benefit from assessing
    whether additional arrangements with countries with robust
    regulatory systems and drug safety protocols, such as Israel,
    Japan, or others, are appropriate, taking into account public
    health and safety, and any differences with regard to how these
    systems operate. Section 728 requires FDA to annually publish
    on its website a report on the utilization of these and other
    agreements entered into with foreign governments with review
    criteria analogous to those of FDA.
        Building on the lessons learned during the COVID-19
    pandemic, which has made in-person inspections more difficult,
    section 721 clarifies that FDA's authority to inspect records,
    among other things, applies not only to restricted devices but
    to all devices, and that FDA's authority to require records in
    advance or in lieu of an inspection applies not only to drugs
    but devices as well. Section 721 also codifies and clarifies
    FDA authority to inspect clinical study sites, also known as
    bioresearch monitoring inspections, including with respect to
    records. Section 723 clarifies that FDA may rely on any records
    or other information inspected to satisfy requirements that may
    pertain to a preapproval or risk-based surveillance inspection,
    or to resolve deficiencies found in such inspections, if
    applicable and appropriate. Finally, section 727 requires FDA
    to ensure timely and effective internal coordination and
    alignment among field investigators and staff regarding the
    reviews of inspection reports and any feedback or corrective
    actions in response to such reports and requires FDA reporting
    to Congress regarding such coordination and feedback and
    regarding certain drug shortage reports.
                3. Appropriate and Consistent Regulation of Certain
                        Products as Drugs
        FDA has consistently regulated contrast agents as drugs for
    decades. However, a 2021 decision by the Court of Appeals for
    the District of Columbia Circuit created uncertainty as to
    whether these products, as well as certain therapeutic
    radioactive products and certain products that have been
    regulated under over-the-counter drug monographs, could be
    regulated by FDA as drugs or medical devices.\17\ Devices have
    different standards for premarket review and different
    regulatory requirements from drugs. Without a legislative
    remedy, sponsors of contrast agents and certain other products
    who went through the drug approval process may be unnecessarily
    subject to new regulatory regimes.
    ---------------------------------------------------------------------------
        \17\Genus Med. Techs., LLC v. FDA, 994 F.3d 631 (D.C. Cir. 2021).
    ---------------------------------------------------------------------------
        This court-mandated change raises concerns about fairness
    and potential negative consequences for patients. The
    uncertainty and determinations regarding which products may
    transition, the timing and process by which they would
    transition, and how they would be regulated as devices would
    impose additional costs on sponsors and the agency. Section 803
    of H.R. 7667 addresses these concerns by preserving the
    longstanding status quo of regulation of these products as
    drugs, as they have been regulated for decades.
                4. Real World Evidence
        Real-world evidence (RWE) has been playing an increasing
    role in health care and regulatory decision-making in recent
    years, for example with respect to clinical practice
    guidelines, improving clinical study designs, and postmarket
    safety monitoring.\18\ While RWE holds great promise for
    further advancing the study, regulation, and use of medical
    products, further understanding and development of RWE and RWE
    generation practices is needed. At least one example in which
    RWE played a significant role in premarket drug review, for a
    product used in combination with other immunosuppressant drugs
    to prevent organ rejection in lung transplant recipients,
    illustrates this point.\19\ First, while FDA relied on RWE in
    its approval of a new indication for Prograf (tacrolimus), it
    has not yet approved a new molecular entity primarily relying
    on RWE; second, the observed clinical benefit was so large that
    it was highly unlikely that the outcomes could be explained by
    bias; and third, in addition to RWE, the approval was also
    supported by randomized controlled trials of the drug in other
    settings, which provided confirmatory evidence of
    effectiveness, and additional clinical trial evidence from
    research publications, which supported the independent
    contribution of the drug as part of a multidrug regimen.\20\
    ---------------------------------------------------------------------------
        \18\Food and Drug Administration, Real-World Evidence (www.fda.gov/
    science-research/science-and-research-special-topics/real-world-
    evidence) (accessed May 24, 2022).
        \19\Food and Drug Administration, FDA Approval Demonstrates the
    Role of Real-World Evidence in Regulatory Decision-Making on Drug
    Effectiveness (Aug. 4, 2021) (www.fda.gov/drugs/news-events-human-
    drugs/fda-approval-demonstrates-role-real-world-evidence-regulatory-
    decision-making-drug-effectiveness).
        \20\Id.
    ---------------------------------------------------------------------------
        There is hope that RWE will not only reduce medical product
    development costs, speed patient access, and lower prices, but
    also provide greater confidence in their safety and
    effectiveness. Thus, it is important to advance the
    development, study, and regulatory application of RWE, while
    being careful to recognize that at the present time
    ``randomized and other types of clinical trials are still
    generally the most reliable way to assess the potential
    effectiveness of a drug and these trials will remain a critical
    part of the drug development process.''\21\
    ---------------------------------------------------------------------------
        \21\Id.
    ---------------------------------------------------------------------------
        Section 805 of H.R. 7667 aims to improve the understanding
    of the potential uses and limitations of RWE in the premarket
    review of medical products by requiring FDA to issue guidance
    addressing the use of RWE, including that obtained through
    COVID-19 emergency use authorizations, to support drug and
    device approvals and clearances. This section also advances
    this goal by requiring FDA to report to Congress regarding the
    number of applications including RWE submitted for products for
    which an emergency use authorization was granted and whether
    such evidence was sufficient to support a regulatory decision.
    Additionally, section 804 clarifies that RWE may augment or
    support appropriate postapproval studies required by FDA,
    including such conditions as the Secretary may require, to
    verify clinical benefit for drugs approved through accelerated
    approval.
                5. Pre-Approval Information Exchange
        Information about a drug or device being studied in
    clinical investigations can be used to inform payors, formulary
    committees, and other entities responsible for the selection of
    drugs or devices for coverage or reimbursement as they plan for
    and make coverage and reimbursement decisions. In its guidance
    on these communications, FDA has explained that the important
    impact these decisions have for many patients renders it
    critical that the information drug and device sponsors provide
    to payors about their products be truthful and not misleading,
    and that appropriate background and context be provided so that
    this sophisticated audience will understand its limitations and
    be able to make informed decisions.\22\
    ---------------------------------------------------------------------------
        \22\Food and Drug Administration, Drug and Device Manufacturer
    Communications with Payors, Formulary Committees, and Similar Entities,
    Questions and Answers (final guidance) (June 2018) (www.fda.gov/media/
    133620/download).
    ---------------------------------------------------------------------------
        In the interest of facilitating the provision of this
    information to these specific audiences and ensuring its
    accuracy and comprehensiveness, section 810 of H.R. 7667
    essentially codifies FDA's guidance on preapproval information
    exchange.\23\ Section 810 of H.R. 7667 amends section 502 of
    the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C.
    Sec. 352) to clarify that no drug or device shall be misbranded
    as a result of providing information regarding investigational
    drugs or devices or uses to payors, formulary committees, or
    other similar entities under specified conditions. It requires
    the information to include a clear statement that the drug or
    device discussed has not been approved, and that the safety and
    efficacy of the drug or device has not been established.
    Additional required disclosures to help ensure the information
    is not misleading include information about the studies the
    product is undergoing, whether an application for the drug or
    device has been submitted to FDA, and if not, when such
    submission is planned.
    ---------------------------------------------------------------------------
        \23\Id.
    ---------------------------------------------------------------------------
                6. Hiring
        FDA needs to be able to hire and retain a highly-skilled
    workforce with various types of specialized expertise in order
    to successfully carry out its mission to promote the public
    health by promptly and efficiently reviewing clinical research
    and taking appropriate action on the marketing of regulated
    products in a timely manner; and to protect the public health
    by ensuring that foods are safe, wholesome, sanitary, and
    properly labeled; human and veterinary drugs are safe and
    effective; there is reasonable assurance of the safety and
    effectiveness of devices intended for human use; cosmetics are
    safe and properly labeled; and public health and safety are
    protected from electronic product radiation.\24\ As the science
    behind the products FDA regulates becomes more complex and
    specialized, so too must the skills and expertise of its
    staff.\25\
    ---------------------------------------------------------------------------
        \24\Section 1003(b) of the FFDCA (21 U.S.C. Sec.  393(b)).
        \25\Food and Drug Administration, 21st Century Cures Workforce
    Planning Report to Congress (June 2018) (www.fda.gov/media/114163/
    download).
    ---------------------------------------------------------------------------
        To advance this end with respect to the development,
    review, and regulation of medical products, in 2016 Congress
    provided FDA specific hiring authority in the 21st Century
    Cures Act, which added section 714A to the FFDCA (21 U.S.C.
    Sec. 379d-3a).\26\ This authority has enabled FDA to simplify
    and expedite the hiring process for certain scientific,
    technical, and professional positions and set higher rates of
    pay for these positions to enable it to better compete with the
    private sector in the recruitment and retention of outstanding,
    highly qualified candidates.\27\
    ---------------------------------------------------------------------------
        \26\Pub. L. No. 114-255 (2016).
        \27\See note 25.
    ---------------------------------------------------------------------------
        FDA's need for highly skilled employees with specialized
    expertise is not limited to its regulation of human drugs,
    biological products, and devices. The successful regulation of
    food, veterinary medicine, tobacco, cosmetics, and electronic
    products also demands the hiring and retention of such highly
    qualified and trained individuals. Section 815 of H.R. 7667
    accomplishes this goal by extending the hiring and pay
    authority Congress granted to FDA in 2016 to the hiring of
    outstanding candidates for scientific, technical, or
    professional positions across the entire agency. This section
    also provides accountability by requiring FDA to develop and
    implement a strategic workforce plan, as recommended by GAO,
    and report to Congress regarding such implementation.

    C. Improvements to Drug Regulation

                1. Accelerated Approval Integrity
        Initiated by FDA through regulation in 1992 in response to
    the HIV/AIDS crisis and codified in section 506(c) of the FFDCA
    (21 U.S.C. Sec. 356(c)) by Congress in 2012, the accelerated
    approval premarket review pathway for new drugs has expedited
    the approvals of hundreds of drugs and biologics in several
    disease areas, most of which have been for oncology and
    hematology indications; as a result, patients with no
    alternative options have had access to life-extending
    treatments for cancer and other serious diseases years earlier
    than they would have had without accelerated approval.\28\
    Drugs approved via accelerated approval must meet the same
    ``safe and effective'' review standard as other drugs,
    including substantial evidence of effectiveness, but rather
    than having to prove clinical benefit in the same way as drugs
    reviewed under the traditional pathway, sponsors of drugs
    reviewed under accelerated approval can demonstrate effect on a
    surrogate or intermediate endpoint reasonably likely to predict
    clinical benefit. This enables shorter studies and earlier
    approvals, but this greater uncertainty regarding benefit to
    patients requires postapproval studies to confirm such benefit.
    If a sponsor fails to conduct such a required study with due
    diligence, such a study fails to verify benefit, or if the drug
    is otherwise not shown to be safe and effective, FDA may
    withdraw approval. If a sponsor fails to complete such a
    postapproval study, this violates section 505(p) of the FFDCA
    (21 U.S.C. Sec. 355(p)) and distribution of the drug in
    interstate commerce is prohibited.
    ---------------------------------------------------------------------------
        \28\Julia A. Beaver, et al., A 25-Year Experience of US Food and
    Drug Administration Accelerated Approval of Malignant Hematology and
    Oncology Drugs and Biologics: A Review, JAMA Oncology (June 1, 2018);
    Food and Drug Administration, Project Confirm, Promoting the
    transparency of Accelerated Approval for oncology indications
    (www.fda.gov/about-fda/oncology-center-excellence/project-confirm).
    ---------------------------------------------------------------------------
        While many in the patient community, among others, have
    touted the success of this program,\29\ others, including some
    patient and provider groups, have criticized various aspects of
    it, such as the uncertainty of clinical benefit; delays in
    postapproval study initiation, conduct, and completion;
    inadequacy of postapproval study design; inadequacy of
    postapproval study reporting and transparency; inadequacy of
    labeling information for providers and patients; and the fact
    that FDA has not withdrawn approvals for a number of drugs
    where confirmatory studies failed to verify benefit, which some
    argue is due to a cumbersome and time-consuming process.\30\
    ---------------------------------------------------------------------------
        \29\House Committee on Energy and Commerce, Subcommittee on Health,
    Testimony of Jeff Allen, Ph.D., President and CEO, Friends of Cancer
    Research, Hearing on The Future of Medicine: Legislation to Encourage
    Innovation and Improve Oversight, 117th Cong. (March 17, 2022)
    (energycommerce.house.gov/sites/democrats.energycommerce.house.gov/
    files/documents/Witness%20Testimony_Allen_HE_2022.03.17.pdf).
        \30\See Bishal Gyawali, M.D., Ph.D., et al., Assessment of the
    Clinical Benefit of Cancer Drugs Receiving Accelerated Approval, JAMA
    Internal Medicine (May 28, 2019) (jamanetwork.com/journals/
    jamainternalmedicine/fullarticle/2733561); House Committee on Energy
    and Commerce, Subcommittee on Health, Testimony of Reshma Ramachandran,
    M.D., M.P.P., Yale School of Medicine, Hearing on The Future of
    Medicine: Legislation to Encourage Innovation and Improve Oversight,
    117th Cong. (March 17, 2022) (energycommerce.house.gov/sites/
    democrats.energycommerce.house.gov/files/documents/
    Witness%20Testimony_Ramachandran_HE_2022.03.17.pdf); National
    Organization for Rare Diseases, FDA's Accelerated Approval Pathway: A
    Rare Disease Perspective (2021) (rarediseases.org/wp-content/uploads/
    2021/06/NRD-2182-Policy-Report_Accelerated-Approval_FNL.pdf).
    ---------------------------------------------------------------------------
        Section 804 of H.R. 7667 aims to improve the integrity and
    performance of this valuable pathway by addressing some of
    these concerns. In the interest of enhancing the quality and
    timeliness of postapproval studies, it requires FDA to specify
    the conditions for such studies, which may include enrollment
    targets and the target date for study completion as well as
    other milestones, by the time the drug is approved, requires
    more frequent reporting of postapproval study progress, and
    makes clear that FDA may require postapproval studies to be
    underway at the time of approval and may withdraw approval
    where the conditions it specified at the time of approval are
    not satisfied. It also clarifies that postapproval studies,
    which FDA regulation requires to be adequate, well controlled,
    and carried out with due diligence, may be supported or
    augmented by real world evidence.\31\ To promote accurate
    provider and patient understanding of the limitations of
    accelerated approvals, section 804 requires the labeling of
    drugs approved under this pathway to include certain
    information, such as the uncertainty regarding benefit, the
    endpoints used in premarket studies, and the fact that
    continued approval depends on the ability of a postapproval
    study to verify benefit.
    ---------------------------------------------------------------------------
        \31\See 21 C.F.R. Sec. 314.510.
    ---------------------------------------------------------------------------
        H.R. 7667 also ensures FDA can expeditiously withdraw
    approval where a postapproval study fails to verify patient
    benefit or if any of the other grounds for withdrawal apply,
    while still providing the sponsor due process by which to
    challenge a proposed withdrawal. The informal hearing required
    by the current process can be cumbersome and time-consuming,
    requires a meeting of an advisory committee even if the same
    committee previously met to discuss the same issues regarding
    withdrawal of the drug's approval, and enables a drug sponsor
    to continue marketing a drug long after a postapproval study
    fails to verify any benefit to patients.\32\ Section 804
    replaces the requirement for an informal hearing with an
    opportunity for written appeal to the Commissioner of Food and
    Drugs, which should significantly streamline the withdrawal
    process, while allowing sponsors to present the same case
    against withdrawal they may currently present to the
    Commissioner. In the interest of fairness and transparency,
    section 804 also requires FDA to provide an explanation for the
    withdrawal, an opportunity for a meeting with the Commissioner,
    a public comment period and responses to public comments, and
    an advisory committee meeting, if one was not held previously,
    to discuss the issues that have led to the determination that
    the product should be withdrawn.
    ---------------------------------------------------------------------------
        \32\House Committee on Energy and Commerce, Subcommittee on Health,
    Testimony of Patrizia Cavazzoni, Director, Center for Drug Evaluation
    and Research, U.S. Food and Drug Administration, Hearing on FDA User
    Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics
    (Feb. 3, 2022).
    ---------------------------------------------------------------------------
                2. Drugs for Rare Diseases, Pediatric Populations, and
                        Certain Infectious Diseases
        Significant progress has been made in recent decades with
    respect to the treatment of rare diseases, also known as orphan
    products, thanks in part to the Orphan Drug Act of 1983. Before
    the enactment of this law, only 38 orphan products existed;
    between 1983 and 2020, FDA approved 599 orphan products to
    treat rare diseases.\33\ However, there is still a long way to
    go; together rare diseases affect more than 25 million
    Americans, 90 percent of these diseases continue not to have an
    FDA-approved treatment, and numerous obstacles to the
    investment in research and development of these drugs
    remain.\34\
    ---------------------------------------------------------------------------
        \33\National Organization for Rare Disorders, Orphan Drugs in the
    United States: An Examination of Patents and Orphan Drug Exclusivity
    (March 25, 2021) (https://rarediseases.org/wp-content/uploads/2021/03/
    NORD-Avalere-Report-2021_FNL-1.pdf).
        \34\Id.; Food and Drug Administration, Remarks by Acting
    Commissioner Woodcock to the 2021 NORD Breakthrough Summit (Oct. 19,
    2021) (www.fda.gov/news-events/speeches-fda-officials/remarks-acting-
    commissioner-woodcock-2021-nord-breakthrough-summit-10192021).
    ---------------------------------------------------------------------------
        A recent decision of the 11th Circuit Court of Appeals
    upended FDA's longstanding interpretation of seven-year orphan
    drug exclusivity under section 527 of the FFDCA (21 U.S.C.
    Sec. 360cc).\35\ Under FDA's implementation of section 527,
    orphan drug exclusivity blocks approval of the same drug only
    for the same use or indication that FDA previously approved,
    which may be in a small subgroup affected by the disease. This
    incentivizes companies to continue to study and obtain approval
    for other uses within the designated disease, such as a
    pediatric indication for a drug approved for adults.\36\
    ---------------------------------------------------------------------------
        \35\Catalyst Pharms., Inc. v. Becerra, 14 F.4th 1299 (11th Cir.
    2021).
        \36\Food and Drug Administration, Overview of Catalyst Pharms.,
    Inc. v. Becerra (www.fda.gov/industry/developing-products-rare-
    diseases-conditions/fdas-overview-catalyst-pharms-inc-v-becerra)
    (accessed May 24, 2022).
    ---------------------------------------------------------------------------
        As a result of the court's decision, which held that
    exclusivity applies to the entire designated disease regardless
    of the specific indications for which a drug is actually
    approved, sponsors would have incentive to obtain approval for
    the smallest, easiest-to-study subpopulation and block approval
    for any other populations or indications within the rare
    disease for seven years.\37\ Were this interpretation to stand,
    there could be a chilling effect on investment in studying and
    obtaining approval for these drugs in different subpopulations,
    which could be especially harmful to populations that tend to
    be studied later in drug development, such as children, the
    elderly, and patients with co-morbidities. The ruling also
    creates uncertainty regarding existing approvals for a number
    of brand-name and generic drugs and could block approval of
    drugs in late-stage development or for which premarket review
    is pending. This problem will grow over time for the hundreds
    of existing terms of orphan exclusivity that would be subject
    to the broad scope resulting from the Catalyst decision.\38\
    ---------------------------------------------------------------------------
        \37\Id.
        \38\Id.
    ---------------------------------------------------------------------------
        Section 812 of H.R. 7667 will prevent the potential
    negative consequences of this decision from occurring by
    amending section 527 of the FFDCA (21 U.S.C. Sec. 360cc) to
    clearly provide that orphan exclusivity applies only to the
    specific indication or use approved by FDA under this section,
    not the entire rare disease or condition for which a drug is
    designated, consistent with FDA's long-held interpretation of
    the law.\39\
    ---------------------------------------------------------------------------
        \39\21 CFR 316.
    ---------------------------------------------------------------------------
        Section 703 of H.R. 7667 further seeks to advance the
    development of drugs for rare diseases by requiring FDA to
    study processes for evaluating drugs for rare diseases in the
    United States and the European Union, convene a public meeting
    to solicit input from stakeholders regarding approaches to
    improving engagement with patients, patient groups, and
    experts, and submit a report to Congress summarizing its
    activities relating to designating, approving, and licensing
    drugs used to treat rare diseases. Section 703 also requires
    GAO to conduct a study on the use of FDA tools to ensure that
    patient and physician perspectives are incorporated throughout
    FDA processes for approving and licensing drugs and making
    determinations related to a drug's approval.
        Section 804 addresses the need for further rare disease
    development by requiring FDA to establish a rare disease
    endpoint advancement pilot program and issue guidance on novel
    surrogate endpoints and trial designs, and section 712 does so
    by reauthorizing orphan drug grants and allowing such grants to
    be used to develop regulatory science pertaining to the
    chemistry, manufacturing, and controls of rare disease drugs.
        Although there has been progress in the treatment of
    pediatric cancer in recent years, particularly with respect to
    the most common malignancy, little improvement has been made in
    the treatment of certain other types of childhood cancer. High
    development costs and the relatively smaller number of
    pediatric patients limit investment in treatments for this
    population; as a result, few cancer drugs have obtained FDA
    approval for pediatric indications and the need for more
    clinical studies in children persists.\40\
    ---------------------------------------------------------------------------
        \40\Theodore W. Laetsch, et al., Opportunities and Challenges in
    Drug Development for Pediatric Cancers, Cancer Discovery (Mar. 2, 2021)
    (aacrjournals.org/cancerdiscovery/article/11/3/545/3017/Opportunities-
    and-Challenges-in-Drug-Development).
    ---------------------------------------------------------------------------
        The FDA Reauthorization Act of 2017 sought to facilitate
    development of appropriate new therapies for pediatric cancer
    patients by requiring pediatric investigations of certain adult
    cancer drugs with new active ingredients directed at a
    molecular target FDA determines to be substantially relevant to
    the growth or progression of a pediatric cancer, unless FDA
    waives or defers the requirement.\41\ Section 713 of H.R. 7667
    takes this mandate a step further, clarifying that the required
    pediatric investigations may be of the new drug for which
    approval is sought or such drug used in combination with a
    previously-approved drug or biological product that meets
    certain conditions. This section also requires FDA to issue
    guidance and report to Congress on its implementation of this
    section, and a GAO report on its success.
    ---------------------------------------------------------------------------
        \41\Pub. L. No. 115-52 (2017).
    ---------------------------------------------------------------------------
        As antibiotic resistance continues to rise throughout the
    world and remains one of the biggest threats to public health,
    there continues to be a critical need for new antibiotic and
    antifungal treatments.\42\ The Generating Antibiotic Incentives
    Now (GAIN) provisions of the FDA Safety and Innovation Act of
    2012 promoted the development and approval of such treatments
    for serious or life-threatening infections by allowing a drug
    designated by FDA as a Qualified Infectious Disease Product
    (QIDP) to be eligible for market exclusivity, priority review
    for the first application submitted for approval, and fast-
    track designation upon request. Section 705 of H.R. 7667
    broadens QIDP designation to antibiotic and antifungal
    biological products, which renders them eligible for fast-track
    designation and provides for priority review for the first
    application for an innovative biological antifungal or
    antibiotic QIDP that requires clinical data to demonstrate
    safety or effectiveness. This section does not extend QIDP
    exclusivity to biological products.
    ---------------------------------------------------------------------------
        \42\World Health Organization, Antibiotic Resistance (www.who.int/
    news-room/fact-sheets/detail/antibiotic-resistance) (accessed May 24,
    2002).
    ---------------------------------------------------------------------------
        H.R. 7667 also addresses the specific need for antifungal
    treatments for coccidioidomycosis, commonly known as Valley
    Fever, which is a serious fungal lung infection that afflicts
    about 15,000 patients in the United States each year, mostly in
    Arizona and California.\43\ Section 704 attempts to advance the
    development of antifungal therapies for this illness by
    requiring FDA to issue guidance assisting entities seeking
    approval for such treatments and to hold a public workshop to
    assist entities developing vaccines for fungal infections,
    including Valley Fever.
    ---------------------------------------------------------------------------
        \43\Centers for Disease Control and Prevention, Valley Fever
    Awareness (www.cdc.gov/fungal/features/valley-fever.html) (accessed May
    24, 2022).
    ---------------------------------------------------------------------------
                3. Generic Drug and Biosimilar Competition
        For a generic drug to be approved by FDA, it generally must
    have the same inactive ingredients in the same concentration
    (within a certain range) as the listed drug.\44\ Currently,
    generic drug sponsors often have to engage in trial and error
    before they successfully match the same inactive ingredients in
    the same proportions as the listed drug in order to obtain
    approval.\45\ This is a costly, burdensome, and inefficient
    process for both the agency and these sponsors, and more
    importantly, can delay patient access to cost-saving generic
    drugs.\46\ Section 601 of H.R. 7667 fixes this problem by
    requiring FDA to provide this information to generic sponsors
    of certain drugs upon request, which will avoid this
    unnecessary back-and-forth and enable patients to have access
    to more affordable drugs sooner, which will reduce costs for
    patients and the health system. This section makes clear this
    information is not protected under the Trade Secrets Act.
    ---------------------------------------------------------------------------
        \44\21 C.F.R. Sec. 314.94(a)(9).
        \45\House Committee on Energy and Commerce, Subcommittee on Health,
    Testimony of David R. Gaugh, RPh, Senior Vice President, Sciences &
    Regulatory Affairs, Association for Accessible Medicines, Hearing on
    The Future of Medicine: Legislation to Encourage Innovation and Improve
    Oversight, 117th Cong. (Mar. 17, 2022) (energycommerce.house.gov/sites/
    democrats.energycommerce.house.gov/files/documents/
    Witness%20Testimony_Gaugh_HE_2022.03.17.pdf).
        \46\Id.
    ---------------------------------------------------------------------------
        An NDA holder for a listed drug can also attempt to block
    competition from generics by changing the labeling of its drug
    shortly before a generic is approved and prepared to enter the
    market. Because generic drug labeling must generally match that
    of the listed drug, any change in a listed drug's labeling can
    temporarily block a generic drug market entry. Section
    505(j)(10)(A) of the FFDCA (21 U.S.C. Sec. 355(j)(10)(A))
    addresses this issue by enabling FDA to approve a generic drug
    despite differences between its proposed labeling and that of
    the listed drug, other than differences in the ``Warnings''
    section, resulting from revisions made to the labeling of the
    listed drug approved by FDA within 60 days of when the generic
    could be approved. Section 602 of H.R. 7667 extends this
    protection to 90 days, which will help cost-saving generic
    drugs get to market sooner in certain circumstances, saving
    patients money.
        Timely, accurate information regarding which drugs are on
    the market, and which are not, can help generic drug
    manufacturers and policymakers identify circumstances where
    generic competition is lacking, which can help spur competition
    and help identify any policy changes that may be appropriate to
    address these circumstances.\47\ This information can also be
    useful to providers, payors, pharmacies, and patients. Congress
    addressed this issue in the FDA Reauthorization Act of 2017,
    which added section 506I to the FFDCA (21 U.S.C. Sec. 356i),
    requiring all drug application holders to report to FDA certain
    information regarding the marketing status of approved drug
    products. Section 801 of H.R. 7667 extends these requirements
    and benefits to biological products, including biosimilars.
    ---------------------------------------------------------------------------
        \47\Food and Drug Administration, Statement from FDA Commissioner
    Scott Gottlieb, M.D., on the agency's efforts to enhance the utility of
    the Orange Book to foster drug competition (Jan. 30, 2019)
    (www.fda.gov/news-events/press-announcements/statement-fda-
    commissioner-scott-gottlieb-md-agencys-efforts-enhance-utility-orange-
    book-foster-drug).
    ---------------------------------------------------------------------------
                4. Advanced and Innovative Manufacturing for Drugs
        The COVID-19 public health emergency has exposed gaps in
    the United States manufacturing supply chain and has reinforced
    the need to develop and implement manufacturing technologies
    that improve drug supply chain resilience, reduce time to
    market, or increase manufacturing capacity.\48\ Advanced
    manufacturing, which is a collective term for new medical
    product manufacturing technologies and approaches that can
    improve drug quality, address shortages of medicines, and speed
    time-to-market, is a key component of the overall United States
    strategy to strengthen domestic drug manufacturing and increase
    the domestic supply of quality medical products for
    consumers.\49\ Patients with diseases including cystic
    fibrosis, HIV, breast cancer, leukemia, and asthma are already
    benefitting from medications manufactured in newer, more
    expedient, and more flexible ways.\50\ Innovations in this area
    promise to rapidly scale manufacturing capabilities for
    vaccines and other medical countermeasures to enable faster
    responses in public health emergencies, shorten supply chains
    and increase manufacturing resilience to disruption by creating
    reserve capacity in network of small manufacturing sites,
    accelerate therapy development for rare diseases by improving
    the cost-efficiency of small-scale manufacturing processes,
    speed availability of emerging therapies, and provide new tools
    to address drug shortages and other challenges, including
    pharmaceutical quality.\51\
    ---------------------------------------------------------------------------
        \48\Manufacturing x Digital (MxD) and the International Academy of
    Automation Engineering (IAAE), Analysis of the Advantages of and
    Barriers to Adoption of Smart Manufacturing for Medical Products--Focus
    on Response to Emerging and Pandemic Threats such as SARS-CoV-2, FDA-
    funded study (June 30, 2021) (www.fda.gov/media/152569/download).
        \49\Food and Drug Administration, Advanced Manufacturing
    (www.fda.gov/emergency-preparedness-and-response/mcm-issues/advanced-
    manufacturing) (accessed May 24, 2022).
        \50\Id.
        \51\Id.; Food and Drug Administration, FDA's Advanced Manufacturing
    Initiatives Helping to Provide Quality Human Drugs for Patients
    (www.fda.gov/news-events/fda-voices/fdas-advanced-manufacturing-
    initiatives-helping-provide-quality-human-drugs-patients) (accessed May
    24, 2022).
    ---------------------------------------------------------------------------
        Section 706 of H.R. 7667 fosters expanded creation and use
    of these methods by requiring FDA to initiate a pilot program
    for the designation of advanced manufacturing technologies. A
    method of manufacturing is eligible for designation if such
    method incorporates a novel technology or novel use of
    technology, will at least maintain equivalent drug quality, and
    will substantially improve the manufacturing process, for
    example by reducing development time or increasing or
    maintaining the supply of certain drugs on the shortage list or
    drugs for serious diseases the manufacture of which has been
    interrupted or discontinued. Designated technologies qualify
    for expedited application development and review and allow the
    holder or their designee to reference or rely upon data and
    information about the designated technology for use in
    manufacturing drugs in the same context of use as the
    designation. This section also encourages advanced
    manufacturing utilization by requiring FDA to hold a public
    meeting, issue guidance, and report to Congress regarding this
    pilot.
        These goals are further advanced through section 702 of
    H.R. 7667, which codifies FDA's Emerging Technologies Program.
    This is a collaborative program wherein industry
    representatives, academics, and others can meet with FDA
    officials to support the adoption and improve the development
    of innovative approaches to drug design and manufacturing. This
    section also authorizes FDA to make grants, provides FDA $20
    million annually to carry out the program, and requires FDA to
    issue guidance regarding such innovative approaches. It also
    requires a report to Congress detailing the effectiveness of
    the program.
                5. Animal Testing
        Animal studies have long been critical to the development
    of safe and effective medical products. For example, scientists
    have relied heavily on animal studies to determine whether a
    drug is toxic before testing it in humans; such studies have
    shown great accuracy in predicting safe doses and determining
    appropriate monitoring for adverse effects.\52\ Conversely,
    although animal testing is still necessary in many situations,
    it is expensive and time-consuming, and does not always predict
    toxic effects in humans.\53\ Some have also raised ethical
    concerns.\54\ Advances in recent years, for example in the use
    of stem cells, engineered tissues, and mathematical modeling,
    have led to the development of alternative testing models that
    promise to improve the predictive ability of pre-clinical
    testing in conjunction with more traditional approaches.\55\
    While most current alternative methods cannot yet predict
    effects in highly complex interacting systems, they hold the
    potential to reduce and refine animal testing, and potentially
    someday replace it.\56\
    ---------------------------------------------------------------------------
        \52\Food and Drug Administration, Advancing New Alternative
    Methodologies at FDA (Jan. 2021) (www.fda.gov/media/144891/download).
        \53\Id.
        \54\Stephanie Liou, The Ethics of Animal Experimentation,
    Huntington's Outreach Project for Education at Stanford (July 6, 2010)
    (hopes.stanford.edu/animal-research/).
        \55\See note 52.
        \56\Food and Drug Administration, Advancing Alternative Methods at
    FDA (www.fda.gov/science-research/about-science-research-fda/advancing-
    alternative-methods-fda) (accessed May 24, 2022).
    ---------------------------------------------------------------------------
        Recognizing these advances and this potential for expanded
    use of non-animal testing, section 701 of H.R. 7667 amends
    certain provisions of the FFDCA pertaining to drug studies to
    allow for the possible use of non-animal nonclinical testing in
    certain circumstances as appropriate. It broadens the purpose
    of a certain type of FDA-sponsor meeting in situations where
    human efficacy studies are not ethical or feasible to include
    reaching agreement on the design of ``nonclinical tests''
    intended to support effectiveness, so that non-animal
    nonclinical studies may be included in these meetings. This
    section also broadens references to animal testing in section
    505(i) regarding investigational new drug exemptions to
    ``nonclinical tests,'' defined to include cell-based assays,
    organ chips and microphysiological systems, computer modeling,
    other nonhuman or human biology-based test methods, and animal
    tests.
                6. Addressing Third-Party Vendor Issues
        In the wake of recent FDA-approved changes to the risk
    evaluation and mitigation strategies (REMS) programs for
    clozapine and isotretinoin, users have experienced problems
    such as long wait times and difficulties obtaining certain
    authorizations. To attempt to avoid such problems in the
    future, section 809 of H.R. 7667 requires FDA to provide a
    single public comment period regarding patient access and
    provider administration when a proposed modification to an
    approved REMS is reviewed under section 505-1(h) of the FFDCA
    (21 U.S.C. Sec. 355-1). This section makes clear that it shall
    not delay any agency action on any modification to a REMS. It
    also requires a GAO study on how any third-party vendor changes
    have impacted patient access to drugs subject to the modified
    REMS and how those access issues were resolved.
                7. Encouraging Blood Donation
        To facilitate FDA collection of certain information
    pertaining to blood donation and ultimately encourage broad
    donation of blood to assure adequate supply, section 802
    exempts from Paperwork Reduction Act requirements FDA
    information gathering regarding patient perspectives during
    medical product development and solicitation of information
    from blood donors and potential blood donors to inform
    recommendations regarding blood donation.
                8. Cell and Gene Therapy Workshop
        In the interest of advancing the understanding of certain
    human cell-, tissue-, and cellular-based medical products and
    the latest scientific information about such products and
    providing a public forum for discussion of related issues,
    section 707 requires FDA to convene a public workshop on
    generating the scientific data necessary to further facilitate
    development of these products.

    D. Improvements for Device Regulation

                1. Cybersecurity
        As cyberattacks generally, and on the health care sector in
    particular, have become more widespread and more sophisticated
    in recent years, medical device cybersecurity is more important
    than ever.\57\ Connected, networked systems that leverage
    wireless technologies provide many advantages in health care
    delivery, but also leave systems more vulnerable to
    cyberattacks. For example, recent ransomware attacks on
    hospitals have rendered medical devices and hospital networks
    inoperable, necessitated moving patients to other hospitals,
    and prevented access to patient records, putting patients at
    risk and imposing substantial financial costs on the health
    care system.\58\ Without adequate cybersecurity across all
    components of larger medical device systems, which can include
    health care facility networks, various individual devices, and
    software update servers, a cybersecurity threat can compromise
    the safety or effectiveness of a device by compromising any
    component in the system.\59\
    ---------------------------------------------------------------------------
        \57\Cybersecurity and Infrastructure Security Agency, Stop
    Ransomware Resources, Sector Risk Management Agencies, Healthcare and
    the Public Sector (www.cisa.gov/stopransomware/healthcare-and-public-
    health-sector) (accessed May 24, 2022); Cybersecurity and
    Infrastructure Security Agency, Federal Bureau of Investigation, and
    Department of Health and Human Services, Alert AA20-302A, Ransomware
    Activity Targeting the Healthcare and Public Health Sector (Oct. 28,
    2020) (www.cisa.gov/uscert/ncas/alerts/aa20-302a).
        \58\Id.; Food and Drug Administration, Cybersecurity in Medical
    Devices: Quality System Considerations and Content of Premarket
    Submissions (draft guidance) (April 8, 2022) (www.fda.gov/media/119933/
    download).
        \59\Id.
    ---------------------------------------------------------------------------
        Section 808 of H.R. 7667 imposes crucial requirements that
    will improve the cybersecurity of medical devices and thereby
    improve the cybersecurity of our entire health care system. It
    requires manufacturers of all cyber devices, defined as any
    device that includes software, can connect to the internet, or
    otherwise could be vulnerable to cybersecurity threats, to
    develop processes to ensure their devices are secure, have
    plans to identify and address cybersecurity vulnerabilities,
    and provide a software bill of materials in their labeling so
    that users can more easily identify threats and
    vulnerabilities. This section also provides that this
    information, as well as any other information pertaining to
    cybersecurity that FDA determines to be appropriate to
    demonstrate a reasonable assurance of safety and effectiveness,
    must be submitted in any premarket submissions and authorizes
    FDA to deny 510(k) clearance if cybersecurity information is
    inadequate. To enable enforcement of these requirements, it
    makes failure to comply a prohibited act.
                2. Bans of Devices for Specific Intended Use(s)
        In 2020, FDA, pursuant to section 516 of the FFDCA (21
    U.S.C. Sec. 360f), issued a final rule banning electric shock
    devices intended to aversively condition patients against self-
    injurious and aggressive behavior.\60\ In 2021, the Court of
    Appeals for the District of Columbia Circuit, without weighing
    in on the reasons for FDA's decision to ban such devices,
    overturned the ban, finding that banning a device for a
    particular use interferes with the practice of medicine in
    contravention of section 1006 of the FFDCA (21 U.S.C.
    Sec. 396).\61\ This section makes two legislative changes to
    address this court decision: one to clarify FDA's authority to
    ban a device, in appropriate circumstances where the
    longstanding banning standard is met, regardless of whether it
    includes other devices that are technologically similar but
    have different intended uses within the scope of the ban, and
    another to effectuate FDA's ban of this particular device,
    including its particular intended use.
    ---------------------------------------------------------------------------
        \60\ Food and Drug Administration, Banned Devices: Electrical
    Stimulation Devices for Self-Injurious or Aggressive Behavior, 85 Fed.
    Reg. 13312 (Mar. 6, 2020).
        \61\Judge Rotenberg Educ. Ctr., Inc. v. FDA, 3 F.4th 390 (D.C. Cir.
    2021).
    ---------------------------------------------------------------------------
        Since the Medical Device Amendments of 1976, FDA has had
    the authority under section 516 of the FFDCA (21 U.S.C.
    Sec. 360f) to ban medical devices that present an unreasonable
    and substantial risk of illness or injury. For an even longer
    time--since Congress first gave FDA authority over devices in
    the FFDCA of 1938--the regulatory status of a product as a
    ``device'' under section 201(h) of the FFDCA (21 U.S.C.
    Sec. 321(h)) has been dependent on its intended use; whereas a
    technology for one use may not be FDA-regulated, the same
    technology for a different use may be a ``device.'' How a
    device is classified, its premarket pathway, labeling, and
    other requirements very much depend on its intended use; a
    device that is safe and effective for one use may be unsafe and
    ineffective for a different use or different population.\62\
    Section 811 of H.R. 7667 makes clear that the same principle
    applies to FDA's banning authority, so that FDA may ban a
    device intended for one particular use. Without this change,
    FDA would either have to ban a technology for all uses, which
    could prevent patient access to safe and effective devices, or
    not ban a device that presents a substantial and unreasonable
    risk of illness or injury for a certain use or population,
    depriving those individuals of the protection Congress intended
    the banning authority to provide for over 45 years.
    ---------------------------------------------------------------------------
        \62\Sections 513(a)(1), 513(a)(2) and 513(i) of the FFDCA (21
    U.S.C. Sec. Sec. 360c(a)(1), 360c(a)(2), 360c(i)).
    ---------------------------------------------------------------------------
        FDA's ban applied to shock devices intended for use on a
    particularly vulnerable patient population--individuals who
    engage in self-injurious and aggressive behavior, conditions
    that present in individuals with intellectual and developmental
    disabilities, such as Autism spectrum disorder, Down syndrome,
    and Tourette's syndrome.\63\ FDA determined that these devices
    intended for this use present an unreasonable and substantial
    risk of illness or injury based on the serious risks they pose,
    the inadequacy of data to show effectiveness, and the positive
    benefit-risk profiles of behavioral and pharmacological
    alternatives developed in recent decades to treat patients with
    these conditions.\64\
    ---------------------------------------------------------------------------
        \63\See note 60.
        \64\Id.
    ---------------------------------------------------------------------------
        Specifically, in its final rule imposing the ban, FDA cited
    medical literature that found that the use of these devices
    included risks of physical harms, including pain, skin burns,
    and tissue damage, as well as serious psychological harms,
    including depression, posttraumatic stress disorder (PTSD),
    suicidality, chronic stress, anxiety, fear, panic, and
    substitution of other negative behaviors.\65\ FDA issued the
    final rule after an extensive process spanning nearly a decade
    over two administrations, with multiple opportunities for
    stakeholder input, including an outside expert advisory
    committee meeting in 2014, a proposed rule in 2016, meetings
    with the affected company and other stakeholders, consideration
    of tens of thousands of pages of scientific literature, state
    court proceedings, and over 1,500 comments, which were
    overwhelmingly supportive of the ban.\66\ Section 811 of H.R.
    7667 would reinstitute this ban without the need for additional
    time-consuming and resource-intensive proceedings.
    ---------------------------------------------------------------------------
        \65\Id.
        \66\Id.
    ---------------------------------------------------------------------------
                3. Public Health Emergency Diagnostic Testing
        One of the lessons learned from the COVID-19 public health
    emergency regards the value that external expertise and
    experience can provide to FDA regarding medical devices that
    are essential during such an emergency, such as personal
    protective equipment and diagnostic tests, including with
    respect to the use of such tests in the detection of an
    emerging threat and its spread across the nation and globe. It
    can be difficult to obtain such expertise in the middle of an
    emergency, given the focus of public health resources on other
    aspects of emergency response. Section 807 of H.R. 7667 aims to
    address this issue by requiring at least one panel of FDA's
    Medical Device Advisory Committee, which shall include at least
    one population-health representative, to meet at least once per
    year to discuss topics related to device use in pandemic
    preparedness and response, including with respect to in vitro
    diagnostics.
        Looking ahead to a post-pandemic world, section 806 of H.R.
    7667 will streamline FDA premarket review and categorization
    under the Clinical Laboratory Improvement Amendments (CLIA) for
    certain diagnostic tests that were granted an emergency use
    authorization during the COVID-19 emergency. More specifically,
    sponsors of such tests that were deemed to be CLIA-waived under
    section 564(m) of the FFDCA (21 U.S.C. Sec. 360bbb-3) as part
    of such authorization that submit requests for de novo
    classification of their test under section 513(f)(2) (21 U.S.C.
    Sec. 360c(f)(2)) of the FFDCA may submit a request for CLIA
    categorization together with their de novo request in a single
    submission.

                            III. Committee Hearings

        For the purposes of section 3(c) of rule XIII of the Rules
    of the House of Representatives, the following hearings were
    used to develop and consider H.R. 7667:
        The Subcommittee on Health held a legislative hearing on
    February 3, 2022, entitled ``FDA User Fee Reauthorization:
    Ensuring Safe and Effective Drugs and Biologics.'' The
    Subcommittee received testimony from the following witnesses:
        Panel I:
               Patrizia Cavazzoni, M.D., Director, Center
            for Drug Evaluation and Research, Food and Drug
            Administration; and
               Peter Marks, M.D., Ph.D., Director, Center
            for Biologics Evaluation and Research, Food and Drug
            Administration.
        Panel II:
               Cartier Esham, Ph.D., Chief Scientific
            Officer, Executive Vice President, Emerging Companies,
            Biotechnology Innovation Organization;
               David Gaugh, Senior Vice President, Sciences
            and Regulatory Affairs, Association for Accessible
            Medicines;
               Reshma Ramachandran, M.D., Chair, Doctors
            for America FDA Task Force, Physician-Fellow, Yale
            National Clinician Scholars Program, Yale School of
            Medicine;
               Juliana M. Reed, Executive Director,
            Biosimilars Forum; and
               Lucy Vereshchagina, Ph.D., Vice President,
            Science and Regulatory Advocacy. Pharmaceutical
            Research and Manufacturers of America.
        The Subcommittee on Health held a hearing on March 17,
    2022, entitled ``The Future of Medicine: Legislation to
    Encourage Innovation and Improve Oversight.'' The Subcommittee
    received testimony from the following witnesses:
               Jeff Allen, Ph.D., President and CEO,
            Friends of Cancer Research;
               Cartier Esham, Ph.D., Chief Scientific
            Officer, Executive Vice President, Emerging Companies,
            Biotechnology Innovation Organization;
               David Gaugh, Senior Vice President, Sciences
            and Regulatory Affairs, Association for Accessible
            Medicines;
               Ruben Mesa, M.D., Executive Director, Mays
            Cancer Center, UT Health San Antonio MD Anderson;
               Reshma Ramachandran, M.D., Chair, Doctors
            for America FDA Task Force, Physician-Fellow, Yale
            National Clinician Scholars Program, Yale School of
            Medicine; and
               Lucy Vereshchagina, Ph.D., Vice President,
            Science and Regulatory Advocacy. Pharmaceutical
            Research and Manufacturers of America.
        The Subcommittee on Health held a legislative hearing on
    March 30, 2022, entitled ``FDA User Fee Reauthorization:
    Ensuring Safe and Effective Medical Devices.'' The Subcommittee
    received testimony from the following witnesses:
        Panel I:
               Jeff Shuren, M.D., Director, Center for
            Devices and Radiological Health, Food and Drug
            Administration.
        Panel II:
               Richard J. Kovacs, M.D., Q.E. and Sally
            Russell Professor of Medicine, Indiana University
            School of Medicine, Chief Medical Officer, American
            College of Cardiology;
               Mark Leahey, President & CEO, Medical Device
            Manufacturers Association;
               Janet Trunzo, Senior Executive Vice
            President, Technology and Regulatory Affairs, Advanced
            Medical Technology Association (AdvaMed); and
               Diane Wurzburger, Executive of Regulatory
            Affairs, GE Healthcare.

                          IV. Committee Consideration

        H.R. 7667, the ``Food and Drug Amendments of 2022,'' was
    introduced on May 6, 2022, by Representatives Eshoo (D-CA),
    Guthrie (R-KY), Pallone (D-NJ), and Rodgers (R-WA) and referred
    to the Committee on Energy and Commerce. Subsequently, on May
    9, 2022, the bill was referred to the Subcommittee on Health.
        On May 11, 2022, the Subcommittee on Health met in open
    markup session, pursuant to notice, to consider H.R. 7667 and
    five other bills. During consideration of the bill, an
    amendment in the nature of a substitute (AINS) offered by
    Representative Eshoo was agreed to by a voice vote. Upon
    conclusion of consideration of the bill, the Subcommittee on
    Health agreed to report the bill favorably to the full
    Committee, amended, by a roll call vote of 30 yeas to zero
    nays.
        On May 18, 2022, the full Committee met in open markup
    session, pursuant to notice, to consider H.R. 7667 and five
    other bills. An AINS offered by Representative Guthrie was
    agreed to by a voice vote. An amendment to the AINS offered by
    Representative Butterfield (D-NC) was agreed to by a voice
    vote. Upon conclusion of consideration of the bill, the full
    Committee agreed to a motion on final passage offered by
    Representative Pallone, Chairman of the Committee, to order
    H.R. 7667 reported favorably to the House, amended, by a roll
    call vote of 55 yeas to zero nays.

                               V. Committee Votes

        Clause 3(b) of rule XIII of the Rules of the House of
    Representatives requires the Committee to list each record vote
    on the motion to report legislation and amendments thereto. The
    Committee advises that there were two record votes taken on
    H.R. 7667, including a motion by Mr. Pallone ordering H.R. 7667
    favorably reported to the House, amended. The motion on final
    passage of the bill was approved by a record vote of 55 yeas to
    zero nays. The following are the record votes taken during
    Committee consideration, including the names of those members
    voting for and against:

    		[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                             VI. Oversight Findings

        Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1)
    of rule X of the Rules of the House of Representatives, the
    oversight findings and recommendations of the Committee are
    reflected in the descriptive portion of the report.

     VII. New Budget Authority, Entitlement Authority, and Tax Expenditures

        Pursuant to 3(c)(2) of rule XIII of the Rules of the House
    of Representatives, the Committee adopts as its own the
    estimate of new budget authority, entitlement authority, or tax
    expenditures or revenues contained in the cost estimate
    prepared by the Director of the Congressional Budget Office
    pursuant to section 402 of the Congressional Budget Act of
    1974.
        The Committee has requested but not received from the
    Director of the Congressional Budget Office a statement as to
    whether this bill contains any new budget authority, spending
    authority, credit authority, or an increase or decrease in
    revenues or tax expenditures.

                        VIII. Federal Mandates Statement

        The Committee adopts as its own the estimate of Federal
    mandates prepared by the Director of the Congressional Budget
    Office pursuant to section 423 of the Unfunded Mandates Reform
    Act.

           IX. Statement of General Performance Goals and Objectives

        Pursuant to clause 3(c)(4) of rule XIII, the general
    performance goal or objective of this legislation is to
    reauthorize important FDA user fee programs and to improve the
    review and regulation of products regulated by FDA.

                       X. Duplication of Federal Programs

        Pursuant to clause 3(c)(5) of rule XIII, no provision of
    H.R. 7667 is known to be duplicative of another Federal
    program, including any program that was included in a report to
    Congress pursuant to section 21 of Public Law 111-139 or the
    most recent Catalog of Federal Domestic Assistance.

                          XI. Committee Cost Estimate

        Pursuant to clause 3(d)(1) of rule XIII, the Committee
    adopts as its own the cost estimate prepared by the Director of
    the Congressional Budget Office pursuant to section 402 of the
    Congressional Budget Act of 1974.

        XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

        Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
    Committee finds that H.R. 7667 contains no earmarks, limited
    tax benefits, or limited tariff benefits.

                       XIII. Advisory Committee Statement

        No advisory committee within the meaning of section 5(b) of
    the Federal Advisory Committee Act was created by this
    legislation.

                    XIV. Applicability to Legislative Branch

        The Committee finds that the legislation does not relate to
    the terms and conditions of employment or access to public
    services or accommodations within the meaning of section
    102(b)(3) of the Congressional Accountability Act.

               XV. Section-by-Section Analysis of the Legislation

                        TITLE I--FEES RELATING TO DRUGS

    Section 101. Short title; finding

        Section 101 establishes a short title for Title I--the
    ``Prescription Drug User Fee Amendments of 2022''--and provides
    that the fees authorized in the title will be dedicated to
    expediting the drug development and review processes, including
    postmarket drug safety activities, as set forth in the
    commitment letter submitted to the Congressional Record.

    Sec. 102. Definitions

        Section 102 adds to the definition of human drug
    application certain applications with respect to allergenic
    extract products, adds to the definition of prescription drug
    product certain allergenic extract products, details how
    product withdrawn from sale may be considered discontinued for
    purposes of the prescription drug program fee, and adds a
    definition for skin-test diagnostic products.

    Sec. 103. Authority to assess and use drug fees

        Section 103 reauthorizes FDA's prescription drug user fee
    program through 2027, maintains the existing fee structure, and
    increases and adjusts fees, including a new strategic hiring
    and a reserve adjustment. This section also excepts skin-test
    diagnostic products from human drug application fees, provides
    a special rule for products that are no longer discontinued,
    and provides program fee exceptions for certain large volume
    parenteral products, products that are pharmaceutically
    equivalent to certain other products, and skin-test diagnostic
    products.

    Sec. 104. Reauthorization; reporting requirements

        Section 104 reauthorizes and updates requirements for FDA
    reporting to Congress and requires reporting regarding certain
    requests for in-person face-to-face meetings in fiscal years
    2023 and 2024.

    Sec 105. Sunset dates

        Section 105 sunsets the authority to collect prescription
    drug user fees on October 1, 2027, and sunsets reporting
    requirements on January 31, 2028.

    Sec 106. Effective date

        Section 106 clarifies that the effective date of this title
    is October 1, 2022, or the date of enactment, whichever is
    later, except that the fees in FFDCA apply to applications
    received on or after October 1, 2022, regardless of the date of
    enactment.

    Sec. 107. Savings clause

        Section 107 clarifies that the prescription drug user fees
    in effect before enactment continue to apply to human drug
    applications and supplements accepted by FDA for filing before
    October 1, 2022.

                       TITLE II--FEES RELATING TO DEVICES

    Sec. 201. Short title; finding

        Section 201 establishes a short title for Title II--the
    ``Medical Device User Fee Amendments of 2022''--and provides
    that the fees authorized in the title will be dedicated to
    expediting the process for device review and assuring device
    safety and effectiveness, as set forth in the commitment letter
    submitted to the Congressional Record.

    Sec. 202. Definitions

        Section 202 amends the definition of ``process for the
    review of device applications'' to include de novo
    classification requests.

    Sec. 203. Authority to assess and use device fees

        Section 203 reauthorizes FDA's medical device user fee
    program through 2027, maintains the existing fee structure, and
    increases and adjusts fees, including a new strategic hiring
    adjustment, operating reserve adjustment, and performance
    improvement adjustment that provides for increased fees in
    later years if FDA meets review goal timelines.

    Sec. 204. Reauthorization; reporting requirements

        Section 204 reauthorizes and updates requirements for FDA
    reporting to Congress.

    Sec. 205. Conformity assessment pilot program

        Section 205 reauthorizes a pilot program for accreditation
    of testing laboratories to assess conformance of a device with
    certain recognized standards and continuation of program after
    completion of pilot.

    Sec. 206. Reauthorization of third-party review program

        Section 206 reauthorizes third party 510(k) review of
    certain devices.

    Sec. 207. Sunset dates

        Section 209 sunsets the authority to collect medical device
    user fees on October 1, 2027, and sunsets reporting
    requirements on January 31, 2028.

    Sec. 208. Effective date

        Section 208 clarifies that the effective date of this title
    is October 1, 2022, or the date of enactment, whichever is
    later, except that the fees in FFDCA apply to submissions
    received on or after October 1, 2022, regardless of the date of
    enactment.

    Sec. 209. Savings clause

        Section 207 clarifies that the medical device user fees in
    effect before enactment continue to apply to device submissions
    received by FDA before October 1, 2022.

                   TITLE III--FEES RELATING TO GENERIC DRUGS

    Sec. 301. Short title; finding

        Section 301 establishes a short title for Title III--the
    ``Generic Drug User Fee Amendments of 2022''--and provides that
    the fees authorized in the title will be dedicated to human
    generic drug activities, as set forth in the commitment letter
    submitted to the Congressional Record.

    Sec. 302. Authority to assess and use human generic drug fees

        Section 302 reauthorizes FDA's generic drug user fee
    program through 2027, maintains existing fee structure, and
    increases and adjusts fees, including capacity planning and
    operating reserve adjustments.

    Sec. 303. Reauthorization; reporting requirements

        Section 303 reauthorizes and updates requirements for FDA
    reporting to Congress.

    Sec. 304. Sunset dates

        Section 304 sunsets the authority to collect generic drug
    user fees on October 1, 2027, and sunsets reporting
    requirements on January 31, 2028.

    Sec. 305. Effective date

        Section 305 clarifies that the effective date of this title
    is October 1, 2022, or the date of enactment, whichever is
    later, except that the fees in FFDCA apply to applications
    received on or after October 1, 2022, regardless of the date of
    enactment.

    Sec. 306. Savings clause

        Section 306 clarifies that the generic drug user fees in
    effect before enactment continue to apply to new drug
    applications and prior approval supplements received by FDA
    before October 1, 2022, and drug master files for Type II
    active pharmaceutical ingredients first referenced before
    October 1, 2022.

           TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

    Sec. 401. Short title; finding

        Section 401 establishes a short title for Title IV--the
    ``Biosimilar User Fee Amendments of 2022''--and provides that
    the fees authorized in the title will be dedicated to
    expediting the review of biosimilar biological product
    applications, including postmarket drug safety activities, as
    set forth in the commitment letter submitted to the
    Congressional Record.

    Sec. 402. Definitions

        Section 402 defines adjustment factor and removes the
    exclusion of allergenic extract product applications from the
    definition of biosimilar biological product application.

    Sec. 403. Authority to assess and use biosimilar fees

        Section 403 reauthorizes the biosimilar user fee program
    through 2027, maintains the existing fee structure, and
    increases and adjusts fees, including a strategic hiring and
    retention adjustment. Section 403 also adds provisions
    regarding removal from the biosimilar development program for
    failure to pay fees under certain circumstances, requests for
    movement to the list of discontinued biosimilar biological
    products, and a special rule for products that are no longer
    discontinued.

    Sec. 404. Reauthorization; reporting requirements

        Section 404 reauthorizes and updates requirements for FDA
    reporting to Congress.

    Sec. 405. Sunset dates

        Section 405 sunsets the authority to collect biosimilar
    user fees on October 1, 2027, and sunsets reporting
    requirements on January 31, 2028.

    Sec. 406. Effective date

        Section 406 clarifies that the effective date of this title
    is October 1, 2022, or the date of enactment, whichever is
    later, except that the fees in FFDCA apply to applications
    received on or after October 1, 2022, regardless of the date of
    enactment.

    Sec. 407. Savings clause

        Section 407 clarifies that the biosimilar user fees in
    effect before enactment continue to apply to biosimilar
    biological product applications and supplements accepted by FDA
    for filing before October 1, 2022.

                TITLE V--IMPROVING DIVERSITY IN CLINICAL STUDIES

    Sec. 501. Diversity action plans for clinical studies

        Section 501 requires sponsors of phase 3 and other pivotal
    studies of new drugs (and biological products that are also
    drugs) and sponsors of studies of devices (including biological
    products that are also devices) except those excepted under 21
    C.F.R. Sec. 812.3(c), to develop and implement a diversity
    action plan. Such plan must include the sponsor's goals for
    enrollment in the clinical studies, the sponsor's rationale for
    such goals, and an explanation for how the sponsor intends to
    meet such goals. FDA may waive this requirement for certain
    drugs and devices based on a determination that submission of a
    diversity action plan is not necessary based on what is known
    about the prevalence of the disease in terms of the patient
    population that may use the drug. Submissions under section 561
    of the FFDCA (21 U.S.C. Sec. 360bbb) are exempt from this
    requirement. This section requires drug sponsors to submit
    their plans to FDA in the form and manner specified in the
    guidance required by this section as soon as practicable but no
    later than when the sponsor seeks feedback from FDA regarding a
    phase 3 study or other pivotal study of the drug.
        The timing and manner of diversity action plan submission
    to FDA for device studies is dependent upon whether submission
    of an application for investigational device exemption (IDE) to
    FDA is required under FDA regulations. FDA regulations, 21
    C.F.R. Sec. 812.20(a), require submission of an IDE application
    for studies of significant risk devices, studies involving
    exceptions from informed consent, and studies for which FDA
    notifies the sponsor an application is required. Under 21
    C.F.R. Sec. 812.2(b), non-significant risk studies are
    considered to have approved IDE applications, without sponsor
    submission of such, as long as the sponsor complies with
    certain abbreviated requirements and FDA does not notify the
    sponsor that IDE application submission is required. Section
    501 of H.R. 7667 provides that device sponsors must submit
    their diversity action plan in their IDE application, if one is
    required; if one is not required, sponsors must submit their
    plans in any premarket notification, application for premarket
    approval, or request for de novo classification the sponsor may
    submit to FDA. Diversity action plans would also be subject to
    inspection by FDA.
        The requirement to submit diversity action plans becomes
    effective six months after publication of the final guidance
    required by this section; sponsors of studies for which
    enrollment has begun after such date must comply. Failure to
    comply prevents a drug or device to which this requirement is
    applicable from being exempt under section 505(i) or 520(g) of
    the FFDCA (21 U.S.C. Sec. Sec. 355(i), 360j(g)) from other
    applicable requirements. For non-significant risk devices, at
    the time the study is being conducted, failure to develop or
    implement a plan as required by this section would prevent the
    device from being exempt under section 520(g) of the FFDCA; at
    the time of any submission for premarket review to FDA, failure
    to submit the diversity action plan to FDA would render the
    device adulterated under section 501(i) of the FFDCA.
        This section also requires FDA to issue new draft guidance
    or update existing draft guidance within 12 months of
    enactment, and to finalize such guidance no later than nine
    months after the close of the comment period. The guidance must
    specify the form and content of diversity action plans
    regarding the sponsor's goals for study enrollment,
    disaggregated into certain demographic categories, including
    with respect to the rationale for enrollment goals, an
    explanation for how the sponsor will meet such goals, and how
    the sponsor will publicly post key information from the plan
    that would be useful to patients and providers on its website.

    Sec. 502. Evaluation of the need for FDA authority to mandate
            postapproval studies or postmarket surveillance due to
            insufficient demographic subgroup data

        Section 502 requires FDA to evaluate, not later than two
    years after the publication of the final guidance required by
    section 501, whether regulations or additional authorities are
    warranted to ensure that sponsors conduct post-approval studies
    or postmarket surveillance where premarket studies collected
    insufficient data for underrepresented subgroups according to
    the sponsor's goals and FDA has requested additional studies to
    be conducted.

    Sec. 503. Public workshops to enhance clinical study diversity

        Section 503 requires FDA, in consultation with drug
    sponsors, medical device manufacturers, patients, and other
    stakeholders, not later than one year after enactment, to
    convene one or more public workshops to solicit input from
    stakeholders on increasing the enrollment of historically
    underrepresented populations in clinical studies.

    Sec. 504. Annual summary report on progress to increase diversity in
            clinical studies

        Section 504 requires FDA, not later than two years after
    the enactment of the Food and Drug Amendments of 2022, and
    annually thereafter, to submit to Congress, and publish on the
    public website of FDA, a report that summarizes the diversity
    action plans received pursuant to section 501 and contains
    information on whether studies for approved and cleared drugs
    and devices met diversity action plan goals, the reasons given
    whenever sponsors failed to meet their goals, and any
    postmarket studies requested or required by FDA where there was
    inadequate premarket study diversity.

    Sec. 505. Public meeting on clinical study flexibilities initiated in
            response to COVID-19 pandemic

        Section 505 requires FDA, not later than 180 days after the
    date on which the COVID-19 public health emergency period ends,
    to convene a public meeting to discuss recommendations provided
    during the COVID-19 public health emergency to mitigate
    disruption of clinical studies. Such meeting shall discuss
    incorporating certain clinical study disruption mitigation
    recommendations into current or additional guidance to improve
    clinical study access and enrollment of diverse patient
    populations.

    Sec. 506. Decentralized clinical studies

        Section 506 requires FDA, not later than 12 months after
    the enactment of the Food and Drug Amendments of 2022, to issue
    draft guidance that addresses considerations for decentralized
    clinical studies, including regarding the engagement,
    enrollment, and retention of a meaningfully diverse clinical
    population with respect to race, ethnicity, age, sex, and
    geographic location, when appropriate. FDA is required to
    finalize this guidance no later than one year after the public
    comment period for the draft guidance ends.

                       TITLE VI--GENERIC DRUG COMPETITION

    Sec. 601. Increasing transparency in generic drug applications

        Section 601 requires FDA to provide generic drug sponsors,
    upon request, information regarding any qualitative or
    quantitative differences in ingredients between their generic
    drug and the reference listed drug to which they are compared,
    to facilitate generic drug development and review. This section
    makes clear these disclosures are authorized by law, including
    under section 1905 of title 18, United States Code. This
    section also requires FDA to issue guidance explaining how it
    determines whether a generic drug is qualitatively and
    quantitatively the same as the listed drug.

    Sec. 602. Enhancing access to affordable medicines

        Section 602 provides that a generic drug is eligible for
    approval notwithstanding differences between its proposed
    labeling and that of the listed drug due to revisions made to
    the labeling of the listed drug approved by FDA within 90 days
    of when the generic application is otherwise eligible for
    approval. This section preserves the provisions requiring that
    the revisions not be to the ``Warnings'' section of the
    labeling, the generic sponsor must submit revised labeling
    within 60 days of approval, and the applicable otherwise meet
    applicable requirements for approval.

        TITLE VII--RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN IMPROVEMENTS

                             SUBTITLE A--IN GENERAL

    Sec. 701. Animal testing alternatives

        Section 701 clarifies one of the purposes of a certain type
    of meeting FDA is required to have with sponsors of drug
    studies and applicants for drug approval, upon reasonable
    written request, in situations where human efficacy studies are
    not ethical or feasible. Section 701 broadens the purpose from
    reaching agreement on the design and size of ``animal and any
    associated clinical trials'' intended to support effectiveness
    to reaching agreement on the design and size of ``nonclinical
    tests and any associated clinical trials'' intended to support
    effectiveness, so that non-animal nonclinical studies would be
    included in these meetings in the event that such studies may
    be sufficient to provide substantial evidence of effectiveness
    in these situations. This section also broadens references to
    animal testing in section 505(i) regarding investigational new
    drug exemptions to ``nonclinical tests.'' Section 701 also
    defines ``nonclinical test'' and clarifies that it includes
    cell-based assays, organ chips and microphysiological systems,
    computer modeling, other nonhuman or human biology-based test
    methods, and animal tests.

    Sec. 702. Emerging technology program

        Section 702 authorizes the Emerging Technologies Program at
    FDA, a collaborative program wherein industry representatives,
    academics, and others can meet with FDA officials to support
    the adoption and improve the development of innovative
    approaches to drug design and manufacturing. This section
    requires FDA to issue guidance regarding requirements related
    to such approaches and report to Congress regarding allocation
    of funds and staff utilization in this program. It authorizes
    FDA to make grants and authorizes $20 million each year for
    fiscal years 2023 through 2027 to carry out the program.

    Sec. 703. Improving the treatment of rare diseases and conditions

        Section 703 requires FDA to submit a report summarizing its
    activities relating to designating, approving, and licensing
    drugs used to treat rare diseases no later than September 30,
    2026. This section also requires FDA to study processes for
    evaluating drugs for rare diseases in the United States and the
    European Union and to convene one or more public meetings to
    solicit input from stakeholders regarding approaches to
    improving engagement with rare disease condition patients,
    patient groups, and experts. Section 703 also requires the
    Government Accountability Office (GAO) to conduct a study on
    the use of FDA tools and mechanisms to ensure that patient and
    physician perspectives are considered and incorporated
    throughout FDA processes for approving and licensing drugs and
    making determinations related to a drug's approval.

    Sec. 704. Antifungal research and development

        Section 704 requires the Secretary to issue guidance for
    industry to assist entities seeking approval or licensure for
    antifungal therapies intended to treat coccidioidomycosis,
    commonly known as Valley Fever, and to hold a public workshop
    to assist entities developing preventative vaccines for fungal
    infections and Valley Fever.

    Sec. 705. Advancing qualified infectious disease product innovation

        Section 705 allows a biological product to qualify as a
    Qualified Infectious Disease Product (QIDP) under Section 505E
    of the FFDCA (21 U.S.C. Sec. 355f), which renders it eligible
    for fast track designation, and provides for priority review
    for the first application for an innovative biological
    antifungal or antibiotic QIDP that requires clinical data to
    demonstrate safety or effectiveness. This section does not
    extend QIDP exclusivity to biological products.

    Sec. 706. Advanced manufacturing technologies designation pilot program

        Section 706 requires FDA to initiate a pilot program for
    designating methods of manufacturing as advanced manufacturing
    technologies. A method of manufacturing is eligible for
    designation if such method both: incorporates a novel
    technology or uses an established technology in a novel way and
    will substantially improve the manufacturing process and
    maintain equivalent or superior drug quality. Designated
    technologies qualify for expedited application development and
    review and allow the holder of such designation, or a person
    authorized by the designation holder, to reference or rely
    upon, in a drug or biologic application, data and information
    about the designated technology for use in manufacturing drugs
    in the same context of use for which FDA granted the
    designation. This section also requires FDA to hold a public
    meeting, issue guidance, and report to Congress regarding this
    pilot, which sunsets on October 1, 2029.

    Sec. 707. Public workshop on cell therapies

        Section 707 requires FDA to convene a public workshop on
    best practices on generating scientific data necessary to
    further facilitate development of certain human cell-, tissue-,
    and cellular-based medical products, and the latest scientific
    information about such products.

    Sec. 708. Reauthorization of best pharmaceuticals for children

        Section 708 reauthorizes the Best Pharmaceuticals for
    Children Act through 2027, which allows the National Institutes
    of Health to fund studies of off-patent drugs in children.

    Sec. 709. Reauthorization for humanitarian device exemption and
            demonstration grants for improving pediatric availability

        Section 709 reauthorizes through 2027 the exemption,
    subject to certain conditions, from the profit limitation on
    devices granted a humanitarian device exemption under section
    520(m) of the FFDCA (21 U.S.C. Sec. 360j(m)). Such devices,
    which are designed to treat or diagnose a disease or condition
    that affects 8,000 or fewer individuals in the United States,
    are exempt from certain requirements if they meet certain
    criteria. Section 709 also reauthorizes demonstration grants
    for improving development of pediatric medical devices through
    2027.

    Sec. 710. Reauthorization of provision related to exclusivity of
            certain drugs containing single enantiomers

        Section 710 reauthorizes the provision allowing for
    exclusivity for certain single enantiomer drugs under certain
    conditions through 2027.

    Sec. 711. Reauthorization of the critical path public-private
            partnership program

        Section 711 reauthorizes the Critical Path Public-Private
    Partnership at $10 million annually through 2027.

    Sec. 712. Reauthorization of orphan drug grants

        Section 712 reauthorizes orphan drug grants through 2027
    and expands uses of such grants to include the development of
    regulatory science pertaining to manufacturing and controls
    related to individualized medical products to treat those with
    rare diseases or conditions.

    Sec. 713. Research into pediatric uses of drugs; additional authorities
            of Food and Drug Administration regarding molecularly targeted
            cancer drugs

        This section builds on the requirement included in Section
    504 of the FDA Reauthorization Act of 2017 for pediatric
    studies by sponsors of certain adult cancer drugs with new
    active ingredients directed at a molecular target FDA
    determines to be substantially relevant to the growth or
    progression of a pediatric cancer. Such required pediatric
    studies shall be designed to yield clinically meaningful data
    regarding dosing, safety, and preliminary efficacy to inform
    potential pediatric labeling. The section also clarifies that
    the required pediatric study may be of the new drug for which
    approval is sought or such drug used in combination with a
    previously approved drug or biological product that meets
    certain conditions. Additionally, Section 713 requires FDA to
    issue guidance and report to Congress on its implementation of
    this section not later than two years after enactment, and a
    GAO report on its success in the development of drugs and
    biological products for pediatric cancer indications.

                            SUBTITLE B--INSPECTIONS

    Sec. 721. Factory inspection

        Section 721 clarifies that the scope of FDA inspectional
    authority extending to all things in a factory, warehouse,
    establishment, or consulting laboratory applies to such places
    that manufacture, process, pack, or hold non-restricted devices
    as well as ones that do so with respect to restricted devices.
    This section also extends the requirement for the provision, to
    FDA, of records requested in advance or in lieu of an
    inspection to persons that own or operate establishments
    engaged in the manufacture, preparation, propagation,
    compounding, or processing of devices. FDA will have to provide
    a rationale for requesting such records and issue guidance
    regarding such requests.
        Section 721 also codifies and clarifies FDA authority to
    inspect clinical study sites, also known as bioresearch
    monitoring inspections. It requires FDA to review its processes
    and practices applicable to such inspections in the United
    States and in foreign countries, evaluate whether updates are
    needed to facilitate consistency, and issue guidance describing
    the conduct of such inspections.

    Sec. 722. Uses of certain evidence

        Section 722 clarifies that the limitation on FDA's use of
    certain evidence regarding product movement in interstate
    commerce obtained from carriers and receivers does not apply to
    information obtained under other authorities such as those
    authorizing inspections unless such limitations are
    specifically incorporated.

    Sec. 723. Improving FDA inspections

        Section 723 provides for FDA consideration of the
    compliance history of other FDA-regulated establishments in the
    country or region in which an establishment is located as a
    factor in establishing a schedule for risk-based inspections.
    It clarifies that FDA may rely on any records or other
    information inspected to satisfy requirements that may pertain
    to a preapproval or risk-based surveillance inspection, or to
    resolve deficiencies found in such inspections, if applicable
    and appropriate. It provides that FDA may enter into agreements
    with foreign governments to recognize inspections of foreign
    establishments to facilitate preapproval inspections and
    requires a periodic assessment of whether additional
    arrangements with foreign governments are appropriate.

    Sec. 724. GAO report on inspections of foreign establishments
            manufacturing drugs

        Section 724 requires GAO to report on FDA and recognized
    foreign government inspections of foreign establishments
    manufacturing drugs.

    Sec. 725. Unannounced foreign facility inspections pilot program

        Section 725 requires FDA to conduct a pilot program in
    which FDA increases the conduct of unannounced surveillance
    inspections of foreign drug establishments, evaluates the
    differences between such inspections of domestic and foreign
    establishments, including the impact of announcing inspections,
    and post a report of its findings and recommendations on the
    FDA website.

    Sec. 726. Reauthorization of inspection program

        Section 726 reauthorizes the third-party inspection program
    until October 1, 2027.

    Sec. 727. Enhancing intra-agency coordination and public health
            assessment with regard to compliance activities

        Section 727 amends section 506D of the FFDCA (21 U.S.C.
    Sec. 356d) to require FDA to ensure timely and effective
    internal coordination and alignment among field investigators
    and staff of CDER's Office of Compliance and Drug Shortage
    Program regarding the reviews of inspection reports and any
    feedback or corrective actions in response to such reports. It
    also requires FDA reporting to Congress regarding certain drug
    shortage reports and the internal coordination and alignment
    required by this section.

    Sec. 728. Reporting of mutual recognition agreements for inspections
            and review activities

        Section 728 requires FDA to publish on its website a
    report, no later than the end of calendar year 2022 and
    annually thereafter, on the utilization of agreements entered
    into pursuant to section 809 of the FFDCA (21 U.S.C. Sec. 384e)
    or otherwise entered into to recognize inspections across
    countries and international regions by drug regulatory
    authorities with analogous review criteria to the FDA.

    Sec. 729. Enhancing transparency of drug facility inspection timelines

        Section 729 amends the information FDA must annually report
    regarding inspections on its website pursuant to section 902 of
    the FDA Reauthorization Act of 2017, including by adding to
    this information the time between a request from FDA and the
    beginning of an inspection for certain generic drugs, drugs
    subject to discontinuance reporting, and drugs on the shortage
    list.

          TITLE VIII--TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY
                                  IMPROVEMENTS

    Sec. 801. Prompt reports of marketing status by holders of approved
            applications for biological products

        Section 801 requires all holders of approved Biologics
    License Applications to submit a one-time notification to FDA
    indicating whether their products listed in the Purple Book are
    still available for sale and to report to FDA on an ongoing
    basis when withdrawing a product from the market.

    Sec. 802. Encouraging blood donation

        Section 802 exempts from Paperwork Reduction Act
    requirements FDA information collections to solicit patient
    perspectives during medical product development and to solicit
    information from blood donors and potential blood donors to
    inform recommendations regarding blood donation.

    Sec. 803. Regulation of certain products as drugs

        Section 803 deems all contrast agents and products under
    over-the-counter drug monographs, and certain radioactive
    products, to be drugs and not medical devices.

    Sec. 804. Postapproval studies and program integrity for accelerated
            approval drugs

        Section 804 requires FDA to specify conditions for required
    postapproval studies for drugs approved under accelerated
    approval, which may include enrollment targets and milestones,
    including the target date for study completion, by the time the
    drug is approved. This section also authorizes FDA to require
    postapproval studies to be underway at the time of approval for
    such drugs, requires FDA to explain any instances where it does
    not require such studies, and provides that postapproval
    studies may be augmented or supported by real world evidence.
    This section clarifies that existing authority to withdraw
    approvals where sponsors fail to conduct studies with due
    diligence applies with respect to the approval conditions and
    streamlines the procedures for withdrawal of approval. To
    withdraw an accelerated approval, it requires FDA to provide an
    explanation for the withdrawal, an opportunity for written
    appeal, a meeting with the Commissioner or their designee,
    responses to public comment, and, upon request, an advisory
    committee meeting if there was not previously one on the
    withdrawal. Section 804 codifies labeling requirements for
    accelerated approval and requires more frequent reports on
    postapproval study progress. It also requires FDA to report to
    Congress on the use of real world evidence to support
    postapproval studies, issue guidance on novel surrogate
    endpoints and trial designs, and establish a rare disease
    endpoint advancement pilot program.

    Sec. 805. Facilitating the use of real world evidence

        Section 805 requires FDA to issue guidance addressing the
    use of real world evidence and real world data, including that
    obtained for drugs and devices authorized for emergency use
    during the COVID-19 public health emergency, to support drug
    and device approvals and clearances. It requires FDA to report
    to Congress regarding the number of applications submitted for
    products for which an emergency use authorization was
    previously granted and, of such applications, how many included
    real world evidence and whether such evidence was sufficient to
    support a regulatory decision.

    Sec. 806. Dual submission for certain devices

        Section 806 provides that sponsors of diagnostic tests that
    have been deemed to be CLIA-waived under section 564(m) of the
    FFDCA (21 U.S.C. Sec. 360j(m)) as part of a COVID-19 emergency
    use authorization that submit requests for de novo
    classification of their test under section 513(f)(2) of the
    FFDCA (21 U.S.C. Sec. 360c(f)(2)) may submit such request
    together with sufficient information to enable FDA to determine
    whether the test satisfies the criteria for CLIA categorization
    under section 353(d)(3) of the Public Health Service Act (42
    U.S.C. Sec. 263a(d)(3)) in a single submission.

    Sec. 807. Medical devices advisory committee meetings

        Section 807 requires the Medical Device Advisory Committee
    to meet at least once a year through 2027 to provide FDA advice
    on topics related to medical devices in pandemic preparedness
    and response, including issues related to in vitro diagnostics.

    Sec. 808. Ensuring cybersecurity of medical devices

        Section 808 requires manufacturers of cyber devices to
    develop processes to ensure their devices are secure, have
    plans to identify and address cybersecurity vulnerabilities,
    provide a software bill of materials in their labeling, and
    submit this information to FDA in any premarket submissions. It
    defines cyber devices as devices that have software, connect to
    the internet, or otherwise could be vulnerable to cybersecurity
    threats. Section 808 authorizes FDA to deny 510(k) clearance if
    cyber security information is inadequate and to exempt types of
    devices from these requirements. It makes failure to comply
    with these requirements a prohibited act.

    Sec. 809. Public docket on proposed changes to third-party vendors

        Section 809 requires FDA to provide a public comment period
    regarding patient access and provider administration when a
    proposed modification to an approved risk evaluation and
    mitigation strategy (REMS) is reviewed under section 505-1(h)
    of the FFDCA (21 U.S.C. Sec. 355 1(h)). This section makes
    clear that it shall not delay any agency action on any
    modification to a REMS.

    Sec. 810. Facilitating exchange of product information prior to
            approval

        Section 810 provides that no drug or device shall be
    considered misbranded as a result of the provision of
    information regarding investigational drugs or devices or uses
    to payors, formulary committees, or other similar entities
    under specified conditions. It requires the information to
    include a clear statement that the drug or device it discusses
    has not been approved and that the safety and efficacy of the
    drug or device has not been established. Additional required
    disclosures include information about studies the drug or
    device is undergoing, how the studies relate to the overall
    plan for the development of the drug or device, whether an
    application for the drug or device has been submitted to FDA,
    and if not, when such submission is planned.

    Sec. 811. Bans of devices for one or more intended uses

        Section 811 amends section 516 of the FFDCA (21 U.S.C.
    Sec. 360f) to make clear that FDA is authorized to ban a
    medical device intended for a particular use. A ban may apply
    to devices intended for more than one use, but in a situation
    where there are devices with the same or similar technological
    characteristics and different intended uses, FDA may ban one
    and not the other. Section 811 also bans electrical stimulation
    devices intended for self-injurious and aggressive behavior,
    which renders such devices adulterated under section 501(g) of
    the FFDCA (21 U.S.C. Sec. 351(g)).

    Sec. 812. Clarifying application of exclusive approval, certification,
            or licensure for drugs designated for rare disease or
            conditions

        Section 812 amends section 527 of the FFDCA (21 U.S.C.
    Sec. 360cc) regarding orphan drugs to provide clarity that
    orphan exclusivity applies only to the specific indication or
    use approved by FDA under this section, not the entire rare
    disease or condition for which the drug was designated,
    consistent with FDA's long-held interpretation of the law.

    Sec. 813. GAO report on third-party review

        Section 813 requires GAO to report on the program for
    accredited third-party review of 510(k) premarket notifications
    for medical devices.

    Sec. 814. Reporting on pending generic drug applications and priority
            review applications

        Section 814 reauthorizes reporting on certain pending
    generic drug applications and priority review applications
    through 2027.

    Sec. 815. FDA workforce improvements

        Section 815 extends the authority Congress granted to FDA
    in the 21st Century Cures Act of 2016 to facilitate the hiring
    and retention of outstanding candidates for scientific,
    technical, or professional positions that support the
    development and regulation of medical products to the hiring of
    candidates for such positions to support the regulation of
    products across the entire agency. This section also requires
    FDA to develop and begin implementation of a strategic
    workforce plan and report to Congress regarding such plan.

           XVI. Changes in Existing Law Made by the Bill, as Reported

      In compliance with clause 3(e) of rule XIII of the Rules of
    the House of Representatives, changes in existing law made by
    the bill, as reported, are shown as follows (existing law
    proposed to be omitted is enclosed in black brackets, new
    matter is printed in italics, and existing law in which no
    change is proposed is shown in roman):

                      FEDERAL FOOD, DRUG, AND COSMETIC ACT

               *       *       *       *       *       *       *
                   CHAPTER III--PROHIBITED ACTS AND PENALTIES

                                prohibited acts

      Sec. 301. The following acts and the causing thereof are
    hereby prohibited:
      (a) The introduction or delivery for introduction into
    interstate commerce of any food, drug, device, tobacco product,
    or cosmetic that is adulterated or misbranded.
      (b) The adulteration or misbranding of any food, drug,
    device, tobacco product, or cosmetic in interstate commerce.
      (c) The receipt in interstate commerce of any food, drug,
    device, tobacco product, or cosmetic that is adulterated or
    misbranded, and the delivery or proffered delivery thereof for
    pay or otherwise.
      (d) The introduction or delivery for introduction into
    interstate commerce of any article in violation of section 404,
    415, 505, or 564.
      (e) The refusal to permit access to or copying of any record
    as required by section 412, 414, 417(j), 416, 504, 564, 703,
    704(a), 760, or 761; or the failure to establish or maintain
    any record, or make any report, required under section 412,
    414(b), 417, 416, 504, 505 (i) or (k), 512(a)(4)(C), 512 (j),
    (l) or (m), 572(i), 515(f), 519, 564, 760, 761, 909, or 920 or
    the refusal to permit access to or verification or copying of
    any such required record; or the violation of any recordkeeping
    requirement under section 204 of the FDA Food Safety
    Modernization Act (except when such violation is committed by a
    farm).
      (f) The refusal to permit entry or inspection as authorized
    by section 704.
      (g) The manufacture within any Territory of any food, drug,
    device, tobacco product, or cosmetic that is adulterated or
    misbranded.
      (h) The giving of a guaranty or undertaking referred to in
    section 303(c)(2), which guaranty or undertaking is false,
    except by a person who relied upon a guaranty or undertaking to
    the same effect signed by, and containing the name and address
    of, the person residing in the United States from whom he
    received in good faith the food, drug, device, tobacco product,
    or cosmetic; or the giving of a guaranty or undertaking
    referred to in section 303(c)(3), which guaranty or undertaking
    is false.
      (i)(1) Forging, counterfeiting, simulating, or falsely
    representing, or without proper authority using any mark,
    stamp, tag, label, or other identification device authorized or
    required by regulations promulgated under the provisions of
    section 404 or 721.
      (2) Making, selling, disposing of, or keeping in possession,
    control, or custody, or concealing any punch, die, plate,
    stone, or other thing designed to print, imprint, or reproduce
    the trademark, trade name, or other identifying mark, imprint,
    or device of another or any likeness of any of the foregoing
    upon any drug or container or labeling thereof so as to render
    such drugs a counterfeit drug.
      (3) The doing of any act which causes a drug to be a
    counterfeit drug, or the sale or dispensing, or the holding for
    sale or dispensing, of a counterfeit drug.
      (j) The using by any person to his own advantage, or
    revealing, other than to the Secretary or officers or employees
    of the Department, or to the courts when relevant in any
    judicial proceeding under this Act, any information acquired
    under authority of section 404, 409, 412, 414, 505, 510, 512,
    513, 514, 515, 516, 518, 519, 520, 571, 572, 573, 704, 708,
    721, 904, 905, 906, 907, 908, 909, or 920(b) concerning any
    method or process which as a trade secret is entitled to
    protection; or the violating of section 408(i)(2) or any
    regulation issued under that section.. This paragraph does not
    authorize the withholding of information from either House of
    Congress or from, to the extent of matter within its
    jurisdiction, any committee or subcommittee of such committee
    or any joint committee of Congress or any subcommittee of such
    joint committee.
      (k) The alteration, mutilation, destruction, obliteration, or
    removal of the whole or any part of the labeling of, or the
    doing of any other act with respect to, a food, drug, device,
    tobacco product, or cosmetic, if such act is done while such
    article is held for sale (whether or not the first sale) after
    shipment in interstate commerce and results in such article
    being adulterated or misbranded.
      (m) The sale or offering for sale of colored oleomargarine or
    colored margarine, or the possession or serving of colored
    oleomargarine or colored margarine in violation of section
    407(b) or 407(c).
      (n) The using, in labeling, advertising or other sales
    promotion of any reference to any report or analysis furnished
    in compliance with section 704.
      (o) In the case of a prescription drug distributed or offered
    for sale in interstate commerce, the failure of the
    manufacturer, packer, or distributor thereof to maintain for
    transmittal, or to transmit, to any practitioner licensed by
    applicable State law to administer such drug who makes written
    request for information as to such drug, true and correct
    copies of all printed matter which is required to be included
    in any package in which that drug is distributed or sold, or
    such other printed matter as is approved by the Secretary.
    Nothing in this paragraph shall be construed to exempt any
    person from any labeling requirement imposed by or under other
    provisions of this Act.
      (p) The failure to register in accordance with section 510 or
    905, the failure to provide any information required by section
    510(j), 510(k), 905(i), or 905(j), or the failure to provide a
    notice required by section 510(j)(2) or 905(i)(3).
      (q)(1) The failure or refusal--
              (A) to comply with any requirement prescribed under
            section 518, 520(g), 903(b), 907, 908, or 915;
              (B) to furnish any notification or other material or
            information required by or under section 519, 520(g),
            904, 909, or 920; or
              (C) to comply with a requirement under section 522 or
            913.
      (2) With respect to any device or tobacco product, the
    submission of any report that is required by or under this Act
    that is false or misleading in any material respect.
      (3) The failure to comply with any requirement under section
    524C (relating to ensuring device cybersecurity).
      (r) The movement of a device, drug, or tobacco product in
    violation of an order under section 304(g) or the removal or
    alteration of any mark or label required by the order to
    identify the device, drug, or tobacco product as detained.
      (s) The failure to provide the notice required by section
    412(c) or 412(e), the failure to make the reports required by
    section 412(f)(1)(B), the failure to retain the records
    required by section 412(b)(4), or the failure to meet the
    requirements prescribed under section 412(f)(3).
      (t) The importation of a drug in violation of section
    801(d)(1), the sale, purchase, or trade of a drug or drug
    sample or the offer to sell, purchase, or trade a drug or drug
    sample in violation of section 503(c), the sale, purchase, or
    trade of a coupon, the offer to sell, purchase, or trade such a
    coupon, or the counterfeiting of such a coupon in violation of
    section 503(c)(2), the distribution of a drug sample in
    violation of section 503(d) or the failure to otherwise comply
    with the requirements of section 503(d), the distribution of
    drugs in violation of section 503(e), failure to comply with
    the requirements under section 582, the failure to comply with
    the requirements under section 584, as applicable, or the
    failure to otherwise comply with the requirements of section
    503(e).
      (u) The failure to comply with any requirements of the
    provisions of, or any regulations or orders of the Secretary,
    under section 512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).
      (v) The introduction or delivery for introduction into
    interstate commerce of a dietary supplement that is unsafe
    under section 413.
      (w) The making of a knowingly false statement in any
    statement, certificate of analysis, record, or report required
    or requested under section 801(d)(3); the failure to submit a
    certificate of analysis as required under such section; the
    failure to maintain records or to submit records or reports as
    required by such section; the release into interstate commerce
    of any article or portion thereof imported into the United
    States under such section or any finished product made from
    such article or portion, except for export in accordance with
    section 801(e) or 802, or with section 351(h) of the Public
    Health Service Act; or the failure to so export or to destroy
    such an article or portions thereof, or such a finished
    product.
      (x) The falsification of a declaration of conformity
    submitted under section 514(c) or the failure or refusal to
    provide data or information requested by the Secretary under
    paragraph (3) of such section.
      (y) In the case of a drug, device, or food--
              (1) the submission of a report or recommendation by a
            person accredited under section 523 that is false or
            misleading in any material respect;
              (2) the disclosure by a person accredited under
            section 523 of confidential commercial information or
            any trade secret without the express written consent of
            the person who submitted such information or secret to
            such person; or
              (3) the receipt by a person accredited under section
            523 of a bribe in any form or the doing of any corrupt
            act by such person associated with a responsibility
            delegated to such person under this Act.
      (z) The dissemination of information in violation of section
    551.
      (aa) The importation of a prescription drug in violation of
    section 804, the falsification of any record required to be
    maintained or provided to the Secretary under such section, or
    any other violation of regulations under such section.
      (bb) The transfer of an article of food in violation of an
    order under section 304(h), or the removal or alteration of any
    mark or label required by the order to identify the article as
    detained.
      (cc) The importing or offering for import into the United
    States of an article of food or a drug by, with the assistance
    of, or at the direction of, a person debarred from such
    activity under section 306(b)(3).
      (dd) The failure to register in accordance with section 415.
      (ee) The importing or offering for import into the United
    States of an article of food in violation of the requirements
    under section 801(m).
      (ff) The importing or offering for import into the United
    States of a drug or device with respect to which there is a
    failure to comply with a request of the Secretary to submit to
    the Secretary a statement under section 801(o).
      (gg) The knowing failure to comply with paragraph (7)(E) of
    section 704(g); the knowing inclusion by a person accredited
    under paragraph (2) of such section of false information in an
    inspection report under paragraph (7)(A) of such section; or
    the knowing failure of such a person to include material facts
    in such a report.
      (hh) The failure by a shipper, carrier by motor vehicle or
    rail vehicle, receiver, or any other person engaged in the
    transportation of food to comply with the sanitary
    transportation practices prescribed by the Secretary under
    section 416.
      (ii) The falsification of a report of a serious adverse event
    submitted to a responsible person (as defined under section 760
    or 761) or the falsification of a serious adverse event report
    (as defined under section 760 or 761) submitted to the
    Secretary.
      (jj)(1) The failure to submit the certification required by
    section 402(j)(5)(B) of the Public Health Service Act, or
    knowingly submitting a false certification under such section.
      (2) The failure to submit clinical trial information required
    under subsection (j) of section 402 of the Public Health
    Service Act.
      (3) The submission of clinical trial information under
    subsection (j) of section 402 of the Public Health Service Act
    that is false or misleading in any particular under paragraph
    (5)(D) of such subsection (j).
      (kk) The dissemination of a television advertisement without
    complying with section 503B.
      (ll) The introduction or delivery for introduction into
    interstate commerce of any food to which has been added a drug
    approved under section 505, a biological product licensed under
    section 351 of the Public Health Service Act, or a drug or a
    biological product for which substantial clinical
    investigations have been instituted and for which the existence
    of such investigations has been made public, unless--
              (1) such drug or such biological product was marketed
            in food before any approval of the drug under section
            505, before licensure of the biological product under
            such section 351, and before any substantial clinical
            investigations involving the drug or the biological
            product have been instituted;
              (2) the Secretary, in the Secretary's discretion, has
            issued a regulation, after notice and comment,
            approving the use of such drug or such biological
            product in the food;
              (3) the use of the drug or the biological product in
            the food is to enhance the safety of the food to which
            the drug or the biological product is added or applied
            and not to have independent biological or therapeutic
            effects on humans, and the use is in conformity with--
                      (A) a regulation issued under section 409
                    prescribing conditions of safe use in food;
                      (B) a regulation listing or affirming
                    conditions under which the use of the drug or
                    the biological product in food is generally
                    recognized as safe;
                      (C) the conditions of use identified in a
                    notification to the Secretary of a claim of
                    exemption from the premarket approval
                    requirements for food additives based on the
                    notifier's determination that the use of the
                    drug or the biological product in food is
                    generally recognized as safe, provided that the
                    Secretary has not questioned the general
                    recognition of safety determination in a letter
                    to the notifier;
                      (D) a food contact substance notification
                    that is effective under section 409(h); or
                      (E) such drug or biological product had been
                    marketed for smoking cessation prior to the
                    date of the enactment of the Food and Drug
                    Administration Amendments Act of 2007; or
              (4) the drug is a new animal drug whose use is not
            unsafe under section 512.
      (mm) The failure to submit a report or provide a notification
    required under section 417(d).
      (nn) The falsification of a report or notification required
    under section 417(d).
      (oo) The sale of tobacco products in violation of a no-
    tobacco-sale order issued under section 303(f).
      (pp) The introduction or delivery for introduction into
    interstate commerce of a tobacco product in violation of
    section 911.
      (qq)(1) Forging, counterfeiting, simulating, or falsely
    representing, or without proper authority using any mark, stamp
    (including tax stamp), tag, label, or other identification
    device upon any tobacco product or container or labeling
    thereof so as to render such tobacco product a counterfeit
    tobacco product.
      (2) Making, selling, disposing of, or keeping in possession,
    control, or custody, or concealing any punch, die, plate,
    stone, or other item that is designed to print, imprint, or
    reproduce the trademark, trade name, or other identifying mark,
    imprint, or device of another or any likeness of any of the
    foregoing upon any tobacco product or container or labeling
    thereof so as to render such tobacco product a counterfeit
    tobacco product.
      (3) The doing of any act that causes a tobacco product to be
    a counterfeit tobacco product, or the sale or dispensing, or
    the holding for sale or dispensing, of a counterfeit tobacco
    product.
      (rr) The charitable distribution of tobacco products.
      (ss) The failure of a manufacturer or distributor to notify
    the Attorney General and the Secretary of the Treasury of their
    knowledge of tobacco products used in illicit trade.
      (tt) Making any express or implied statement or
    representation directed to consumers with respect to a tobacco
    product, in a label or labeling or through the media or
    advertising, that either conveys, or misleads or would mislead
    consumers into believing, that--
              (1) the product is approved by the Food and Drug
            Administration;
              (2) the Food and Drug Administration deems the
            product to be safe for use by consumers;
              (3) the product is endorsed by the Food and Drug
            Administration for use by consumers; or
              (4) the product is safe or less harmful by virtue
            of--
                      (A) its regulation or inspection by the Food
                    and Drug Administration; or
                      (B) its compliance with regulatory
                    requirements set by the Food and Drug
                    Administration;
            including any such statement or representation
            rendering the product misbranded under section 903.

      (uu) The operation of a facility that manufactures,
    processes, packs, or holds food for sale in the United States
    if the owner, operator, or agent in charge of such facility is
    not in compliance with section 418.
      (vv) The failure to comply with the requirements under
    section 419.
      (ww) The failure to comply with section 420.
      (xx) The refusal or failure to follow an order under section
    423.
      (yy) The knowing and willful failure to comply with the
    notification requirement under section 417(h).
      (zz) The importation or offering for importation of a food if
    the importer (as defined in section 805) does not have in place
    a foreign supplier verification program in compliance with such
    section 805.
      (aaa) The failure to register in accordance with section
    801(s).
      (bbb) The failure to notify the Secretary in violation of
    section 568.
      (ccc)(1) The resale of a compounded drug that is labeled
    ``not for resale'' in accordance with section 503B.
      (2) With respect to a drug to be compounded pursuant to
    section 503A or 503B, the intentional falsification of a
    prescription, as applicable.
      (3) The failure to report drugs or adverse events by an
    entity that is registered in accordance with subsection (b) of
    section 503B.
      (ddd)(1) The manufacture or the introduction or delivery for
    introduction into interstate commerce of a rinse-off cosmetic
    that contains intentionally-added plastic microbeads.
      (2) In this paragraph--
              (A) the term ``plastic microbead'' means any solid
            plastic particle that is less than five millimeters in
            size and is intended to be used to exfoliate or cleanse
            the human body or any part thereof; and
              (B) the term ``rinse-off cosmetic'' includes
            toothpaste.
      (eee) The failure to comply with any order issued under
    section 569D.

               *       *       *       *       *       *       *

                          CHAPTER V--DRUGS AND DEVICES

                        Subchapter A--Drugs and Devices

                         adulterated drugs and devices

      Sec. 501. A drug or device shall be deemed to be
    adulterated--
      (a)(1) If it consists in whole or in part of any filthy,
    putrid, or decomposed substance; or (2)(A) if it has been
    prepared, packed, or held under insanitary conditions whereby
    it may have been contaminated with filth, or whereby it may
    have been rendered injurious to health; or (B) if it is a drug
    and the methods used in, or the facilities or controls used
    for, its manufacture, processing, packing, or holding do not
    conform to or are not operated or administered in conformity
    with current good manufacturing practice to assure that such
    drug meets the requirements of this Act as to safety and has
    the identity and strength, and meets the quality and purity
    characteristics, which it purports or is represented to
    possess; or (C) if it is a compounded positron emission
    tomography drug and the methods used in, or the facilities and
    controls used for, its compounding, processing, packing, or
    holding do not conform to or are not operated or administered
    in conformity with the positron emission tomography compounding
    standards and the official monographs of the United States
    Pharmacopoeia to assure that such drug meets the requirements
    of this Act as to safety and has the identity and strength, and
    meets the quality and purity characteristics, that it purports
    or is represented to possess; or (3) if its container is
    composed, in whole or in part, of any poisonous or deleterious
    substance which may render the contents injurious to health; or
    (4) if (A) it bears or contains, for purposes of coloring only,
    a color additive which is unsafe within the meaning of section
    721(a), or (B) it is a color additive the intended use of which
    in or on drugs or devices is for purposes of coloring only and
    is unsafe within the meaning of section 721(a); or (5) if it is
    a new animal drug which is unsafe within the meaning of section
    512; or (6) if it is an animal feed bearing or containing a new
    animal drug, and such animal feed is unsafe within the meaning
    of section 512.
      (b) If it purports to be or is represented as a drug the name
    of which is recognized in an official compendium, and its
    strength differs from, or its quality or purity falls below,
    the standards set forth in such compendium. Such determination
    as to strength, quality, or purity shall be made in accordance
    with the tests or methods of assay set forth in such
    compendium, except that whenever tests or methods of assay have
    not been prescribed in such compendium, or such tests or
    methods of assay as are prescribed are, in the judgment of the
    Secretary, insufficient for the making of such determination,
    the Secretary shall bring such fact to the attention of the
    appropriate body charged with the revision of such compendium,
    and if such body fails within a reasonable time to prescribe
    tests or methods of assay which, in the judgment of the
    Secretary, are sufficient for purposes of this paragraph, then
    the Secretary shall promulgate regulations prescribing
    appropriate tests or methods of assay in accordance with which
    such determination as to strength, quality, or purity shall be
    made. No drug defined in an official compendium shall be deemed
    to be adulterated under this paragraph because it differs from
    the standard of strength, quality, or purity therefor set forth
    in such compendium, if its difference in strength, quality, or
    purity from such standards is plainly stated on its label.
    Whenever a drug is recognized in both the United States
    Pharmacopeia and the Homeopathic Pharmacopeia of the United
    States it shall be subject to the requirements of the United
    States Pharmacopeia unless it is labeled and offered for sale
    as a homeopathic drug, in which case it shall be subject to the
    provisions of the Homeopathic Pharmacopeia of the United States
    and not to those of the United States Pharmacopeia.
      (c) If it is not subject to the provisions of paragraph (b)
    of this section and its strength differs from, or its purity or
    quality falls below, that which it purports or is represented
    to possess.
      (d) If it is a drug and any substance has been (1) mixed or
    packed therewith so as to reduce its quality or strength or (2)
    substituted wholly or in part therefor.
      (e)(1) If it is, or purports to be or is represented as, a
    device which is subject to a performance standard established
    under section 514, unless such device is in all respects in
    conformity with such standard.
      (2) If it is declared to be, purports to be, or is
    represented as, a device that is in conformity with any
    standard recognized under section 514(c) unless such device is
    in all respects in conformity with such standard.
      (f)(1) If it is a class III device--
              (A)(i) which is required by an order issued under
            subsection (b) of section 515 to have an approval under
            such section of an application for premarket approval
            and which is not exempt from section 515 under section
            520(g), and
              (ii)(I) for which an application for premarket
            approval or a notice of completion of a product
            development protocol was not filed with the Secretary
            within the ninety-day period beginning on the date of
            the issuance of such order, or
              (II) for which such an application was filed and
            approval of the application has been denied, suspended,
            or withdrawn, or such a notice was filed and has been
            declared not completed or the approval of the device
            under the protocol has been withdrawn;
              (B)(i) which was classified under section 513(f) into
            class III, which under section 515(a) is required to
            have in effect an approved application for premarket
            approval, and which is not exempt from section 515
            under section 520(g), and
              (ii) which has an application which has been
            suspended or is otherwise not in effect; or
              (C) which was classified under section 520(l) into
            class III, which under such section is required to have
            in effect an approved application under section 515,
            and which has an application which has been suspended
            or is otherwise not in effect.
      (2)(A) In the case of a device classified under section
    513(f) into class III and intended solely for investigational
    use, paragraph (1)(B) shall not apply with respect to such
    device during the period ending on the ninetieth day after the
    date of the promulgation of the regulations prescribing the
    procedures and conditions required by section 520(g)(2).
      (B) In the case of a device subject to an order issued under
    subsection (b) of section 515, paragraph (1) shall not apply
    with respect to such device during the period ending--
              (i) on the last day of the thirtieth calendar month
            beginning after the month in which the classification
            of the device in class III became effective under
            section 513, or
              (ii) on the ninetieth day after the date of the
            issuance of such order,
    whichever occurs later.
      (3) In the case of a device with respect to which a
    regulation was promulgated under section 515(b) prior to the
    date of enactment of the Food and Drug Administration Safety
    and Innovation Act, a reference in this subsection to an order
    issued under section 515(b) shall be deemed to include such
    regulation.
      (g) If it is a banned device.
      (h) If it is a device and the methods used in, or the
    facilities or controls used for, its manufacture, packing,
    storage, or installation are not in conformity with applicable
    requirements under section 520(f)(1) or an applicable condition
    prescribed by an order under section 520(f)(2).
      (i) If it is a device for which an exemption has been granted
    under section 520(g) for investigational use and the person who
    was granted such exemption or any investigator who uses such
    device under such exemption fails to comply with a requirement
    prescribed by or under such section.
      (j) If it is a drug or device and it has been manufactured,
    processed, packed, or held in any factory, warehouse, or
    establishment and the owner, operator, or agent of such
    factory, warehouse, or establishment delays, denies, or limits
    an inspection, or refuses to permit entry or inspection.
    For purposes of paragraph (a)(2)(B), the term ``current good
    manufacturing practice'' includes the implementation of
    oversight and controls over the manufacture of drugs to ensure
    quality, including managing the risk of and establishing the
    safety of raw materials, materials used in the manufacturing of
    drugs, and finished drug products.
      (k) If it is a device subject to the requirements set forth
    in section 524C (relating to ensuring device cybersecurity) and
    fails to comply with any requirement under that section.

                          misbranded drugs and devices

      Sec. 502. A drug or device shall be deemed to be misbranded--
      (a)(1) If its labeling is false or misleading in any
    particular. Health care economic information provided to a
    payor, formulary committee, or other similar entity with
    knowledge and expertise in the area of health care economic
    analysis, carrying out its responsibilities for the selection
    of [drugs for coverage] drugs or devices for coverage or
    reimbursement, shall not be considered to be false or
    misleading under this paragraph if the health care economic
    information relates to an indication approved [under section
    505 or under section 351(a) of the Public Health Service Act]
    under section 505, 510(k), 513(f)(2), or 515 of this Act or
    section 351 of the Public Health Service Act for such [drug]
    drug or device, is based on competent and reliable scientific
    evidence, and includes, where applicable, a conspicuous and
    prominent statement describing any material differences between
    the health care economic information and the labeling approved
    for the [drug] drug or device [under section 505 or under
    section 351 of the Public Health Service Act] under section
    505, 510(k), 513(f)(2), or 515 of this Act or section 351 of
    the Public Health Service Act. The requirements set forth [in
    section 505(a) or in subsections (a) and (k) of section 351 of
    the Public Health Service Act] in section 505, 510(k),
    513(f)(2), or 515 of this Act or section 351 of the Public
    Health Service Act shall not apply to health care economic
    information provided to such a payor, committee, or entity in
    accordance with this paragraph. Information that is relevant to
    the substantiation of the health care economic information
    presented pursuant to this paragraph shall be made available to
    the Secretary upon request.
      (2)(A) For purposes of this paragraph, the term ``health care
    economic information'' means any analysis (including the
    clinical data, inputs, clinical or other assumptions, methods,
    results, and other components underlying or comprising the
    analysis) that identifies, measures, or describes the economic
    consequences, which may be based on the separate or aggregated
    clinical consequences of the represented health outcomes, of
    the use of a [drug] drug or device. Such analysis may be
    comparative to the use of another [drug] drug or device, to
    another health care intervention, or to no intervention.
      (B) Such term does not include any analysis that relates only
    to an indication that is not approved [under section 505 or
    under section 351 of the Public Health Service Act] under
    section 505, 510(k), 513(f)(2), or 515 of this Act or section
    351 of the Public Health Service Act for such [drug] drug or
    device.
      (b) If in a package form unless it bears a label containing
    (1) the name and place of business of the manufacturer, packer,
    or distributor; and (2) an accurate statement of the quantity
    of the contents in terms of weight, measure, or numerical
    count: Provided, That under clause (2) of this paragraph
    reasonable variations shall be permitted, and exemptions as to
    small packages shall be established, by regulations prescribed
    by the Secretary.
      (c) If any word, statement, or other information required by
    or under authority of this Act to appear on the label or
    labeling is not prominently placed thereon with such
    conspicuousness (as compared with other words, statements,
    designs, or devices, in the labeling) and in such terms as to
    render it likely to be read and understood by the ordinary
    individual under customary conditions of purchase and use.
      (e)(1)(A) If it is a drug, unless its label bears, to the
    exclusion of any other nonproprietary name (except the
    applicable systematic chemical name or the chemical formula)--
              (i) the established name (as defined in subparagraph
            (3)) of the drug, if there is such a name;
              (ii) the established name and quantity or, if
            determined to be appropriate by the Secretary, the
            proportion of each active ingredient, including the
            quantity, kind, and proportion of any alcohol, and also
            including whether active or not the established name
            and quantity or if determined to be appropriate by the
            Secretary, the proportion of any bromides, ether,
            chloroform, acetanilide, acetophenetidin, amidopyrine,
            antipyrine, atropine, hyoscine, hyoscyamine, arsenic,
            digitalis, digitalis glucosides, mercury, ouabain,
            strophanthin, strychnine, thyroid, or any derivative or
            preparation of any such substances, contained therein,
            except that the requirement for stating the quantity of
            the active ingredients, other than the quantity of
            those specifically named in this subclause, shall not
            apply to nonprescription drugs not intended for human
            use; and
              (iii) the established name of each inactive
            ingredient listed in alphabetical order on the outside
            container of the retail package and, if determined to
            be appropriate by the Secretary, on the immediate
            container, as prescribed in regulation promulgated by
            the Secretary, except that nothing in this subclause
            shall be deemed to require that any trade secret be
            divulged, and except that the requirements of this
            subclause with respect to alphabetical order shall
            apply only to nonprescription drugs that are not also
            cosmetics and that this subclause shall not apply to
            nonprescription drugs not intended for human use.
      (B) For any prescription drug the established name of such
    drug or ingredient, as the case may be, on such label (and on
    any labeling on which a name for such drug or ingredient is
    used) shall be printed prominently and in type at least half as
    large as that used thereon for any proprietary name or
    designation for such drug or ingredient, except that to the
    extent that compliance with the requirements of subclause (ii)
    or (iii) of clause (A) or this clause is impracticable,
    exemptions shall be established by regulations promulgated by
    the Secretary.
      (2) If it is a device and it has an established name, unless
    its label bears, to the exclusion of any other nonproprietary
    name, its established name (as defined in subparagraph (4))
    prominently printed in type at least half as large as that used
    thereon for any proprietary name or designation for such
    device, except that to the extent compliance with the
    requirements of this subparagraph is impracticable, exemptions
    shall be established by regulations promulgated by the
    Secretary.
      (3) As used in subparagraph (1), the term ``established
    name'', with respect to a drug or ingredient thereof, means (A)
    the applicable official name designated pursuant to section
    508, or (B) if there is no such name and such drug, or such
    ingredient, is an article recognized in an official compendium,
    then the official title thereof in such compendium, or (C) if
    neither clause (A) nor clause (B) of this subparagraph applies,
    then the common or usual name, if any, of such drug or of such
    ingredient, except that where clause (B) of this subparagraph
    applies to an article recognized in the United States
    Pharmacopeia and in the Homeopathic Pharmacopeia under
    different official titles, the official title used in the
    United States Pharmacopeia shall apply unless it is labeled and
    offered for sale as a homeopathic drug, in which case the
    official title used in the Homeopathic Pharmacopeia shall
    apply.
      (4) As used in subparagraph (2), the term ``established
    name'' with respect to a device means (A) the applicable
    official name of the device designated pursuant to section 508,
    (B) if there is no such name and such device is an article
    recognized in an official compendium, then the official title
    thereof in such compendium, or (C) if neither clause (A) nor
    clause (B) of this subparagraph applies, then any common or
    usual name of such device.
      (f) Unless its labeling bears (1) adequate directions for
    use; and (2) such adequate warnings against use in those
    pathological conditions or by children where its use may be
    dangerous to health, or against unsafe dosage or methods or
    duration of administration or application, in such manner and
    form, as are necessary for the protection of users, except that
    where any requirement of clause (1) of this paragraph, as
    applied to any drug or device, is not necessary for the
    protection of the public health, the Secretary shall promulgate
    regulations exempting such drug or device from such
    requirement. Required labeling for prescription devices
    intended for use in health care facilities or by a health care
    professional and required labeling for in vitro diagnostic
    devices intended for use by health care professionals or in
    blood establishments may be made available solely by electronic
    means, provided that the labeling complies with all applicable
    requirements of law, and that the manufacturer affords such
    users the opportunity to request the labeling in paper form,
    and after such request, promptly provides the requested
    information without additional cost.
      (g) If it purports to be a drug the name of which is
    recognized in an official compendium, unless it is packaged and
    labeled as prescribed therein. The method of packing may be
    modified with the consent of the Secretary. Whenever a drug is
    recognized in both the United States Pharmacopeia and the
    Homeopathic Pharmacopeia of the United States, it shall be
    subject to the requirements of the United States Pharmacopeia
    with respect to packaging, and labeling unless it is labeled
    and offered for sale as a homeopathic drug, in which case it
    shall be subject to the provisions of the Homeopathic
    Pharmacopeia of the United States, and not to those of the
    United States Pharmacopeia, except that in the event of
    inconsistency between the requirements of this paragraph and
    those of paragraph (e) as to the name by which the drug or its
    ingredients shall be designated, the requirements of paragraph
    (e) shall prevail.
      (h) If it has been found by the Secretary to be a drug liable
    to deterioration, unless it is packaged in such form and
    manner, and its label bears a statement of such precautions, as
    the Secretary shall by regulations require as necessary for the
    protection of the public health. No such regulation shall be
    established for any drug recognized in an official compendium
    until the Secretary shall have informed the appropriate body
    charged with the revision of such compendium of the need for
    such packaging or labeling requirements and such body shall
    have failed within a reasonable time to prescribe such
    requirements.
      (i)(1) If it is a drug and its container is so made, formed,
    or filled as to be misleading; or (2) if it is an imitation of
    another drug; or (3) if it is offered for sale under the name
    of another drug.
      (j) If it is dangerous to health when used in the dosage or
    manner; or with the frequency or duration prescribed,
    recommended, or suggested in the labeling thereof.
      (m) If it is a color additive the intended use of which is
    for the purpose of coloring only, unless its packaging and
    labeling are in conformity with such packaging and labeling
    requirements applicable to such color additive, as may be
    contained in regulations issued under section 721.
      (n) In the case of any prescription drug distributed or
    offered for sale in any State, unless the manufacturer, packer,
    or distributor thereof includes in all advertisements and other
    descriptive printed matter issued or caused to be issued by the
    manufacturer, packer, or distributor with respect to that drug
    a true statement of (1) the established name as defined in
    section 502(e), printed prominently and in type at least half
    as large as that used for any trade or brand name thereof, (2)
    the formula showing quantitatively each ingredient of such drug
    to the extent required for labels under section 502(e), and (3)
    such other information in brief summary relating to side
    effects, contraindications, and effectiveness as shall be
    required in regulations which shall be issued by the Secretary
    in accordance with section 701(a), and in the case of published
    direct-to-consumer advertisements the following statement
    printed in conspicuous text: ``You are encouraged to report
    negative side effects of prescription drugs to the FDA. Visit
    www.fda.gov/medwatch, or call 1-800-FDA-1088.'', except that
    (A) except in extraordinary circumstances, no regulation issued
    under this paragraph shall require prior approval by the
    Secretary of the content of any advertisement, and (B) no
    advertisement of a prescription drug, published after the
    effective date of regulations issued under this paragraph
    applicable to advertisements of prescription drugs, shall, with
    respect to the matters specified in this paragraph or covered
    by such regulations, be subject to the provisions of sections
    12 through 17 of the Federal Trade Commission Act, as amended
    (15 U.S.C. 52-57). This paragraph (n) shall not be applicable
    to any printed matter which the Secretary determines to be
    labeling as defined in section 201(m) of this Act. Nothing in
    the Convention on Psychotropic Substances, signed at Vienna,
    Austria, on February 21, 1971, shall be construed to prevent
    drug price communications to consumers. In the case of an
    advertisement for a drug subject to section 503(b)(1) presented
    directly to consumers in television or radio format and stating
    the name of the drug and its conditions of use, the major
    statement relating to side effects and contraindications shall
    be presented in a clear, conspicuous, and neutral manner.
      (o) If it was manufactured, prepared, propagated, compounded,
    or processed in an establishment not duly registered under
    section 510, if it is a drug and was imported or offered for
    import by a commercial importer of drugs not duly registered
    under section 801(s), if it was not included in a list required
    by section 510(j), if a notice or other information respecting
    it was not provided as required by such section or section
    510(k), or if it does not bear such symbols from the uniform
    system for identification of devices prescribed under section
    510(e) as the Secretary by regulation requires.
      (p) If it is a drug and its packaging or labeling is in
    violation of an applicable regulation issued pursuant to
    section 3 or 4 of the Poison Prevention Packaging Act of 1970.
      (q) In the case of any restricted device distributed or
    offered for sale in any State, if (1) its advertising is false
    or misleading in any particular, or (2) it is sold,
    distributed, or used in violation of regulations prescribed
    under section 520(e).
      (r) In the case of any restricted device distributed or
    offered for sale in any State, unless the manufacturer, packer,
    or distributor thereof includes in all advertisements and other
    descriptive printed matter issued or caused to be issued by the
    manufacturer, packer, or distributor with respect to that
    device (1) a true statement of the device's established name as
    defined in section 502(e), printed prominently and in type at
    least half as large as that used for any trade or brand name
    thereof, and (2) a brief statement of the intended uses of the
    device and relevant warnings, precautions, side effects, and
    contraindications and, in the case of specific devices made
    subject to a finding by the Secretary after notice and
    opportunity for comment that such action is necessary to
    protect the public health, a full description of the components
    of such device or the formula showing quantitatively each
    ingredient of such device to the extent required in regulations
    which shall be issued by the Secretary after an opportunity for
    a hearing. Except in extraordinary circumstances, no regulation
    issued under this paragraph shall require prior approval by the
    Secretary of the content of any advertisement and no
    advertisement of a restricted device, published after the
    effective date of this paragraph shall, with respect to the
    matters specified in this paragraph or covered by regulations
    issued hereunder, be subject to the provisions of sections 12
    through 15 of the Federal Trade Commission Act (15 U.S.C. 52-
    55). This paragraph shall not be applicable to any printed
    matter which the Secretary determines to be labeling as defined
    in section 201(m).
      (s) If it is a device subject to a performance standard
    established under section 514, unless it bears such labeling as
    may be prescribed in such performance standard.
      (t) If it is a device and there was a failure or refusal (1)
    to comply with any requirement prescribed under section 518
    respecting the device, (2) to furnish any material or
    information required by or under section 519 respecting the
    device, [or (3)] (3) to comply with a requirement under section
    522, or (4) to furnish a software bill of materials as required
    under section 524C (relating to ensuring device cybersecurity).
      (u)(1) Subject to paragraph (2), if it is a reprocessed
    single-use device, unless it, or an attachment thereto,
    prominently and conspicuously bears the name of the
    manufacturer of the reprocessed device, a generally recognized
    abbreviation of such name, or a unique and generally recognized
    symbol identifying such manufacturer.
      (2) If the original device or an attachment thereto does not
    prominently and conspicuously bear the name of the manufacturer
    of the original device, a generally recognized abbreviation of
    such name, or a unique and generally recognized symbol
    identifying such manufacturer, a reprocessed device may satisfy
    the requirements of paragraph (1) through the use of a
    detachable label on the packaging that identifies the
    manufacturer and is intended to be affixed to the medical
    record of a patient.
      (v) If it is a reprocessed single-use device, unless all
    labeling of the device prominently and conspicuously bears the
    statement ``Reprocessed device for single use. Reprocessed by
    __.'' The name of the manufacturer of the reprocessed device
    shall be placed in the space identifying the person responsible
    for reprocessing.
      (w) If it is a new animal drug--
              (1) that is conditionally approved under section 571
            and its labeling does not conform with the approved
            application or section 571(f), or that is not
            conditionally approved under section 571 and its label
            bears the statement set forth in section 571(f)(1)(A);
              (2) that is indexed under section 572 and its
            labeling does not conform with the index listing under
            section 572(e) or 572(h), or that has not been indexed
            under section 572 and its label bears the statement set
            forth in section 572(h); or
              (3) for which an application has been approved under
            section 512 and the labeling of such drug does not
            include the application number in the format:
            ``Approved by FDA under (A)NADA # xxx-xxx'', except
            that this subparagraph shall not apply to
            representative labeling required under section
            514.1(b)(3)(v)(b) of title 21, Code of Federal
            Regulations (or any successor regulation) for animal
            feed bearing or containing a new animal drug.
      (x) If it is a nonprescription drug (as defined in section
    760) that is marketed in the United States, unless the label of
    such drug includes a domestic address or domestic phone number
    through which the responsible person (as described in section
    760) may receive a report of a serious adverse event (as
    defined in section 760) with such drug.
      (y) If it is a drug subject to an approved risk evaluation
    and mitigation strategy pursuant to section 505(p) and the
    responsible person (as such term is used in section 505-1)
    fails to comply with a requirement of such strategy provided
    for under subsection (d), (e), or (f) of section 505-1.
      (z) If it is a drug, and the responsible person (as such term
    is used in section 505(o)) is in violation of a requirement
    established under paragraph (3) (relating to postmarket studies
    and clinical trials) or paragraph (4) (relating to labeling) of
    section 505(o) with respect to such drug.
      (aa) If it is a drug, or an active pharmaceutical ingredient,
    and it was manufactured, prepared, propagated, compounded, or
    processed in a facility for which fees have not been paid as
    required by section 744B(a)(4) or for which identifying
    information required by section 744B(f) has not been submitted,
    or it contains an active pharmaceutical ingredient that was
    manufactured, prepared, propagated, compounded, or processed in
    such a facility.
      (bb) If the advertising or promotion of a compounded drug is
    false or misleading in any particular.
      (cc) If it is a drug and it fails to bear the product
    identifier as required by section 582.
      (dd) If it is an antimicrobial drug, as defined in section
    511A(f), and its labeling fails to conform with the
    requirements under section 511A(d).
      (ee) If it is a nonprescription drug that is subject to
    section 505G, is not the subject of an application approved
    under section 505, and does not comply with the requirements
    under section 505G.
      (ff) If it is a drug and it was manufactured, prepared,
    propagated, compounded, or processed in a facility for which
    fees have not been paid as required by section 744M.
      (gg)(1) Unless its labeling bears adequate directions for use
    in accordance with paragraph (f), except that (in addition to
    drugs or devices that conform with exemptions pursuant to such
    paragraph) no drug or device shall be deemed to be misbranded
    under such paragraph through the provision of product
    information to a payor, formulary committee, or other similar
    entity with knowledge and expertise in the area of health care
    economic analysis carrying out its responsibilities for the
    selection of drugs or devices for coverage or reimbursement if
    the product information relates to an investigational drug or
    device or investigational use of a drug or device that is
    approved, cleared, granted marketing authorization, or licensed
    under section 505, 510(k), 513(f)(2), or 515 of this Act or
    section 351 of the Public Health Service Act (as applicable),
    provided--
              (A) the product information includes--
                      (i) a clear statement that the
                    investigational drug or device or
                    investigational use of a drug or device has not
                    been approved, cleared, granted marketing
                    authorization, or licensed under section 505,
                    510(k), 513(f)(2), or 515 of this Act or
                    section 351 of the Public Health Service Act
                    (as applicable) and that the safety and
                    effectiveness of the drug or device or use has
                    not been established;
                      (ii) information related to the stage of
                    development of the drug or device involved,
                    such as--
                              (I) the status of any study or
                            studies in which the investigational
                            drug or device or investigational use
                            is being investigated;
                              (II) how the study or studies relate
                            to the overall plan for the development
                            of the drug or device; and
                              (III) whether an application,
                            premarket notification, or request for
                            classification for the investigational
                            drug or device or investigational use
                            has been submitted to the Secretary and
                            when such a submission is planned;
                      (iii) in the case of information that
                    includes factual presentations of results from
                    studies, which shall not be selectively
                    presented, a description of--
                              (I) all material aspects of study
                            design, methodology, and results; and
                              (II) all material limitations related
                            to the study design, methodology, and
                            results;
                      (iv) where applicable, a prominent statement
                    disclosing the indication or indications for
                    which the Secretary has approved, granted
                    marketing authorization, cleared, or licensed
                    the product pursuant to section 505, 510(k),
                    513(f)(2), or 515 of this Act or section 351 of
                    the Public Health Service Act, and a copy of
                    the most current required labeling; and
                      (v) updated information, if previously
                    communicated information becomes materially
                    outdated as a result of significant changes or
                    as a result of new information regarding the
                    product or its review status; and
              (B) the product information does not include--
                      (i) information that represents that an
                    unapproved product--
                              (I) has been approved, cleared,
                            granted marketing authorization, or
                            licensed under section 505, 510(k),
                            513(f)(2), or 515 of this Act or
                            section 351 of the Public Health
                            Service Act (as applicable); or
                              (II) has otherwise been determined to
                            be safe or effective for the purpose or
                            purposes for which the drug or device
                            is being studied; or
                      (ii) information that represents that an
                    unapproved use of a drug or device that has
                    been so approved, granted marketing
                    authorization, cleared, or licensed--
                              (I) is so approved, granted marketing
                            authorization, cleared, or licensed; or
                              (II) that the product is safe or
                            effective for the use or uses for which
                            the drug or device is being studied.
      (2) For purposes of this paragraph, the term ``product
    information'' includes--
              (A) information describing the drug or device (such
            as drug class, device description, and features);
              (B) information about the indication or indications
            being investigated;
              (C) the anticipated timeline for a possible approval,
            clearance, marketing authorization, or licensure
            pursuant to section 505, 510(k), 513, or 515 of this
            Act or section 351 of the Public Health Service Act;
              (D) drug or device pricing information;
              (E) patient utilization projections;
              (F) product-related programs or services; and
              (G) factual presentations of results from studies
            that do not characterize or make conclusions regarding
            safety or efficacy.

    exemptions and consideration for certain drugs, devices, and biological
                                    products

      Sec. 503. (a) The Secretary is hereby directed to promulgate
    regulations exempting from any labeling or packaging
    requirement of this Act drugs and devices which are, in
    accordance with the practice of the trade, to be processed,
    labeled, or repacked in substantial quantities at
    establishments other than those where originally processed or
    packed, on condition that such drugs and devices are not
    adulterated or misbranded, under the provisions of this Act
    upon removal from such processing, labeling, or repacking
    establishment.
      (b)(1) A drug intended for use by man which--
              (A) because of its toxicity or other potentiality for
            harmful effect, or the method of its use, or the
            collateral measures necessary to its use, is not safe
            for use except under the supervision of a practitioner
            licensed by law to administer such drug; or
              (B) is limited by an approved application under
            section 505 to use under the professional supervision
            of a practitioner licensed by law to administer such
            drug;
    shall be dispensed only (i) upon a written prescription of a
    practitioner licensed by law to administer such drug, or (ii)
    upon an oral prescription of such practitioner which is reduced
    promptly to writing and filed by the pharmacist, or (iii) by
    refilling any such written or oral prescription if such
    refilling is authorized by the prescriber either in the
    original prescription or by oral order which is reduced
    promptly to writing and filed by the pharmacist. The act of
    dispensing a drug contrary to the provisions of this paragraph
    shall be deemed to be an act which results in the drug being
    misbranded while held for sale.
      (2) Any drug dispensed by filling or refilling a written or
    oral prescription of a practitioner licensed by law to
    administer such drug shall be exempt from the requirements of
    section 502, except paragraphs (a), (i) (2) and (3), (k), and
    (l), and the packaging requirements of paragraphs (g), (h), and
    (p), if the drug bears a label containing the name and address
    of the dispenser, the serial number and date of the
    prescription or of its filling, the name of the prescriber,
    and, if stated in the prescription, the name of the patient,
    and the directions for use and cautionary statements, if any,
    contained in such prescription. This exemption shall not apply
    to any drug dispensed in the course of the conduct of a
    business of dispensing drugs pursuant to diagnosis by mail, or
    to a drug dispensed in violation of paragraph (1) of this
    subsection.
      (3) The Secretary may by regulation remove drugs subject to
    section 505 from the requirements of paragraph (1) of this
    subsection when such requirements are not necessary for the
    protection of the public health.
      (4)(A) A drug that is subject to paragraph (1) shall be
    deemed to be misbranded if at any time prior to dispensing the
    label of the drug fails to bear, at a minimum, the symbol ``Rx
    only''.
      (B) A drug to which paragraph (1) does not apply shall be
    deemed to be misbranded if at any time prior to dispensing the
    label of the drug bears the symbol described in subparagraph
    (A).
      (5) Nothing in this subsection shall be construed to relieve
    any person from any requirement prescribed by or under
    authority of law with respect to drugs now included or which
    may hereafter be included within the classifications stated in
    section 3220 of the Internal Revenue Code (26 U.S.C. 3220), or
    to marihuana as defined in section 3238(b) of the Internal
    Revenue Code (26 U.S.C. 3238(b)).
      (c)(1) No person may sell, purchase, or trade or offer to
    sell, purchase, or trade any drug sample. For purposes of this
    paragraph and subsection (d), the term ``drug sample'' means a
    unit of a drug, subject to subsection (b), which is not
    intended to be sold and is intended to promote the sale of the
    drug. Nothing in this paragraph shall subject an officer or
    executive of a drug manufacturer or distributor to criminal
    liability solely because of a sale, purchase, trade, or offer
    to sell, purchase, or trade in violation of this paragraph by
    other employees of the manufacturer or distributor.
      (2) No person may sell, purchase, or trade, offer to sell,
    purchase, or trade, or counterfeit any coupon. For purposes of
    this paragraph, the term ``coupon'' means a form which may be
    redeemed, at no cost or at a reduced cost, for a drug which is
    prescribed in accordance with subsection (b).
      (3)(A) No person may sell, purchase, or trade, or offer to
    sell, purchase, or trade, any drug--
              (i) which is subject to subsection (b), and
              (ii)(I) which was purchased by a public or private
            hospital or other health care entity, or
              (II) which was donated or supplied at a reduced price
            to a charitable organization described in section
            501(c)(3) of the Internal Revenue Code of 1954.
      (B) Subparagraph (A) does not apply to--
              (i) the purchase or other acquisition by a hospital
            or other health care entity which is a member of a
            group purchasing organization of a drug for its own use
            from the group purchasing organization or from other
            hospitals or health care entities which are members of
            such organization,
              (ii) the sale, purchase, or trade of a drug or an
            offer to sell, purchase, or trade a drug by an
            organization described in subparagraph (A)(ii)(II) to a
            nonprofit affiliate of the organization to the extent
            otherwise permitted by law,
              (iii) a sale, purchase, or trade of a drug or an
            offer to sell, purchase, or trade a drug among
            hospitals or other health care entities which are under
            common control,
              (iv) a sale, purchase, or trade of a drug or an offer
            to sell, purchase, or trade a drug for emergency
            medical reasons, or
              (v) a sale, purchase, or trade of a drug, an offer to
            sell, purchase, or trade a drug, or the dispensing of a
            drug pursuant to a prescription executed in accordance
            with subsection (b).
    For purposes of this paragraph, the term ``entity'' does not
    include a wholesale distributor of drugs or a retail pharmacy
    licensed under State law and the term ``emergency medical
    reasons'' includes transfers of a drug between health care
    entities or from a health care entity to a retail pharmacy
    undertaken to alleviate temporary shortages of the drug arising
    from delays in or interruptions of regular distribution
    schedules.
      (d)(1) Except as provided in paragraphs (2) and (3), no
    person may distribute any drug sample. For purposes of this
    subsection, the term ``distribute'' does not include the
    providing of a drug sample to a patient by a--
              (A) practitioner licensed to prescribe such drug,
              (B) health care professional acting at the direction
            and under the supervision of such a practitioner, or
              (C) pharmacy of a hospital or of another health care
            entity that is acting at the direction of such a
            practitioner and that received such sample pursuant to
            paragraph (2) or (3).
      (2)(A) The manufacturer or authorized distributor of record
    of a drug subject to subsection (b) may, in accordance with
    this paragraph, distribute drug samples by mail or common
    carrier to practitioners licensed to prescribe such drugs or,
    at the request of a licensed practitioner, to pharmacies of
    hospitals or other health care entities. Such a distribution of
    drug samples may only be made--
              (i) in response to a written request for drug samples
            made on a form which meets the requirements of
            subparagraph (B), and
              (ii) under a system which requires the recipient of
            the drug sample to execute a written receipt for the
            drug sample upon its delivery and the return of the
            receipt to the manufacturer or authorized distributor
            of record.
      (B) A written request for a drug sample required by
    subparagraph (A)(i) shall contain--
              (i) the name, address, professional designation, and
            signature of the practitioner making the request,
              (ii) the identity of the drug sample requested and
            the quantity requested,
              (iii) the name of the manufacturer of the drug sample
            requested, and
              (iv) the date of the request.
      (C) Each drug manufacturer or authorized distributor of
    record which makes distributions by mail or common carrier
    under this paragraph shall maintain, for a period of 3 years,
    the request forms submitted for such distributions and the
    receipts submitted for such distributions and shall maintain a
    record of distributions of drug samples which identifies the
    drugs distributed and the recipients of the distributions.
    Forms, receipts, and records required to be maintained under
    this subparagraph shall be made available by the drug
    manufacturer or authorized distributor of record to Federal and
    State officials engaged in the regulation of drugs and in the
    enforcement of laws applicable to drugs.
      (3) The manufacturer or authorized distributor of record of a
    drug subject to subsection (b) may, by means other than mail or
    common carrier, distribute drug samples only if the
    manufacturer or authorized distributor of record makes the
    distributions in accordance with subparagraph (A) and carries
    out the activities described in subparagraphs (B) through (F)
    as follows:
              (A) Drug samples may only be distributed--
                      (i) to practitioners licensed to prescribe
                    such drugs if they make a written request for
                    the drug samples, or
                      (ii) at the written request of such a
                    licensed practitioner, to pharmacies of
                    hospitals or other health care entities.
            A written request for drug samples shall be made on a
            form which contains the practitioner's name, address,
            and professional designation, the identity of the drug
            sample requested, the quantity of drug samples
            requested, the name of the manufacturer or authorized
            distributor of record of the drug sample, the date of
            the request and signature of the practitioner making
            the request.
              (B) Drug manufacturers or authorized distributors of
            record shall store drug samples under conditions that
            will maintain their stability, integrity, and
            effectiveness and will assure that the drug samples
            will be free of contamination, deterioration, and
            adulteration.
              (C) Drug manufacturers or authorized distributors of
            record shall conduct, at least annually, a complete and
            accurate inventory of all drug samples in the
            possession of representatives of the manufacturer or
            authorized distributor of record. Drug manufacturers or
            authorized distributors of record shall maintain lists
            of the names and address of each of their
            representatives who distribute drug samples and of the
            sites where drug samples are stored. Drug manufacturers
            or authorized distributors of record shall maintain
            records for at least 3 years of all drug samples
            distributed, destroyed, or returned to the manufacturer
            or authorized distributor of record, of all inventories
            maintained under this subparagraph, of all thefts or
            significant losses of drug samples, and of all requests
            made under subparagraph (A) for drug samples. Records
            and lists maintained under this subparagraph shall be
            made available by the drug manufacturer or authorized
            distributor of record to the Secretary upon request.
              (D) Drug manufacturers or authorized distributors of
            record shall notify the Secretary of any significant
            loss of drug samples and any known theft of drug
            samples.
              (E) Drug manufacturers or authorized distributors of
            record shall report to the Secretary any conviction of
            their representatives for violations of subsection
            (c)(1) or a State law because of the sale, purchase, or
            trade of a drug sample or the offer to sell, purchase,
            or trade a drug sample.
              (F) Drug manufacturers or authorized distributors of
            record shall provide to the Secretary the name and
            telephone number of the individual responsible for
            responding to a request for information respecting drug
            samples.
              (4) In this subsection, the term ``authorized
            distributors of record'' means those distributors with
            whom a manufacturer has established an ongoing
            relationship to distribute such manufacturer's
            products.
      (e)
              (1) Requirement.--Subject to section 583:
                      (A) In general.--No person may engage in
                    wholesale distribution of a drug subject to
                    subsection (b)(1) in any State unless such
                    person--
                              (i)(I) is licensed by the State from
                            which the drug is distributed; or
                              (II) if the State from which the drug
                            is distributed has not established a
                            licensure requirement, is licensed by
                            the Secretary; and
                              (ii) if the drug is distributed
                            interstate, is licensed by the State
                            into which the drug is distributed if
                            the State into which the drug is
                            distributed requires the licensure of a
                            person that distributes drugs into the
                            State.
                      (B) Standards.--Each Federal and State
                    license described in subparagraph (A) shall
                    meet the standards, terms, and conditions
                    established by the Secretary under section 583.
              (2) Reporting and database.--
                      (A) Reporting.--Beginning January 1, 2015,
                    any person who owns or operates an
                    establishment that engages in wholesale
                    distribution shall--
                              (i) report to the Secretary, on an
                            annual basis pursuant to a schedule
                            determined by the Secretary--
                                      (I) each State by which the
                                    person is licensed and the
                                    appropriate identification
                                    number of each such license;
                                    and
                                      (II) the name, address, and
                                    contact information of each
                                    facility at which, and all
                                    trade names under which, the
                                    person conducts business; and
                              (ii) report to the Secretary within a
                            reasonable period of time and in a
                            reasonable manner, as determined by the
                            Secretary, any significant disciplinary
                            actions, such as the revocation or
                            suspension of a wholesale distributor
                            license, taken by a State or the
                            Federal Government during the reporting
                            period against the wholesale
                            distributor.
                      (B) Database.--Not later than January 1,
                    2015, the Secretary shall establish a database
                    of authorized wholesale distributors. Such
                    database shall--
                              (i) identify each authorized
                            wholesale distributor by name, contact
                            information, and each State where such
                            wholesale distributor is appropriately
                            licensed to engage in wholesale
                            distribution;
                              (ii) be available to the public on
                            the Internet Web site of the Food and
                            Drug Administration; and
                              (iii) be regularly updated on a
                            schedule determined by the Secretary.
                      (C) Coordination.--The Secretary shall
                    establish a format and procedure for
                    appropriate State officials to access the
                    information provided pursuant to subparagraph
                    (A) in a prompt and secure manner.
                      (D) Confidentiality.--Nothing in this
                    paragraph shall be construed as authorizing the
                    Secretary to disclose any information that is a
                    trade secret or confidential information
                    subject to section 552(b)(4) of title 5, United
                    States Code, or section 1905 of title 18,
                    United States Code.
              (3) Costs.--
                      (A) Authorized fees of secretary.--If a State
                    does not establish a licensing program for
                    persons engaged in the wholesale distribution
                    of a drug subject to subsection (b), the
                    Secretary shall license a person engaged in
                    wholesale distribution located in such State
                    and may collect a reasonable fee in such amount
                    necessary to reimburse the Secretary for costs
                    associated with establishing and administering
                    the licensure program and conducting periodic
                    inspections under this section. The Secretary
                    shall adjust fee rates as needed on an annual
                    basis to generate only the amount of revenue
                    needed to perform this service. Fees authorized
                    under this paragraph shall be collected and
                    available for obligation only to the extent and
                    in the amount provided in advance in
                    appropriations Acts. Such fees are authorized
                    to remain available until expended. Such sums
                    as may be necessary may be transferred from the
                    Food and Drug Administration salaries and
                    expenses appropriation account without fiscal
                    year limitation to such appropriation account
                    for salaries and expenses with such fiscal year
                    limitation.
                      (B) State licensing fees.--Nothing in this
                    Act shall prohibit States from collecting fees
                    from wholesale distributors in connection with
                    State licensing of such distributors.
              (4) For the purposes of this subsection and
            subsection (d), the term ``wholesale distribution''
            means the distribution of a drug subject to subsection
            (b) to a person other than a consumer or patient, or
            receipt of a drug subject to subsection (b) by a person
            other than the consumer or patient, but does not
            include--
                      (A) intracompany distribution of any drug
                    between members of an affiliate or within a
                    manufacturer;
                      (B) the distribution of a drug, or an offer
                    to distribute a drug among hospitals or other
                    health care entities which are under common
                    control;
                      (C) the distribution of a drug or an offer to
                    distribute a drug for emergency medical
                    reasons, including a public health emergency
                    declaration pursuant to section 319 of the
                    Public Health Service Act, except that, for
                    purposes of this paragraph, a drug shortage not
                    caused by a public health emergency shall not
                    constitute an emergency medical reason;
                      (D) the dispensing of a drug pursuant to a
                    prescription executed in accordance with
                    subsection (b)(1);
                      (E) the distribution of minimal quantities of
                    drug by a licensed retail pharmacy to a
                    licensed practitioner for office use;
                      (F) the distribution of a drug or an offer to
                    distribute a drug by a charitable organization
                    to a nonprofit affiliate of the organization to
                    the extent otherwise permitted by law;
                      (G) the purchase or other acquisition by a
                    dispenser, hospital, or other health care
                    entity of a drug for use by such dispenser,
                    hospital, or other health care entity;
                      (H) the distribution of a drug by the
                    manufacturer of such drug;
                      (I) the receipt or transfer of a drug by an
                    authorized third-party logistics provider
                    provided that such third-party logistics
                    provider does not take ownership of the drug;
                      (J) a common carrier that transports a drug,
                    provided that the common carrier does not take
                    ownership of the drug;
                      (K) the distribution of a drug, or an offer
                    to distribute a drug by an authorized
                    repackager that has taken ownership or
                    possession of the drug and repacks it in
                    accordance with section 582(e);
                      (L) salable drug returns when conducted by a
                    dispenser;
                      (M) the distribution of a collection of
                    finished medical devices, which may include a
                    product or biological product, assembled in kit
                    form strictly for the convenience of the
                    purchaser or user (referred to in this
                    subparagraph as a ``medical convenience kit'')
                    if--
                              (i) the medical convenience kit is
                            assembled in an establishment that is
                            registered with the Food and Drug
                            Administration as a device manufacturer
                            in accordance with section 510(b)(2);
                              (ii) the medical convenience kit does
                            not contain a controlled substance that
                            appears in a schedule contained in the
                            Comprehensive Drug Abuse Prevention and
                            Control Act of 1970;
                              (iii) in the case of a medical
                            convenience kit that includes a
                            product, the person that manufacturers
                            the kit--
                                      (I) purchased such product
                                    directly from the
                                    pharmaceutical manufacturer or
                                    from a wholesale distributor
                                    that purchased the product
                                    directly from the
                                    pharmaceutical manufacturer;
                                    and
                                      (II) does not alter the
                                    primary container or label of
                                    the product as purchased from
                                    the manufacturer or wholesale
                                    distributor; and
                              (iv) in the case of a medical
                            convenience kit that includes a
                            product, the product is--
                                      (I) an intravenous solution
                                    intended for the replenishment
                                    of fluids and electrolytes;
                                      (II) a product intended to
                                    maintain the equilibrium of
                                    water and minerals in the body;
                                      (III) a product intended for
                                    irrigation or reconstitution;
                                      (IV) an anesthetic;
                                      (V) an anticoagulant;
                                      (VI) a vasopressor; or
                                      (VII) a sympathomimetic;
                      (N) the distribution of an intravenous drug
                    that, by its formulation, is intended for the
                    replenishment of fluids and electrolytes (such
                    as sodium, chloride, and potassium) or calories
                    (such as dextrose and amino acids);
                      (O) the distribution of an intravenous drug
                    used to maintain the equilibrium of water and
                    minerals in the body, such as dialysis
                    solutions;
                      (P) the distribution of a drug that is
                    intended for irrigation, or sterile water,
                    whether intended for such purposes or for
                    injection;
                      (Q) the distribution of medical gas, as
                    defined in section 575;
                      (R) facilitating the distribution of a
                    product by providing solely administrative
                    services, including processing of orders and
                    payments; or
                      (S) the transfer of a product by a hospital
                    or other health care entity, or by a wholesale
                    distributor or manufacturer operating at the
                    direction of the hospital or other health care
                    entity, to a repackager described in section
                    581(16)(B) and registered under section 510 for
                    the purpose of repackaging the drug for use by
                    that hospital, or other health care entity and
                    other health care entities that are under
                    common control, if ownership of the drug
                    remains with the hospital or other health care
                    entity at all times.
              (5) Third-party logistics providers.--Notwithstanding
            paragraphs (1) through (4), each entity that meets the
            definition of a third-party logistics provider under
            section 581(22) shall obtain a license as a third-party
            logistics provider as described in section 584(a) and
            is not required to obtain a license as a wholesale
            distributor if the entity never assumes an ownership
            interest in the product it handles.
              (6) Affiliate.--For purposes of this subsection, the
            term ``affiliate'' means a business entity that has a
            relationship with a second business entity if, directly
            or indirectly--
                      (A) one business entity controls, or has the
                    power to control, the other business entity; or
                      (B) a third party controls, or has the power
                    to control, both of the business entities.
      (f)(1)(A) A drug intended for use by animals other than man,
    other than a veterinary feed directive drug intended for use in
    animal feed or an animal feed bearing or containing a
    veterinary feed directive drug, which--
              (i) because of its toxicity or other potentiality for
            harmful effect, or the method of its use, or the
            collateral measures necessary for its use, is not safe
            for animal use except under the professional
            supervision of a licensed veterinarian, or
              (ii) is limited by an approved application under
            subsection (b) of section 512, a conditionally-approved
            application under section 571, or an index listing
            under section 572 to use under the professional
            supervision of a licensed veterinarian,
    shall be dispensed only by or upon the lawful written or oral
    order of a licensed veterinarian in the course of the
    veterinarian's professional practice.
      (B) For purposes of subparagraph (A), an order is lawful if
    the order--
              (i) is a prescription or other order authorized by
            law,
              (ii) is, if an oral order, promptly reduced to
            writing by the person lawfully filling the order, and
            filed by that person, and
              (iii) is refilled only if authorized in the original
            order or in a subsequent oral order promptly reduced to
            writing by the person lawfully filling the order, and
            filed by that person.
      (C) The act of dispensing a drug contrary to the provisions
    of this paragraph shall be deemed to be an act which results in
    the drug being misbranded while held for sale.
      (2) Any drug when dispensed in accordance with paragraph (1)
    of this subsection--
              (A) Shall be exempt from the requirements of section
            502, except subsections (a), (g), (h), (i)(2), (i)(3),
            and (p) of such section, and
              (B) shall be exempt from the packaging requirements
            of subsections (g), (h), and (p) of such section, if--
                      (i) when dispensed by a licensed
                    veterinarian, the drug bears a label containing
                    the name and address of the practitioner and
                    any directions for use and cautionary
                    statements specified by the practitioner, or
                      (ii) when dispensed by filling the lawful
                    order of a licensed veterinarian, the drug
                    bears a label containing the name and address
                    of the dispenser, the serial number and date of
                    the order or of its filing, the name of the
                    licensed veterinarian, and the directions for
                    use and cautionary statements, if any,
                    contained in such order.
    The preceding sentence shall not apply to any drug dispensed in
    the course of the conduct of a business of dispensing drugs
    pursuant to diagnosis by mail.
      (3) The Secretary may by regulation exempt drugs for animals
    other than man subject to section 512, 571, or 572 from the
    requirements of paragraph (1) when such requirements are not
    necessary for the protection of the public health.
      (4) A drug which is subject to paragraph (1) shall be deemed
    to be misbranded if at any time prior to dispensing its label
    fails to bear the statement ``Caution: Federal law restricts
    this drug to use by or on the order of a licensed
    veterinarian.''. A drug to which paragraph (1) does not apply
    shall be deemed to be misbranded if at any time prior to
    dispensing its label bears the statement specified in the
    preceding sentence.
      (g)(1)(A) The Secretary shall, in accordance with this
    subsection, assign a primary agency center to regulate products
    that constitute a combination of a drug, device, or biological
    product.
      (B) The Secretary shall conduct the premarket review of any
    combination product under a single application, whenever
    appropriate.
      (C) For purposes of this subsection, the term ``primary mode
    of action'' means the single mode of action of a combination
    product expected to make the greatest contribution to the
    overall intended therapeutic effects of the combination
    product.
      (D) The Secretary shall determine the primary mode of action
    of the combination product. If the Secretary determines that
    the primary mode of action is that of--
              (i) a drug (other than a biological product), the
            agency center charged with premarket review of drugs
            shall have primary jurisdiction;
              (ii) a device, the agency center charged with
            premarket review of devices shall have primary
            jurisdiction; or
              (iii) a biological product, the agency center charged
            with premarket review of biological products shall have
            primary jurisdiction.
      (E) In determining the primary mode of action of a
    combination product, the Secretary shall not determine that the
    primary mode of action is that of a drug or biological product
    solely because the combination product has any chemical action
    within or on the human body.
      (F) If a sponsor of a combination product disagrees with the
    determination under subparagraph (D)--
              (i) such sponsor may request, and the Secretary shall
            provide, a substantive rationale to such sponsor that
            references scientific evidence provided by the sponsor
            and any other scientific evidence relied upon by the
            Secretary to support such determination; and
              (ii)(I) the sponsor of the combination product may
            propose one or more studies (which may be nonclinical,
            clinical, or both) to establish the relevance, if any,
            of the chemical action in achieving the primary mode of
            action of such product;
              (II) if the sponsor proposes any such studies, the
            Secretary and the sponsor of such product shall
            collaborate and seek to reach agreement, within a
            reasonable time of such proposal, not to exceed 90
            calendar days, on the design of such studies; and
              (III) if an agreement is reached under subclause (II)
            and the sponsor conducts one or more of such studies,
            the Secretary shall consider the data resulting from
            any such study when reevaluating the determination of
            the primary mode of action of such product, and unless
            and until such reevaluation has occurred and the
            Secretary issues a new determination, the determination
            of the Secretary under subparagraph (D) shall remain in
            effect.
      (2)(A)(i) To establish clarity and certainty for the sponsor,
    the sponsor of a combination product may request a meeting on
    such combination product. If the Secretary concludes that a
    determination of the primary mode of action pursuant to
    paragraph (1)(D) is necessary, the sponsor may request such
    meeting only after the Secretary makes such determination. If
    the sponsor submits a written meeting request, the Secretary
    shall, not later than 75 calendar days after receiving such
    request, meet with the sponsor of such combination product.
      (ii) A meeting under clause (i) may--
              (I) address the standards and requirements for market
            approval or clearance of the combination product;
              (II) address other issues relevant to such
            combination product, such as requirements related to
            postmarket modification of such combination product and
            good manufacturing practices applicable to such
            combination product; and
              (III) identify elements under subclauses (I) and (II)
            that may be more appropriate for discussion and
            agreement with the Secretary at a later date given that
            scientific or other information is not available, or
            agreement is otherwise not feasible regarding such
            elements, at the time a request for such meeting is
            made.
      (iii) Any agreement under this subparagraph shall be in
    writing and made part of the administrative record by the
    Secretary.
      (iv) Any such agreement shall remain in effect, except--
              (I) upon the written agreement of the Secretary and
            the sponsor or applicant; or
              (II) pursuant to a decision by the director of the
            reviewing division of the primary agency center, or a
            person more senior than such director, in consultation
            with consulting centers and the Office, as appropriate,
            that an issue essential to determining whether the
            standard for market clearance or other applicable
            standard under this Act or the Public Health Service
            Act applicable to the combination product has been
            identified since the agreement was reached, or that
            deviating from the agreement is otherwise justifiable
            based on scientific evidence, for public health
            reasons.
      (3) For purposes of conducting the premarket review of a
    combination product that contains an approved constituent part
    described in paragraph (4), the Secretary may require that the
    sponsor of such combination product submit to the Secretary
    only data or information that the Secretary determines is
    necessary to meet the standard for clearance or approval, as
    applicable, under this Act or the Public Health Service Act,
    including any incremental risks and benefits posed by such
    combination product, using a risk-based approach and taking
    into account any prior finding of safety and effectiveness or
    substantial equivalence for the approved constituent part
    relied upon by the applicant in accordance with paragraph (5).
      (4) For purposes of paragraph (3), an approved constituent
    part is--
              (A) a drug constituent part of a combination product
            being reviewed in a single application or request under
            section 515, 510(k), or 513(f)(2) (submitted in
            accordance with paragraph (5)), that is an approved
            drug, provided such application or request complies
            with paragraph (5);
              (B) a device constituent part approved under section
            515 that is referenced by the sponsor and that is
            available for use by the Secretary under section
            520(h)(4); or
              (C) any constituent part that was previously
            approved, cleared, or classified under section 505,
            510(k), 513(f)(2), or 515 of this Act for which the
            sponsor has a right of reference or any constituent
            part that is a nonprescription drug, as defined in
            section 760(a)(2).
      (5)(A) If an application is submitted under section 515 or
    510(k) or a request is submitted under section 513(f)(2),
    consistent with any determination made under paragraph (1)(D),
    for a combination product containing as a constituent part an
    approved drug--
              (i) the application or request shall include the
            certification or statement described in section
            505(b)(2); and
              (ii) the applicant or requester shall provide notice
            as described in section 505(b)(3).
      (B) For purposes of this paragraph and paragraph (4), the
    term ``approved drug'' means an active ingredient--
              (i) that was in an application previously approved
            under section 505(c);
              (ii) where such application is relied upon by the
            applicant submitting the application or request
            described in subparagraph (A);
              (iii) for which full reports of investigations that
            have been made to show whether such drug is safe for
            use and whether such drug is effective in use were not
            conducted by or for the applicant submitting the
            application or request described in subparagraph (A);
            and
              (iv) for which the applicant submitting the
            application or request described in subparagraph (A)
            has not obtained a right of reference or use from the
            person by or for whom the investigations described in
            clause (iii) were conducted.
      (C) The following provisions shall apply with respect to an
    application or request described in subparagraph (A) to the
    same extent and in the same manner as if such application or
    request were an application described in section 505(b)(2) that
    referenced the approved drug:
              (i) Subparagraphs (A), (B), (C), and (D) of section
            505(c)(3).
              (ii) Clauses (ii), (iii), and (iv) of section
            505(c)(3)(E).
              (iii) Subsections (b) and (c) of section 505A.
              (iv) Section 505E(a).
              (v) Section 527(a).
      (D) Notwithstanding any other provision of this subsection,
    an application or request for classification for a combination
    product described in subparagraph (A) shall be considered an
    application submitted under section 505(b)(2) for purposes of
    section 271(e)(2)(A) of title 35, United States Code.
      (6) Nothing in this subsection shall be construed as
    prohibiting a sponsor from submitting separate applications for
    the constituent parts of a combination product, unless the
    Secretary determines that a single application is necessary.
      (7) Nothing in this subsection shall prevent the Secretary
    from using any agency resources of the Food and Drug
    Administration necessary to ensure adequate review of the
    safety, effectiveness, or substantial equivalence of an
    article.
      (8)(A) Not later than 60 days after the date of the enactment
    of this paragraph, the Secretary shall establish within the
    Office of the Commissioner of Food and Drugs an office to
    ensure the prompt assignment of combination products to agency
    centers, the timely and effective premarket review of such
    products, and consistent and appropriate postmarket regulation
    of like products subject to the same statutory requirements to
    the extent permitted by law. Additionally, the office shall, in
    determining whether a product is to be designated a combination
    product, consult with the component within the Office of the
    Commissioner of Food and Drugs that is responsible for such
    determinations. Such office (referred to in this paragraph as
    the ``Office'') shall have appropriate scientific and medical
    expertise, and shall be headed by a director.
      (B) In carrying out this subsection, the Office shall, for
    each combination product, promptly assign an agency center with
    primary jurisdiction in accordance with paragraph (1) for the
    premarket review of such product.
      (C)(i) In carrying out this subsection, the Office shall help
    to ensure timely and effective premarket review that involves
    more than one agency center by coordinating such reviews,
    overseeing the timeliness of such reviews, and overseeing the
    alignment of feedback regarding such reviews.
      (ii) In order to ensure the timeliness and alignment of the
    premarket review of a combination product, the agency center
    with primary jurisdiction for the product, and the consulting
    agency center, shall be responsible to the Office with respect
    to the timeliness and alignment of the premarket review.
      (iii) The Office shall ensure that, with respect to a
    combination product, a designated person or persons in the
    primary agency center is the primary point or points of contact
    for the sponsor of such combination product. The Office shall
    also coordinate communications to and from any consulting
    center involved in such premarket review, if requested by such
    primary agency center or any such consulting center. Agency
    communications and commitments, to the extent consistent with
    other provisions of law and the requirements of all affected
    agency centers, from the primary agency center shall be
    considered as communication from the Secretary on behalf of all
    agency centers involved in the review.
      (iv) The Office shall, with respect to the premarket review
    of a combination product--
              (I) ensure that any meeting between the Secretary and
            the sponsor of such product is attended by each agency
            center involved in the review, as appropriate;
              (II) ensure that each consulting agency center has
            completed its premarket review and provided the results
            of such review to the primary agency center in a timely
            manner; and
              (III) ensure that each consulting center follows the
            guidance described in clause (vi) and advises, as
            appropriate, on other relevant regulations, guidances,
            and policies.
      (v) In seeking agency action with respect to a combination
    product, the sponsor of such product--
              (I) shall identify the product as a combination
            product; and
              (II) may request in writing the participation of
            representatives of the Office in meetings related to
            such combination product, or to have the Office
            otherwise engage on such regulatory matters concerning
            the combination product.
      (vi) Not later than 4 years after the date of enactment of
    the 21st Century Cures Act, and after a public comment period
    of not less than 60 calendar days, the Secretary shall issue a
    final guidance that describes--
              (I) the structured process for managing pre-
            submission interactions with sponsors developing
            combination products;
              (II) the best practices for ensuring that the
            feedback in such pre-submission interactions represents
            the Agency's best advice based on the information
            provided during such pre-submission interactions;
              (III) the information that is required to be
            submitted with a meeting request under paragraph (2),
            how such meetings relate to other types of meetings in
            the Food and Drug Administration, and the form and
            content of any agreement reached through a meeting
            under such paragraph (2);
      (D) In carrying out this subsection, the Office shall ensure
    the consistency and appropriateness of postmarket regulation of
    like products subject to the same statutory requirements to the
    extent permitted by law.
      (E)(i) Any dispute regarding the timeliness of the premarket
    review of a combination product may be presented to the Office
    for resolution, unless the dispute is clearly premature.
      (ii) During the review process, any dispute regarding the
    substance of the premarket review may be presented to the
    Commissioner of Food and Drugs after first being considered by
    the agency center with primary jurisdiction of the premarket
    review, under the scientific dispute resolution procedures for
    such center. The Commissioner of Food and Drugs shall consult
    with the Director of the Office in resolving the substantive
    dispute.
      (F) The Secretary, acting through the Office, shall review
    each agreement, guidance, or practice of the Secretary that is
    specific to the assignment of combination products to agency
    centers and shall determine whether the agreement, guidance, or
    practice is consistent with the requirements of this
    subsection. In carrying out such review, the Secretary shall
    consult with stakeholders and the directors of the agency
    centers. After such consultation, the Secretary shall determine
    whether to continue in effect, modify, revise, or eliminate
    such agreement, guidance, or practice, and shall publish in the
    Federal Register a notice of the availability of such modified
    or revised agreement, guidance or practice. Nothing in this
    paragraph shall be construed as preventing the Secretary from
    following each agreement, guidance, or practice until
    continued, modified, revised, or eliminated.
      (G) Not later than one year after the date of the enactment
    of this paragraph (except with respect to clause (iv),
    beginning not later than one year after the date of the
    enactment of the 21st Century Cures Act) and annually
    thereafter, the Secretary shall report to the appropriate
    committees of Congress on the activities and impact of the
    Office. The report shall include provisions--
              (i) describing the numbers and types of combination
            products under review and the timeliness in days of
            such assignments, reviews, and dispute resolutions;
              (ii) identifying the number of premarket reviews of
            such products that involved a consulting agency center;
              (iii) describing improvements in the consistency of
            postmarket regulation of combination products; and
              (iv) identifying the percentage of combination
            products for which a dispute resolution, with respect
            to premarket review, was requested by the combination
            product's sponsor.
      (H) Nothing in this paragraph shall be construed to limit the
    regulatory authority of any agency center.
      (9) As used in this subsection:
              (A) The term ``agency center'' means a center or
            alternative organizational component of the Food and
            Drug Administration.
              (B) The term ``biological product'' has the meaning
            given the term in section 351(i) of the Public Health
            Service Act (42 U.S.C. 262(i)).
              (C) The term ``market clearance'' includes--
                      (i) approval of an application under section
                    505, 507, 515, or 520(g);
                      (ii) a finding of substantial equivalence
                    under this subchapter;
                      (iii) approval of a biologics license
                    application under subsection (a) of section 351
                    of the Public Health Service Act (42 U.S.C.
                    262); and
                      (iv) de novo classification under section
                    513(a)(1).
              (D) The terms ``premarket review'' and ``reviews''
            include all activities of the Food and Drug
            Administration conducted prior to approval or clearance
            of an application, notification, or request for
            classification submitted under section 505, 510(k),
            513(f)(2), 515, or 520 of this Act or under section 351
            of the Public Health Service Act, including with
            respect to investigational use of the product.
      (h)(1) Any contrast agent, radioactive drug, or OTC monograph
    drug shall be deemed to be a drug under section 201(g) and not
    a device under section 201(h).
      (2) For purposes of this subsection:
              (A) The term ``contrast agent'' means an article that
            is intended for use in conjunction with a medical
            imaging device, and--
                      (i) is a diagnostic radiopharmaceutical, as
                    defined in sections 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) The term `radioactive drug' has the meaning given
            such term in section 310.3(n) of title 21, Code of
            Federal Regulations (or any successor regulations),
            except that such term does not include--
                      (i) an implant or article similar to an
                    implant;
                      (ii) an article that applies radiation from
                    outside of the body; or
                      (iii) the radiation source of an article
                    described in clause (i) or (ii).
              (C) The term `OTC monograph drug' has the meaning
            given such term in section 744L.
      (3) Nothing in this subsection shall be construed as allowing
    for the classification of a product as a drug (as defined in
    section 201(g)) if such product--
              (A) is not described in paragraph (1); and
              (B) meets the definition of a device under section
            201(h),
    unless another provision of this Act otherwise indicates a
    different classification.

               *       *       *       *       *       *       *

                                   new drugs

      Sec. 505. (a) No person shall introduce or deliver for
    introduction into interstate commerce any new drug, unless an
    approval of an application filed pursuant to subsection (b) or
    (j) is effective with respect to such drug.
      (b)
      (b)(1)(A) Any person may file with the Secretary an
    application with respect to any drug subject to the provisions
    of subsection (a). Such persons shall submit to the Secretary
    as part of the application--
              (i) full reports of investigations which have been
            made to show whether such drug is safe for use and
            whether such drug is effective in use;
              (ii) a full list of the articles used as components
            of such drug;
              (iii) a full statement of the composition of such
            drug;
              (iv) a full description of the methods used in, and
            the facilities and controls used for, the manufacture,
            processing, and packing of such drug;
              (v) such samples of such drug and of the articles
            used as components thereof as the Secretary may
            require;
              (vi) specimens of the labeling proposed to be used
            for such drug;
              (vii) any assessments required under section 505B;
            and
              (viii) the patent number and expiration date of each
            patent for which a claim of patent infringement could
            reasonably be asserted if a person not licensed by the
            owner of the patent engaged in the manufacture, use, or
            sale of the drug, and that--
                      (I) claims the drug for which the applicant
                    submitted the application and is a drug
                    substance (active ingredient) patent or a drug
                    product (formulation or composition) patent; or
                      (II) claims a method of using such drug for
                    which approval is sought or has been granted in
                    the application.
      (B) If an application is filed under this subsection for a
    drug, and a patent of the type described in subparagraph
    (A)(viii) is issued after the filing date but before approval
    of the application, the applicant shall amend the application
    to include the patent number and expiration date.
      (2) An application submitted under paragraph (1) for a drug
    for which the investigations described in clause (A) of such
    paragraph and relied upon by the applicant for approval of the
    application were not conducted by or for the applicant and for
    which the applicant has not obtained a right of reference or
    use from the person by or for whom the investigations were
    conducted shall also include--
              (A) a certification, in the opinion of the applicant
            and to the best of his knowledge, with respect to each
            patent which claims the drug for which such
            investigations were conducted or which claims a use for
            such drug for which the applicant is seeking approval
            under this subsection and for which information is
            required to be filed under paragraph (1) or subsection
            (c)--
                      (i) that such patent information has not been
                    filed,
                      (ii) that such patent has expired,
                      (iii) of the date on which such patent will
                    expire, or
                      (iv) that such patent is invalid or will not
                    be infringed by the manufacture, use, or sale
                    of the new drug for which the application is
                    submitted; and
              (B) if with respect to the drug for which
            investigations described in paragraph (1)(A) were
            conducted information was filed under paragraph (1) or
            subsection (c) for a method of use patent which does
            not claim a use for which the applicant is seeking
            approval under this subsection, a statement that the
            method of use patent does not claim such a use.
      (3) Notice of opinion that patent is invalid or will not be
    infringed.--
              (A) Agreement to give notice.--An applicant that
            makes a certification described in paragraph (2)(A)(iv)
            shall include in the application a statement that the
            applicant will give notice as required by this
            paragraph.
              (B) Timing of notice.--An applicant that makes a
            certification described in paragraph (2)(A)(iv) shall
            give notice as required under this paragraph--
                      (i) if the certification is in the
                    application, not later than 20 days after the
                    date of the postmark on the notice with which
                    the Secretary informs the applicant that the
                    application has been filed; or
                      (ii) if the certification is in an amendment
                    or supplement to the application, at the time
                    at which the applicant submits the amendment or
                    supplement, regardless of whether the applicant
                    has already given notice with respect to
                    another such certification contained in the
                    application or in an amendment or supplement to
                    the application.
              (C) Recipients of notice.--An applicant required
            under this paragraph to give notice shall give notice
            to--
                      (i) each owner of the patent that is the
                    subject of the certification (or a
                    representative of the owner designated to
                    receive such a notice); and
                      (ii) the holder of the approved application
                    under this subsection for the drug that is
                    claimed by the patent or a use of which is
                    claimed by the patent (or a representative of
                    the holder designated to receive such a
                    notice).
              (D) Contents of notice.--A notice required under this
            paragraph shall--
                      (i) state that an application that contains
                    data from bioavailability or bioequivalence
                    studies has been submitted under this
                    subsection for the drug with respect to which
                    the certification is made to obtain approval to
                    engage in the commercial manufacture, use, or
                    sale of the drug before the expiration of the
                    patent referred to in the certification; and
                      (ii) include a detailed statement of the
                    factual and legal basis of the opinion of the
                    applicant that the patent is invalid or will
                    not be infringed.
      (4)(A) An applicant may not amend or supplement an
    application referred to in paragraph (2) to seek approval of a
    drug that is a different drug than the drug identified in the
    application as submitted to the Secretary.
      (B) With respect to the drug for which such an application is
    submitted, nothing in this subsection or subsection (c)(3)
    prohibits an applicant from amending or supplementing the
    application to seek approval of a different strength.
      (5)(A) The Secretary shall issue guidance for the individuals
    who review applications submitted under paragraph (1) or under
    section 351 of the Public Health Service Act, which shall
    relate to promptness in conducting the review, technical
    excellence, lack of bias and conflict of interest, and
    knowledge of regulatory and scientific standards, and which
    shall apply equally to all individuals who review such
    applications.
      (B) The Secretary shall meet with a sponsor of an
    investigation or an applicant for approval for a drug under
    this subsection or section 351 of the Public Health Service Act
    if the sponsor or applicant makes a reasonable written request
    for a meeting for the purpose of reaching agreement on the
    design and size--
              (i)(I) of clinical trials intended to form the
            primary basis of an effectiveness claim; or
              (II) in the case where human efficacy studies are not
            ethical or feasible, of [animal] nonclinical tests and
            any associated clinical trials which, in combination,
            are intended to form the primary basis of an
            effectiveness claim; or
              (ii) with respect to an application for approval of a
            biological product under section 351(k) of the Public
            Health Service Act, of any necessary clinical study or
            studies.
    The sponsor or applicant shall provide information necessary
    for discussion and agreement on the design and size of the
    clinical trials. Minutes of any such meeting shall be prepared
    by the Secretary and made available to the sponsor or applicant
    upon request.
      (C) Any agreement regarding the parameters of the design and
    size of clinical trials of a new drug under this paragraph that
    is reached between the Secretary and a sponsor or applicant
    shall be reduced to writing and made part of the administrative
    record by the Secretary. Such agreement shall not be changed
    after the testing begins, except--
              (i) with the written agreement of the sponsor or
            applicant; or
              (ii) pursuant to a decision, made in accordance with
            subparagraph (D) by the director of the reviewing
            division, that a substantial scientific issue essential
            to determining the safety or effectiveness of the drug
            has been identified after the testing has begun.
      (D) A decision under subparagraph (C)(ii) by the director
    shall be in writing and the Secretary shall provide to the
    sponsor or applicant an opportunity for a meeting at which the
    director and the sponsor or applicant will be present and at
    which the director will document the scientific issue involved.
      (E) The written decisions of the reviewing division shall be
    binding upon, and may not directly or indirectly be changed by,
    the field or compliance division personnel unless such field or
    compliance division personnel demonstrate to the reviewing
    division why such decision should be modified.
      (F) No action by the reviewing division may be delayed
    because of the unavailability of information from or action by
    field personnel unless the reviewing division determines that a
    delay is necessary to assure the marketing of a safe and
    effective drug.
      (G) For purposes of this paragraph, the reviewing division is
    the division responsible for the review of an application for
    approval of a drug under this subsection or section 351 of the
    Public Health Service Act (including all scientific and medical
    matters, chemistry, manufacturing, and controls).
              (6) An application submitted under this subsection
            shall be accompanied by the certification required
            under section 402(j)(5)(B) of the Public Health Service
            Act. Such certification shall not be considered an
            element of such application.
      (c)(1) Within one hundred and eighty days after the filing of
    an application under subsection (b), or such additional period
    as may be agreed upon by the Secretary and the applicant, the
    Secretary shall either--
              (A) approve the application if he then finds that
            none of the grounds for denying approval specified in
            subsection (d) applies, or
              (B) give the applicant notice of an opportunity for a
            hearing before the Secretary under subsection (d) on
            the question whether such application is approvable. If
            the applicant elects to accept the opportunity for
            hearing by written request within thirty days after
            such notice, such hearing shall commence not more than
            ninety days after the expiration of such thirty days
            unless the Secretary and the applicant otherwise agree.
            Any such hearing shall thereafter be conducted on an
            expedited basis and the Secretary's order thereon shall
            be issued within ninety days after the date fixed by
            the Secretary for filing final briefs.
      (2) Not later than 30 days after the date of approval of an
    application submitted under subsection (b), the holder of the
    approved application shall file with the Secretary the patent
    number and the expiration date of any patent described in
    subsection (b)(1)(A)(viii), except that a patent that is
    identified as claiming a method of using such drug shall be
    filed only if the patent claims a method of use approved in the
    application. If a patent described in subsection
    (b)(1)(A)(viii) is issued after the date of approval of an
    application submitted under subsection (b), the holder of the
    approved application shall, not later than 30 days after the
    date of issuance of the patent, file the patent number and the
    expiration date of the patent, except that a patent that claims
    a method of using such drug shall be filed only if approval for
    such use has been granted in the application. If the patent
    information described in subsection (b) could not be filed with
    the submission of an application under subsection (b) because
    the application was filed before the patent information was
    required under subsection (b) or a patent was issued after the
    application was approved under such subsection, the holder of
    an approved application shall file with the Secretary, the
    patent number and the expiration date of any patent described
    in subsection (b)(1)(A)(viii). If the holder of an approved
    application could not file patent information under subsection
    (b) because it was not required at the time the application was
    approved, the holder shall file such information under this
    subsection not later than thirty days after the date of the
    enactment of this sentence, and if the holder of an approved
    application could not file patent information under subsection
    (b) because no patent of the type for which information is
    required to be submitted in subsection (b)(1)(A)(viii) had been
    issued when an application was filed or approved, the holder
    shall file such information under this subsection not later
    than thirty days after the date the patent involved is issued.
    Upon the submission of patent information under this
    subsection, the Secretary shall publish it. Patent
    informationthat is not the type of patent information
    requiredby subsection (b)(1)(A)(viii) shall not be submitted
    underthis paragraph.
      (3) The approval of an application filed under subsection (b)
    which contains a certification required by paragraph (2) of
    such subsection shall be made effective on the last applicable
    date determined by applying the following to each certification
    made under subsection (b)(2)(A):
              (A) If the applicant only made a certification
            described in clause (i) or (ii) of subsection (b)(2)(A)
            or in both such clauses, the approval may be made
            effective immediately.
              (B) If the applicant made a certification described
            in clause (iii) of subsection (b)(2)(A), the approval
            may be made effective on the date certified under
            clause (iii).
              (C) If the applicant made a certification described
            in clause (iv) of subsection (b)(2)(A), the approval
            shall be made effective immediately unless, before the
            expiration of 45 days after the date on which the
            notice described in subsection (b)(3) is received, an
            action is brought for infringement of the patent that
            is the subject of the certification and for which
            information was submitted to the Secretary under
            paragraph (2) or subsection (b)(1) before the date on
            which the application (excluding an amendment or
            supplement to the application) was submitted. If such
            an action is brought before the expiration of such
            days, the approval may be made effective upon the
            expiration of the thirty-month period beginning on the
            date of the receipt of the notice provided under
            subsection (b)(3) or such shorter or longer period as
            the court may order because either party to the action
            failed to reasonably cooperate in expediting the
            action, except that--
                      (i) if before the expiration of such period
                    the district court decides that the patent is
                    invalid or not infringed (including any
                    substantive determination that there is no
                    cause of action for patent infringement or
                    invalidity), the approval shall be made
                    effective on--
                              (I) the date on which the court
                            enters judgment reflecting the
                            decision; or
                              (II) the date of a settlement order
                            or consent decree signed and entered by
                            the court stating that the patent that
                            is the subject of the certification is
                            invalid or not infringed;
                      (ii) if before the expiration of such period
                    the district court decides that the patent has
                    been infringed--
                              (I) if the judgment of the district
                            court is appealed, the approval shall
                            be made effective on--
                                      (aa) the date on which the
                                    court of appeals decides that
                                    the patent is invalid or not
                                    infringed (including any
                                    substantive determination that
                                    there is no cause of action for
                                    patent infringement or
                                    invalidity); or
                                      (bb) the date of a settlement
                                    order or consent decree signed
                                    and entered by the court of
                                    appeals stating that the patent
                                    that is the subject of the
                                    certification is invalid or not
                                    infringed; or
                              (II) if the judgment of the district
                            court is not appealed or is affirmed,
                            the approval shall be made effective on
                            the date specified by the district
                            court in a court order under section
                            271(e)(4)(A) of title 35, United States
                            Code;
                      (iii) if before the expiration of such period
                    the court grants a preliminary injunction
                    prohibiting the applicant from engaging in the
                    commercial manufacture or sale of the drug
                    until the court decides the issues of patent
                    validity and infringement and if the court
                    decides that such patent is invalid or not
                    infringed, the approval shall be made effective
                    as provided in clause (i); or
                      (iv) if before the expiration of such period
                    the court grants a preliminary injunction
                    prohibiting the applicant from engaging in the
                    commercial manufacture or sale of the drug
                    until the court decides the issues of patent
                    validity and infringement and if the court
                    decides that such patent has been infringed,
                    the approval shall be made effective as
                    provided in clause (ii).
            In such an action, each of the parties shall reasonably
            cooperate in expediting the action.
              (D) Civil action to obtain patent certainty.--
                      (i) Declaratory judgment absent infringement
                    action.--
                              (I) In general.--No action may be
                            brought under section 2201 of title 28,
                            United States Code, by an applicant
                            referred to in subsection (b)(2) for a
                            declaratory judgment with respect to a
                            patent which is the subject of the
                            certification referred to in
                            subparagraph (C) unless--
                                      (aa) the 45-day period
                                    referred to in such
                                    subparagraph has expired;
                                      (bb) neither the owner of
                                    such patent nor the holder of
                                    the approved application under
                                    subsection (b) for the drug
                                    that is claimed by the patent
                                    or a use of which is claimed by
                                    the patent brought a civil
                                    action against the applicant
                                    for infringement of the patent
                                    before the expiration of such
                                    period; and
                                      (cc) in any case in which the
                                    notice provided under paragraph
                                    (2)(B) relates to
                                    noninfringement, the notice was
                                    accompanied by a document
                                    described in subclause (III).
                              (II) Filing of civil action.--If the
                            conditions described in items (aa),
                            (bb), and as applicable, (cc) of
                            subclause (I) have been met, the
                            applicant referred to in such subclause
                            may, in accordance with section 2201 of
                            title 28, United States Code, bring a
                            civil action under such section against
                            the owner or holder referred to in such
                            subclause (but not against any owner or
                            holder that has brought such a civil
                            action against the applicant, unless
                            that civil action was dismissed without
                            prejudice) for a declaratory judgment
                            that the patent is invalid or will not
                            be infringed by the drug for which the
                            applicant seeks approval, except that
                            such civil action may be brought for a
                            declaratory judgment that the patent
                            will not be infringed only in a case in
                            which the condition described in
                            subclause (I)(cc) is applicable. A
                            civil action referred to in this
                            subclause shall be brought in the
                            judicial district where the defendant
                            has its principal place of business or
                            a regular and established place of
                            business.
                              (III) Offer of confidential access to
                            application.--For purposes of subclause
                            (I)(cc), the document described in this
                            subclause is a document providing an
                            offer of confidential access to the
                            application that is in the custody of
                            the applicant referred to in subsection
                            (b)(2) for the purpose of determining
                            whether an action referred to in
                            subparagraph (C) should be brought. The
                            document providing the offer of
                            confidential access shall contain such
                            restrictions as to persons entitled to
                            access, and on the use and disposition
                            of any information accessed, as would
                            apply had a protective order been
                            entered for the purpose of protecting
                            trade secrets and other confidential
                            business information. A request for
                            access to an application under an offer
                            of confidential access shall be
                            considered acceptance of the offer of
                            confidential access with the
                            restrictions as to persons entitled to
                            access, and on the use and disposition
                            of any information accessed, contained
                            in the offer of confidential access,
                            and those restrictions and other terms
                            of the offer of confidential access
                            shall be considered terms of an
                            enforceable contract. Any person
                            provided an offer of confidential
                            access shall review the application for
                            the sole and limited purpose of
                            evaluating possible infringement of the
                            patent that is the subject of the
                            certification under subsection
                            (b)(2)(A)(iv) and for no other purpose,
                            and may not disclose information of no
                            relevance to any issue of patent
                            infringement to any person other than a
                            person provided an offer of
                            confidential access. Further, the
                            application may be redacted by the
                            applicant to remove any information of
                            no relevance to any issue of patent
                            infringement.
                      (ii) Counterclaim to infringement action.--
                              (I) In general.--If an owner of the
                            patent or the holder of the approved
                            application under subsection (b) for
                            the drug that is claimed by the patent
                            or a use of which is claimed by the
                            patent brings a patent infringement
                            action against the applicant, the
                            applicant may assert a counterclaim
                            seeking an order requiring the holder
                            to correct or delete the patent
                            information submitted by the holder
                            under subsection (b) or this subsection
                            on the ground that the patent does not
                            claim either--
                                      (aa) the drug for which the
                                    application was approved; or
                                      (bb) an approved method of
                                    using the drug.
                              (II) No independent cause of
                            action.--Subclause (I) does not
                            authorize the assertion of a claim
                            described in subclause (I) in any civil
                            action or proceeding other than a
                            counterclaim described in subclause
                            (I).
                      (iii) No damages.--An applicant shall not be
                    entitled to damages in a civil action under
                    clause (i) or a counterclaim under clause (ii).
              (E)
              (ii) If an application submitted under subsection (b)
            for a drug, no active moiety (as defined by the
            Secretary in section 314.3 of title 21, Code of Federal
            Regulations (or any successor regulations)) of which
            has been approved in any other application under
            subsection (b), is approved after the date of the
            enactment of this clause, no application which refers
            to the drug for which the subsection (b) application
            was submitted and for which the investigations
            described in subsection (b)(1)(A)(i) and relied upon by
            the applicant for approval of the application were not
            conducted by or for the applicant and for which the
            applicant has not obtained a right of reference or use
            from the person by or for whom the investigations were
            conducted may be submitted under subsection (b) before
            the expiration of five years from the date of the
            approval of the application under subsection (b),
            except that such an application may be submitted under
            subsection (b) after the expiration of four years from
            the date of the approval of the subsection (b)
            application if it contains a certification of patent
            invalidity or noninfringement described in clause (iv)
            of subsection (b)(2)(A). The approval of such an
            application shall be made effective in accordance with
            this paragraph except that, if an action for patent
            infringement is commenced during the one-year period
            beginning forty-eight months after the date of the
            approval of the subsection (b) application, the thirty-
            month period referred to in subparagraph (C) shall be
            extended by such amount of time (if any) which is
            required for seven and one-half years to have elapsed
            from the date of approval of the subsection (b)
            application.
              (iii) If an application submitted under subsection
            (b) for a drug, which includes an active moiety (as
            defined by the Secretary in section 314.3 of title 21,
            Code of Federal Regulations (or any successor
            regulations)) that has been approved in another
            application approved under subsection (b), is approved
            after the date of the enactment of this clause and if
            such application contains reports of new clinical
            investigations (other than bioavailability studies)
            essential to the approval of the application and
            conducted or sponsored by the applicant, the Secretary
            may not make the approval of an application submitted
            under subsection (b) for the conditions of approval of
            such drug in the approved subsection (b) application
            effective before the expiration of three years from the
            date of the approval of the application under
            subsection (b) if the investigations described in
            subsection (b)(1)(A)(i) and relied upon by the
            applicant for approval of the application were not
            conducted by or for the applicant and if the applicant
            has not obtained a right of reference or use from the
            person by or for whom the investigations were
            conducted.
              (iv) If a supplement to an application approved under
            subsection (b) is approved after the date of enactment
            of this clause and the supplement contains reports of
            new clinical investigations (other than bioavailabilty
            studies) essential to the approval of the supplement
            and conducted or sponsored by the person submitting the
            supplement, the Secretary may not make the approval of
            an application submitted under subsection (b) for a
            change approved in the supplement effective before the
            expiration of three years from the date of the approval
            of the supplement under subsection (b) if the
            investigations described in subsection (b)(1)(A)(i) and
            relied upon by the applicant for approval of the
            application were not conducted by or for the applicant
            and if the applicant has not obtained a right of
            reference or use from the person by or for whom the
            investigations were conducted.
              (v) If an application (or supplement to an
            application) submitted under subsection (b) for a drug,
            which includes anactive moiety (as defined by the
            Secretary in section 314.3 of title 21, Code of Federal
            Regulations (or any successor regulations)) that has
            been approved in another application under subsection
            (b), was approved during the period beginning January
            1, 1982, and ending on the date of the enactment of
            this clause, the Secretary may not make the approval of
            an application submitted under this subsection and for
            which the investigations described in subsection
            (b)(1)(A)(i) and relied upon by the applicant for
            approval of the application were not conducted by or
            for the applicant and for which the applicant has not
            obtained a right of reference or use from the person by
            or for whom the investigations were conducted and which
            refers to the drug for which the subsection (b)
            application was submitted effective before the
            expiration of two years from the date of enactment of
            this clause.
      (4) A drug manufactured in a pilot or other small facility
    may be used to demonstrate the safety and effectiveness of the
    drug and to obtain approval for the drug prior to manufacture
    of the drug in a larger facility, unless the Secretary makes a
    determination that a full scale production facility is
    necessary to ensure the safety or effectiveness of the drug.
      (5)(A) The Secretary may rely upon qualified data summaries
    to support the approval of a supplemental application, with
    respect to a qualified indication for a drug, submitted under
    subsection (b), if such supplemental application complies with
    subparagraph (B).
      (B) A supplemental application is eligible for review as
    described in subparagraph (A) only if--
              (i) there is existing data available and acceptable
            to the Secretary demonstrating the safety of the drug;
            and
              (ii) all data used to develop the qualified data
            summaries are submitted to the Secretary as part of the
            supplemental application.
      (C) The Secretary shall post on the Internet website of the
    Food and Drug Administration and update annually--
              (i) the number of applications reviewed solely under
            subparagraph (A) or section 351(a)(2)(E) of the Public
            Health Service Act;
              (ii) the average time for completion of review under
            subparagraph (A) or section 351(a)(2)(E) of the Public
            Health Service Act;
              (iii) the average time for review of supplemental
            applications where the Secretary did not use review
            flexibility under subparagraph (A) or section
            351(a)(2)(E) of the Public Health Service Act; and
              (iv) the number of applications reviewed under
            subparagraph (A) or section 351(a)(2)(E) of the Public
            Health Service Act for which the Secretary made use of
            full data sets in addition to the qualified data
            summary.
      (D) In this paragraph--
              (i) the term ``qualified indication'' means an
            indication for a drug that the Secretary determines to
            be appropriate for summary level review under this
            paragraph; and
              (ii) the term ``qualified data summary'' means a
            summary of clinical data that demonstrates the safety
            and effectiveness of a drug with respect to a qualified
            indication.
      (d) If the Secretary finds, after due notice to the applicant
    in accordance with subsection (c) and giving him an opportunity
    for a hearing, in accordance with said subsection, that (1) the
    investigations, reports of which are required to be submitted
    to the Secretary pursuant to subsection (b), do not include
    adequate tests by all methods reasonably applicable to show
    whether or not such drug is safe for use under the conditions
    prescribed, recommended, or suggested in the proposed labeling
    thereof; (2) the results of such tests show that such drug is
    unsafe for use under such conditions or do not show that such
    drug is safe for use under such conditions; (3) the methods
    used in, and the facilities and controls used for, the
    manufacture, processing, and packing of such drug are
    inadequate to preserve its identity, strength, quality, and
    purity; (4) upon the basis of the information submitted to him
    as part of the application, or upon the basis of any other
    information before him with respect to such drug, he has
    insufficient information to determine whether such drug is safe
    for use under such conditions; or (5) evaluated on the basis of
    the information submitted to him as part of the application and
    any other information before him with respect to such drug,
    there is a lack of substantial evidence that the drug will have
    the effect it purports or is represented to have under the
    conditions of use prescribed, recommended, or suggested in the
    proposed labeling thereof; or (6) the application failed to
    contain the patent information prescribed by subsection (b); or
    (7) based on a fair evaluation of all material facts, such
    labeling is false or misleading in any particular; he shall
    issue an order refusing to approve the application. If, after
    such notice and opportunity for hearing, the Secretary finds
    that clauses (1) through (6) do not apply, he shall issue an
    order approving the application. As used in this subsection and
    subsection (e), the term ``substantial evidence'' means
    evidence consisting of adequate and well-controlled
    investigations, including clinical investigations, by experts
    qualified by scientific training and experience to evaluate the
    effectiveness of the drug involved, on the basis of which it
    could fairly and responsibly be concluded by such experts that
    the drug will have the effect it purports or is represented to
    have under the conditions of use prescribed, recommended, or
    suggested in the labeling or proposed labeling thereof. If the
    Secretary determines, based on relevant science, that data from
    one adequate and well-controlled clinical investigation and
    confirmatory evidence (obtained prior to or after such
    investigation) are sufficient to establish effectiveness, the
    Secretary may consider such data and evidence to constitute
    substantial evidence for purposes of the preceding sentence.
    The Secretary shall implement a structured risk-benefit
    assessment framework in the new drug approval process to
    facilitate the balanced consideration of benefits and risks, a
    consistent and systematic approach to the discussion and
    regulatory decisionmaking, and the communication of the
    benefits and risks of new drugs. Nothing in the preceding
    sentence shall alter the criteria for evaluating an application
    for marketing approval of a drug.
      (e) The Secretary shall, after due notice and opportunity for
    hearing to the applicant, withdraw approval of an application
    with respect to any drug under this section if the Secretary
    finds (1) that clinical or other experience, tests, or other
    scientific data show that such drug is unsafe for use under the
    conditions of use upon the basis of which the application was
    approved; (2) that new evidence of clinical experience, not
    contained in such application or not available to the Secretary
    until after such application was approved, or tests by new
    methods, or tests by methods not deemed reasonably applicable
    when such application was approved, evaluated together with the
    evidence available to the Secretary when the application was
    approved, shows that such drug is not shown to be safe for use
    under the conditions of use upon the basis of which the
    application was approved; or (3) on the basis of new
    information before him with respect to such drug, evaluated
    together with the evidence available to him when the
    application was approved, that there is a lack of substantial
    evidence that the drug will have the effect it purports or is
    represented to have under the conditions of use prescribed,
    recommended, or suggested in the labeling thereof; or (4) the
    patent information prescribed by subsection (c) was not filed
    within thirty days after the receipt of written notice from the
    Secretary specifying the failure to file such information; or
    (5) that the application contains any untrue statement of a
    material fact: Provided, That if the Secretary (or in his
    absence the officer acting as Secretary) finds that there is an
    imminent hazard to the public health, he may suspend the
    approval of such application immediately, and give the
    applicant prompt notice of his action and afford the applicant
    the opportunity for an expedited hearing under this subsection;
    but the authority conferred by this proviso to suspend the
    approval of an application shall not be delegated. The
    Secretary may also, after due notice and opportunity for
    hearing to the applicant, withdraw the approval of an
    application submitted under subsection (b) or (j) with respect
    to any drug under this section if the Secretary finds (1) that
    the applicant has failed to establish a system for maintaining
    required records, or has repeatedly or deliberately failed to
    maintain such records or to make required reports, in
    accordance with a regulation or order under subsection (k) or
    to comply with the notice requirements of section 510(k)(2), or
    the applicant has refused to permit access to, or copying or
    verification of, such records as required by paragraph (2) of
    such subsection; or (2) that on the basis of new information
    before him, evaluated together with the evidence before him
    when the application was approved, the methods used in, or the
    facilities and controls used for, the manufacture, processing,
    and packing of such drug are inadequate to assure and preserve
    its identity, strength, quality, and purity and were not made
    adequate within a reasonable time after receipt of written
    notice from the Secretary specifying the matter complained of;
    or (3) that on the basis of new information before him,
    evaluated together with the evidence before him when the
    application was approved, the labeling of such drug, based on a
    fair evaluation of all material facts, is false or misleading
    in any particular and was not corrected within a reasonable
    time after receipt of written notice from the Secretary
    specifying the matter complained of. Any order under this
    subsection shall state the findings upon which it is based. The
    Secretary may withdraw the approval of an application submitted
    under this section, or suspend the approval of such an
    application, as provided under this subsection, without first
    ordering the applicant to submit an assessment of the approved
    risk evaluation and mitigation strategy for the drug under
    section 505-1(g)(2)(D).
      (f) Whenever the Secretary finds that the facts so require,
    he shall revoke any previous order under subsection (d) or (e)
    refusing, withdrawing, or suspending approval of an application
    and shall approve such application or reinstate such approval,
    as may be appropriate.
      (g) Orders of the Secretary issued under this section shall
    be served (1) in person by any officer or employee of the
    Department designated by the Secretary or (2) by mailing the
    order by registered mail or by certified mail addressed to the
    applicant or respondent at his last-known address in the
    records of the Secretary.
      (h) An appeal may be taken by the applicant from an order of
    the Secretary refusing or withdrawing approval of an
    application under this section. Such appeal shall be taken by
    filing in the United States court of appeals for the circuit
    wherein such applicant resides or has his principal place of
    business, or in the United States Court of Appeals for the
    District of Columbia Circuit, within sixty days after the entry
    of such order, a written petition praying that the order of the
    Secretary be set aside. A copy of such petition shall be
    forthwith transmitted by the clerk of the court to the
    Secretary, or any officer designated by him for that purpose,
    and thereupon the Secretary shall certify and file in the court
    the record upon which the order complained of was entered, as
    provided in section 2112 of title 28, United States Code. Upon
    the filing of such petition such court shall have exclusive
    jurisdiction to affirm or set aside such order, except that
    until the filing of the record the Secretary may modify or set
    aside his order. No objection to the order of the Secretary
    shall be considered by the court unless such objection shall
    have been urged before the Secretary or unless there were
    reasonable grounds for failure so to do. The finding of the
    Secretary as to the facts, if supported by substantial
    evidence, shall be conclusive. If any person shall apply to the
    court for leave to adduce additional evidence, and shall show
    to the satisfaction of the court that such additional evidence
    is material and that there were reasonable grounds for failure
    to adduce such evidence in the proceeding before the Secretary,
    the court may order such additional evidence to be taken before
    the Secretary and to be adduced upon the hearing in such manner
    and upon such terms and conditions as to the court may seem
    proper. The Secretary may modify his findings as to the facts
    by reason of the additional evidence so taken, and he shall
    file with the court such modified findings which, if supported
    by substantial evidence, shall be conclusive, and his
    recommendation, if any, for the setting aside of the original
    order. The judgment of the court affirming or setting aside any
    such order of the Secretary shall be final, subject to review
    by the Supreme Court of the United States upon certiorari or
    certification as provided in section 1254 of title 28 of the
    United States Code. The commencement of proceedings under this
    subsection shall not, unless specifically ordered by the court
    to the contrary, operate as a stay of the Secretary's order.
      (i)(1) The Secretary shall promulgate regulations for
    exempting from the operation of the foregoing subsections of
    this section drugs intended solely for investigational use by
    experts qualified by scientific training and experience to
    investigate the safety and effectiveness of drugs. Such
    regulations may, within the discretion of the Secretary, among
    other conditions relating to the protection of the public
    health, provide for conditioning such exemption upon--
              (A) the submission to the Secretary, before any
            clinical testing of a new drug is undertaken, of
            reports, by the manufacturer or the sponsor of the
            investigation of such drug, or [preclinical tests
            (including tests on animals)] nonclinical tests of such
            drug adequate to justify the proposed clinical testing;
              (B) the manufacturer or the sponsor of the
            investigation of a new drug proposed to be distributed
            to investigators for clinical testing obtaining a
            signed agreement from each of such investigators that
            patients to whom the drug is administered will be under
            his personal supervision, or under the supervision of
            investigators responsible to him, and that he will not
            supply such drug to any other investigator, or to
            clinics, for administration to human beings;
              (C) the establishment and maintenance of such
            records, and the making of such reports to the
            Secretary, by the manufacturer or the sponsor of the
            investigation of such drug, of data (including but not
            limited to analytical reports by investigators)
            obtained as the result of such investigational use of
            such drug, as the Secretary finds will enable him to
            evaluate the safety and effectiveness of such drug in
            the event of the filing of an application pursuant to
            subsection (b); and
                      (D) the submission to the Secretary by the
                    manufacturer or the sponsor of the
                    investigation of a new drug of a statement of
                    intent regarding whether the manufacturer or
                    sponsor has plans for assessing pediatric
                    safety and efficacy.
      (2) Subject to paragraph (3), a clinical investigation of a
    new drug may begin 30 days after the Secretary has received
    from the manufacturer or sponsor of the investigation a
    submission containing such information about the drug and the
    clinical investigation, including--
              (A) information on design of the investigation and
            adequate reports of basic information, certified by the
            applicant to be accurate reports, necessary to assess
            the safety of the drug for use in clinical
            investigation; and
              (B) adequate information on the chemistry and
            manufacturing of the drug, controls available for the
            drug, and primary data tabulations from [animal]
            nonclinical tests or human studies.
      (3)(A) At any time, the Secretary may prohibit the sponsor of
    an investigation from conducting the investigation (referred to
    in this paragraph as a ``clinical hold'') if the Secretary
    makes a determination described in subparagraph (B). The
    Secretary shall specify the basis for the clinical hold,
    including the specific information available to the Secretary
    which served as the basis for such clinical hold, and confirm
    such determination in writing.
      (B) For purposes of subparagraph (A), a determination
    described in this subparagraph with respect to a clinical hold
    is that--
              (i) the drug involved represents an unreasonable risk
            to the safety of the persons who are the subjects of
            the clinical investigation, taking into account the
            qualifications of the clinical investigators,
            information about the drug, the design of the clinical
            investigation, the condition for which the drug is to
            be investigated, and the health status of the subjects
            involved; or
              (ii) the clinical hold should be issued for such
            other reasons as the Secretary may by regulation
            establish (including reasons established by regulation
            before the date of the enactment of the Food and Drug
            Administration Modernization Act of 1997).
      (C) Any written request to the Secretary from the sponsor of
    an investigation that a clinical hold be removed shall receive
    a decision, in writing and specifying the reasons therefor,
    within 30 days after receipt of such request. Any such request
    shall include sufficient information to support the removal of
    such clinical hold.
      (4) Regulations under paragraph (1) shall provide that such
    exemption shall be conditioned upon the manufacturer, or the
    sponsor of the investigation, requiring that experts using such
    drugs for investigational purposes certify to such manufacturer
    or sponsor that they will inform any human beings to whom such
    drugs, or any controls used in connection therewith, are being
    administered, or their representatives, that such drugs are
    being used for investigational purposes and will obtain the
    consent of such human beings or their representatives, except
    where it is not feasible, it is contrary to the best interests
    of such human beings, or the proposed clinical testing poses no
    more than minimal risk to such human beings and includes
    appropriate safeguards as prescribed to protect the rights,
    safety, and welfare of such human beings. Nothing in this
    subsection shall be construed to require any clinical
    investigator to submit directly to the Secretary reports on the
    investigational use of drugs. The Secretary shall update such
    regulations to require inclusion in the informed consent
    documents and process a statement that clinical trial
    information for such clinical investigation has been or will be
    submitted for inclusion in the registry data bank pursuant to
    subsection (j) of section 402 of the Public Health Service Act.
      (5)(A) In order for a new drug that is being studied in a
    phase 3 study, as defined in section 312.21(c) of title 21,
    Code of Federal Regulations (or successor regulations), or
    other pivotal study (other than bioavailability or
    bioequivalence studies), to be exempt pursuant to this
    subsection, the sponsor of a clinical investigation of such new
    drug shall submit to the Secretary a diversity action plan.
      (B) Such diversity action plan shall include--
              (i) the sponsor's goals for enrollment in such
            clinical study;
              (ii) the sponsor's rationale for such goals; and
              (iii) an explanation of how the sponsor intends to
            meet such goals.
      (C) The sponsor shall submit such diversity action plan in
    the form and manner specified in the guidance required by
    section 524B as soon as practicable but no later than when the
    sponsor seeks feedback regarding such a phase 3 study or other
    pivotal study of the drug.
      (D) The Secretary may waive the requirement in subparagraph
    (A) if the Secretary determines that a waiver is necessary
    based on what is known about the prevalence of the disease in
    terms of the patient population that may use the new drug.
      (E) No diversity action plan shall be required for a
    submission described in section 561.
      (j)(1) Any person may file with the Secretary an abbreviated
    application for the approval of a new drug.
      (2)(A) An abbreviated application for a new drug shall
    contain--
              (i) information to show that the conditions of use
            prescribed, recommended, or suggested in the labeling
            proposed for the new drug have been previously approved
            for a drug listed under paragraph (7) (hereinafter in
            this subsection referred to as a ``listed drug'');
              (ii)(I) if the listed drug referred to in clause (i)
            has only one active ingredient, information to show
            that the active ingredient of the new drug is the same
            as that of the listed drug;
              (II) if the listed drug referred to in clause (i) has
            more than one active ingredient, information to show
            that the active ingredients of the new drug are the
            same as those of the listed drug, or
              (III) if the listed drug referred to in clause (i)
            has more than one active ingredient and if one of the
            active ingredients of the new drug is different and the
            application is filed pursuant to the approval of a
            petition filed under subparagraph (C), information to
            show that the other active ingredients of the new drug
            are the same as the active ingredients of the listed
            drug, information to show that the different active
            ingredient is an active ingredient of a listed drug or
            of a drug which does not meet the requirements of
            section 201(p), and such other information respecting
            the different active ingredient with respect to which
            the petition was filed as the Secretary may require;
              (iii) information to show that the route of
            administration, the dosage form, and the strength of
            the new drug are the same as those of the listed drug
            referred to in clause (i) or, if the route of
            administration, the dosage form, or the strength of the
            new drug is different and the application is filed
            pursuant to the approval of a petition filed under
            subparagraph (C), such information respecting the route
            of administration, dosage form, or strength with
            respect to which the petition was filed as the
            Secretary may require;
              (iv) information to show that the new drug is
            bioequivalent to the listed drug referred to in clause
            (i), except that if the application is filed pursuant
            to the approval of a petition filed under subparagraph
            (C), information to show that the active ingredients of
            the new drug are of the same pharmacological or
            therapeutic class as those of the listed drug referred
            to in clause (i) and the new drug can be expected to
            have the same therapeutic effect as the listed drug
            when administered to patients for a condition of use
            referred to in clause (i);
              (v) information to show that the labeling proposed
            for the new drug is the same as the labeling approved
            for the listed drug referred to in clause (i) except
            for changes required because of differences approved
            under a petition filed under subparagraph (C) or
            because the new drug and the listed drug are produced
            or distributed by different manufacturers;
              (vi) the items specified in clauses (ii) through (vi)
            of subsection (b)(1)(A);
              (vii) a certification, in the opinion of the
            applicant and to the best of his knowledge, with
            respect to each patent which claims the listed drug
            referred to in clause (i) or which claims a use for
            such listed drug for which the applicant is seeking
            approval under this subsection and for which
            information is required to be filed under subsection
            (b) or (c)--
                      (I) that such patent information has not been
                    filed,
                      (II) that such patent has expired,
                      (III) of the date on which such patent will
                    expire, or
                      (IV) that such patent is invalid or will not
                    be infringed by the manufacture, use, or sale
                    of the new drug for which the application is
                    submitted; and
              (viii) if with respect to the listed drug referred to
            in clause (i) information was filed under subsection
            (b) or (c) for a method of use patent which does not
            claim a use for which the applicant is seeking approval
            under this subsection, a statement that the method of
            use patent does not claim such a use.
    The Secretary may not require that an abbreviated application
    contain information in addition to that required by clauses (i)
    through (viii).
      (B) Notice of opinion that patent is invalid or will not be
    infringed.--
              (i) Agreement to give notice.--An applicant that
            makes a certification described in subparagraph
            (A)(vii)(IV) shall include in the application a
            statement that the applicant will give notice as
            required by this subparagraph.
              (ii) Timing of notice.--An applicant that makes a
            certification described in subparagraph (A)(vii)(IV)
            shall give notice as required under this subparagraph--
                      (I) if the certification is in the
                    application, not later than 20 days after the
                    date of the postmark on the notice with which
                    the Secretary informs the applicant that the
                    application has been filed; or
                      (II) if the certification is in an amendment
                    or supplement to the application, at the time
                    at which the applicant submits the amendment or
                    supplement, regardless of whether the applicant
                    has already given notice with respect to
                    another such certification contained in the
                    application or in an amendment or supplement to
                    the application.
              (iii) Recipients of notice.--An applicant required
            under this subparagraph to give notice shall give
            notice to--
                      (I) each owner of the patent that is the
                    subject of the certification (or a
                    representative of the owner designated to
                    receive such a notice); and
                      (II) the holder of the approved application
                    under subsection (b) for the drug that is
                    claimed by the patent or a use of which is
                    claimed by the patent (or a representative of
                    the holder designated to receive such a
                    notice).
              (iv) Contents of notice.--A notice required under
            this subparagraph shall--
                      (I) state that an application that contains
                    data from bioavailability or bioequivalence
                    studies has been submitted under this
                    subsection for the drug with respect to which
                    the certification is made to obtain approval to
                    engage in the commercial manufacture, use, or
                    sale of the drug before the expiration of the
                    patent referred to in the certification; and
                      (II) include a detailed statement of the
                    factual and legal basis of the opinion of the
                    applicant that the patent is invalid or will
                    not be infringed.
      (C) If a person wants to submit an abbreviated application
    for a new drug which has a different active ingredient or whose
    route of administration, dosage form, or strength differ from
    that of a listed drug, such person shall submit a petition to
    the Secretary seeking permission to file such an application.
    The Secretary shall approve or disapprove a petition submitted
    under this subparagraph within ninety days of the date the
    petition is submitted. The Secretary shall approve such a
    petition unless the Secretary finds--
              (i) that investigations must be conducted to show the
            safety and effectiveness of the drug or of any of its
            active ingredients, the route of administration, the
            dosage form, or strength which differ from the listed
            drug; or
              (ii) that any drug with a different active ingredient
            may not be adequately evaluated for approval as safe
            and effective on the basis of the information required
            to be submitted in an abbreviated application.
      (D)(i) An applicant may not amend or supplement an
    application to seek approval of a drug referring to a different
    listed drug from the listed drug identified in the application
    as submitted to the Secretary.
      (ii) With respect to the drug for which an application is
    submitted, nothing in this subsection prohibits an applicant
    from amending or supplementing the application to seek approval
    of a different strength.
      (iii) Within 60 days after the date of the enactment of the
    Medicare Prescription Drug, Improvement, and Modernization Act
    of 2003, the Secretary shall issue guidance defining the term
    ``listed drug'' for purposes of this subparagraph.
      (3)(A) The Secretary shall issue guidance for the individuals
    who review applications submitted under paragraph (1), which
    shall relate to promptness in conducting the review, technical
    excellence, lack of bias and conflict of interest, and
    knowledge of regulatory and scientific standards, and which
    shall apply equally to all individuals who review such
    applications.
      (B) The Secretary shall meet with a sponsor of an
    investigation or an applicant for approval for a drug under
    this subsection if the sponsor or applicant makes a reasonable
    written request for a meeting for the purpose of reaching
    agreement on the design and size of bioavailability and
    bioequivalence studies needed for approval of such application.
    The sponsor or applicant shall provide information necessary
    for discussion and agreement on the design and size of such
    studies. Minutes of any such meeting shall be prepared by the
    Secretary and made available to the sponsor or applicant.
      (C) Any agreement regarding the parameters of design and size
    of bioavailability and bioequivalence studies of a drug under
    this paragraph that is reached between the Secretary and a
    sponsor or applicant shall be reduced to writing and made part
    of the administrative record by the Secretary. Such agreement
    shall not be changed after the testing begins, except--
              (i) with the written agreement of the sponsor or
            applicant; or
              (ii) pursuant to a decision, made in accordance with
            subparagraph (D) by the director of the reviewing
            division, that a substantial scientific issue essential
            to determining the safety or effectiveness of the drug
            has been identified after the testing has begun.
      (D) A decision under subparagraph (C)(ii) by the director
    shall be in writing and the Secretary shall provide to the
    sponsor or applicant an opportunity for a meeting at which the
    director and the sponsor or applicant will be present and at
    which the director will document the scientific issue involved.
      (E) The written decisions of the reviewing division shall be
    binding upon, and may not directly or indirectly be changed by,
    the field or compliance office personnel unless such field or
    compliance office personnel demonstrate to the reviewing
    division why such decision should be modified.
      (F) No action by the reviewing division may be delayed
    because of the unavailability of information from or action by
    field personnel unless the reviewing division determines that a
    delay is necessary to assure the marketing of a safe and
    effective drug.
      (G) For purposes of this paragraph, the reviewing division is
    the division responsible for the review of an application for
    approval of a drug under this subsection (including scientific
    matters, chemistry, manufacturing, and controls).
      (H)(i) Upon request (in controlled correspondence or
    otherwise) by a person that has submitted or intends to submit
    an abbreviated application for a new drug under this subsection
    for which the Secretary has specified in regulation, including
    under section 314.94(a)(9), title 21, Code of Federal
    Regulations (or a successor regulation), or recommended in
    applicable guidance, certain qualitative or quantitative
    criteria with respect to an inactive ingredient, or on the
    Secretary's own initiative during the review of such
    abbreviated application, the Secretary shall inform the person
    whether such new drug is qualitatively and quantitatively the
    same as the listed drug.
      (ii) Notwithstanding section 301(j), if the Secretary
    determines that such new drug is not qualitatively or
    quantitatively the same as the listed drug, the Secretary shall
    identify and disclose to the person--
              (I) the ingredient or ingredients that cause the new
            drug not to be qualitatively or quantitatively the same
            as the listed drug; and
              (II) for any ingredient for which there is an
            identified quantitative deviation, the amount of such
            deviation.
      (iii) If the Secretary determines that such new drug is
    qualitatively and quantitatively the same as the listed drug,
    the Secretary shall not change or rescind such determination
    after the submission of an abbreviated application for such new
    drug under this subsection unless--
              (I) the formulation of the listed drug has been
            changed and the Secretary has determined that the prior
            listed drug formulation was withdrawn for reasons of
            safety or effectiveness; or
              (II) the Secretary makes a written determination that
            the prior determination must be changed because an
            error has been identified.
      (iv) If the Secretary makes a written determination described
    in clause (iii)(II), the Secretary shall provide notice and a
    copy of the written determination to the person making the
    request under clause (i).
      (v) The disclosures required by this subparagraph are
    disclosures authorized by law including for purposes of section
    1905 of title 18, United States Code.
      (4) Subject to paragraph (5), the Secretary shall approve an
    application for a drug unless the Secretary finds--
              (A) the methods used in, or the facilities and
            controls used for, the manufacture, processing, and
            packing of the drug are inadequate to assure and
            preserve its identity, strength, quality, and purity;
              (B) information submitted with the application is
            insufficient show that each of the proposed conditions
            of use have been previously approved for the listed
            drug referred to in the application;
              (C)(i) if the listed drug has only one active
            ingredient, information submitted with the application
            is insufficient to show that the active ingredient is
            the same as that of the listed drug;
              (ii) if the listed drug has more than one active
            ingredient, information submitted with the application
            is insufficient to show that the active ingredients are
            the same as the active ingredients of the listed drug,
            or
              (iii) if the listed drug has more than one active
            ingredient and if the application is for a drug which
            has an active ingredient different from the listed
            drug, information submitted with the application is
            insufficient to show--
                      (I) that the other active ingredients are the
                    same as the active ingredients of the listed
                    drug, or
                      (II) that the different active ingredient is
                    an active ingredient of a listed drug or a drug
                    which does not meet the requirements of section
                    201(p),
            or no petition to file an application for the drug with
            the different ingredient was approved under paragraph
            (2)(C);
              (D)(i) if the application is for a drug whose route
            of administration, dosage form, or strength of the drug
            is the same as the route of administration, dosage
            form, or strength of the listed drug referred to in the
            application, information submitted in the application
            is insufficient to show that the route of
            administration, dosage form, or strength is the same as
            that of the listed drug, or
              (ii) if the application is for a drug whose route of
            administration, dosage form, or strength of the drug is
            different from that of the listed drug referred to in
            the application, no petition to file an application for
            the drug with the different route of administration,
            dosage form, or strength was approved under paragraph
            (2)(C);
              (E) if the application was filed pursuant to the
            approval of a petition under paragraph (2)(C), the
            application did not contain the information required by
            the Secretary respecting the active ingredient, route
            of administration, dosage form, or strength which is
            not the same;
              (F) information submitted in the application is
            insufficient to show that the drug is bioequivalent to
            the listed drug referred to in the application or, if
            the application was filed pursuant to a petition
            approved under paragraph (2)(C), information submitted
            in the application is insufficient to show that the
            active ingredients of the new drug are of the same
            pharmacological or therapeutic class as those of the
            listed drug referred to in paragraph (2)(A)(i) and that
            the new drug can be expected to have the same
            therapeutic effect as the listed drug when administered
            to patients for a condition of use referred to in such
            paragraph;
              (G) information submitted in the application is
            insufficient to show that the labeling proposed for the
            drug is the same as the labeling approved for the
            listed drug referred to in the application except for
            changes required because of differences approved under
            a petition filed under paragraph (2)(C) or because the
            drug and the listed drug are produced or distributed by
            different manufacturers;
              (H) information submitted in the application or any
            other information available to the Secretary shows that
            (i) the inactive ingredients of the drug are unsafe for
            use under the conditions prescribed, recommended, or
            suggested in the labeling proposed for the drug, or
            (ii) the composition of the drug is unsafe under such
            conditions because of the type or quantity of inactive
            ingredients included or the manner in which the
            inactive ingredients are included;
              (I) the approval under subsection (c) of the listed
            drug referred to in the application under this
            subsection has been withdrawn or suspended for grounds
            described in the first sentence of subsection (e), the
            Secretary has published a notice of opportunity for
            hearing to withdraw approval of the listed drug under
            subsection (c) for grounds described in the first
            sentence of subsection (e), the approval under this
            subsection of the listed drug referred to in the
            application under this subsection has been withdrawn or
            suspended under paragraph (6), or the Secretary has
            determined that the listed drug has been withdrawn from
            sale for safety or effectiveness reasons;
              (J) the application does not meet any other
            requirement of paragraph (2)(A); or
              (K) the application contains an untrue statement of
            material fact.
      (5)(A) Within one hundred and eighty days of the initial
    receipt of an application under paragraph (2) or within such
    additional period as may be agreed upon by the Secretary and
    the applicant, the Secretary shall approve or disapprove the
    application.
      (B) The approval of an application submitted under paragraph
    (2) shall be made effective on the last applicable date
    determined by applying the following to each certification made
    under paragraph (2)(A)(vii):
              (i) If the applicant only made a certification
            described in subclause (I) or (II) of paragraph
            (2)(A)(vii) or in both such subclauses, the approval
            may be made effective immediately.
              (ii) If the applicant made a certification described
            in subclause (III) of paragraph (2)(A)(vii), the
            approval may be made effective on the date certified
            under subclause (III).
              (iii) If the applicant made a certification described
            in subclause (IV) of paragraph (2)(A)(vii), the
            approval shall be made effective immediately unless,
            before the expiration of 45 days after the date on
            which the notice described in paragraph (2)(B) is
            received, an action is brought for infringement of the
            patent that is the subject of the certification and for
            which information was submitted to the Secretary under
            subsection (b)(1) or (c)(2) before the date on which
            the application (excluding an amendment or supplement
            to the application), which the Secretary later
            determines to be substantially complete, was submitted.
            If such an action is brought before the expiration of
            such days, the approval shall be made effective upon
            the expiration of the thirty-month period beginning on
            the date of the receipt of the notice provided under
            paragraph (2)(B)(i) or such shorter or longer period as
            the court may order because either party to the action
            failed to reasonably cooperate in expediting the
            action, except that--
                      (I) if before the expiration of such period
                    the district court decides that the patent is
                    invalid or not infringed (including any
                    substantive determination that there is no
                    cause of action for patent infringement or
                    invalidity), the approval shall be made
                    effective on--
                              (aa) the date on which the court
                            enters judgment reflecting the
                            decision; or
                              (bb) the date of a settlement order
                            or consent decree signed and entered by
                            the court stating that the patent that
                            is the subject of the certification is
                            invalid or not infringed;
                      (II) if before the expiration of such period
                    the district court decides that the patent has
                    been infringed--
                              (aa) if the judgment of the district
                            court is appealed, the approval shall
                            be made effective on--
                                      (AA) the date on which the
                                    court of appeals decides that
                                    the patent is invalid or not
                                    infringed (including any
                                    substantive determination that
                                    there is no cause of action for
                                    patent infringement or
                                    invalidity); or
                                      (BB) the date of a settlement
                                    order or consent decree signed
                                    and entered by the court of
                                    appeals stating that the patent
                                    that is the subject of the
                                    certification is invalid or not
                                    infringed; or
                              (bb) if the judgment of the district
                            court is not appealed or is affirmed,
                            the approval shall be made effective on
                            the date specified by the district
                            court in a court order under section
                            271(e)(4)(A) of title 35, United States
                            Code;
                      (III) if before the expiration of such period
                    the court grants a preliminary injunction
                    prohibiting the applicant from engaging in the
                    commercial manufacture or sale of the drug
                    until the court decides the issues of patent
                    validity and infringement and if the court
                    decides that such patent is invalid or not
                    infringed, the approval shall be made effective
                    as provided in subclause (I); or
                      (IV) if before the expiration of such period
                    the court grants a preliminary injunction
                    prohibiting the applicant from engaging in the
                    commercial manufacture or sale of the drug
                    until the court decides the issues of patent
                    validity and infringement and if the court
                    decides that such patent has been infringed,
                    the approval shall be made effective as
                    provided in subclause (II).
            In such an action, each of the parties shall reasonably
            cooperate in expediting the action.
              (iv)  180-day exclusivity period.--
                      (I) Effectiveness of application.--Subject to
                    subparagraph (D), if the application contains a
                    certification described in paragraph
                    (2)(A)(vii)(IV) and is for a drug for which a
                    first applicant has submitted an application
                    containing such a certification, the
                    application shall be made effective on the date
                    that is 180 days after the date of the first
                    commercial marketing of the drug (including the
                    commercial marketing of the listed drug) by any
                    first applicant.
                      (II) Definitions.--In this paragraph:
                              (aa)  180-day exclusivity period.--
                            The term ``180-day exclusivity period''
                            means the 180-day period ending on the
                            day before the date on which an
                            application submitted by an applicant
                            other than a first applicant could
                            become effective under this clause.
                              (bb) First applicant.--As used in
                            this subsection, the term ``first
                            applicant'' means an applicant that, on
                            the first day on which a substantially
                            complete application containing a
                            certification described in paragraph
                            (2)(A)(vii)(IV) is submitted for
                            approval of a drug, submits a
                            substantially complete application that
                            contains and lawfully maintains a
                            certification described in paragraph
                            (2)(A)(vii)(IV) for the drug.
                              (cc) Substantially complete
                            application.--As used in this
                            subsection, the term ``substantially
                            complete application'' means an
                            application under this subsection that
                            on its face is sufficiently complete to
                            permit a substantive review and
                            contains all the information required
                            by paragraph (2)(A).
                              (dd) Tentative approval.--
                                      (AA) In general.--The term
                                    ``tentative approval'' means
                                    notification to an applicant by
                                    the Secretary that an
                                    application under this
                                    subsection meets the
                                    requirements of paragraph
                                    (2)(A), but cannot receive
                                    effective approval because the
                                    application does not meet the
                                    requirements of this
                                    subparagraph, there is a period
                                    of exclusivity for the listed
                                    drug under subparagraph (F) or
                                    section 505A, or there is a 7-
                                    year period of exclusivity for
                                    the listed drug under section
                                    527.
                                      (BB) Limitation.--A drug that
                                    is granted tentative approval
                                    by the Secretary is not an
                                    approved drug and shall not
                                    have an effective approval
                                    until the Secretary issues an
                                    approval after any necessary
                                    additional review of the
                                    application.
              (v)  180-day exclusivity period for competitive
            generic therapies.--
                      (I) Effectiveness of application.--Subject to
                    subparagraph (D)(iv), if the application is for
                    a drug that is the same as a competitive
                    generic therapy for which any first approved
                    applicant has commenced commercial marketing,
                    the application shall be made effective on the
                    date that is 180 days after the date of the
                    first commercial marketing of the competitive
                    generic therapy (including the commercial
                    marketing of the listed drug) by any first
                    approved applicant.
                      (II) Limitation.--The exclusivity period
                    under subclause (I) shall not apply with
                    respect to a competitive generic therapy that
                    has previously received an exclusivity period
                    under subclause (I).
                      (III) Definitions.--In this clause and
                    subparagraph (D)(iv):
                              (aa) The term ``competitive generic
                            therapy'' means a drug--
                                      (AA) that is designated as a
                                    competitive generic therapy
                                    under section 506H; and
                                      (BB) for which there are no
                                    unexpired patents or
                                    exclusivities on the list of
                                    products described in section
                                    505(j)(7)(A) at the time of
                                    submission.
                              (bb) The term ``first approved
                            applicant'' means any applicant that
                            has submitted an application that--
                                      (AA) is for a competitive
                                    generic therapy that is
                                    approved on the first day on
                                    which any application for such
                                    competitive generic therapy is
                                    approved;
                                      (BB) is not eligible for a
                                    180-day exclusivity period
                                    under clause (iv) for the drug
                                    that is the subject of the
                                    application for the competitive
                                    generic therapy; and
                                      (CC) is not for a drug for
                                    which all drug versions have
                                    forfeited eligibility for a
                                    180-day exclusivity period
                                    under clause (iv) pursuant to
                                    subparagraph (D).
              (C) Civil action to obtain patent certainty.--
                      (i) Declaratory judgment absent infringement
                    action.--
                              (I) In general.--No action may be
                            brought under section 2201 of title 28,
                            United States Code, by an applicant
                            under paragraph (2) for a declaratory
                            judgment with respect to a patent which
                            is the subject of the certification
                            referred to in subparagraph (B)(iii)
                            unless--
                                      (aa) the 45-day period
                                    referred to in such
                                    subparagraph has expired;
                                      (bb) neither the owner of
                                    such patent nor the holder of
                                    the approved application under
                                    subsection (b) for the drug
                                    that is claimed by the patent
                                    or a use of which is claimed by
                                    the patent brought a civil
                                    action against the applicant
                                    for infringement of the patent
                                    before the expiration of such
                                    period; and
                                      (cc) in any case in which the
                                    notice provided under paragraph
                                    (2)(B) relates to
                                    noninfringement, the notice was
                                    accompanied by a document
                                    described in subclause (III).
                              (II) Filing of civil action.--If the
                            conditions described in items (aa),
                            (bb), and as applicable, (cc) of
                            subclause (I) have been met, the
                            applicant referred to in such subclause
                            may, in accordance with section 2201 of
                            title 28, United States Code, bring a
                            civil action under such section against
                            the owner or holder referred to in such
                            subclause (but not against any owner or
                            holder that has brought such a civil
                            action against the applicant, unless
                            that civil action was dismissed without
                            prejudice) for a declaratory judgment
                            that the patent is invalid or will not
                            be infringed by the drug for which the
                            applicant seeks approval, except that
                            such civil action may be brought for a
                            declaratory judgment that the patent
                            will not be infringed only in a case in
                            which the condition described in
                            subclause (I)(cc) is applicable. A
                            civil action referred to in this
                            subclause shall be brought in the
                            judicial district where the defendant
                            has its principal place of business or
                            a regular and established place of
                            business.
                              (III) Offer of confidential access to
                            application.--For purposes of subclause
                            (I)(cc), the document described in this
                            subclause is a document providing an
                            offer of confidential access to the
                            application that is in the custody of
                            the applicant under paragraph (2) for
                            the purpose of determining whether an
                            action referred to in subparagraph
                            (B)(iii) should be brought. The
                            document providing the offer of
                            confidential access shall contain such
                            restrictions as to persons entitled to
                            access, and on the use and disposition
                            of any information accessed, as would
                            apply had a protective order been
                            entered for the purpose of protecting
                            trade secrets and other confidential
                            business information. A request for
                            access to an application under an offer
                            of confidential access shall be
                            considered acceptance of the offer of
                            confidential access with the
                            restrictions as to persons entitled to
                            access, and on the use and disposition
                            of any information accessed, contained
                            in the offer of confidential access,
                            and those restrictions and other terms
                            of the offer of confidential access
                            shall be considered terms of an
                            enforceable contract. Any person
                            provided an offer of confidential
                            access shall review the application for
                            the sole and limited purpose of
                            evaluating possible infringement of the
                            patent that is the subject of the
                            certification under paragraph
                            (2)(A)(vii)(IV) and for no other
                            purpose, and may not disclose
                            information of no relevance to any
                            issue of patent infringement to any
                            person other than a person provided an
                            offer of confidential access. Further,
                            the application may be redacted by the
                            applicant to remove any information of
                            no relevance to any issue of patent
                            infringement.
                      (ii) Counterclaim to infringement action.--
                              (I) In general.--If an owner of the
                            patent or the holder of the approved
                            application under subsection (b) for
                            the drug that is claimed by the patent
                            or a use of which is claimed by the
                            patent brings a patent infringement
                            action against the applicant, the
                            applicant may assert a counterclaim
                            seeking an order requiring the holder
                            to correct or delete the patent
                            information submitted by the holder
                            under subsection (b) or (c) on the
                            ground that the patent does not claim
                            either--
                                      (aa) the drug for which the
                                    application was approved; or
                                      (bb) an approved method of
                                    using the drug.
                              (II) No independent cause of
                            action.--Subclause (I) does not
                            authorize the assertion of a claim
                            described in subclause (I) in any civil
                            action or proceeding other than a
                            counterclaim described in subclause
                            (I).
                      (iii) No damages.--An applicant shall not be
                    entitled to damages in a civil action under
                    clause (i) or a counterclaim under clause (ii).
              (D) Forfeiture of 180-day exclusivity period.--
                      (i) Definition of forfeiture event.--In this
                    subparagraph, the term ``forfeiture event'',
                    with respect to an application under this
                    subsection, means the occurrence of any of the
                    following:
                              (I) Failure to market.--The first
                            applicant fails to market the drug by
                            the later of--
                                      (aa) the earlier of the date
                                    that is--
                                              (AA) 75 days after
                                            the date on which the
                                            approval of the
                                            application of the
                                            first applicant is made
                                            effective under
                                            subparagraph (B)(iii);
                                            or
                                              (BB) 30 months after
                                            the date of submission
                                            of the application of
                                            the first applicant; or
                                      (bb) with respect to the
                                    first applicant or any other
                                    applicant (which other
                                    applicant has received
                                    tentative approval), the date
                                    that is 75 days after the date
                                    as of which, as to each of the
                                    patents with respect to which
                                    the first applicant submitted
                                    and lawfully maintained a
                                    certification qualifying the
                                    first applicant for the 180-day
                                    exclusivity period under
                                    subparagraph (B)(iv), at least
                                    1 of the following has
                                    occurred:
                                              (AA) In an
                                            infringement action
                                            brought against that
                                            applicant with respect
                                            to the patent or in a
                                            declaratory judgment
                                            action brought by that
                                            applicant with respect
                                            to the patent, a court
                                            enters a final decision
                                            from which no appeal
                                            (other than a petition
                                            to the Supreme Court
                                            for a writ of
                                            certiorari) has been or
                                            can be taken that the
                                            patent is invalid or
                                            not infringed.
                                              (BB) In an
                                            infringement action or
                                            a declaratory judgment
                                            action described in
                                            subitem (AA), a court
                                            signs a settlement
                                            order or consent decree
                                            that enters a final
                                            judgment that includes
                                            a finding that the
                                            patent is invalid or
                                            not infringed.
                                              (CC) The patent
                                            information submitted
                                            under subsection (b) or
                                            (c) is withdrawn by the
                                            holder of the
                                            application approved
                                            under subsection (b).
                              (II) Withdrawal of application.--The
                            first applicant withdraws the
                            application or the Secretary considers
                            the application to have been withdrawn
                            as a result of a determination by the
                            Secretary that the application does not
                            meet the requirements for approval
                            under paragraph (4).
                              (III) Amendment of certification.--
                            The first applicant amends or withdraws
                            the certification for all of the
                            patents with respect to which that
                            applicant submitted a certification
                            qualifying the applicant for the 180-
                            day exclusivity period.
                              (IV) Failure to obtain tentative
                            approval.--The first applicant fails to
                            obtain tentative approval of the
                            application within 30 months after the
                            date on which the application is filed,
                            unless the failure is caused by a
                            change in or a review of the
                            requirements for approval of the
                            application imposed after the date on
                            which the application is filed.
                              (V) Agreement with another applicant,
                            the listed drug application holder, or
                            a patent owner.--The first applicant
                            enters into an agreement with another
                            applicant under this subsection for the
                            drug, the holder of the application for
                            the listed drug, or an owner of the
                            patent that is the subject of the
                            certification under paragraph
                            (2)(A)(vii)(IV), the Federal Trade
                            Commission or the Attorney General
                            files a complaint, and there is a final
                            decision of the Federal Trade
                            Commission or the court with regard to
                            the complaint from which no appeal
                            (other than a petition to the Supreme
                            Court for a writ of certiorari) has
                            been or can be taken that the agreement
                            has violated the antitrust laws (as
                            defined in section 1 of the Clayton Act
                            (15 U.S.C. 12), except that the term
                            includes section 5 of the Federal Trade
                            Commission Act (15 U.S.C. 45) to the
                            extent that that section applies to
                            unfair methods of competition).
                              (VI) Expiration of all patents.--All
                            of the patents as to which the
                            applicant submitted a certification
                            qualifying it for the 180-day
                            exclusivity period have expired.
                      (ii) Forfeiture.--The 180-day exclusivity
                    period described in subparagraph (B)(iv) shall
                    be forfeited by a first applicant if a
                    forfeiture event occurs with respect to that
                    first applicant.
                      (iii) Subsequent applicant.--If all first
                    applicants forfeit the 180-day exclusivity
                    period under clause (ii)--
                              (I) approval of any application
                            containing a certification described in
                            paragraph (2)(A)(vii)(IV) shall be made
                            effective in accordance with
                            subparagraph (B)(iii); and
                              (II) no applicant shall be eligible
                            for a 180-day exclusivity period.
                      (iv) Special forfeiture rule for competitive
                    generic therapy.--The 180-day exclusivity
                    period described in subparagraph (B)(v) shall
                    be forfeited by a first approved applicant if
                    the applicant fails to market the competitive
                    generic therapy within 75 days after the date
                    on which the approval of the first approved
                    applicant's application for the competitive
                    generic therapy is made effective.
      (E) If the Secretary decides to disapprove an application,
    the Secretary shall give the applicant notice of an opportunity
    for a hearing before the Secretary on the question of whether
    such application is approvable. If the applicant elects to
    accept the opportunity for hearing by written request within
    thirty days after such notice, such hearing shall commence not
    more than ninety days after the expiration of such thirty days
    unless the Secretary and the applicant otherwise agree. Any
    such hearing shall thereafter be conducted on an expedited
    basis and the Secretary's order thereon shall be issued within
    ninety days after the date fixed by the Secretary for filing
    final briefs.
      (F)
      (ii) If an application submitted under subsection (b) for a
    drug, no active moiety (as defined by the Secretary in section
    314.3 of title 21, Code of Federal Regulations (or any
    successor regulations)) of which has been approved in any other
    application under subsection (b), is approved after the date of
    the enactment of this subsection, no application may be
    submitted under this subsection which refers to the drug for
    which the subsection (b) application was submitted before the
    expiration of five years from the date of the approval of the
    application under subsection (b), except that such an
    application may be submitted under this subsection after the
    expiration of four years from the date of the approval of the
    subsection (b) application if it contains a certification of
    patent invalidity or noninfringement described in subclause
    (IV) of paragraph (2)(A)(vii). The approval of such an
    application shall be made effective in accordance with
    subparagraph (B) except that, if an action for patent
    infringement is commenced during the one-year period beginning
    forty-eight months after the date of the approval of the
    subsection (b) application, the thirty-month period referred to
    in subparagraph (B)(iii) shall be extended by such amount of
    time (if any) which is required for seven and one-half years to
    have elapsed from the date of approval of the subsection (b)
    application.
      (iii) If an application submitted under subsection (b) for a
    drug, which includes an active moiety (as defined by the
    Secretary in section 314.3 of title 21, Code of Federal
    Regulations (or any successor regulations)) that has been
    approved in another application approved under subsection (b),
    is approved after the date of enactment of this subsection and
    if such application contains reports of new clinical
    investigations (other than bioavailability studies) essential
    to the approval of the application and conducted or sponsored
    by the applicant, the Secretary may not make the approval of an
    application submitted under this subsection for the conditions
    of approval of such drug in the subsection (b) application
    effective before the expiration of three years from the date of
    the approval of the application under subsection (b) for such
    drug.
      (iv) If a supplement to an application approved under
    subsection (b) is approved after the date of enactment of this
    subsection and the supplement contains reports of new clinical
    investigations (other than bioavailability studies) essential
    to the approval of the supplement and conducted or sponsored by
    the person submitting the supplement, the Secretary may not
    make the approval of an application submitted under this
    subsection for a change approved in the supplement effective
    before the expiration of three years from the date of the
    approval of the supplement under subsection (b).
      (v) If an application (or supplement to an application)
    submitted under subsection (b) for a drug, which includes an
    active moiety (as defined by the Secretary in section 314.3 of
    title 21, Code of Federal Regulations (or any successor
    regulations)) that has been approved in another application
    under subsection (b), was approved during the period beginning
    January 1, 1982, and ending on the date of the enactment of
    this subsection, the Secretary may not make the approval of an
    application submitted under this subsection which refers to the
    drug for which the subsection (b) application was submitted or
    which refers to a change approved in a supplement to the
    subsection (b) application effective before the expiration of
    two years from the date of enactment of this subsection.
      (6) If a drug approved under this subsection refers in its
    approved application to a drug the approval of which was
    withdrawn or suspended for grounds described in the first
    sentence of subsection (e) or was withdrawn or suspended under
    this paragraph or which, as determined by the Secretary, has
    been withdrawn from sale for safety or effectiveness reasons,
    the approval of the drug under this subsection shall be
    withdrawn or suspended--
              (A) for the same period as the withdrawal or
            suspension under subsection (e) or this paragraph, or
              (B) if the listed drug has been withdrawn from sale,
            for the period of withdrawal from sale or, if earlier,
            the period ending on the date the Secretary determines
            that the withdrawal from sale is not for safety or
            effectiveness reasons.
      (7)(A)(i) Within sixty days of the date of the enactment of
    this subsection, the Secretary shall publish and make available
    to the public--
              (I) a list in alphabetical order of the official and
            proprietary name of each drug which has been approved
            for safety and effectiveness under subsection (c)
            before the date of the enactment of this subsection;
              (II) the date of approval if the drug is approved
            after 1981 and the number of the application which was
            approved; and
              (III) whether in vitro or in vivo bioequivalence
            studies, or both such studies, are required for
            applications filed under this subsection which will
            refer to the drug published.
      (ii) Every thirty days after the publication of the first
    list under clause (i) the Secretary shall revise the list to
    include each drug which has been approved for safety and
    effectiveness under subsection (c) or approved under this
    subsection during the thirty-day period.
      (iii) When patent information submitted under subsection (c)
    respecting a drug included on the list is to be published by
    the Secretary, the Secretary shall, in revisions made under
    clause (ii), include such information for such drug.
      (iv) For each drug included on the list, the Secretary shall
    specify any exclusivity period that is applicable, for which
    the Secretary has determined the expiration date, and for which
    such period has not yet expired, under--
              (I) clause (ii), (iii), or (iv) of subsection
            (c)(3)(E);
              (II) clause (iv) or (v) of paragraph (5)(B);
              (III) clause (ii), (iii), or (iv) of paragraph
            (5)(F);
              (IV) section 505A;
              (V) section 505E;
              (VI) section 527(a); or
              (VII) subsection (u).
      (B) A drug approved for safety and effectiveness under
    subsection (c) or approved under this subsection shall, for
    purposes of this subsection, be considered to have been
    published under subparagraph (A) on the date of its approval or
    the date of enactment, whichever is later.
      (C) If the approval of a drug was withdrawn or suspended for
    grounds described in the first sentence of subsection (e) or
    was withdrawn or suspended under paragraph (6) or if the
    Secretary determines that a drug has been withdrawn from sale
    for safety or effectiveness reasons, it may not be published in
    the list under subparagraph (A) or, if the withdrawal or
    suspension occurred after its publication in such list, it
    shall be immediately removed from such list--
              (i) for the same period as the withdrawal or
            suspension under subsection (e) or paragraph (6), or
              (ii) if the listed drug has been withdrawn from sale,
            for the period of withdrawal from sale or, if earlier,
            the period ending on the date the Secretary determines
            that the withdrawal from sale is not for safety or
            effectiveness reasons.
    A notice of the removal shall be published in the Federal
    Register.
      (D) In the case of a listed drug for which the list under
    subparagraph (A)(i) includes a patent for such drug, and any
    claim of the patent has been cancelled or invalidated pursuant
    to a final decision issued by the Patent Trial and Appeal Board
    of the United States Patent and Trademark Office or by a court,
    from which no appeal has been, or can be, taken, if the holder
    of the applicable application approved under subsection (c)
    determines that a patent for such drug, or any patent
    information for such drug, no longer meets the listing
    requirements under this section--
              (i) the holder of such approved application shall
            notify the Secretary, in writing, within 14 days of
            such decision of such cancellation or invalidation and
            request that such patent or patent information, as
            applicable, be amended or withdrawn in accordance with
            the decision issued by the Patent Trial and Appeal
            Board or a court;
              (ii) the holder of such approved application shall
            include in any notification under clause (i)
            information related to such patent cancellation or
            invalidation decision and submit such information,
            including a copy of such decision, to the Secretary;
            and
              (iii) the Secretary shall, in response to a
            notification under clause (i), amend or remove patent
            or patent information in accordance with the relevant
            decision from the Patent Trial and Appeals Board or
            court, as applicable, except that the Secretary shall
            not remove from the list any patent or patent
            information before the expiration of any 180-day
            exclusivity period under paragraph (5)(B)(iv) that
            relies on a certification described in paragraph
            (2)(A)(vii)(IV).
      (8) For purposes of this subsection:
              (A)(i) The term ``bioavailability'' means the rate
            and extent to which the active ingredient or
            therapeutic ingredient is absorbed from a drug and
            becomes available at the site of drug action.
              (ii) For a drug that is not intended to be absorbed
            into the bloodstream, the Secretary may assess
            bioavailability by scientifically valid measurements
            intended to reflect the rate and extent to which the
            active ingredient or therapeutic ingredient becomes
            available at the site of drug action.
              (B) A drug shall be considered to be bioequivalent to
            a listed drug if--
                      (i) the rate and extent of absorption of the
                    drug do not show a significant difference from
                    the rate and extent of absorption of the listed
                    drug when administered at the same molar dose
                    of the therapeutic ingredient under similar
                    experimental conditions in either a single dose
                    or multiple doses; or
                      (ii) the extent of absorption of the drug
                    does not show a significant difference from the
                    extent of absorption of the listed drug when
                    administered at the same molar dose of the
                    therapeutic ingredient under similar
                    experimental conditions in either a single dose
                    or multiple doses and the difference from the
                    listed drug in the rate of absorption of the
                    drug is intentional, is reflected in its
                    proposed labeling, is not essential to the
                    attainment of effective body drug
                    concentrations on chronic use, and is
                    considered medically insignificant for the
                    drug.
              (C) For a drug that is not intended to be absorbed
            into the bloodstream, the Secretary may establish
            alternative, scientifically valid methods to show
            bioequivalence if the alternative methods are expected
            to detect a significant difference between the drug and
            the listed drug in safety and therapeutic effect.
      (9) The Secretary shall, with respect to each application
    submitted under this subsection, maintain a record of--
              (A) the name of the applicant,
              (B) the name of the drug covered by the application,
              (C) the name of each person to whom the review of the
            chemistry of the application was assigned and the date
            of such assignment, and
              (D) the name of each person to whom the
            bioequivalence review for such application was assigned
            and the date of such assignment.
    The information the Secretary is required to maintain under
    this paragraph with respect to an application submitted under
    this subsection shall be made available to the public after the
    approval of such application.
      (10)(A) If the proposed labeling of a drug that is the
    subject of an application under this subsection differs from
    the listed drug due to a labeling revision described under
    clause (i), the drug that is the subject of such application
    shall, notwithstanding any other provision of this Act, be
    eligible for approval and shall not be considered misbranded
    under section 502 if--
              [(i) the application is otherwise eligible for
            approval under this subsection but for expiration of
            patent, an exclusivity period, or of a delay in
            approval described in paragraph (5)(B)(iii), and a
            revision to the labeling of the listed drug has been
            approved by the Secretary within 60 days of such
            expiration;
              [(ii) the labeling revision described under clause
            (i) does not include a change to the ``Warnings''
            section of the labeling;
              [(iii) the sponsor of the application under this
            subsection agrees to submit revised labeling of the
            drug that is the subject of such application not later
            than 60 days after the notification of any changes to
            such labeling required by the Secretary; and]
              (i) a revision to the labeling of the listed drug has
            been approved by the Secretary within 90 days of when
            the application is otherwise eligible for approval
            under this subsection;
              (ii) the sponsor of the application agrees to submit
            revised labeling for the drug that is the subject of
            the application not later than 60 days after approval
            under this subsection of the application;
              (iii) the labeling revision described under clause
            (i) does not include a change to the ``Warnings''
            section of the labeling; and
              (iv) such application otherwise meets the applicable
            requirements for approval under this subsection.
      (B) If, after a labeling revision described in subparagraph
    (A)(i), the Secretary determines that the continued presence in
    interstate commerce of the labeling of the listed drug (as in
    effect before the revision described in subparagraph (A)(i))
    adversely impacts the safe use of the drug, no application
    under this subsection shall be eligible for approval with such
    labeling.
      (11)(A) Subject to subparagraph (B), the Secretary shall
    prioritize the review of, and act within 8 months of the date
    of the submission of, an original abbreviated new drug
    application submitted for review under this subsection that is
    for a drug--
              (i) for which there are not more than 3 approved drug
            products listed under paragraph (7) and for which there
            are no blocking patents and exclusivities; or
              (ii) that has been included on the list under section
            506E.
      (B) To qualify for priority review under this paragraph, not
    later than 60 days prior to the submission of an application
    described in subparagraph (A) or that the Secretary may
    prioritize pursuant to subparagraph (D), the applicant shall
    provide complete, accurate information regarding facilities
    involved in manufacturing processes and testing of the drug
    that is the subject of the application, including facilities in
    corresponding Type II active pharmaceutical ingredients drug
    master files referenced in an application and sites or
    organizations involved in bioequivalence and clinical studies
    used to support the application, to enable the Secretary to
    make a determination regarding whether an inspection of a
    facility is necessary. Such information shall include the
    relevant (as determined by the Secretary) sections of such
    application, which shall be unchanged relative to the date of
    the submission of such application, except to the extent that a
    change is made to such information to exclude a facility that
    was not used to generate data to meet any application
    requirements for such submission and that is not the only
    facility intended to conduct one or more unit operations in
    commercial production. Information provided by an applicant
    under this subparagraph shall not be considered the submission
    of an application under this subsection.
      (C) The Secretary may expedite an inspection or reinspection
    under section 704 of an establishment that proposes to
    manufacture a drug described in subparagraph (A).
      (D) Nothing in this paragraph shall prevent the Secretary
    from prioritizing the review of other applications as the
    Secretary determines appropriate.
      (12) The Secretary shall publish on the internet website of
    the Food and Drug Administration, and update at least once
    every 6 months, a list of all drugs approved under subsection
    (c) for which all patents and periods of exclusivity under this
    Act have expired and for which no application has been approved
    under this subsection.
      (13) Upon the request of an applicant regarding one or more
    specified pending applications under this subsection, the
    Secretary shall, as appropriate, provide review status updates
    indicating the categorical status of the applications by each
    relevant review discipline.
      (k)(1) In the case of any drug for which an approval of an
    application filed under subsection (b) or (j) is in effect, the
    applicant shall establish and maintain such records, and make
    such reports to the Secretary, of data relating to clinical
    experience and other data or information, received or otherwise
    obtained by such applicant with respect to such drug, as the
    Secretary may by general regulation, or by order with respect
    to such application, prescribe on the basis of a finding that
    such records and reports are necessary in order to enable the
    Secretary to determine, or facilitate a determination, whether
    there is or may be ground for invoking subsection (e) of this
    section. Regulations and orders issued under this subsection
    and under subsection (i) shall have due regard for the
    professional ethics of the medical profession and the interests
    of patients and shall provide, where the Secretary deems it to
    be appropriate, for the examination, upon request, by the
    persons to whom such regulations or orders are applicable, of
    similar information received or otherwise obtained by the
    Secretary.
      (2) Every person required under this section to maintain
    records, and every person in charge or custody thereof, shall,
    upon request of an officer or employee designated by the
    Secretary, permit such officer or employee at all reasonable
    times to have access to and copy and verify such records.
              (3) Active postmarket risk identification.--
                      (A) Definition.--In this paragraph, the term
                    ``data'' refers to information with respect to
                    a drug approved under this section or under
                    section 351 of the Public Health Service Act,
                    including claims data, patient survey data,
                    standardized analytic files that allow for the
                    pooling and analysis of data from disparate
                    data environments, and any other data deemed
                    appropriate by the Secretary.
                      (B) Development of postmarket risk
                    identification and analysis methods.--The
                    Secretary shall, not later than 2 years after
                    the date of the enactment of the Food and Drug
                    Administration Amendments Act of 2007, in
                    collaboration with public, academic, and
                    private entities--
                              (i) develop methods to obtain access
                            to disparate data sources including the
                            data sources specified in subparagraph
                            (C);
                              (ii) develop validated methods for
                            the establishment of a postmarket risk
                            identification and analysis system to
                            link and analyze safety data from
                            multiple sources, with the goals of
                            including, in aggregate--
                                      (I) at least 25,000,000
                                    patients by July 1, 2010; and
                                      (II) at least 100,000,000
                                    patients by July 1, 2012; and
                              (iii) convene a committee of experts,
                            including individuals who are
                            recognized in the field of protecting
                            data privacy and security, to make
                            recommendations to the Secretary on the
                            development of tools and methods for
                            the ethical and scientific uses for,
                            and communication of, postmarketing
                            data specified under subparagraph (C),
                            including recommendations on the
                            development of effective research
                            methods for the study of drug safety
                            questions.
                      (C) Establishment of the postmarket risk
                    identification and analysis system.--
                              (i) In general.--The Secretary shall,
                            not later than 1 year after the
                            development of the risk identification
                            and analysis methods under subparagraph
                            (B), establish and maintain
                            procedures--
                                      (I) for risk identification
                                    and analysis based on
                                    electronic health data, in
                                    compliance with the regulations
                                    promulgated under section
                                    264(c) of the Health Insurance
                                    Portability and Accountability
                                    Act of 1996, and in a manner
                                    that does not disclose
                                    individually identifiable
                                    health information in violation
                                    of paragraph (4)(B);
                                      (II) for the reporting (in a
                                    standardized form) of data on
                                    all serious adverse drug
                                    experiences (as defined in
                                    section 505-1(b)) submitted to
                                    the Secretary under paragraph
                                    (1), and those adverse events
                                    submitted by patients,
                                    providers, and drug sponsors,
                                    when appropriate;
                                      (III) to provide for active
                                    adverse event surveillance
                                    using the following data
                                    sources, as available:
                                              (aa) Federal health-
                                            related electronic data
                                            (such as data from the
                                            Medicare program and
                                            the health systems of
                                            the Department of
                                            Veterans Affairs);
                                              (bb) private sector
                                            health-related
                                            electronic data (such
                                            as pharmaceutical
                                            purchase data and
                                            health insurance claims
                                            data); and
                                              (cc) other data as
                                            the Secretary deems
                                            necessary to create a
                                            robust system to
                                            identify adverse events
                                            and potential drug
                                            safety signals;
                                      (IV) to identify certain
                                    trends and patterns with
                                    respect to data accessed by the
                                    system;
                                      (V) to provide regular
                                    reports to the Secretary
                                    concerning adverse event
                                    trends, adverse event patterns,
                                    incidence and prevalence of
                                    adverse events, and other
                                    information the Secretary
                                    determines appropriate, which
                                    may include data on comparative
                                    national adverse event trends;
                                    and
                                      (VI) to enable the program to
                                    export data in a form
                                    appropriate for further
                                    aggregation, statistical
                                    analysis, and reporting.
                              (ii) Timeliness of reporting.--The
                            procedures established under clause (i)
                            shall ensure that such data are
                            accessed, analyzed, and reported in a
                            timely, routine, and systematic manner,
                            taking into consideration the need for
                            data completeness, coding, cleansing,
                            and standardized analysis and
                            transmission.
                              (iii) Private sector resources.--To
                            ensure the establishment of the active
                            postmarket risk identification and
                            analysis system under this subsection
                            not later than 1 year after the
                            development of the risk identification
                            and analysis methods under subparagraph
                            (B), as required under clause (i), the
                            Secretary may, on a temporary or
                            permanent basis, implement systems or
                            products developed by private entities.
                              (iv) Complementary approaches.--To
                            the extent the active postmarket risk
                            identification and analysis system
                            under this subsection is not sufficient
                            to gather data and information relevant
                            to a priority drug safety question, the
                            Secretary shall develop, support, and
                            participate in complementary approaches
                            to gather and analyze such data and
                            information, including--
                                      (I) approaches that are
                                    complementary with respect to
                                    assessing the safety of use of
                                    a drug in domestic populations
                                    not included, or
                                    underrepresented, in the trials
                                    used to approve the drug (such
                                    as older people, people with
                                    comorbidities, pregnant women,
                                    or children); and
                                      (II) existing approaches such
                                    as the Vaccine Adverse Event
                                    Reporting System and the
                                    Vaccine Safety Datalink or
                                    successor databases.
                              (v) Authority for contracts.--The
                            Secretary may enter into contracts with
                            public and private entities to fulfill
                            the requirements of this subparagraph.
              (4) Advanced analysis of drug safety data.--
                      (A) Purpose.--The Secretary shall establish
                    collaborations with public, academic, and
                    private entities, which may include the Centers
                    for Education and Research on Therapeutics
                    under section 912 of the Public Health Service
                    Act, to provide for advanced analysis of drug
                    safety data described in paragraph (3)(C) and
                    other information that is publicly available or
                    is provided by the Secretary, in order to--
                              (i) improve the quality and
                            efficiency of postmarket drug safety
                            risk-benefit analysis;
                              (ii) provide the Secretary with
                            routine access to outside expertise to
                            study advanced drug safety questions;
                            and
                              (iii) enhance the ability of the
                            Secretary to make timely assessments
                            based on drug safety data.
                      (B) Privacy.--Such analysis shall not
                    disclose individually identifiable health
                    information when presenting such drug safety
                    signals and trends or when responding to
                    inquiries regarding such drug safety signals
                    and trends.
                      (C) Public process for priority questions.--
                    At least biannually, the Secretary shall seek
                    recommendations from the Drug Safety and Risk
                    Management Advisory Committee (or any successor
                    committee) and from other advisory committees,
                    as appropriate, to the Food and Drug
                    Administration on--
                              (i) priority drug safety questions;
                            and
                              (ii) mechanisms for answering such
                            questions, including through--
                                      (I) active risk
                                    identification under paragraph
                                    (3); and
                                      (II) when such risk
                                    identification is not
                                    sufficient, postapproval
                                    studies and clinical trials
                                    under subsection (o)(3).
                      (D) Procedures for the development of drug
                    safety collaborations.--
                              (i) In general.--Not later than 180
                            days after the date of the
                            establishment of the active postmarket
                            risk identification and analysis system
                            under this subsection, the Secretary
                            shall establish and implement
                            procedures under which the Secretary
                            may routinely contract with one or more
                            qualified entities to--
                                      (I) classify, analyze, or
                                    aggregate data described in
                                    paragraph (3)(C) and
                                    information that is publicly
                                    available or is provided by the
                                    Secretary;
                                      (II) allow for prompt
                                    investigation of priority drug
                                    safety questions, including--
                                              (aa) unresolved
                                            safety questions for
                                            drugs or classes of
                                            drugs; and
                                              (bb) for a newly-
                                            approved drugs, safety
                                            signals from clinical
                                            trials used to approve
                                            the drug and other
                                            preapproval trials;
                                            rare, serious drug side
                                            effects; and the safety
                                            of use in domestic
                                            populations not
                                            included, or
                                            underrepresented, in
                                            the trials used to
                                            approve the drug (such
                                            as older people, people
                                            with comorbidities,
                                            pregnant women, or
                                            children);
                                      (III) perform advanced
                                    research and analysis on
                                    identified drug safety risks;
                                      (IV) focus postapproval
                                    studies and clinical trials
                                    under subsection (o)(3) more
                                    effectively on cases for which
                                    reports under paragraph (1) and
                                    other safety signal detection
                                    is not sufficient to resolve
                                    whether there is an elevated
                                    risk of a serious adverse event
                                    associated with the use of a
                                    drug; and
                                      (V) carry out other
                                    activities as the Secretary
                                    deems necessary to carry out
                                    the purposes of this paragraph.
                              (ii) Request for specific
                            methodology.--The procedures described
                            in clause (i) shall permit the
                            Secretary to request that a specific
                            methodology be used by the qualified
                            entity. The qualified entity shall work
                            with the Secretary to finalize the
                            methodology to be used.
                      (E) Use of analyses.--The Secretary shall
                    provide the analyses described in this
                    paragraph, including the methods and results of
                    such analyses, about a drug to the sponsor or
                    sponsors of such drug.
                      (F) Qualified entities.--
                              (i) In general.--The Secretary shall
                            enter into contracts with a sufficient
                            number of qualified entities to develop
                            and provide information to the
                            Secretary in a timely manner.
                              (ii) Qualification.--The Secretary
                            shall enter into a contract with an
                            entity under clause (i) only if the
                            Secretary determines that the entity
                            has a significant presence in the
                            United States and has one or more of
                            the following qualifications:
                                      (I) The research,
                                    statistical, epidemiologic, or
                                    clinical capability and
                                    expertise to conduct and
                                    complete the activities under
                                    this paragraph, including the
                                    capability and expertise to
                                    provide the Secretary de-
                                    identified data consistent with
                                    the requirements of this
                                    subsection.
                                      (II) An information
                                    technology infrastructure in
                                    place to support electronic
                                    data and operational standards
                                    to provide security for such
                                    data.
                                      (III) Experience with, and
                                    expertise on, the development
                                    of drug safety and
                                    effectiveness research using
                                    electronic population data.
                                      (IV) An understanding of drug
                                    development or risk/benefit
                                    balancing in a clinical
                                    setting.
                                      (V) Other expertise which the
                                    Secretary deems necessary to
                                    fulfill the activities under
                                    this paragraph.
                      (G) Contract requirements.--Each contract
                    with a qualified entity under subparagraph
                    (F)(i) shall contain the following
                    requirements:
                              (i) Ensuring privacy.--The qualified
                            entity shall ensure that the entity
                            will not use data under this subsection
                            in a manner that--
                                      (I) violates the regulations
                                    promulgated under section
                                    264(c) of the Health Insurance
                                    Portability and Accountability
                                    Act of 1996;
                                      (II) violates sections 552 or
                                    552a of title 5, United States
                                    Code, with regard to the
                                    privacy of individually-
                                    identifiable beneficiary health
                                    information; or
                                      (III) discloses individually
                                    identifiable health information
                                    when presenting drug safety
                                    signals and trends or when
                                    responding to inquiries
                                    regarding drug safety signals
                                    and trends.
                            Nothing in this clause prohibits lawful
                            disclosure for other purposes.
                              (ii) Component of another
                            organization.--If a qualified entity is
                            a component of another organization--
                                      (I) the qualified entity
                                    shall establish appropriate
                                    security measures to maintain
                                    the confidentiality and privacy
                                    of such data; and
                                      (II) the entity shall not
                                    make an unauthorized disclosure
                                    of such data to the other
                                    components of the organization
                                    in breach of such
                                    confidentiality and privacy
                                    requirement.
                              (iii) Termination or nonrenewal.--If
                            a contract with a qualified entity
                            under this subparagraph is terminated
                            or not renewed, the following
                            requirements shall apply:
                                      (I) Confidentiality and
                                    privacy protections.--The
                                    entity shall continue to comply
                                    with the confidentiality and
                                    privacy requirements under this
                                    paragraph with respect to all
                                    data disclosed to the entity.
                                      (II) Disposition of data.--
                                    The entity shall return any
                                    data disclosed to such entity
                                    under this subsection to which
                                    it would not otherwise have
                                    access or, if returning the
                                    data is not practicable,
                                    destroy the data.
                      (H) Competitive procedures.--The Secretary
                    shall use competitive procedures (as defined in
                    section 4(5) of the Federal Procurement Policy
                    Act) to enter into contracts under subparagraph
                    (G).
                      (I) Review of contract in the event of a
                    merger or acquisition.--The Secretary shall
                    review the contract with a qualified entity
                    under this paragraph in the event of a merger
                    or acquisition of the entity in order to ensure
                    that the requirements under this paragraph will
                    continue to be met.
                      (J) Coordination.--In carrying out this
                    paragraph, the Secretary shall provide for
                    appropriate communications to the public,
                    scientific, public health, and medical
                    communities, and other key stakeholders, and to
                    the extent practicable shall coordinate with
                    the activities of private entities,
                    professional associations, or other entities
                    that may have sources of drug safety data.
              (5) The Secretary shall--
                      (A) conduct regular screenings of the Adverse
                    Event Reporting System database and post a
                    quarterly report on the Adverse Event Reporting
                    System Web site of any new safety information
                    or potential signal of a serious risk
                    identified by Adverse Event Reporting System
                    within the last quarter; and
                      (B) on an annual basis, review the entire
                    backlog of postmarket safety commitments to
                    determine which commitments require revision or
                    should be eliminated, report to the Congress on
                    these determinations, and assign start dates
                    and estimated completion dates for such
                    commitments; and
              (C) make available on the Internet website of the
            Food and Drug Administration--
                      (i) guidelines, developed with input from
                    experts qualified by scientific training and
                    experience to evaluate the safety and
                    effectiveness of drugs, that detail best
                    practices for drug safety surveillance using
                    the Adverse Event Reporting System; and
                      (ii) criteria for public posting of adverse
                    event signals.
      (l)(1) Safety and effectiveness data and information which
    has been submitted in an application under subsection (b) for a
    drug and which has not previously been disclosed to the public
    shall be made available to the public, upon request, unless
    extraordinary circumstances are shown--
              (A) if no work is being or will be undertaken to have
            the application approved,
              (B) if the Secretary has determined that the
            application is not approvable and all legal appeals
            have been exhausted,
              (C) if approval of the application under subsection
            (c) is withdrawn and all legal appeals have been
            exhausted,
              (D) if the Secretary has determined that such drug is
            not a new drug, or
              (E) upon the effective date of the approval of the
            first application under subsection (j) which refers to
            such drug or upon the date upon which the approval of
            an application under subsection (j) which refers to
            such drug could be made effective if such an
            application had been submitted.
      (2) Action Package for Approval.--
              (A) Action package.--The Secretary shall publish the
            action package for approval of an application under
            subsection (b) or section 351 of the Public Health
            Service Act on the Internet Web site of the Food and
            Drug Administration--
                      (i) not later than 30 days after the date of
                    approval of such applications--
                              (I) for a drug, no active moiety (as
                            defined by the Secretary in section
                            314.3 of title 21, Code of Federal
                            Regulations (or any successor
                            regulations)) of which has been
                            approved in any other application under
                            this section; or
                              (II) for a biological product, no
                            active ingredient of which has been
                            approved in any other application under
                            section 351 of the Public Health
                            Service Act; and
                      (ii) not later than 30 days after the third
                    request for such action package for approval
                    received under section 552 of title 5, United
                    States Code, for any other drug or biological
                    product.
              (B) Immediate publication of summary review.--
            Notwithstanding subparagraph (A), the Secretary shall
            publish, on the Internet Web site of the Food and Drug
            Administration, the materials described in subparagraph
            (C)(iv) not later than 48 hours after the date of
            approval of the drug, except where such materials
            require redaction by the Secretary.
              (C) Contents.--An action package for approval of an
            application under subparagraph (A) shall be dated and
            shall include the following:
                      (i) Documents generated by the Food and Drug
                    Administration related to review of the
                    application.
                      (ii) Documents pertaining to the format and
                    content of the application generated during
                    drug development.
                      (iii) Labeling submitted by the applicant.
                      (iv) A summary review that documents
                    conclusions from all reviewing disciplines
                    about the drug, noting any critical issues and
                    disagreements with the applicant and within the
                    review team and how they were resolved,
                    recommendations for action, and an explanation
                    of any nonconcurrence with review conclusions.
                      (v) The Division Director and Office
                    Director's decision document which includes--
                              (I) a brief statement of concurrence
                            with the summary review;
                              (II) a separate review or addendum to
                            the review if disagreeing with the
                            summary review; and
                              (III) a separate review or addendum
                            to the review to add further analysis.
                      (vi) Identification by name of each officer
                    or employee of the Food and Drug Administration
                    who--
                              (I) participated in the decision to
                            approve the application; and
                              (II) consents to have his or her name
                            included in the package.
              (D) Review.--A scientific review of an application is
            considered the work of the reviewer and shall not be
            altered by management or the reviewer once final.
              (E) Confidential information.--This paragraph does
            not authorize the disclosure of any trade secret,
            confidential commercial or financial information, or
            other matter listed in section 552(b) of title 5,
            United States Code.
      (m) For purposes of this section, the term ``patent'' means a
    patent issued by the United States Patent and Trademark Office.
      (n)(1) For the purpose of providing expert scientific advice
    and recommendations to the Secretary regarding a clinical
    investigation of a drug or the approval for marketing of a drug
    under section 505 or section 351 of the Public Health Service
    Act, the Secretary shall establish panels of experts or use
    panels of experts established before the date of enactment of
    the Food and Drug Administration Modernization Act of 1997, or
    both.
      (2) The Secretary may delegate the appointment and oversight
    authority granted under section 1004 to a director of a center
    or successor entity within the Food and Drug Administration.
      (3) The Secretary shall make appointments to each panel
    established under paragraph (1) so that each panel shall
    consist of--
              (A) members who are qualified by training and
            experience to evaluate the safety and effectiveness of
            the drugs to be referred to the panel and who, to the
            extent feasible, possess skill and experience in the
            development, manufacture, or utilization of such drugs;
              (B) members with diverse expertise in such fields as
            clinical and administrative medicine, pharmacy,
            pharmacology, pharmacoeconomics, biological and
            physical sciences, and other related professions;
              (C) a representative of consumer interests, and a
            representative of interests of the drug manufacturing
            industry not directly affected by the matter to be
            brought before the panel; and
              (D) two or more members who are specialists or have
            other expertise in the particular disease or condition
            for which the drug under review is proposed to be
            indicated.
    Scientific, trade, and consumer organizations shall be afforded
    an opportunity to nominate individuals for appointment to the
    panels. No individual who is in the regular full-time employ of
    the United States and engaged in the administration of this Act
    may be a voting member of any panel. The Secretary shall
    designate one of the members of each panel to serve as chairman
    thereof.
      (4) The Secretary shall, as appropriate, provide education
    and training to each new panel member before such member
    participates in a panel's activities, including education
    regarding requirements under this Act and related regulations
    of the Secretary, and the administrative processes and
    procedures related to panel meetings.
      (5) Panel members (other than officers or employees of the
    United States), while attending meetings or conferences of a
    panel or otherwise engaged in its business, shall be entitled
    to receive compensation for each day so engaged, including
    traveltime, at rates to be fixed by the Secretary, but not to
    exceed the daily equivalent of the rate in effect for positions
    classified above grade GS-15 of the General Schedule. While
    serving away from their homes or regular places of business,
    panel members may be allowed travel expenses (including per
    diem in lieu of subsistence) as authorized by section 5703 of
    title 5, United States Code, for persons in the Government
    service employed intermittently.
      (6) The Secretary shall ensure that scientific advisory
    panels meet regularly and at appropriate intervals so that any
    matter to be reviewed by such a panel can be presented to the
    panel not more than 60 days after the matter is ready for such
    review. Meetings of the panel may be held using electronic
    communication to convene the meetings.
      (7) Within 90 days after a scientific advisory panel makes
    recommendations on any matter under its review, the Food and
    Drug Administration official responsible for the matter shall
    review the conclusions and recommendations of the panel, and
    notify the affected persons of the final decision on the
    matter, or of the reasons that no such decision has been
    reached. Each such final decision shall be documented including
    the rationale for the decision.
      (o) Postmarket Studies and Clinical Trials; Labeling.--
              (1) In general.--A responsible person may not
            introduce or deliver for introduction into interstate
            commerce the new drug involved if the person is in
            violation of a requirement established under paragraph
            (3) or (4) with respect to the drug.
              (2) Definitions.--For purposes of this subsection:
                      (A) Responsible person.--The term
                    ``responsible person'' means a person who--
                              (i) has submitted to the Secretary a
                            covered application that is pending; or
                              (ii) is the holder of an approved
                            covered application.
                      (B) Covered application.--The term ``covered
                    application'' means--
                              (i) an application under subsection
                            (b) for a drug that is subject to
                            section 503(b); and
                              (ii) an application under section 351
                            of the Public Health Service Act.
                      (C) New safety information; serious risk.--
                    The terms ``new safety information'', ``serious
                    risk'', and ``signal of a serious risk'' have
                    the meanings given such terms in section 505-
                    1(b).
              (3) Studies and clinical trials.--
                      (A) In general.--For any or all of the
                    purposes specified in subparagraph (B), the
                    Secretary may, subject to subparagraph (D),
                    require a responsible person for a drug to
                    conduct a postapproval study or studies of the
                    drug, or a postapproval clinical trial or
                    trials of the drug, on the basis of scientific
                    data deemed appropriate by the Secretary,
                    including information regarding chemically-
                    related or pharmacologically-related drugs.
                      (B) Purposes of study or clinical trial.--The
                    purposes referred to in this subparagraph with
                    respect to a postapproval study or postapproval
                    clinical trial are the following:
                              (i) To assess a known serious risk
                            related to the use of the drug
                            involved.
                              (ii) To assess signals of serious
                            risk related to the use of the drug.
                              (iii) To identify an unexpected
                            serious risk when available data
                            indicates the potential for a serious
                            risk.
                      (C) Establishment of requirement after
                    approval of covered application.--The Secretary
                    may require a postapproval study or studies or
                    postapproval clinical trial or trials for a
                    drug for which an approved covered application
                    is in effect as of the date on which the
                    Secretary seeks to establish such requirement
                    only if the Secretary becomes aware of new
                    safety information.
                      (D) Determination by secretary.--
                              (i) Postapproval studies.--The
                            Secretary may not require the
                            responsible person to conduct a study
                            under this paragraph, unless the
                            Secretary makes a determination that
                            the reports under subsection (k)(1) and
                            the active postmarket risk
                            identification and analysis system as
                            available under subsection (k)(3) will
                            not be sufficient to meet the purposes
                            set forth in subparagraph (B).
                              (ii) Postapproval clinical trials.--
                            The Secretary may not require the
                            responsible person to conduct a
                            clinical trial under this paragraph,
                            unless the Secretary makes a
                            determination that a postapproval study
                            or studies will not be sufficient to
                            meet the purposes set forth in
                            subparagraph (B).
                      (E) Notification; timetables; periodic
                    reports.--
                              (i) Notification.--The Secretary
                            shall notify the responsible person
                            regarding a requirement under this
                            paragraph to conduct a postapproval
                            study or clinical trial by the target
                            dates for communication of feedback
                            from the review team to the responsible
                            person regarding proposed labeling and
                            postmarketing study commitments as set
                            forth in the letters described in
                            section 101(c) of the Food and Drug
                            Administration Amendments Act of 2007.
                              (ii) Timetable; periodic reports.--
                            For each study or clinical trial
                            required to be conducted under this
                            paragraph, the Secretary shall require
                            that the responsible person submit a
                            timetable for completion of the study
                            or clinical trial. With respect to each
                            study required to be conducted under
                            this paragraph or otherwise undertaken
                            by the responsible person to
                            investigate a safety issue, the
                            Secretary shall require the responsible
                            person to periodically report to the
                            Secretary on the status of such study
                            including whether any difficulties in
                            completing the study have been
                            encountered. With respect to each
                            clinical trial required to be conducted
                            under this paragraph or otherwise
                            undertaken by the responsible person to
                            investigate a safety issue, the
                            Secretary shall require the responsible
                            person to periodically report to the
                            Secretary on the status of such
                            clinical trial including whether
                            enrollment has begun, the number of
                            participants enrolled, the expected
                            completion date, whether any
                            difficulties completing the clinical
                            trial have been encountered, and
                            registration information with respect
                            to the requirements under section
                            402(j) of the Public Health Service
                            Act. If the responsible person fails to
                            comply with such timetable or violates
                            any other requirement of this
                            subparagraph, the responsible person
                            shall be considered in violation of
                            this subsection, unless the responsible
                            person demonstrates good cause for such
                            noncompliance or such other violation.
                            The Secretary shall determine what
                            constitutes good cause under the
                            preceding sentence.
                      (F) Dispute resolution.--The responsible
                    person may appeal a requirement to conduct a
                    study or clinical trial under this paragraph
                    using dispute resolution procedures established
                    by the Secretary in regulation and guidance.
              (4) Safety labeling changes requested by secretary.--
                      (A) New safety or new effectiveness
                    information.--If the Secretary becomes aware of
                    new information, including any new safety
                    information or information related to reduced
                    effectiveness, that the Secretary determines
                    should be included in the labeling of the drug,
                    the Secretary shall promptly notify the
                    responsible person or, if the same drug
                    approved under section 505(b) is not currently
                    marketed, the holder of an approved application
                    under 505(j).
                      (B) Response to notification.--Following
                    notification pursuant to subparagraph (A), the
                    responsible person or the holder of the
                    approved application under section 505(j) shall
                    within 30 days--
                              (i) submit a supplement proposing
                            changes to the approved labeling to
                            reflect the new safety information,
                            including changes to boxed warnings,
                            contraindications, warnings,
                            precautions, or adverse reactions, or
                            new effectiveness information; or
                              (ii) notify the Secretary that the
                            responsible person or the holder of the
                            approved application under section
                            505(j) does not believe a labeling
                            change is warranted and submit a
                            statement detailing the reasons why
                            such a change is not warranted.
                      (C) Review.--Upon receipt of such supplement,
                    the Secretary shall promptly review and act
                    upon such supplement. If the Secretary
                    disagrees with the proposed changes in the
                    supplement or with the statement setting forth
                    the reasons why no labeling change is
                    necessary, the Secretary shall initiate
                    discussions to reach agreement on whether the
                    labeling for the drug should be modified to
                    reflect the new safety or new effectiveness
                    information, and if so, the contents of such
                    labeling changes.
                      (D) Discussions.--Such discussions shall not
                    extend for more than 30 days after the response
                    to the notification under subparagraph (B),
                    unless the Secretary determines an extension of
                    such discussion period is warranted.
                      (E) Order.--Within 15 days of the conclusion
                    of the discussions under subparagraph (D), the
                    Secretary may issue an order directing the
                    responsible person or the holder of the
                    approved application under section 505(j) to
                    make such a labeling change as the Secretary
                    deems appropriate to address the new safety or
                    new effectiveness information. Within 15 days
                    of such an order, the responsible person or the
                    holder of the approved application under
                    section 505(j) shall submit a supplement
                    containing the labeling change.
                      (F) Dispute resolution.--Within 5 days of
                    receiving an order under subparagraph (E), the
                    responsible person or the holder of the
                    approved application under section 505(j) may
                    appeal using dispute resolution procedures
                    established by the Secretary in regulation and
                    guidance.
                      (G) Violation.--If the responsible person or
                    the holder of the approved application under
                    section 505(j) has not submitted a supplement
                    within 15 days of the date of such order under
                    subparagraph (E), and there is no appeal or
                    dispute resolution proceeding pending, the
                    responsible person or holder shall be
                    considered to be in violation of this
                    subsection. If at the conclusion of any dispute
                    resolution procedures the Secretary determines
                    that a supplement must be submitted and such a
                    supplement is not submitted within 15 days of
                    the date of that determination, the responsible
                    person or holder shall be in violation of this
                    subsection.
                      (H) Public health threat.--Notwithstanding
                    subparagraphs (A) through (F), if the Secretary
                    concludes that such a labeling change is
                    necessary to protect the public health, the
                    Secretary may accelerate the timelines in such
                    subparagraphs.
                      (I) Rule of construction.--This paragraph
                    shall not be construed to affect the
                    responsibility of the responsible person or the
                    holder of the approved application under
                    section 505(j) to maintain its label in
                    accordance with existing requirements,
                    including subpart B of part 201 and sections
                    314.70 and 601.12 of title 21, Code of Federal
                    Regulations (or any successor regulations).
              (5) Non-delegation.--Determinations by the Secretary
            under this subsection for a drug shall be made by
            individuals at or above the level of individuals
            empowered to approve a drug (such as division directors
            within the Center for Drug Evaluation and Research).
      (p) Risk Evaluation and Mitigation Strategy.--
              (1) In general.--A person may not introduce or
            deliver for introduction into interstate commerce a new
            drug if--
                      (A)(i) the application for such drug is
                    approved under subsection (b) or (j) and is
                    subject to section 503(b); or
                      (ii) the application for such drug is
                    approved under section 351 of the Public Health
                    Service Act; and
                      (B) a risk evaluation and mitigation strategy
                    is required under section 505-1 with respect to
                    the drug and the person fails to maintain
                    compliance with the requirements of the
                    approved strategy or with other requirements
                    under section 505-1, including requirements
                    regarding assessments of approved strategies.
              (2) Certain postmarket studies.--The failure to
            conduct a postmarket study under section 506, subpart H
            of part 314, or subpart E of part 601 of title 21, Code
            of Federal Regulations (or any successor regulations),
            is deemed to be a violation of paragraph (1).
      (q) Petitions and Civil Actions Regarding Approval of Certain
    Applications.--
              (1) In general.--
                      (A) Determination.--The Secretary shall not
                    delay approval of a pending application
                    submitted under subsection (b)(2) or (j) of
                    this section or section 351(k) of the Public
                    Health Service Act because of any request to
                    take any form of action relating to the
                    application, either before or during
                    consideration of the request, unless--
                              (i) the request is in writing and is
                            a petition submitted to the Secretary
                            pursuant to section 10.30 or 10.35 of
                            title 21, Code of Federal Regulations
                            (or any successor regulations); and
                              (ii) the Secretary determines, upon
                            reviewing the petition, that a delay is
                            necessary to protect the public health.
                    Consideration of the petition shall be separate
                    and apart from review and approval of any
                    application.
                      (B) Notification.--If the Secretary
                    determines under subparagraph (A) that a delay
                    is necessary with respect to an application,
                    the Secretary shall provide to the applicant,
                    not later than 30 days after making such
                    determination, the following information:
                              (i) Notification of the fact that a
                            determination under subparagraph (A)
                            has been made.
                              (ii) If applicable, any clarification
                            or additional data that the applicant
                            should submit to the docket on the
                            petition to allow the Secretary to
                            review the petition promptly.
                              (iii) A brief summary of the specific
                            substantive issues raised in the
                            petition which form the basis of the
                            determination.
                      (C) Format.--The information described in
                    subparagraph (B) shall be conveyed via either,
                    at the discretion of the Secretary--
                              (i) a document; or
                              (ii) a meeting with the applicant
                            involved.
                      (D) Public disclosure.--Any information
                    conveyed by the Secretary under subparagraph
                    (C) shall be considered part of the application
                    and shall be subject to the disclosure
                    requirements applicable to information in such
                    application.
                      (E) Denial based on intent to delay.--If the
                    Secretary determines that a petition or a
                    supplement to the petition was submitted with
                    the primary purpose of delaying the approval of
                    an application and the petition does not on its
                    face raise valid scientific or regulatory
                    issues, the Secretary may deny the petition at
                    any point based on such determination. The
                    Secretary may issue guidance to describe the
                    factors that will be used to determine under
                    this subparagraph whether a petition is
                    submitted with the primary purpose of delaying
                    the approval of an application.
                      (F) Final agency action.--The Secretary shall
                    take final agency action on a petition not
                    later than 150 days after the date on which the
                    petition is submitted. The Secretary shall not
                    extend such period for any reason, including--
                              (i) any determination made under
                            subparagraph (A);
                              (ii) the submission of comments
                            relating to the petition or
                            supplemental information supplied by
                            the petitioner; or
                              (iii) the consent of the petitioner.
                      (G) Extension of 30-month period.--If the
                    filing of an application resulted in first-
                    applicant status under subsection
                    (j)(5)(D)(i)(IV) and approval of the
                    application was delayed because of a petition,
                    the 30-month period under such subsection is
                    deemed to be extended by a period of time equal
                    to the period beginning on the date on which
                    the Secretary received the petition and ending
                    on the date of final agency action on the
                    petition (inclusive of such beginning and
                    ending dates), without regard to whether the
                    Secretary grants, in whole or in part, or
                    denies, in whole or in part, the petition.
                      (H) Certification.--The Secretary shall not
                    consider a petition for review unless the party
                    submitting such petition does so in written
                    form and the subject document is signed and
                    contains the following certification: ``I
                    certify that, to my best knowledge and belief:
                    (a) this petition includes all information and
                    views upon which the petition relies; (b) this
                    petition includes representative data and/or
                    information known to the petitioner which are
                    unfavorable to the petition; and (c) I have
                    taken reasonable steps to ensure that any
                    representative data and/or information which
                    are unfavorable to the petition were disclosed
                    to me. I further certify that the information
                    upon which I have based the action requested
                    herein first became known to the party on whose
                    behalf this petition is submitted on or about
                    the following date: __________. If I received
                    or expect to receive payments, including cash
                    and other forms of consideration, to file this
                    information or its contents, I received or
                    expect to receive those payments from the
                    following persons or organizations:
                    _____________. I verify under penalty of
                    perjury that the foregoing is true and correct
                    as of the date of the submission of this
                    petition.'', with the date on which such
                    information first became known to such party
                    and the names of such persons or organizations
                    inserted in the first and second blank space,
                    respectively.
                      (I) Verification.--The Secretary shall not
                    accept for review any supplemental information
                    or comments on a petition unless the party
                    submitting such information or comments does so
                    in written form and the subject document is
                    signed and contains the following verification:
                    ``I certify that, to my best knowledge and
                    belief: (a) I have not intentionally delayed
                    submission of this document or its contents;
                    and (b) the information upon which I have based
                    the action requested herein first became known
                    to me on or about __________. If I received or
                    expect to receive payments, including cash and
                    other forms of consideration, to file this
                    information or its contents, I received or
                    expect to receive those payments from the
                    following persons or organizations: _____. I
                    verify under penalty of perjury that the
                    foregoing is true and correct as of the date of
                    the submission of this petition.'', with the
                    date on which such information first became
                    known to the party and the names of such
                    persons or organizations inserted in the first
                    and second blank space, respectively.
              (2) Exhaustion of administrative remedies.--
                      (A) Final agency action within 150 days.--The
                    Secretary shall be considered to have taken
                    final agency action on a petition if--
                              (i) during the 150-day period
                            referred to in paragraph (1)(F), the
                            Secretary makes a final decision within
                            the meaning of section 10.45(d) of
                            title 21, Code of Federal Regulations
                            (or any successor regulation); or
                              (ii) such period expires without the
                            Secretary having made such a final
                            decision.
                      (B) Dismissal of certain civil actions.--If a
                    civil action is filed against the Secretary
                    with respect to any issue raised in the
                    petition before the Secretary has taken final
                    agency action on the petition within the
                    meaning of subparagraph (A), the court shall
                    dismiss without prejudice the action for
                    failure to exhaust administrative remedies.
                      (C) Administrative record.--For purposes of
                    judicial review related to the approval of an
                    application for which a petition under
                    paragraph (1) was submitted, the administrative
                    record regarding any issue raised by the
                    petition shall include--
                              (i) the petition filed under
                            paragraph (1) and any supplements and
                            comments thereto;
                              (ii) the Secretary's response to such
                            petition, if issued; and
                              (iii) other information, as
                            designated by the Secretary, related to
                            the Secretary's determinations
                            regarding the issues raised in such
                            petition, as long as the information
                            was considered by the agency no later
                            than the date of final agency action as
                            defined under subparagraph (2)(A), and
                            regardless of whether the Secretary
                            responded to the petition at or before
                            the approval of the application at
                            issue in the petition.
              (3) Annual report on delays in approvals per
            petitions.--The Secretary shall annually submit to the
            Congress a report that specifies--
                      (A) the number of applications that were
                    approved during the preceding 12-month period;
                      (B) the number of such applications whose
                    effective dates were delayed by petitions
                    referred to in paragraph (1) during such
                    period;
                      (C) the number of days by which such
                    applications were so delayed; and
                      (D) the number of such petitions that were
                    submitted during such period.
              (4) Exceptions.--
                      (A) This subsection does not apply to--
                              (i) a petition that relates solely to
                            the timing of the approval of an
                            application pursuant to subsection
                            (j)(5)(B)(iv); or
                              (ii) a petition that is made by the
                            sponsor of an application and that
                            seeks only to have the Secretary take
                            or refrain from taking any form of
                            action with respect to that
                            application.
                      (B) Paragraph (2) does not apply to a
                    petition addressing issues concerning an
                    application submitted pursuant to section
                    351(k) of the Public Health Service Act.
              (5) Definitions.--
                      (A) Application.--For purposes of this
                    subsection, the term ``application'' means an
                    application submitted under subsection (b)(2)
                    or (j) of this section or section 351(k) of the
                    Public Health Service Act.
                      (B) Petition.--For purposes of this
                    subsection, other than paragraph (1)(A)(i), the
                    term ``petition'' means a request described in
                    paragraph (1)(A)(i).
      (r) Postmarket Drug Safety Information for Patients and
    Providers.--
              (1) Establishment.--Not later than 1 year after the
            date of the enactment of the Food and Drug
            Administration Amendments Act of 2007, the Secretary
            shall improve the transparency of information about
            drugs and allow patients and health care providers
            better access to information about drugs by developing
            and maintaining an Internet Web site that--
                      (A) provides links to drug safety information
                    listed in paragraph (2) for prescription drugs
                    that are approved under this section or
                    licensed under section 351 of the Public Health
                    Service Act; and
                      (B) improves communication of drug safety
                    information to patients and providers.
              (2) Internet web site.--The Secretary shall carry out
            paragraph (1) by--
                      (A) developing and maintaining an accessible,
                    consolidated Internet Web site with easily
                    searchable drug safety information, including
                    the information found on United States
                    Government Internet Web sites, such as the
                    United States National Library of Medicine's
                    Daily Med and Medline Plus Web sites, in
                    addition to other such Web sites maintained by
                    the Secretary;
                      (B) ensuring that the information provided on
                    the Internet Web site is comprehensive and
                    includes, when available and appropriate--
                              (i) patient labeling and patient
                            packaging inserts;
                              (ii) a link to a list of each drug,
                            whether approved under this section or
                            licensed under such section 351, for
                            which a Medication Guide, as provided
                            for under part 208 of title 21, Code of
                            Federal Regulations (or any successor
                            regulations), is required;
                              (iii) a link to the registry and
                            results data bank provided for under
                            subsections (i) and (j) of section 402
                            of the Public Health Service Act;
                              (iv) the most recent safety
                            information and alerts issued by the
                            Food and Drug Administration for drugs
                            approved by the Secretary under this
                            section, such as product recalls,
                            warning letters, and import alerts;
                              (v) publicly available information
                            about implemented RiskMAPs and risk
                            evaluation and mitigation strategies
                            under subsection (o);
                              (vi) guidance documents and
                            regulations related to drug safety; and
                              (vii) other material determined
                            appropriate by the Secretary;
                      (C) providing access to summaries of the
                    assessed and aggregated data collected from the
                    active surveillance infrastructure under
                    subsection (k)(3) to provide information of
                    known and serious side-effects for drugs
                    approved under this section or licensed under
                    such section 351;
                      (D) preparing and making publicly available
                    on the Internet website established under
                    paragraph (1) best practices for drug safety
                    surveillance activities for drugs approved
                    under this section or section 351 of the Public
                    Health Service Act;
                      (E) enabling patients, providers, and drug
                    sponsors to submit adverse event reports
                    through the Internet Web site;
                      (F) providing educational materials for
                    patients and providers about the appropriate
                    means of disposing of expired, damaged, or
                    unusable medications; and
                      (G) supporting initiatives that the Secretary
                    determines to be useful to fulfill the purposes
                    of the Internet Web site.
              (3) Posting of drug labeling.--The Secretary shall
            post on the Internet Web site established under
            paragraph (1) the approved professional labeling and
            any required patient labeling of a drug approved under
            this section or licensed under such section 351 not
            later than 21 days after the date the drug is approved
            or licensed, including in a supplemental application
            with respect to a labeling change.
              (4) Private sector resources.--To ensure development
            of the Internet Web site by the date described in
            paragraph (1), the Secretary may, on a temporary or
            permanent basis, implement systems or products
            developed by private entities.
              (5) Authority for contracts.--The Secretary may enter
            into contracts with public and private entities to
            fulfill the requirements of this subsection.
              (6) Review.--The Advisory Committee on Risk
            Communication under section 567 shall, on a regular
            basis, perform a comprehensive review and evaluation of
            the types of risk communication information provided on
            the Internet Web site established under paragraph (1)
            and, through other means, shall identify, clarify, and
            define the purposes and types of information available
            to facilitate the efficient flow of information to
            patients and providers, and shall recommend ways for
            the Food and Drug Administration to work with outside
            entities to help facilitate the dispensing of risk
            communication information to patients and providers.
      (s) Referral to Advisory Committee.--The Secretary shall--
              (1) refer a drug or biological product to a Food and
            Drug Administration advisory committee for review at a
            meeting of such advisory committee prior to the
            approval of such drug or biological if it is--
                      (A) a drug, no active moiety (as defined by
                    the Secretary in section 314.3 of title 21,
                    Code of Federal Regulations (or any successor
                    regulations)) of which has been approved in any
                    other application under this section; or
                      (B) a biological product, no active
                    ingredient of which has been approved in any
                    other application under section 351 of the
                    Public Health Service Act; or
              (2) if the Secretary does not refer a drug or
            biological product described in paragraph (1) to a Food
            and Drug Administration advisory committee prior to
            such approval, provide in the action letter on the
            application for the drug or biological product a
            summary of the reasons why the Secretary did not refer
            the drug or biological product to an advisory committee
            prior to approval.
      (t) Database for Authorized Generic Drugs.--
              (1) In general.--
                      (A) Publication.--The Commissioner shall--
                              (i) not later than 9 months after the
                            date of the enactment of the Food and
                            Drug Administration Amendments Act of
                            2007, publish a complete list on the
                            Internet Web site of the Food and Drug
                            Administration of all authorized
                            generic drugs (including drug trade
                            name, brand company manufacturer, and
                            the date the authorized generic drug
                            entered the market); and
                              (ii) update the list quarterly to
                            include each authorized generic drug
                            included in an annual report submitted
                            to the Secretary by the sponsor of a
                            listed drug during the preceding 3-
                            month period.
                      (B) Notification.--The Commissioner shall
                    notify relevant Federal agencies, including the
                    Centers for Medicare & Medicaid Services and
                    the Federal Trade Commission, when the
                    Commissioner first publishes the information
                    described in subparagraph (A) that the
                    information has been published and that the
                    information will be updated quarterly.
              (2) Inclusion.--The Commissioner shall include in the
            list described in paragraph (1) each authorized generic
            drug included in an annual report submitted to the
            Secretary by the sponsor of a listed drug after January
            1, 1999.
              (3) Authorized generic drug.--In this section, the
            term ``authorized generic drug'' means a listed drug
            (as that term is used in subsection (j)) that--
                      (A) has been approved under subsection (c);
                    and
                      (B) is marketed, sold, or distributed
                    directly or indirectly to retail class of trade
                    under a different labeling, packaging (other
                    than repackaging as the listed drug in blister
                    packs, unit doses, or similar packaging for use
                    in institutions), product code, labeler code,
                    trade name, or trade mark than the listed drug.
      (u) Certain Drugs Containing Single Enantiomers.--
              (1) In general.--For purposes of subsections
            (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is
            submitted under subsection (b) for a non-racemic drug
            containing as an active moiety (as defined by the
            Secretary in section 314.3 of title 21, Code of Federal
            Regulations (or any successor regulations)) a single
            enantiomer that is contained in a racemic drug approved
            in another application under subsection (b), the
            applicant may, in the application for such non-racemic
            drug, elect to have the single enantiomer not be
            considered the same active moiety as that contained in
            the approved racemic drug, if--
                      (A)(i) the single enantiomer has not been
                    previously approved except in the approved
                    racemic drug; and
                      (ii) the application submitted under
                    subsection (b) for such non-racemic drug--
                              (I) includes full reports of new
                            clinical investigations (other than
                            bioavailability studies)--
                                      (aa) necessary for the
                                    approval of the application
                                    under subsections (c) and (d);
                                    and
                                      (bb) conducted or sponsored
                                    by the applicant; and
                              (II) does not rely on any clinical
                            investigations that are part of an
                            application submitted under subsection
                            (b) for approval of the approved
                            racemic drug; and
                      (B) the application submitted under
                    subsection (b) for such non-racemic drug is not
                    submitted for approval of a condition of use--
                              (i) in a therapeutic category in
                            which the approved racemic drug has
                            been approved; or
                              (ii) for which any other enantiomer
                            of the racemic drug has been approved.
              (2) Limitation.--
                      (A) No approval in certain therapeutic
                    categories.--Until the date that is 10 years
                    after the date of approval of a non-racemic
                    drug described in paragraph (1) and with
                    respect to which the applicant has made the
                    election provided for by such paragraph, the
                    Secretary shall not approve such non-racemic
                    drug for any condition of use in the
                    therapeutic category in which the racemic drug
                    has been approved.
                      (B) Labeling.--If applicable, the labeling of
                    a non-racemic drug described in paragraph (1)
                    and with respect to which the applicant has
                    made the election provided for by such
                    paragraph shall include a statement that the
                    non-racemic drug is not approved, and has not
                    been shown to be safe and effective, for any
                    condition of use of the racemic drug.
              (3) Definition.--
                      (A) In general.--For purposes of this
                    subsection, the term ``therapeutic category''
                    means a therapeutic category identified in the
                    list developed by the United States
                    Pharmacopeia pursuant to section 1860D-
                    4(b)(3)(C)(ii) of the Social Security Act and
                    as in effect on the date of the enactment of
                    this subsection.
                      (B) Publication by secretary.--The Secretary
                    shall publish the list described in
                    subparagraph (A) and may amend such list by
                    regulation.
              (4) Availability.--The election referred to in
            paragraph (1) may be made only in an application that
            is submitted to the Secretary after the date of the
            enactment of this subsection and before October 1,
            [2022] 2027.
      (v) Antibiotic Drugs Submitted Before November 21, 1997.--
              (1) Antibiotic drugs approved before november 21,
            1997.--
                      (A) In general.--Notwithstanding any
                    provision of the Food and Drug Administration
                    Modernization Act of 1997 or any other
                    provision of law, a sponsor of a drug that is
                    the subject of an application described in
                    subparagraph (B)(i) shall be eligible for, with
                    respect to the drug, the 3-year exclusivity
                    period referred to under clauses (iii) and (iv)
                    of subsection (c)(3)(E) and under clauses (iii)
                    and (iv) of subsection (j)(5)(F), subject to
                    the requirements of such clauses, as
                    applicable.
                      (B) Application; antibiotic drug described.--
                              (i) Application.--An application
                            described in this clause is an
                            application for marketing submitted
                            under this section after the date of
                            the enactment of this subsection in
                            which the drug that is the subject of
                            the application contains an antibiotic
                            drug described in clause (ii).
                              (ii) Antibiotic drug.--An antibiotic
                            drug described in this clause is an
                            antibiotic drug that was the subject of
                            an application approved by the
                            Secretary under section 507 of this Act
                            (as in effect before November 21,
                            1997).
              (2) Antibiotic drugs submitted before november 21,
            1997, but not approved.--
                      (A) In general.--Notwithstanding any
                    provision of the Food and Drug Administration
                    Modernization Act of 1997 or any other
                    provision of law, a sponsor of a drug that is
                    the subject of an application described in
                    subparagraph (B)(i) may elect to be eligible
                    for, with respect to the drug--
                              (i)(I) the 3-year exclusivity period
                            referred to under clauses (iii) and
                            (iv) of subsection (c)(3)(E) and under
                            clauses (iii) and (iv) of subsection
                            (j)(5)(F), subject to the requirements
                            of such clauses, as applicable; and
                              (II) the 5-year exclusivity period
                            referred to under clause (ii) of
                            subsection (c)(3)(E) and under clause
                            (ii) of subsection (j)(5)(F), subject
                            to the requirements of such clauses, as
                            applicable; or
                              (ii) a patent term extension under
                            section 156 of title 35, United States
                            Code, subject to the requirements of
                            such section.
                      (B) Application; antibiotic drug described.--
                              (i) Application.--An application
                            described in this clause is an
                            application for marketing submitted
                            under this section after the date of
                            the enactment of this subsection in
                            which the drug that is the subject of
                            the application contains an antibiotic
                            drug described in clause (ii).
                              (ii) Antibiotic drug.--An antibiotic
                            drug described in this clause is an
                            antibiotic drug that was the subject of
                            1 or more applications received by the
                            Secretary under section 507 of this Act
                            (as in effect before November 21,
                            1997), none of which was approved by
                            the Secretary under such section.
              (3) Limitations.--
                      (A) Exclusivities and extensions.--Paragraphs
                    (1)(A) and (2)(A) shall not be construed to
                    entitle a drug that is the subject of an
                    approved application described in subparagraphs
                    (1)(B)(i) or (2)(B)(i), as applicable, to any
                    market exclusivities or patent extensions other
                    than those exclusivities or extensions
                    described in paragraph (1)(A) or (2)(A).
                      (B) Conditions of use.--Paragraphs (1)(A) and
                    (2)(A)(i) shall not apply to any condition of
                    use for which the drug referred to in
                    subparagraph (1)(B)(i) or (2)(B)(i), as
                    applicable, was approved before the date of the
                    enactment of this subsection.
              (4) Application of certain provisions.--
            Notwithstanding section 125, or any other provision, of
            the Food and Drug Administration Modernization Act of
            1997, or any other provision of law, and subject to the
            limitations in paragraphs (1), (2), and (3), the
            provisions of the Drug Price Competition and Patent
            Term Restoration Act of 1984 shall apply to any drug
            subject to paragraph (1) or any drug with respect to
            which an election is made under paragraph (2)(A).
      (w) Deadline for Determination on Certain Petitions.--The
    Secretary shall issue a final, substantive determination on a
    petition submitted pursuant to subsection (b) of section
    314.161 of title 21, Code of Federal Regulations (or any
    successor regulations), no later than 270 days after the date
    the petition is submitted.
      (x) Date of Approval in the Case of Recommended Controls
    Under the CSA.--
              (1) In general.--In the case of an application under
            subsection (b) with respect to a drug for which the
            Secretary provides notice to the sponsor that the
            Secretary intends to issue a scientific and medical
            evaluation and recommend controls under the Controlled
            Substances Act, approval of such application shall not
            take effect until the interim final rule controlling
            the drug is issued in accordance with section 201(j) of
            the Controlled Substances Act.
              (2) Date of approval.--For purposes of this section,
            with respect to an application described in paragraph
            (1), the term ``date of approval'' shall mean the later
            of--
                      (A) the date an application under subsection
                    (b) is approved under subsection (c); or
                      (B) the date of issuance of the interim final
                    rule controlling the drug.
      (y) Contrast Agents Intended for Use With Applicable Medical
    Imaging Devices.--
              (1) In general.--The sponsor of a contrast agent for
            which an application has been approved under this
            section may submit a supplement to the application
            seeking approval for a new use following the
            authorization of a premarket submission for an
            applicable medical imaging device for that use with the
            contrast agent pursuant to section 520(p)(1).
              (2) Review of supplement.--In reviewing a supplement
            submitted under this subsection, the agency center
            charged with the premarket review of drugs may--
                      (A) consult with the center charged with the
                    premarket review of devices; and
                      (B) review information and data submitted to
                    the Secretary by the sponsor of an applicable
                    medical imaging device pursuant to section 515,
                    510(k), or 513(f)(2) so long as the sponsor of
                    such applicable medical imaging device has
                    provided to the sponsor of the contrast agent a
                    right of reference.
              (3) Definitions.--For purposes of this subsection--
                      (A) the term ``new use'' means a use of a
                    contrast agent that is described in the
                    approved labeling of an applicable medical
                    imaging device described in section 520(p), but
                    that is not described in the approved labeling
                    of the contrast agent; and
                      (B) the terms ``applicable medical imaging
                    device'' and ``contrast agent'' have the
                    meanings given such terms in section 520(p).
      (z) Nonclinical Test Defined.--For purposes of this section,
    the term ``nonclinical test'' means a test conducted in vitro,
    in silico, or in chemico, or a nonhuman in vivo test, that
    occurs before or during the clinical trial phase of the
    investigation of the safety and effectiveness of a drug. Such
    test may include the following:
              (1) Cell-based assays.
              (2) Organ chips and microphysiological systems.
              (3) Computer modeling.
              (4) Other nonhuman or human biology-based test
            methods.
              (5) Animal tests.

               *       *       *       *       *       *       *

    SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL
                        PRODUCTS.

      (a) New Drugs and Biological Products.--
              (1) In general.--
                      (A) General requirements.--Except with
                    respect to an application for which
                    subparagraph (B) applies, a person that
                    submits, on or after the date of the enactment
                    of the Pediatric Research Equity Act of 2007,
                    an application (or supplement to an
                    application) for a drug--
                              (i) under section 505 for a new
                            active ingredient, new indication, new
                            dosage form, new dosing regimen, or new
                            route of administration; or
                              (ii) under section 351 of the Public
                            Health Service Act (42 U.S.C. 262) for
                            a new active ingredient, new
                            indication, new dosage form, new dosing
                            regimen, or new route of
                            administration,
                    shall submit with the application the
                    assessments described in paragraph (2).
                      (B) Certain molecularly targeted cancer
                    indications.--A person that submits, on or
                    after the date that is 3 years after the date
                    of enactment of the FDA Reauthorization Act of
                    2017, an original application for a new active
                    ingredient under section 505 of this Act or
                    section 351 of the Public Health Service Act,
                    shall submit with the application reports on
                    the investigation described in paragraph (3) if
                    the drug or biological product that is the
                    subject of the application is--
                              (i) intended for the treatment of an
                            adult cancer; and
                              (ii) directed at a molecular target
                            that the Secretary determines to be
                            substantially relevant to the growth or
                            progression of a pediatric cancer.
                      (C) Rule of construction.--No application
                    that is subject to the requirements of
                    subparagraph (B) shall be subject to the
                    requirements of subparagraph (A), and no
                    application (or supplement to an application)
                    that is subject to the requirements of
                    subparagraph (A) shall be subject to the
                    requirements of subparagraph (B).
              (2) Assessments.--
                      (A) In general.--The assessments referred to
                    in paragraph (1)(A) shall contain data,
                    gathered using appropriate formulations for
                    each age group for which the assessment is
                    required, that are adequate--
                              (i) to assess the safety and
                            effectiveness of the drug or the
                            biological product for the claimed
                            indications in all relevant pediatric
                            subpopulations; and
                              (ii) to support dosing and
                            administration for each pediatric
                            subpopulation for which the drug or the
                            biological product is safe and
                            effective.
                      (B) Similar course of disease or similar
                    effect of drug or biological product.--
                              (i) In general.--If the course of the
                            disease and the effects of the drug are
                            sufficiently similar in adults and
                            pediatric patients, the Secretary may
                            conclude that pediatric effectiveness
                            can be extrapolated from adequate and
                            well-controlled studies in adults,
                            usually supplemented with other
                            information obtained in pediatric
                            patients, such as pharmacokinetic
                            studies.
                              (ii) Extrapolation between age
                            groups.--A study may not be needed in
                            each pediatric age group if data from
                            one age group can be extrapolated to
                            another age group.
                              (iii) Information on extrapolation.--
                            A brief documentation of the scientific
                            data supporting the conclusion under
                            clauses (i) and (ii) shall be included
                            in any pertinent reviews for the
                            application under section 505 of this
                            Act or section 351 of the Public Health
                            Service Act (42 U.S.C. 262).
              (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.]
                      (A) In general.--For purposes of paragraph
                    (1)(B), the investigation described in this
                    paragraph is (as determined by the Secretary) a
                    molecularly targeted pediatric cancer
                    investigation of--
                              (i) the drug or biological product
                            for which the application referred to
                            in such paragraph is submitted; or
                              (ii) such drug or biological product
                            in combination with--
                                      (I) an active ingredient of a
                                    drug or biological product--
                                              (aa) for which an
                                            approved application
                                            under section 505(j)
                                            under this Act or under
                                            section 351(k) of the
                                            Public Health Service
                                            Act is in effect; and
                                              (bb) that is
                                            determined by the
                                            Secretary to be the
                                            standard of care for
                                            treating a pediatric
                                            cancer; or
                                      (II) an active ingredient of
                                    a drug or biological product--
                                              (aa) for which an
                                            approved application
                                            under section 505(b) of
                                            this Act or section
                                            351(a) of the Public
                                            Health Service Act to
                                            treat an adult cancer
                                            is in effect and is
                                            held by the same person
                                            submitting the
                                            application under
                                            paragraph (1)(B); and
                                              (bb) that is directed
                                            at a molecular target
                                            that the Secretary
                                            determines to be
                                            substantially relevant
                                            to the growth or
                                            progression of a
                                            pediatric cancer.
                      (B) Additional requirements.--
                              (i) Design of investigation.--A
                            molecularly targeted pediatric cancer
                            investigation referred to in
                            subparagraph (A) shall be designed to
                            yield clinically meaningful pediatric
                            study data that is 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.
                              (ii) Limitation.--An investigation
                            described in subparagraph (A)(ii) may
                            be required only if the drug or
                            biological product for which the
                            application referred to in paragraph
                            (1)(B) contains either--
                                      (I) a single new active
                                    ingredient; or
                                      (II) more than one active
                                    ingredient, if an application
                                    for the combination of active
                                    ingredients has not previously
                                    been approved but each active
                                    ingredient has been previously
                                    approved to treat an adult
                                    cancer.
                              (iii) Results of already-completed
                            preclinical studies of application
                            drug.--The Secretary may require that
                            reports on an investigation required
                            pursuant to paragraph (1)(B) include
                            the results of all preclinical studies
                            on which the decision to conduct such
                            investigation was based.
                              (iv) Rule of construction regarding
                            inactive ingredients.--With respect to
                            a combination of active ingredients
                            referred to in subparagraph (A)(ii),
                            such subparagraph shall not be
                            construed as addressing the use of
                            inactive ingredients with such
                            combination.
                      [(B)] (C) Extrapolation of data.--Paragraph
                    (2)(B) shall apply to [investigations described
                    in this paragraph] investigations referred to
                    in subparagraph (A) 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)] (D) 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)] the assessments required under
                    paragraph (1)(A).
              (4) Deferral.--
                      (A) In general.--On the initiative of the
                    Secretary or at the request of the applicant,
                    the Secretary may defer submission of some or
                    all assessments required under paragraph (1)(A)
                    or reports on the investigation required under
                    paragraph (1)(B) until a specified date after
                    approval of the drug or issuance of the license
                    for a biological product if--
                              (i) the Secretary finds that--
                                      (I) the drug or biological
                                    product is ready for approval
                                    for use in adults before
                                    pediatric studies are complete;
                                      (II) pediatric studies should
                                    be delayed until additional
                                    safety or effectiveness data
                                    have been collected; or
                                      (III) there is another
                                    appropriate reason for
                                    deferral; and
                              (ii) the applicant submits to the
                            Secretary--
                                      (I) certification of the
                                    grounds for deferring the
                                    assessments or reports on the
                                    investigation;
                                      (II) a pediatric study plan
                                    as described in subsection (e);
                                      (III) evidence that the
                                    studies are being conducted or
                                    will be conducted with due
                                    diligence and at the earliest
                                    possible time; and
                                      (IV) a timeline for the
                                    completion of such studies.
                      (B) Deferral extension.--
                              (i) In general.--On the initiative of
                            the Secretary or at the request of the
                            applicant, the Secretary may grant an
                            extension of a deferral approved under
                            subparagraph (A) for submission of some
                            or all assessments required under
                            paragraph (1)(A) or reports on the
                            investigation required under paragraph
                            (1)(B) if--
                                      (I) the Secretary determines
                                    that the conditions described
                                    in subclause (II) or (III) of
                                    subparagraph (A)(i) continue to
                                    be met; and
                                      (II) the applicant submits a
                                    new timeline under subparagraph
                                    (A)(ii)(IV) and any significant
                                    updates to the information
                                    required under subparagraph
                                    (A)(ii).
                              (ii) Timing and information.--If the
                            deferral extension under this
                            subparagraph is requested by the
                            applicant, the applicant shall submit
                            the deferral extension request
                            containing the information described in
                            this subparagraph not less than 90 days
                            prior to the date that the deferral
                            would expire. The Secretary shall
                            respond to such request not later than
                            45 days after the receipt of such
                            letter. If the Secretary grants such an
                            extension, the specified date shall be
                            the extended date. The sponsor of the
                            required assessment under paragraph
                            (1)(A) or reports on the investigation
                            under paragraph (1)(B) shall not be
                            issued a letter described in subsection
                            (d) unless the specified or extended
                            date of submission for such required
                            studies has passed or if the request
                            for an extension is pending. For a
                            deferral that has expired prior to the
                            date of enactment of the Food and Drug
                            Administration Safety and Innovation
                            Act or that will expire prior to 270
                            days after the date of enactment of
                            such Act, a deferral extension shall be
                            requested by an applicant not later
                            than 180 days after the date of
                            enactment of such Act. The Secretary
                            shall respond to any such request as
                            soon as practicable, but not later than
                            1 year after the date of enactment of
                            such Act. Nothing in this clause shall
                            prevent the Secretary from updating the
                            status of a study or studies publicly
                            if components of such study or studies
                            are late or delayed.
                      (C) Annual review.--
                              (i) In general.--On an annual basis
                            following the approval of a deferral
                            under subparagraph (A), the applicant
                            shall submit to the Secretary the
                            following information:
                                      (I) Information detailing the
                                    progress made in conducting
                                    pediatric studies.
                                      (II) If no progress has been
                                    made in conducting such
                                    studies, evidence and
                                    documentation that such studies
                                    will be conducted with due
                                    diligence and at the earliest
                                    possible time.
                                      (III) Projected completion
                                    date for pediatric studies.
                                      (IV) The reason or reasons
                                    why a deferral or deferral
                                    extension continues to be
                                    necessary.
                              (ii) Public availability.--Not later
                            than 90 days after the submission to
                            the Secretary of the information
                            submitted through the annual review
                            under clause (i), the Secretary shall
                            make available to the public in an
                            easily accessible manner, including
                            through the Internet Web site of the
                            Food and Drug Administration--
                                      (I) such information;
                                      (II) the name of the
                                    applicant for the product
                                    subject to the assessment or
                                    investigation;
                                      (III) the date on which the
                                    product was approved; and
                                      (IV) the date of each
                                    deferral or deferral extension
                                    under this paragraph for the
                                    product.
              (5) Waivers.--
                      (A) Full waiver.--On the initiative of the
                    Secretary or at the request of an applicant,
                    the Secretary shall grant a full waiver, as
                    appropriate, of the requirement to submit
                    assessments or reports on the investigation for
                    a drug or biological product under this
                    subsection if the applicant certifies and the
                    Secretary finds that--
                              (i) necessary studies are impossible
                            or highly impracticable (because, for
                            example, the number of patients is so
                            small or the patients are
                            geographically dispersed);
                              (ii) there is evidence strongly
                            suggesting that the drug or biological
                            product would be ineffective or unsafe
                            in all pediatric age groups; or
                              (iii) the drug or biological
                            product--
                                      (I) does not represent a
                                    meaningful therapeutic benefit
                                    over existing therapies for
                                    pediatric patients; and
                                      (II) is not likely to be used
                                    in a substantial number of
                                    pediatric patients.
                      (B) Partial waiver.--On the initiative of the
                    Secretary or at the request of an applicant,
                    the Secretary shall grant a partial waiver, as
                    appropriate, of the requirement to submit
                    assessments or reports on the investigation for
                    a drug or biological product under this
                    subsection with respect to a specific pediatric
                    age group if the applicant certifies and the
                    Secretary finds that--
                              (i) necessary studies are impossible
                            or highly impracticable (because, for
                            example, the number of patients in that
                            age group is so small or patients in
                            that age group are geographically
                            dispersed);
                              (ii) there is evidence strongly
                            suggesting that the drug or biological
                            product would be ineffective or unsafe
                            in that age group;
                              (iii) the drug or biological
                            product--
                                      (I) does not represent a
                                    meaningful therapeutic benefit
                                    over existing therapies for
                                    pediatric patients in that age
                                    group; and
                                      (II) is not likely to be used
                                    by a substantial number of
                                    pediatric patients in that age
                                    group; or
                              (iv) the applicant can demonstrate
                            that reasonable attempts to produce a
                            pediatric formulation necessary for
                            that age group have failed.
                      (C) Pediatric formulation not possible.--If a
                    partial waiver is granted on the ground that it
                    is not possible to develop a pediatric
                    formulation, the waiver shall cover only the
                    pediatric groups requiring that formulation. An
                    applicant seeking such a partial waiver shall
                    submit to the Secretary documentation detailing
                    why a pediatric formulation cannot be developed
                    and, if the waiver is granted, the applicant's
                    submission shall promptly be made available to
                    the public in an easily accessible manner,
                    including through posting on the Web site of
                    the Food and Drug Administration.
                      (D) Labeling requirement.--If the Secretary
                    grants a full or partial waiver because there
                    is evidence that a drug or biological product
                    would be ineffective or unsafe in pediatric
                    populations, the information shall be included
                    in the labeling for the drug or biological
                    product.
      (b) Marketed Drugs and Biological Products.--
              (1) In general.--The Secretary may (by order in the
            form of a letter) require the sponsor or holder of an
            approved application for a drug under section 505 or
            the holder of a license for a biological product under
            section 351 of the Public Health Service Act to submit
            by a specified date the assessments described in
            subsection (a)(2), if the Secretary finds that--
                      (A)(i) the drug or biological product is used
                    for a substantial number of pediatric patients
                    for the labeled indications; and
                      (ii) adequate pediatric labeling could confer
                    a benefit on pediatric patients;
                      (B) there is reason to believe that the drug
                    or biological product would represent a
                    meaningful therapeutic benefit over existing
                    therapies for pediatric patients for 1 or more
                    of the claimed indications; or
                      (C) the absence of adequate pediatric
                    labeling could pose a risk to pediatric
                    patients.
              (2) Waivers.--
                      (A) Full waiver.--At the request of an
                    applicant, the Secretary shall grant a full
                    waiver, as appropriate, of the requirement to
                    submit assessments under this subsection if the
                    applicant certifies and the Secretary finds
                    that--
                              (i) necessary studies are impossible
                            or highly impracticable (because, for
                            example, the number of patients in that
                            age group is so small or patients in
                            that age group are geographically
                            dispersed); or
                              (ii) there is evidence strongly
                            suggesting that the drug or biological
                            product would be ineffective or unsafe
                            in all pediatric age groups.
                      (B) Partial waiver.--At the request of an
                    applicant, the Secretary shall grant a partial
                    waiver, as appropriate, of the requirement to
                    submit assessments under this subsection with
                    respect to a specific pediatric age group if
                    the applicant certifies and the Secretary finds
                    that--
                              (i) necessary studies are impossible
                            or highly impracticable (because, for
                            example, the number of patients in that
                            age group is so small or patients in
                            that age group are geographically
                            dispersed);
                              (ii) there is evidence strongly
                            suggesting that the drug or biological
                            product would be ineffective or unsafe
                            in that age group;
                              (iii)(I) the drug or biological
                            product--
                                      (aa) does not represent a
                                    meaningful therapeutic benefit
                                    over existing therapies for
                                    pediatric patients in that age
                                    group; and
                                      (bb) is not likely to be used
                                    in a substantial number of
                                    pediatric patients in that age
                                    group; and
                              (II) the absence of adequate labeling
                            could not pose significant risks to
                            pediatric patients; or
                              (iv) the applicant can demonstrate
                            that reasonable attempts to produce a
                            pediatric formulation necessary for
                            that age group have failed.
                      (C) Pediatric formulation not possible.--If a
                    waiver is granted on the ground that it is not
                    possible to develop a pediatric formulation,
                    the waiver shall cover only the pediatric
                    groups requiring that formulation. An applicant
                    seeking either a full or partial waiver shall
                    submit to the Secretary documentation detailing
                    why a pediatric formulation cannot be developed
                    and, if the waiver is granted, the applicant's
                    submission shall promptly be made available to
                    the public in an easily accessible manner,
                    including through posting on the Web site of
                    the Food and Drug Administration.
                      (D) Labeling requirement.--If the Secretary
                    grants a full or partial waiver because there
                    is evidence that a drug or biological product
                    would be ineffective or unsafe in pediatric
                    populations, the information shall be included
                    in the labeling for the drug or biological
                    product.
              (3) Effect of subsection.--Nothing in this subsection
            alters or amends section 301(j) of this Act or section
            552 of title 5 or section 1905 of title 18, United
            States Code.
      (c) Meaningful Therapeutic Benefit.--For the purposes of
    paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a)
    and paragraphs (1)(B) and (2)(B)(iii)(I)(aa) of subsection (b),
    a drug or biological product shall be considered to represent a
    meaningful therapeutic benefit over existing therapies if the
    Secretary determines that--
              (1) if approved, the drug or biological product could
            represent an improvement in the treatment, diagnosis,
            or prevention of a disease, compared with marketed
            products adequately labeled for that use in the
            relevant pediatric population; or
              (2) the drug or biological product is in a class of
            products or for an indication for which there is a need
            for additional options.
      (d) Submission of Assessments And Reports on the
    Investigation.--If a person fails to submit a required
    assessment described in subsection (a)(2) or the investigation
    described in subsection (a)(3), fails to meet the applicable
    requirements in subsection (a)(4), or fails to submit a request
    for approval of a pediatric formulation described in subsection
    (a) or (b), in accordance with applicable provisions of
    subsections (a) and (b), the following shall apply:
              (1) Beginning 270 days after the date of enactment of
            the Food and Drug Administration Safety and Innovation
            Act, the Secretary shall issue a non-compliance letter
            to such person informing them of such failure to submit
            or meet the requirements of the applicable subsection.
            Such letter shall require the person to respond in
            writing within 45 calendar days of issuance of such
            letter. Such response may include the person's request
            for a deferral extension if applicable. Such letter and
            the person's written response to such letter shall be
            made publicly available on the Internet Web site of the
            Food and Drug Administration 60 calendar days after
            issuance, with redactions for any trade secrets and
            confidential commercial information. If the Secretary
            determines that the letter was issued in error, the
            requirements of this paragraph shall not apply. The
            Secretary shall inform the Pediatric Advisory Committee
            of letters issued under this paragraph and responses to
            such letters.
              (2) The drug or biological product that is the
            subject of an assessment described in subsection (a)(2)
            or the investigation described in subsection (a)(3),
            applicable requirements in subsection (a)(4), or
            request for approval of a pediatric formulation, may be
            considered misbranded solely because of that failure
            and subject to relevant enforcement action (except that
            the drug or biological product shall not be subject to
            action under section 303), but such failure shall not
            be the basis for a proceeding--
                      (A) to withdraw approval for a drug under
                    section 505(e); or
                      (B) to revoke the license for a biological
                    product under section 351 of the Public Health
                    Service Act.
      (e) Pediatric Study Plans.--
              (1) In general.--An applicant subject to subsection
            (a) shall submit to the Secretary an initial pediatric
            study plan prior to the submission of the assessments
            described under subsection (a)(2) or the investigation
            described in subsection (a)(3). The Secretary shall
            determine whether subparagraph (A) or (B) of subsection
            (a)(1) shall apply with respect to an application
            before the date on which the applicant is required to
            submit the initial pediatric study plan under paragraph
            (2)(A).
              (2) Timing; content; meetings.--
                      (A) Timing.--An applicant shall submit the
                    initial pediatric study plan under paragraph
                    (1)--
                              (i) before the date on which the
                            applicant submits the assessments under
                            subsection (a)(2) or the investigation
                            described in subsection (a)(3); and
                              (ii) not later than--
                                      (I) 60 calendar days after
                                    the date of the end-of-Phase 2
                                    meeting (as such term is used
                                    in section 312.47 of title 21,
                                    Code of Federal Regulations, or
                                    successor regulations); or
                                      (II) such other time as may
                                    be agreed upon between the
                                    Secretary and the applicant.
                    Nothing in this section shall preclude the
                    Secretary from accepting the submission of an
                    initial pediatric study plan earlier than the
                    date otherwise applicable under this
                    subparagraph.
                      (B) Content of initial pediatric study
                    plan.--The initial pediatric study plan shall
                    include--
                              (i) an outline of the pediatric study
                            or studies that the applicant plans to
                            conduct (including, to the extent
                            practicable study objectives and
                            design, age groups, relevant endpoints,
                            and statistical approach);
                              (ii) any request for a deferral,
                            partial waiver, or waiver under this
                            section, if applicable, along with any
                            supporting information; and
                              (iii) other information specified in
                            the regulations promulgated under
                            paragraph (7).
                      (C) Meetings.--The Secretary--
                              (i) shall meet with the applicant--
                                      (I) if requested by the
                                    applicant with respect to a
                                    drug or biological product that
                                    is intended to treat a serious
                                    or life-threatening disease or
                                    condition, to discuss
                                    preparation of the initial
                                    pediatric study plan, not later
                                    than the end-of-Phase 1 meeting
                                    (as such term is used in
                                    section 312.82(b) of title 21,
                                    Code of Federal Regulations, or
                                    successor regulations) or
                                    within 30 calendar days of
                                    receipt of such request,
                                    whichever is later;
                                      (II) to discuss the initial
                                    pediatric study plan as soon as
                                    practicable, but not later than
                                    90 calendar days after the
                                    receipt of such plan under
                                    subparagraph (A); and
                                      (III) to discuss the bases
                                    for the deferral under
                                    subsection (a)(4) or a full or
                                    partial waiver under subsection
                                    (a)(5);
                              (ii) may determine that a written
                            response to the initial pediatric study
                            plan is sufficient to communicate
                            comments on the initial pediatric study
                            plan, and that no meeting under clause
                            (i)(II) is necessary; and
                              (iii) if the Secretary determines
                            that no meeting under clause (i)(II) is
                            necessary, shall so notify the
                            applicant and provide written comments
                            of the Secretary as soon as
                            practicable, but not later than 90
                            calendar days after the receipt of the
                            initial pediatric study plan.
              (3) Agreed initial pediatric study plan.--Not later
            than 90 calendar days following the meeting under
            paragraph (2)(C)(i)(II) or the receipt of a written
            response from the Secretary under paragraph
            (2)(C)(iii), the applicant shall document agreement on
            the initial pediatric study plan in a submission to the
            Secretary marked ``Agreed Initial Pediatric Study
            Plan'', and the Secretary shall confirm such agreement
            to the applicant in writing not later than 30 calendar
            days of receipt of such agreed initial pediatric study
            plan.
              (4) Deferral and waiver.--If the agreed initial
            pediatric study plan contains a request from the
            applicant for a deferral, partial waiver, or waiver
            under this section, the written confirmation under
            paragraph (3) shall include a recommendation from the
            Secretary as to whether such request meets the
            standards under paragraphs (3) or (4) of subsection
            (a).
              (5) Amendments to the agreed initial pediatric study
            plan.--At the initiative of the Secretary or the
            applicant, the agreed initial pediatric study plan may
            be amended at any time. The requirements of paragraph
            (2)(C) shall apply to any such proposed amendment in
            the same manner and to the same extent as such
            requirements apply to an initial pediatric study plan
            under paragraph (1). The requirements of paragraphs (3)
            and (4) shall apply to any agreement resulting from
            such proposed amendment in the same manner and to the
            same extent as such requirements apply to an agreed
            initial pediatric study plan.
              (6) Internal committee.--The Secretary shall consult
            the internal committee under section 505C on the review
            of the initial pediatric study plan, agreed initial
            pediatric study plan, and any significant amendments to
            such plans.
              (7) Required rulemaking.--Not later than 1 year after
            the date of enactment of the Food and Drug
            Administration Safety and Innovation Act, the Secretary
            shall promulgate proposed regulations and issue
            guidance to implement the provisions of this
            subsection.
      (f) Review of Pediatric Study Plans,Assessments, Deferrals,
    Deferral Extensions, and Waivers.--
              (1) Review.--Beginning not later than 30 days after
            the date of the enactment of the Pediatric Research
            Equity Act of 2007, the Secretary shall utilize the
            internal committee established under section 505C to
            provide consultation to reviewing divisions on initial
            pediatric study plans, agreed initial pediatric study
            plans, and any significant amendments to such plans,
            and assessments prior to approval of an application or
            supplement for which a pediatric assessment is required
            under this section and all deferral, deferral
            extension, and waiver requests granted pursuant to this
            section.
              (2) Activity by committee.--The committee referred to
            in paragraph (1) may operate using appropriate members
            of such committee and need not convene all members of
            the committee.
              (3) Documentation of committee action.--For each drug
            or biological product, the committee referred to in
            paragraph (1) shall document, for each activity
            described in paragraph (4) or (5), which members of the
            committee participated in such activity.
              (4) Review of pediatric study plans, assessments,
            deferrals, deferral extensions, and waivers.--
            Consultation on initial pediatric study plans, agreed
            initial pediatric study plans, and assessments by the
            committee referred to in paragraph (1) pursuant to this
            section shall occur prior to approval of an application
            or supplement for which a pediatric assessment is
            required under this section. The committee shall review
            all requests for deferrals, deferral extensions, and
            waivers from the requirement to submit a pediatric
            assessment granted under this section and shall provide
            recommendations as needed to reviewing divisions,
            including with respect to whether such a supplement,
            when submitted, shall be considered for priority
            review.
              (5) Retrospective review of pediatric assessments,
            deferrals, and waivers.--Not later than 1 year after
            the date of the enactment of the Pediatric Research
            Equity Act of 2007, the committee referred to in
            paragraph (1) shall conduct a retrospective review and
            analysis of a representative sample of assessments
            submitted and deferrals and waivers approved under this
            section since the enactment of the Pediatric Research
            Equity Act of 2003. Such review shall include an
            analysis of the quality and consistency of pediatric
            information in pediatric assessments and the
            appropriateness of waivers and deferrals granted. Based
            on such review, the Secretary shall issue
            recommendations to the review divisions for
            improvements and initiate guidance to industry related
            to the scope of pediatric studies required under this
            section.
              (6) Tracking of assessments and labeling changes.--
            The Secretary, in consultation with the committee
            referred to in paragraph (1), shall track and make
            available to the public in an easily accessible manner,
            including through posting on the Web site of the Food
            and Drug Administration--
                      (A) the number of assessments conducted under
                    this section;
                      (B) the specific drugs and biological
                    products and their uses assessed under this
                    section;
                      (C) the types of assessments conducted under
                    this section, including trial design, the
                    number of pediatric patients studied, and the
                    number of centers and countries involved;
                      (D) aggregated on an annual basis--
                              (i) the total number of deferrals and
                            deferral extensions requested and
                            granted under this section and, if
                            granted, the reasons for each such
                            deferral or deferral extension;
                              (ii) the timeline for completion of
                            the assessments;
                              (iii) the number of assessments
                            completed and pending; and
                              (iv) the number of postmarket non-
                            compliance letters issued pursuant to
                            subsection (d), and the recipients of
                            such letters;
                      (E) the number of waivers requested and
                    granted under this section and, if granted, the
                    reasons for the waivers;
                      (F) the number of pediatric formulations
                    developed and the number of pediatric
                    formulations not developed and the reasons any
                    such formulation was not developed;
                      (G) the labeling changes made as a result of
                    assessments conducted under this section;
                      (H) an annual summary of labeling changes
                    made as a result of assessments conducted under
                    this section for distribution pursuant to
                    subsection (h)(2);
                      (I) an annual summary of information
                    submitted pursuant to subsection (a)(3)(B); and
                      (J) the number of times the committee
                    referred to in paragraph (1) made a
                    recommendation to the Secretary under paragraph
                    (4) regarding priority review, the number of
                    times the Secretary followed or did not follow
                    such a recommendation, and, if not followed,
                    the reasons why such a recommendation was not
                    followed.
      (g) Labeling Changes.--
              (1) Dispute resolution.--
                      (A) Request for labeling change and failure
                    to agree.--If, on or after the date of the
                    enactment of the Pediatric Research Equity Act
                    of 2007, the Commissioner determines that a
                    sponsor and the Commissioner have been unable
                    to reach agreement on appropriate changes to
                    the labeling for the drug that is the subject
                    of the application or supplement, not later
                    than 180 days after the date of the submission
                    of the application or supplement that receives
                    a priority review or 330 days after the date of
                    the submission of an application or supplement
                    that receives a standard review--
                              (i) the Commissioner shall request
                            that the sponsor of the application
                            make any labeling change that the
                            Commissioner determines to be
                            appropriate; and
                              (ii) if the sponsor does not agree
                            within 30 days after the Commissioner's
                            request to make a labeling change
                            requested by the Commissioner, the
                            Commissioner shall refer the matter to
                            the Pediatric Advisory Committee.
                      (B) Action by the pediatric advisory
                    committee.--Not later than 90 days after
                    receiving a referral under subparagraph
                    (A)(ii), the Pediatric Advisory Committee
                    shall--
                              (i) review the pediatric study
                            reports; and
                              (ii) make a recommendation to the
                            Commissioner concerning appropriate
                            labeling changes, if any.
                      (C) Consideration of recommendations.--The
                    Commissioner shall consider the recommendations
                    of the Pediatric Advisory Committee and, if
                    appropriate, not later than 30 days after
                    receiving the recommendation, make a request to
                    the sponsor of the application or supplement to
                    make any labeling changes that the Commissioner
                    determines to be appropriate.
                      (D) Misbranding.--If the sponsor of the
                    application or supplement, within 30 days after
                    receiving a request under subparagraph (C),
                    does not agree to make a labeling change
                    requested by the Commissioner, the Commissioner
                    may deem the drug that is the subject of the
                    application or supplement to be misbranded.
                      (E) No effect on authority.--Nothing in this
                    subsection limits the authority of the United
                    States to bring an enforcement action under
                    this Act when a drug lacks appropriate
                    pediatric labeling. Neither course of action
                    (the Pediatric Advisory Committee process or an
                    enforcement action referred to in the preceding
                    sentence) shall preclude, delay, or serve as
                    the basis to stay the other course of action.
              (2) Other labeling changes.--If, on or after the date
            of the enactment of the Pediatric Research Equity Act
            of 2007, the Secretary makes a determination that a
            pediatric assessment conducted under this section does
            or does not demonstrate that the drug that is the
            subject of such assessment is safe and effective in
            pediatric populations or subpopulations, including
            whether such assessment results are inconclusive, the
            Secretary shall order the labeling of such product to
            include information about the results of the assessment
            and a statement of the Secretary's determination.
      (h) Dissemination of Pediatric Information.--
              (1) In general.--Not later than 210 days after the
            date of submission of an application (or supplement to
            an application) that contains a pediatric assessment
            under this section, if the application (or supplement)
            receives a priority review, or not later than 330 days
            after the date of submission of an application (or
            supplement to an application) that contains a pediatric
            assessment under this section, if the application (or
            supplement) receives a standard review, the Secretary
            shall make available to the public in an easily
            accessible manner the medical, statistical, and
            clinical pharmacology reviews of such pediatric
            assessments, and shall post such assessments on the Web
            site of the Food and Drug Administration.
              (2) Dissemination of information regarding labeling
            changes.--Beginning on the date of the enactment of the
            Pediatric Research Equity Act of 2007, the Secretary
            shall require that the sponsors of the assessments that
            result in labeling changes that are reflected in the
            annual summary developed pursuant to subsection
            (f)(6)(H) distribute such information to physicians and
            other health care providers.
              (3) Effect of subsection.--Nothing in this subsection
            shall alter or amend section 301(j) of this Act or
            section 552 of title 5 or section 1905 of title 18,
            United States Code.
      (i) Adverse Event Reporting.--
              (1) Reporting in first 18-month period.--Beginning on
            the date of the enactment of the Pediatric Research
            Equity Act of 2007, during the 18-month period
            beginning on the date a labeling change is made
            pursuant to subsection (g), the Secretary shall ensure
            that all adverse event reports that have been received
            for such drug (regardless of when such report was
            received) are referred to the Office of Pediatric
            Therapeutics. In considering such reports, the Director
            of such Office shall provide for the review of such
            reports by the Pediatric Advisory Committee, including
            obtaining any recommendations of such committee
            regarding whether the Secretary should take action
            under this Act in response to such reports.
              (2) Reporting in subsequent periods.--Following the
            18-month period described in paragraph (1), the
            Secretary shall, as appropriate, refer to the Office of
            Pediatric Therapeutics all pediatric adverse event
            reports for a drug for which a pediatric study was
            conducted under this section. In considering such
            reports, the Director of such Office may provide for
            the review of such reports by the Pediatric Advisory
            Committee, including obtaining any recommendation of
            such Committee regarding whether the Secretary should
            take action in response to such reports.
              (3) Preservation of authority.--Nothing in this
            subsection shall prohibit the Office of Pediatric
            Therapeutics from providing for the review of adverse
            event reports by the Pediatric Advisory Committee prior
            to the 18-month period referred to in paragraph (1), if
            such review is necessary to ensure safe use of a drug
            in a pediatric population.
              (4) Effect.--The requirements of this subsection
            shall supplement, not supplant, other review of such
            adverse event reports by the Secretary.
      (j) Scope of Authority.--Nothing in this section provides to
    the Secretary any authority to require a pediatric assessment
    of any drug or biological product, or any assessment regarding
    other populations or uses of a drug or biological product,
    other than the pediatric assessments described in this section.
      (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).
      (l) New Active Ingredient.--
              (1) Non-interchangeable biosimilar biological
            product.--A biological product that is biosimilar to a
            reference product under section 351 of the Public
            Health Service Act, and that the Secretary has not
            determined to meet the standards described in
            subsection (k)(4) of such section for
            interchangeability with the reference product, shall be
            considered to have a new active ingredient under this
            section.
              (2) Interchangeable biosimilar biological product.--A
            biological product that is interchangeable with a
            reference product under section 351 of the Public
            Health Service Act shall not be considered to have a
            new active ingredient under this section.
      (m) List of Primary Molecular Targets.--
              (1) In general.--Within one year of the date of
            enactment of the FDA Reauthorization Act of 2017, the
            Secretary shall establish and update regularly, and
            shall publish on the internet website of the Food and
            Drug Administration--
                      (A) a list of molecular targets considered,
                    on the basis of data the Secretary determines
                    to be adequate, to be substantially relevant to
                    the growth and progression of a pediatric
                    cancer, and that may trigger the requirements
                    under this section; and
                      (B) a list of molecular targets of new cancer
                    drugs and biological products in development
                    for which pediatric cancer study requirements
                    under this section will be automatically
                    waived.
              (2) Consultation.--In establishing the lists
            described in paragraph (1), the Secretary shall consult
            the National Cancer Institute, members of the internal
            committee under section 505C, and the Pediatric
            Oncology Subcommittee of the Oncologic Drugs Advisory
            Committee, and shall take into account comments from
            the meeting under subsection (c).
              (3) Rule of construction.--Nothing in paragraph (1)
            shall be construed--
                      (A) to require the inclusion of a molecular
                    target on the list published under such
                    paragraph as a condition for triggering the
                    requirements under subsection (a)(1)(B) with
                    respect to a drug or biological product
                    directed at such molecular target; or
                      (B) to authorize the disclosure of
                    confidential commercial information, as
                    prohibited under section 301(j) of this Act or
                    section 1905 of title 18, United States Code.

               *       *       *       *       *       *       *

    SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW QUALIFIED INFECTIOUS
                        DISEASE PRODUCTS.

      (a) Extension.--If the Secretary approves an application
    pursuant to section 505 for a drug that has been designated as
    a qualified infectious disease product under subsection (d),
    the 4- and 5-year periods described in subsections
    (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-year
    periods described in clauses (iii) and (iv) of subsection
    (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of
    section 505, or the 7-year period described in section 527, as
    applicable, shall be extended by 5 years.
      (b) Relation to Pediatric Exclusivity.--Any extension under
    subsection (a) of a period shall be in addition to any
    extension of the period under section 505A with respect to the
    drug.
      (c) Limitations.--Subsection (a) does not apply to the
    approval of--
              (1) a supplement to an application under section
            505(b) for any qualified infectious disease product for
            which an extension described in subsection (a) is in
            effect or has expired;
              (2) a subsequent application filed with respect to a
            product approved under section 505 for a change that
            results in a new indication, route of administration,
            dosing schedule, dosage form, delivery system, delivery
            device, or strength; [or]
              (3) a product that does not meet the definition of a
            qualified infectious disease product under subsection
            (g) based upon its approved uses[.]; or
              (4) an application pursuant to section 351(a) of the
            Public Health Service Act.
      (d) Designation.--
              (1) In general.--The manufacturer or sponsor of a
            drug may request the Secretary to designate a drug as a
            qualified infectious disease product at any time before
            the submission of an application under section 505(b)
            of this Act or section 351(a) of the Public Health
            Service Act for such drug. The Secretary shall, not
            later than 60 days after the submission of such a
            request, determine whether the drug is a qualified
            infectious disease product.
              (2) Limitation.--Except as provided in paragraph (3),
            a designation under this subsection shall not be
            withdrawn for any reason, including modifications to
            the list of qualifying pathogens under subsection
            (f)(2)(C).
              (3) Revocation of designation.--The Secretary may
            revoke a designation of a drug as a qualified
            infectious disease product if the Secretary finds that
            the request for such designation contained an untrue
            statement of material fact.
      (e) Regulations.--
              (1) In general.--Not later than 2 years after the
            date of enactment of the Food and Drug Administration
            Safety and Innovation Act, the Secretary shall adopt
            final regulations implementing this section, including
            developing the list of qualifying pathogens described
            in subsection (f).
              (2) Procedure.--In promulgating a regulation
            implementing this section, the Secretary shall--
                      (A) issue a notice of proposed rulemaking
                    that includes the proposed regulation;
                      (B) provide a period of not less than 60 days
                    for comments on the proposed regulation; and
                      (C) publish the final regulation not less
                    than 30 days before the effective date of the
                    regulation.
              (3) Restrictions.--Notwithstanding any other
            provision of law, the Secretary shall promulgate
            regulations implementing this section only as described
            in paragraph (2), except that the Secretary may issue
            interim guidance for sponsors seeking designation under
            subsection (d) prior to the promulgation of such
            regulations.
              (4) Designation prior to regulations.--The Secretary
            shall designate drugs as qualified infectious disease
            products under subsection (d) prior to the promulgation
            of regulations under this subsection, if such drugs
            meet the definition of a qualified infectious disease
            product described in subsection (g).
      (f) Qualifying Pathogen.--
              (1) Definition.--In this section, the term
            ``qualifying pathogen'' means a pathogen identified and
            listed by the Secretary under paragraph (2) that has
            the potential to pose a serious threat to public
            health, such as--
                      (A) resistant gram positive pathogens,
                    including methicillin-resistant Staphylococcus
                    aureus, vancomycin-resistant Staphylococcus
                    aureus, and vancomycin-resistant enterococcus;
                      (B) multi-drug resistant gram negative
                    bacteria, including Acinetobacter, Klebsiella,
                    Pseudomonas, and E. coli species;
                      (C) multi-drug resistant tuberculosis; and
                      (D) Clostridium difficile.
              (2) List of qualifying pathogens.--
                      (A) In general.--The Secretary shall
                    establish and maintain a list of qualifying
                    pathogens, and shall make public the
                    methodology for developing such list.
                      (B) Considerations.--In establishing and
                    maintaining the list of pathogens described
                    under this section, the Secretary shall--
                              (i) consider--
                                      (I) the impact on the public
                                    health due to drug-resistant
                                    organisms in humans;
                                      (II) the rate of growth of
                                    drug-resistant organisms in
                                    humans;
                                      (III) the increase in
                                    resistance rates in humans; and
                                      (IV) the morbidity and
                                    mortality in humans; and
                              (ii) consult with experts in
                            infectious diseases and antibiotic
                            resistance, including the Centers for
                            Disease Control and Prevention, the
                            Food and Drug Administration, medical
                            professionals, and the clinical
                            research community.
                      (C) Review.--Every 5 years, or more often as
                    needed, the Secretary shall review, provide
                    modifications to, and publish the list of
                    qualifying pathogens under subparagraph (A) and
                    shall by regulation revise the list as
                    necessary, in accordance with subsection (e).
      [(g) Qualified Infectious Disease Product.--The term
    ``qualified infectious disease product'' means an antibacterial
    or antifungal drug for human use intended to treat serious or
    life-threatening infections, including those caused by--
              [(1) an antibacterial or antifungal resistant
            pathogen, including novel or emerging infectious
            pathogens; or
              [(2) qualifying pathogens listed by the Secretary
            under subsection (f).]
      (g) Qualified Infectious Disease Product.--The term
    ``qualified infectious disease product'' means a drug,
    including an antibacterial or antifungal drug or a biological
    product, for human use that--
              (1) acts directly on bacteria or fungi or on
            substances produced by such bacteria or fungi; and
              (2) is intended to treat a serious or life-
            threatening infection, including such an infection
            caused by--
                      (A) an antibacterial or antifungal resistant
                    pathogen, including novel or emerging
                    infectious pathogens; or
                      (B) qualifying pathogens listed by the
                    Secretary under subsection (f).

               *       *       *       *       *       *       *

    SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-THREATENING
                        DISEASES OR CONDITIONS.

      (a) Designation of a Drug as a Breakthrough Therapy.--
              (1) In general.--The Secretary shall, at the request
            of the sponsor of a drug, expedite the development and
            review of such drug if the drug is intended, alone or
            in combination with 1 or more other drugs, to treat a
            serious or life-threatening disease or condition and
            preliminary clinical evidence indicates that the drug
            may demonstrate substantial improvement over existing
            therapies on 1 or more clinically significant
            endpoints, such as substantial treatment effects
            observed early in clinical development. (In this
            section, such a drug is referred to as a ``breakthrough
            therapy''.)
              (2) Request for designation.--The sponsor of a drug
            may request the Secretary to designate the drug as a
            breakthrough therapy. A request for the designation may
            be made concurrently with, or at any time after, the
            submission of an application for the investigation of
            the drug under section 505(i) or section 351(a)(3) of
            the Public Health Service Act.
              (3) Designation.--
                      (A) In general.--Not later than 60 calendar
                    days after the receipt of a request under
                    paragraph (2), the Secretary shall determine
                    whether the drug that is the subject of the
                    request meets the criteria described in
                    paragraph (1). If the Secretary finds that the
                    drug meets the criteria, the Secretary shall
                    designate the drug as a breakthrough therapy
                    and shall take such actions as are appropriate
                    to expedite the development and review of the
                    application for approval of such drug.
                      (B) Actions.--The actions to expedite the
                    development and review of an application under
                    subparagraph (A) may include, as appropriate--
                              (i) holding meetings with the sponsor
                            and the review team throughout the
                            development of the drug;
                              (ii) providing timely advice to, and
                            interactive communication with, the
                            sponsor regarding the development of
                            the drug to ensure that the development
                            program to gather the nonclinical and
                            clinical data necessary for approval is
                            as efficient as practicable;
                              (iii) involving senior managers and
                            experienced review staff, as
                            appropriate, in a collaborative, cross-
                            disciplinary review;
                              (iv) assigning a cross-disciplinary
                            project lead for the Food and Drug
                            Administration review team to
                            facilitate an efficient review of the
                            development program and to serve as a
                            scientific liaison between the review
                            team and the sponsor; and
                              (v) taking steps to ensure that the
                            design of the clinical trials is as
                            efficient as practicable, when
                            scientifically appropriate, such as by
                            minimizing the number of patients
                            exposed to a potentially less
                            efficacious treatment.
      (b) Designation of Drug as Fast Track Product.--
              (1) In general.--The Secretary shall, at the request
            of the sponsor of a new drug, facilitate the
            development and expedite the review of such drug if it
            is intended, whether alone or in combination with one
            or more other drugs, for the treatment of a serious or
            life-threatening disease or condition, and it
            demonstrates the potential to address unmet medical
            needs for such a disease or condition, or if the
            Secretary designates the drug as a qualified infectious
            disease product under section 505E(d). (In this
            section, such a drug is referred to as a ``fast track
            product''.)
              (2) Request for designation.--The sponsor of a new
            drug may request the Secretary to designate the drug as
            a fast track product. A request for the designation may
            be made concurrently with, or at any time after,
            submission of an application for the investigation of
            the drug under section 505(i) or section 351(a)(3) of
            the Public Health Service Act.
              (3) Designation.--Within 60 calendar days after the
            receipt of a request under paragraph (2), the Secretary
            shall determine whether the drug that is the subject of
            the request meets the criteria described in paragraph
            (1). If the Secretary finds that the drug meets the
            criteria, the Secretary shall designate the drug as a
            fast track product and shall take such actions as are
            appropriate to expedite the development and review of
            the application for approval of such product.
      (c) Accelerated Approval of a Drug for a Serious or Life-
    Threatening Disease or Condition, Including a Fast Track
    Product.--
              (1) In general.--
                      (A) Accelerated approval.--The Secretary may
                    approve an application for approval of a
                    product for a serious or life-threatening
                    disease or condition, including a fast track
                    product, under section 505(c) or section 351(a)
                    of the Public Health Service Act upon a
                    determination that the product has an effect on
                    a surrogate endpoint that is reasonably likely
                    to predict clinical benefit, or on a clinical
                    endpoint that can be measured earlier than
                    irreversible morbidity or mortality, that is
                    reasonably likely to predict an effect on
                    irreversible morbidity or mortality or other
                    clinical benefit, taking into account the
                    severity, rarity, or prevalence of the
                    condition and the availability or lack of
                    alternative treatments. The approval described
                    in the preceding sentence is referred to in
                    this section as ``accelerated approval''.
                      (B) Evidence.--The evidence to support that
                    an endpoint is reasonably likely to predict
                    clinical benefit under subparagraph (A) may
                    include epidemiological, pathophysiological,
                    therapeutic, pharmacologic, or other evidence
                    developed using biomarkers, for example, or
                    other scientific methods or tools.
              [(2) Limitation.--Approval of a product under this
            subsection may be subject to 1 or both of the following
            requirements:
                      [(A) That the sponsor conduct appropriate
                    postapproval studies to verify and describe the
                    predicted effect on irreversible morbidity or
                    mortality or other clinical benefit.
                      [(B) That the sponsor submit copies of all
                    promotional materials related to the product
                    during the preapproval review period and,
                    following approval and for such period
                    thereafter as the Secretary determines to be
                    appropriate, at least 30 days prior to
                    dissemination of the materials.
              [(3) Expedited withdrawal of approval.--The Secretary
            may withdraw approval of a product approved under
            accelerated approval using expedited procedures (as
            prescribed by the Secretary in regulations which shall
            include an opportunity for an informal hearing) if--
                      [(A) the sponsor fails to conduct any
                    required postapproval study of the drug with
                    due diligence;
                      [(B) a study required to verify and describe
                    the predicted effect on irreversible morbidity
                    or mortality or other clinical benefit of the
                    product fails to verify and describe such
                    effect or benefit;
                      [(C) other evidence demonstrates that the
                    product is not safe or effective under the
                    conditions of use; or
                      [(D) the sponsor disseminates false or
                    misleading promotional materials with respect
                    to the product.]
              (2) Limitation.--
                      (A) In general.--Approval of a product under
                    this subsection may be subject to 1 or both of
                    the following requirements:
                              (i) That the sponsor conduct an
                            appropriate postapproval study or
                            studies (which may be augmented or
                            supported by real world evidence) to
                            verify and describe the predicted
                            effect on irreversible morbidity or
                            mortality or other clinical benefit.
                              (ii) That the sponsor submit copies
                            of all promotional materials related to
                            the product during the preapproval
                            review period and, following approval
                            and for such period thereafter as the
                            Secretary determines to be appropriate,
                            at least 30 days prior to dissemination
                            of the materials.
                      (B) Studies not required.--If the Secretary
                    does not require that the sponsor of a product
                    approved under accelerated approval conduct a
                    postapproval study under this paragraph, the
                    Secretary shall publish on the website of the
                    Food and Drug Administration the rationale for
                    why such study is not appropriate or necessary.
                      (C) Postapproval study conditions.--Not later
                    than the time of approval of a product under
                    accelerated approval, the Secretary shall
                    specify the conditions for a postapproval study
                    or studies required to be conducted under this
                    paragraph with respect to such product, which
                    may include enrollment targets, the study
                    protocol, and milestones, including the target
                    date of study completion.
                      (D) Studies begun before approval.--The
                    Secretary may require such study or studies to
                    be underway prior to approval.
              (3) Expedited withdrawal of approval.--
                      (A) In general.--The Secretary may withdraw
                    approval of a product approved under
                    accelerated approval using expedited procedures
                    described in subparagraph (B), if--
                              (i) the sponsor fails to conduct any
                            required postapproval study of the
                            product with due diligence, including
                            with respect to conditions specified by
                            the Secretary under paragraph (2)(C);
                              (ii) a study required to verify and
                            describe the predicted effect on
                            irreversible morbidity or mortality or
                            other clinical benefit of the product
                            fails to verify and describe such
                            effect or benefit;
                              (iii) other evidence demonstrates
                            that the product is not shown to be
                            safe or effective under the conditions
                            of use; or
                              (iv) the sponsor disseminates false
                            or misleading promotional materials
                            with respect to the product.
                      (B) Expedited procedures described.--
                    Expedited procedures described in this
                    subparagraph shall consist of, prior to the
                    withdrawal of accelerated approval--
                              (i) providing the sponsor with--
                                      (I) due notice;
                                      (II) an explanation for the
                                    proposed withdrawal;
                                      (III) an opportunity for a
                                    meeting with the Commissioner
                                    of Food and Drugs or the
                                    Commissioner's designee; and
                                      (IV) an opportunity for
                                    written appeal to--
                                              (aa) the Commissioner
                                            of Food and Drugs; or
                                              (bb) a designee of
                                            the Commissioner who
                                            has not participated in
                                            the proposed withdrawal
                                            of approval (other than
                                            a meeting pursuant to
                                            subclause (III)) and is
                                            not a subordinate of an
                                            individual (other than
                                            the Commissioner) who
                                            participated in such
                                            proposed withdrawal;
                              (ii) providing an opportunity for
                            public comment on the notice proposing
                            to withdraw approval;
                              (iii) the publication of a summary of
                            the public comments received, and the
                            Secretary's response to such comments,
                            on the website of the Food and Drug
                            Administration; and
                              (iv) convening and consulting an
                            advisory committee on issues related to
                            the proposed withdrawal, if requested
                            by the sponsor and if no such advisory
                            committee has previously advised the
                            Secretary on such issues with respect
                            to the withdrawal of the product prior
                            to the sponsor's request.
              (4) Labeling.--
                      (A) In general.--Subject to subparagraph (B),
                    the labeling for a product approved under
                    accelerated approval shall include--
                              (i) a statement indicating that the
                            product was approved under accelerated
                            approval;
                              (ii) a statement indicating that
                            continued approval of the product is
                            subject to postmarketing studies to
                            verify clinical benefit;
                              (iii) identification of the surrogate
                            or intermediate endpoint or endpoints
                            that supported approval and any known
                            limitations of such surrogate or
                            intermediate endpoint or endpoints in
                            determining clinical benefit; and
                              (iv) a succinct description of the
                            product and any uncertainty about
                            anticipated clinical benefit and a
                            discussion of available evidence with
                            respect to such clinical benefit.
                      (B) Applicability.--The labeling requirements
                    of subparagraph (A) shall apply only to
                    products approved under accelerated approval
                    for which the predicted effect on irreversible
                    morbidity or mortality or other clinical
                    benefit has not been verified.
                      (C) Rule of construction.--With respect to
                    any application pending before the Secretary on
                    the date of enactment of the Food and Drug
                    Amendments of 2022, the Secretary shall allow
                    any applicable changes to the product labeling
                    required to comply with subparagraph (A) to be
                    made by supplement after the approval of such
                    application.
              (5) Reporting.--Not later than September 30, 2025,
            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 describing circumstances in which
            the Secretary considered real world evidence submitted
            to support postapproval studies required under this
            subsection that were completed after the date of
            enactment of the Food and Drug Amendments of 2022.
      (d) Review of Incomplete Applications for Approval of a Fast
    Track Product.--
              (1) In general.--If the Secretary determines, after
            preliminary evaluation of clinical data submitted by
            the sponsor, that a fast track product may be
            effective, the Secretary shall evaluate for filing, and
            may commence review of portions of, an application for
            the approval of the product before the sponsor submits
            a complete application. The Secretary shall commence
            such review only if the applicant--
                      (A) provides a schedule for submission of
                    information necessary to make the application
                    complete; and
                      (B) pays any fee that may be required under
                    section 736.
              (2) Exception.--Any time period for review of human
            drug applications that has been agreed to by the
            Secretary and that has been set forth in goals
            identified in letters of the Secretary (relating to the
            use of fees collected under section 736 to expedite the
            drug development process and the review of human drug
            applications) shall not apply to an application
            submitted under paragraph (1) until the date on which
            the application is complete.
      (e) Construction.--
              (1) Purpose.--The amendments made by the Food and
            Drug Administration Safety and Innovation Act and the
            21st Century Cures Act to this section are intended to
            encourage the Secretary to utilize innovative and
            flexible approaches to the assessment of products under
            accelerated approval for treatments for patients with
            serious or life-threatening diseases or conditions and
            unmet medical needs.
              (2) Construction.--Nothing in this section shall be
            construed to alter the standards of evidence under
            subsection (c) or (d) of section 505 (including the
            substantial evidence standard in section 505(d)) of
            this Act or under section 351(a) of the Public Health
            Service Act. Such sections and standards of evidence
            apply to the review and approval of products under this
            section, including whether a product is safe and
            effective. Nothing in this section alters the ability
            of the Secretary to rely on evidence that does not come
            from adequate and well-controlled investigations for
            the purpose of determining whether an endpoint is
            reasonably likely to predict clinical benefit as
            described in subsection (b)(1)(B).
      (f) Awareness Efforts.--The Secretary shall--
              (1) develop and disseminate to physicians, patient
            organizations, pharmaceutical and biotechnology
            companies, and other appropriate persons a description
            of the provisions of this section applicable to
            breakthrough therapies, accelerated approval, and and
            fast track products; and
              (2) establish a program to encourage the development
            of surrogate and clinical endpoints, including
            biomarkers, and other scientific methods and tools that
            can assist the Secretary in determining whether the
            evidence submitted in an application is reasonably
            likely to predict clinical benefit for serious or life-
            threatening conditions for which significant unmet
            medical needs exist.
      (g) Regenerative Advanced Therapy.--
              (1) In general.--The Secretary, at the request of the
            sponsor of a drug, shall facilitate an efficient
            development program for, and expedite review of, such
            drug if the drug qualifies as a regenerative advanced
            therapy under the criteria described in paragraph (2).
              (2) Criteria.--A drug is eligible for designation as
            a regenerative advanced therapy under this subsection
            if--
                      (A) the drug is a regenerative medicine
                    therapy (as defined in paragraph (8));
                      (B) the drug is intended to treat, modify,
                    reverse, or cure a serious or life-threatening
                    disease or condition; and
                      (C) preliminary clinical evidence indicates
                    that the drug has the potential to address
                    unmet medical needs for such a disease or
                    condition.
              (3) Request for designation.--The sponsor of a drug
            may request the Secretary to designate the drug as a
            regenerative advanced therapy concurrently with, or at
            any time after, submission of an application for the
            investigation of the drug under section 505(i) of this
            Act or section 351(a)(3) of the Public Health Service
            Act.
              (4) Designation.--Not later than 60 calendar days
            after the receipt of a request under paragraph (3), the
            Secretary shall determine whether the drug that is the
            subject of the request meets the criteria described in
            paragraph (2). If the Secretary determines that the
            drug meets the criteria, the Secretary shall designate
            the drug as a regenerative advanced therapy and shall
            take such actions as are appropriate under paragraph
            (1). If the Secretary determines that a drug does not
            meet the criteria for such designation, the Secretary
            shall include with the determination a written
            description of the rationale for such determination.
              (5) Actions.--The sponsor of a regenerative advanced
            therapy shall be eligible for the actions to expedite
            development and review of such therapy under subsection
            (a)(3)(B), including early interactions to discuss any
            potential surrogate or intermediate endpoint to be used
            to support the accelerated approval of an application
            for the product under subsection (c).
              (6) Access to expedited approval pathways.--An
            application for a regenerative advanced therapy under
            section 505(b)(1) of this Act or section 351(a) of the
            Public Health Service Act may be--
                      (A) eligible for priority review, as
                    described in the Manual of Policies and
                    Procedures of the Food and Drug Administration
                    and goals identified in the letters described
                    in section 101(b) of the Prescription Drug User
                    Fee Amendments of 2012; and
                      (B) eligible for accelerated approval under
                    subsection (c), as agreed upon pursuant to
                    subsection (a)(3)(B), through, as appropriate--
                              (i) surrogate or intermediate
                            endpoints reasonably likely to predict
                            long-term clinical benefit; or
                              (ii) reliance upon data obtained from
                            a meaningful number of sites, including
                            through expansion to additional sites,
                            as appropriate.
              (7) Postapproval requirements.--The sponsor of a
            regenerative advanced therapy that is granted
            accelerated approval and is subject to the postapproval
            requirements under subsection (c) may, as appropriate,
            fulfill such requirements, as the Secretary may
            require, through--
                      (A) the submission of clinical evidence,
                    clinical studies, patient registries, or other
                    sources of real world evidence, such as
                    electronic health records;
                      (B) the collection of larger confirmatory
                    data sets, as agreed upon pursuant to
                    subsection (a)(3)(B); or
                      (C) postapproval monitoring of all patients
                    treated with such therapy prior to approval of
                    the therapy.
              (8) Definition.--For purposes of this section, the
            term ``regenerative medicine therapy'' includes cell
            therapy, therapeutic tissue engineering products, human
            cell and tissue products, and combination products
            using any such therapies or products, except for those
            regulated solely under section 361 of the Public Health
            Service Act and part 1271 of title 21, Code of Federal
            Regulations.
      (h) Limited Population Pathway for Antibacterial and
    Antifungal Drugs.--
              (1) In general.--The Secretary may approve an
            antibacterial or antifungal drug, alone or in
            combination with one or more other drugs, as a limited
            population drug pursuant to this subsection only if--
                      (A) the drug is intended to treat a serious
                    or life-threatening infection in a limited
                    population of patients with unmet needs;
                      (B) the standards for approval under section
                    505(c) and (d), or the standards for licensure
                    under section 351 of the Public Health Service
                    Act, as applicable, are met; and
                      (C) the Secretary receives a written request
                    from the sponsor to approve the drug as a
                    limited population drug pursuant to this
                    subsection.
              (2) Benefit-risk consideration.--The Secretary's
            determination of safety and effectiveness of an
            antibacterial or antifungal drug shall reflect the
            benefit-risk profile of such drug in the intended
            limited population, taking into account the severity,
            rarity, or prevalence of the infection the drug is
            intended to treat and the availability or lack of
            alternative treatment in such limited population. Such
            drug may be approved under this subsection
            notwithstanding a lack of evidence to fully establish a
            favorable benefit-risk profile in a population that is
            broader than the intended limited population.
              (3) Additional requirements.--A drug approved under
            this subsection shall be subject to the following
            requirements, in addition to any other applicable
            requirements of this Act:
                      (A) Labeling.--To indicate that the safety
                    and effectiveness of a drug approved under this
                    subsection has been demonstrated only with
                    respect to a limited population--
                              (i) all labeling and advertising of
                            an antibacterial or antifungal drug
                            approved under this subsection shall
                            contain the statement ``Limited
                            Population'' in a prominent manner and
                            adjacent to, and not more prominent
                            than--
                                      (I) the proprietary name of
                                    such drug, if any; or
                                      (II) if there is no
                                    proprietary name, the
                                    established name of the drug,
                                    if any, as defined in section
                                    503(e)(3), or, in the case of a
                                    drug that is a biological
                                    product, the proper name, as
                                    defined by regulation; and
                              (ii) the prescribing information for
                            the drug required by section 201.57 of
                            title 21, Code of Federal Regulations
                            (or any successor regulation) shall
                            also include the following statement:
                            ``This drug is indicated for use in a
                            limited and specific population of
                            patients.''.
                      (B) Promotional material.--The sponsor of an
                    antibacterial or antifungal drug subject to
                    this subsection shall submit to the Secretary
                    copies of all promotional materials related to
                    such drug at least 30 calendar days prior to
                    dissemination of the materials.
              (4) Other programs.--A sponsor of a drug that seeks
            approval of a drug under this subsection may also seek
            designation or approval, as applicable, of such drug
            under other applicable sections or subsections of this
            Act or the Public Health Service Act.
              (5) Guidance.--Not later than 18 months after the
            date of enactment of the 21st Century Cures Act, the
            Secretary shall issue draft guidance describing
            criteria, processes, and other general considerations
            for demonstrating the safety and effectiveness of
            limited population antibacterial and antifungal drugs.
            The Secretary shall publish final guidance within 18
            months of the close of the public comment period on
            such draft guidance. The Secretary may approve
            antibacterial and antifungal drugs under this
            subsection prior to issuing guidance under this
            paragraph.
              (6) Advice.--The Secretary shall provide prompt
            advice to the sponsor of a drug for which the sponsor
            seeks approval under this subsection to enable the
            sponsor to plan a development program to obtain the
            necessary data for such approval, and to conduct any
            additional studies that would be required to gain
            approval of such drug for use in a broader population.
              (7) Termination of limitations.--If, after approval
            of a drug under this subsection, the Secretary approves
            a broader indication for such drug under section 505(b)
            or section 351(a) of the Public Health Service Act, the
            Secretary may remove any postmarketing conditions,
            including requirements with respect to labeling and
            review of promotional materials under paragraph (3),
            applicable to the approval of the drug under this
            subsection.
              (8) Rules of construction.--Nothing in this
            subsection shall be construed to alter the authority of
            the Secretary to approve drugs pursuant to this Act or
            section 351 of the Public Health Service Act, including
            the standards of evidence and applicable conditions for
            approval under such Acts, the standards of approval of
            a drug under such Acts, or to alter the authority of
            the Secretary to monitor drugs pursuant to such Acts.
              (9) Reporting and accountability.--
                      (A) Biennial reporting.--The Secretary shall
                    report to Congress not less often than once
                    every 2 years on the number of requests for
                    approval, and the number of approvals, of an
                    antibacterial or antifungal drug under this
                    subsection.
                      (B) GAO report.--Not later than December
                    2021, the Comptroller General of the United
                    States shall submit to the Committee on Energy
                    and Commerce of the House of Representatives
                    and the Committee on Health, Education, Labor
                    and Pensions of the Senate a report on the
                    coordination of activities required under
                    section 319E of the Public Health Service Act.
                    Such report shall include a review of such
                    activities, and the extent to which the use of
                    the pathway established under this subsection
                    has streamlined premarket approval for
                    antibacterial or antifungal drugs for limited
                    populations, if such pathway has functioned as
                    intended, if such pathway has helped provide
                    for safe and effective treatment for patients,
                    if such premarket approval would be appropriate
                    for other categories of drugs, and if the
                    authorities under this subsection have affected
                    antibacterial or antifungal resistance.

               *       *       *       *       *       *       *

    SEC. 506B. REPORTS OF POSTMARKETING STUDIES.

      (a) Submission.--
              (1) In general.--A sponsor of a drug that has entered
            into an agreement with the Secretary to conduct a
            postmarketing study of a drug shall submit to the
            Secretary, within 1 year after the approval of such
            drug and annually thereafter until the study is
            completed or terminated, a report of the progress of
            the study or the reasons for the failure of the sponsor
            to conduct the study. The report shall be submitted in
            such form as is prescribed by the Secretary in
            regulations issued by the Secretary.
              (2) Accelerated approval.--Notwithstanding paragraph
            (1), a sponsor of a drug approved under accelerated
            approval shall submit to the Secretary a report of the
            progress of any study required under section 506(c),
            including progress toward enrollment targets,
            milestones, and other information as required by the
            Secretary, not later than 180 days after the approval
            of such drug and not less frequently than every 180
            days thereafter, until the study is completed or
            terminated.
              [(2)] (3) Agreements prior to effective date.--Any
            agreement entered into between the Secretary and a
            sponsor of a drug, prior to the date of enactment of
            the Food and Drug Administration Modernization Act of
            1997, to conduct a postmarketing study of a drug shall
            be subject to the requirements of paragraph (1). An
            initial report for such an agreement shall be submitted
            within 6 months after the date of the issuance of the
            regulations under paragraph (1).
      (b) Consideration of Information as Public Information.--Any
    information pertaining to a report described in subsection (a)
    shall be considered to be public information to the extent that
    the information is necessary--
              (1) to identify the sponsor; and
              (2) to establish the status of a study described in
            subsection (a) and the reasons, if any, for any failure
            to carry out the study.
      (c) Status of Studies and Reports.--The Secretary shall
    annually develop and publish in the Federal Register a report
    that provides information on the status of the postmarketing
    studies--
              (1) that sponsors have entered into agreements to
            conduct; and
              (2) for which reports have been submitted under
            subsection (a)(1).
      (d) Disclosure.--If a sponsor fails to complete an agreed
    upon study required by this section by its original or
    otherwise negotiated deadline, the Secretary shall publish a
    statement on the Internet site of the Food and Drug
    Administration stating that the study was not completed and, if
    the reasons for such failure to complete the study were not
    satisfactory to the Secretary, a statement that such reasons
    were not satisfactory to the Secretary.
      (e) Notification.--With respect to studies of the type
    required under section 506(c)(2)(A) or under section 314.510 or
    601.41 of title 21, Code of Federal Regulations, as each of
    such sections was in effect on the day before the effective
    date of this subsection, the Secretary may require that a
    sponsor who, for reasons not satisfactory to the Secretary,
    fails to complete by its deadline a study under any of such
    sections of such type for a drug or biological product
    (including such a study conducted after such effective date)
    notify practitioners who prescribe such drug or biological
    product of the failure to complete such study and the questions
    of clinical benefit, and, where appropriate, questions of
    safety, that remain unanswered as a result of the failure to
    complete such study. Nothing in this subsection shall be
    construed as altering the requirements of the types of studies
    required under section 506(c)(2)(A) or under section 314.510 or
    601.41 of title 21, Code of Federal Regulations, as so in
    effect, or as prohibiting the Secretary from modifying such
    sections of title 21 of such Code to provide for studies in
    addition to those of such type.

               *       *       *       *       *       *       *

    SEC. 506C-1. ANNUAL REPORTING ON DRUG SHORTAGES.

      (a) Annual Reports to Congress.--Not later than March 31 of
    each calendar year, 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, with respect to the preceding calendar year,
    on drug shortages that--
              (1) specifies the number of manufacturers that
            submitted a notification to the Secretary under section
            506C(a) during such calendar year;
              [(2) describes the communication between the field
            investigators of the Food and Drug Administration and
            the staff of the Center for Drug Evaluation and
            Research's Office of Compliance and Drug Shortage
            Program, including the Food and Drug Administration's
            procedures for enabling and ensuring such
            communication;]
              (2)(A) describes the communication between the field
            investigators of the Food and Drug Administration and
            the staff of the Center for Drug Evaluation and
            Research's Office of Compliance and Drug Shortage
            Program, including the Food and Drug Administration's
            procedures for enabling and ensuring such
            communication;
              (B) provides the number of reports described in
            section 704(b)(2) that were required to be sent to the
            appropriate offices of the Food and Drug Administration
            and the number of such reports that were sent; and
              (C) describes the coordination and alignment
            activities undertaken pursuant to section 506D(g);
              (3)(A) lists the major actions taken by the Secretary
            to prevent or mitigate the drug shortages described in
            paragraph (7);
              (B) in the list under subparagraph (A), includes--
                      (i) the number of applications and
                    supplements for which the Secretary expedited
                    review under section 506C(g)(1) during such
                    calendar year; and
                      (ii) the number of establishment inspections
                    or reinspections that the Secretary expedited
                    under section 506C(g)(2) during such calendar
                    year;
              (4) describes the coordination between the Food and
            Drug Administration and the Drug Enforcement
            Administration on efforts to prevent or alleviate drug
            shortages;
              (5) identifies the number of and describes the
            instances in which the Food and Drug Administration
            exercised regulatory flexibility and discretion to
            prevent or alleviate a drug shortage;
              (6) lists the names of manufacturers that were issued
            letters under section 506C(f); and
              (7) specifies the number of drug shortages occurring
            during such calendar year, as identified by the
            Secretary.
      (b) Trend Analysis.--The Secretary is authorized to retain a
    third party to conduct a study, if the Secretary believes such
    a study would help clarify the causes, trends, or solutions
    related to drug shortages.
      (c) Definition.--In this section, the term ``drug shortage''
    or ``shortage'' has the meaning given such term in section
    506C.

    SEC. 506D. COORDINATION; TASK FORCE AND STRATEGIC PLAN.

      (a) Task Force and Strategic Plan.--
              (1) In general.--
                      (A) Task force.--As soon as practicable after
                    the date of enactment of the Food and Drug
                    Administration Safety and Innovation Act, the
                    Secretary shall establish a task force to
                    develop and implement a strategic plan for
                    enhancing the Secretary's response to
                    preventing and mitigating drug shortages.
                      (B) Strategic plan.--The strategic plan
                    described in subparagraph (A) shall include--
                              (i) plans for enhanced interagency
                            and intra-agency coordination,
                            communication, and decisionmaking;
                              (ii) plans for ensuring that drug
                            shortages are considered when the
                            Secretary initiates a regulatory action
                            that could precipitate a drug shortage
                            or exacerbate an existing drug
                            shortage;
                              (iii) plans for effective
                            communication with outside
                            stakeholders, including who the
                            Secretary should alert about potential
                            or actual drug shortages, how the
                            communication should occur, and what
                            types of information should be shared;
                              (iv) plans for considering the impact
                            of drug shortages on research and
                            clinical trials; and
                              (v) an examination of whether to
                            establish a ``qualified manufacturing
                            partner program'', as described in
                            subparagraph (C).
                      (C) Description of program.--In conducting
                    the examination of a ``qualified manufacturing
                    partner program'' under subparagraph (B)(v),
                    the Secretary--
                              (i) shall take into account that--
                                      (I) a ``qualified
                                    manufacturer'', for purposes of
                                    such program, would need to
                                    have the capability and
                                    capacity to supply products
                                    determined or anticipated to be
                                    in shortage; and
                                      (II) in examining the
                                    capability and capacity to
                                    supply products in shortage,
                                    the ``qualified manufacturer''
                                    could have a site that
                                    manufactures a drug listed
                                    under section 506E or have the
                                    capacity to produce drugs in
                                    response to a shortage within a
                                    rapid timeframe; and
                              (ii) shall examine whether incentives
                            are necessary to encourage the
                            participation of ``qualified
                            manufacturers'' in such a program.
                      (D) Consultation.--In carrying out this
                    paragraph, the task force shall ensure
                    consultation with the appropriate offices
                    within the Food and Drug Administration,
                    including the Office of the Commissioner, the
                    Center for Drug Evaluation and Research, the
                    Office of Regulatory Affairs, and employees
                    within the Department of Health and Human
                    Services with expertise regarding drug
                    shortages. The Secretary shall engage external
                    stakeholders and experts as appropriate.
              (2) Timing.--Not later than 1 year after the date of
            enactment of the Food and Drug Administration Safety
            and Innovation Act, the task force shall--
                      (A) publish the strategic plan described in
                    paragraph (1); and
                      (B) submit such plan to Congress.
      (b) Communication.--The Secretary shall ensure that, prior to
    any enforcement action or issuance of a warning letter that the
    Secretary determines could reasonably be anticipated to lead to
    a meaningful disruption in the supply in the United States of a
    drug described under section 506C(a), there is communication
    with the appropriate office of the Food and Drug Administration
    with expertise regarding drug shortages regarding whether the
    action or letter could cause, or exacerbate, a shortage of the
    drug.
      (c) Action.--If the Secretary determines, after the
    communication described in subsection (b), that an enforcement
    action or a warning letter could reasonably cause or exacerbate
    a shortage of a drug described under section 506C(a), then the
    Secretary shall evaluate the risks associated with the impact
    of such shortage upon patients and those risks associated with
    the violation involved before taking such action or issuing
    such letter, unless there is imminent risk of serious adverse
    health consequences or death to humans.
      (d) Reporting by Other Entities.--The Secretary shall
    identify or establish a mechanism by which health care
    providers and other third-party organizations may report to the
    Secretary evidence of a drug shortage.
      (e) Review and Construction.--No determination, finding,
    action, or omission of the Secretary under this section shall--
              (1) be subject to judicial review; or
              (2) be construed to establish a defense to an
            enforcement action by the Secretary.
      (f) Sunset.--Subsections (a), (b), (c), and (e) shall cease
    to be effective on the date that is 5 years after the date of
    enactment of the Food and Drug Administration Safety and
    Innovation Act.
      (g) Coordination.--The Secretary shall ensure timely and
    effective internal coordination and alignment among the field
    investigators of the Food and Drug Administration and the staff
    of the Center for Drug Evaluation and Research's Office of
    Compliance and Drug Shortage Program regarding--
              (1) the reviews of reports shared pursuant to section
            704(b)(2); and
              (2) any feedback or corrective or preventive actions
            in response to such reports.

               *       *       *       *       *       *       *

    SEC. 506I. PROMPT REPORTS OF MARKETING STATUS.

      (a) Notification of Withdrawal.--[The holder of an
    application approved under subsection (c) or (j) of section
    505] The holder of an application approved under subsection (c)
    or (j) of section 505 of this Act or subsection (a) or (k) of
    section 351 of the Public Health Service Act 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]
            established name (for biological products, by proper
            name) and by proprietary name, if any;
              (3) new drug application number [or abbreviated
            application number], abbreviated application number, or
            biologics license application number;
              (4) strength of the drug;
              (5) date on which the drug is expected to no longer
            be available for sale; and
              (6) reason for withdrawal of the drug.
      (b) Notification of Drug Not Available for Sale.--[The holder
    of an application approved under subsection (c) or (j)] The
    holder of an application approved under subsection (c) or (j)
    of section 505 of this Act or subsection (a) or (k) of section
    351 of the Public Health Service Act 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]
            established name (for biological products, by proper
            name) and by proprietary name, if any;
              (2) new drug application number [or abbreviated
            application number], abbreviated application number, or
            biologics license application number;
              (3) strength of the drug;
              (4) date on which the drug will be available for
            sale, if known; and
              (5) reason for not marketing the drug after approval.
      [(c) Additional One-time Report.--Within 180 days of the date
    of enactment of this section, all holders of applications
    approved under subsection (c) or (j) of section 505 shall
    review the information in the list published under subsection
    505(j)(7)(A) and shall notify the Secretary in writing that--
              [(1) all of the application holder's drugs in the
            active section of the list published under subsection
            505(j)(7)(A) are available for sale; or
              [(2) one or more of the application holder's drugs in
            the active section of the list published under
            subsection 505(j)(7)(A) have been withdrawn from sale
            or have never been available for sale, and include with
            such notice the information required pursuant to
            subsection (a) or (b), as applicable.
      [(d) Failure to Meet Requirements.--If a holder of an
    approved application fails to submit the information required
    under subsection (a), (b), or (c), the Secretary may move the
    application holder's drugs from the active section of the list
    published under subsection 505(j)(7)(A) to the discontinued
    section of the list, except that the Secretary shall remove
    from the list in accordance with subsection 505(j)(7)(C) drugs
    the Secretary determines have been withdrawn from sale for
    reasons of safety of effectiveness.]
      (c) Additional One-Time Report.--Within 180 days of the date
    of enactment of the Food and Drug Amendments of 2022, all
    holders of applications approved under subsection (a) or (k) of
    section 351 of the Public Health Service Act shall review the
    information in the list published under section 351(k)(9)(A)
    and shall submit a written notice to the Secretary--
              (1) stating that all of the application holder's
            biological products in the list published under section
            351(k)(9)(A) that are not listed as discontinued are
            available for sale; or
              (2) including the information required pursuant to
            subsection (a) or (b), as applicable, for each of the
            application holder's biological products that are in
            the list published under section 351(k)(9)(A) and not
            listed as discontinued, but have been discontinued from
            sale or never have been available for sale.
      (d) Failure To Meet Requirements.--If a holder of an approved
    application fails to submit the information required under
    subsection (a), (b), or (c), the Secretary may--
              (1) move the application holder's drugs from the
            active section of the list published under section
            505(j)(7)(A) to the discontinued section of the list,
            except that the Secretary shall remove from the list in
            accordance with section 505(j)(7)(C) drugs the
            Secretary determines have been withdrawn from sale for
            reasons of safety or effectiveness; and
              (2) identify the application holder's biological
            products as discontinued in the list published under
            section 351(k)(9)(A) of the Public Health Service Act,
            except that the Secretary shall remove from the list in
            accordance with section 351(k)(9)(B) of such Act
            biological products for which the license has been
            revoked or suspended for reasons of safety, purity, or
            potency.
      (e) Updates.--The Secretary shall update the list published
    under [subsection 505(j)(7)(A)] section 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)] section
    505(j)(7)(C). The Secretary shall update the list published
    under section 351(k)(9)(A) of the Public Health Service Act
    based on information provided under subsections (a), (b), and
    (c) by identifying as discontinued biological products that are
    not available for sale, except that biological products for
    which the license has been revoked or suspended for safety,
    purity, or potency reasons shall be removed from the list in
    accordance with section 351(k)(9)(B) of the Public Health
    Service Act. The Secretary shall make [monthly updates to the
    list] monthly updates to the lists referred to in the preceding
    sentences based on the information provided pursuant to
    subsections (a) and (b), [and shall update the list based on]
    and shall update such lists 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. 506K. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PILOT
                        PROGRAM.

      (a) In General.--Not later than 1 year after the date of
    enactment of this section, the Secretary shall initiate a pilot
    program under which persons may request designation of an
    advanced manufacturing technology as described in subsection
    (b).
      (b) Designation Process.--The Secretary shall establish a
    process for the designation under this section of methods of
    manufacturing drugs, including biological products, and active
    pharmaceutical ingredients of such drugs, as advanced
    manufacturing technologies. A method of manufacturing, or a
    combination of manufacturing methods, is eligible for
    designation as an advanced manufacturing technology if such
    method or combination of methods incorporates a novel
    technology, or uses an established technique or technology in a
    novel way, that will substantially improve the manufacturing
    process for a drug and maintain equivalent or provide superior
    drug quality, including by--
              (1) reducing development time for a drug using the
            designated manufacturing method; or
              (2) increasing or maintaining the supply of--
                      (A) a drug that is described in section
                    506C(a) and is intended to treat a serious or
                    life-threatening condition; or
                      (B) a drug that is on the drug shortage list
                    under section 506E.
      (c) Evaluation and Designation of an Advanced Manufacturing
    Technology.--
              (1) Submission.--A person who requests designation of
            a method of manufacturing as an advanced manufacturing
            technology under this section shall submit to the
            Secretary data or information demonstrating that the
            method of manufacturing meets the criteria described in
            subsection (b) in a particular context of use. The
            Secretary may facilitate the development and review of
            such data or information by--
                      (A) providing timely advice to, and
                    interactive communication with, such person
                    regarding the development of the method of
                    manufacturing; and
                      (B) involving senior managers and experienced
                    staff of the Food and Drug Administration, as
                    appropriate, in a collaborative, cross-
                    disciplinary review of the method of
                    manufacturing, as applicable.
              (2) Evaluation and designation.--Not later than 180
            calendar days after the receipt of a request under
            paragraph (1), the Secretary shall determine whether to
            designate such method of manufacturing as an advanced
            manufacturing technology, in a particular context of
            use, based on the data and information submitted under
            paragraph (1) and the criteria described in subsection
            (b).
      (d) Review of Advanced Manufacturing Technologies.--If the
    Secretary designates a method of manufacturing as an advanced
    manufacturing technology, the Secretary shall--
              (1) expedite the development and review of an
            application submitted under section 505 of this Act or
            section 351 of the Public Health Service Act, including
            supplemental applications, for drugs that are
            manufactured using a designated advanced manufacturing
            technology and could help mitigate or prevent a
            shortage or substantially improve manufacturing
            processes for a drug and maintain equivalent or provide
            superior drug quality, as described in subsection (b);
            and
              (2) allow the holder of an advanced technology
            designation, or a person authorized by the advanced
            manufacturing technology designation holder, to
            reference or rely upon, in an application submitted
            under section 505 of this Act or section 351 of the
            Public Health Service Act, including a supplemental
            application, data and information about the designated
            advanced manufacturing technology for use in
            manufacturing drugs in the same context of use for
            which the designation was granted.
      (e) Implementation and Evaluation of Advanced Manufacturing
    Technologies Pilot.--
              (1) Public meeting.--The Secretary shall publish in
            the Federal Register a notice of a public meeting, to
            be held not later than 180 days after the date of
            enactment of this section, to discuss and obtain input
            and recommendations from relevant stakeholders
            regarding--
                      (A) the goals and scope of the pilot program,
                    and a suitable framework, procedures, and
                    requirements for such program; and
                      (B) ways in which the Food and Drug
                    Administration will support the use of advanced
                    manufacturing technologies and other innovative
                    manufacturing approaches for drugs.
              (2) Pilot program guidance.--
                      (A) In general.--The Secretary shall--
                              (i) not later than 180 days after the
                            public meeting under paragraph (1),
                            issue draft guidance regarding the
                            goals and implementation of the pilot
                            program under this section; and
                              (ii) not later than 2 years after the
                            date of enactment of this section,
                            issue final guidance regarding the
                            implementation of such program.
                      (B) Content.--The guidance described in
                    subparagraph (A) shall address--
                              (i) the process by which a person may
                            request a designation under subsection
                            (b);
                              (ii) the data and information that a
                            person requesting such a designation is
                            required to submit under subsection
                            (c), and how the Secretary intends to
                            evaluate such submissions;
                              (iii) the process to expedite the
                            development and review of applications
                            under subsection (d); and
                              (iv) the criteria described in
                            subsection (b) for eligibility for such
                            a designation.
              (3) Report.--Not later than 3 years after the date of
            enactment of this section and annually thereafter, the
            Secretary shall publish on the website of the Food and
            Drug Administration and 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 a report containing a description
            and evaluation of the pilot program being conducted
            under this section, including the types of innovative
            manufacturing approaches supported under the program.
            Such report shall include the following:
                      (A) The number of persons that have requested
                    designations and that have been granted
                    designations.
                      (B) The number of methods of manufacturing
                    that have been the subject of designation
                    requests and that have been granted
                    designations.
                      (C) The average number of calendar days for
                    completion of evaluations under subsection
                    (c)(2).
                      (D) An analysis of the factors in data
                    submissions that are relevant to determinations
                    to designate and not to designate after
                    evaluation under subsection (c)(2).
                      (E) The number of applications received under
                    section 505 of this Act or section 351 of the
                    Public Health Service Act, including
                    supplemental applications, that have included
                    an advanced manufacturing technology designated
                    under this section, and the number of such
                    applications approved.
      (f) Sunset.--The Secretary--
              (1) may not consider any requests for designation
            submitted under subsection (c) after October 1, 2029;
            and
              (2) may continue all activities under this section
            with respect to advanced manufacturing technologies
            that were designated pursuant to subsection (d) prior
            to such date, if the Secretary determines such
            activities are in the interest of the public health.

               *       *       *       *       *       *       *

      Sec. 510. (a) As used in this section--
              (1) the term ``manufacture, preparation, propagation,
            compounding, or processing'' shall include repackaging
            or otherwise changing the container, wrapper, or
            labeling of any drug package or device package in
            furtherance of the distribution of the drug or device
            from the original place of manufacture to the person
            who makes final delivery or sale to the ultimate
            consumer or user; and
              (2) the term ``name'' shall include in the case of a
            partnership the name of each partner and, in the case
            of a corporation, the name of each corporate officer
            and director, and the State of incorporation.
      (b)(1) During the period beginning on October 1 and ending on
    December 31 of each year, every person who owns or operates any
    establishment in any State engaged in the manufacture,
    preparation, propagation, compounding, or processing of a drug
    or drugs shall register with the Secretary the name of such
    person, places of business of such person, all such
    establishments, the unique facility identifier of each such
    establishment, and a point of contact e-mail address.
      (2) During the period beginning on October 1 and ending on
    December 31 of each year, every person who owns or operates any
    establishment in any State engaged in the manufacture,
    preparation, propagation, compounding, or processing of a
    device or devices shall register with the Secretary his name,
    places of business, and all such establishments.
      (3) The Secretary shall specify the unique facility
    identifier system that shall be used by registrants under
    paragraph (1). The requirement to include a unique facility
    identifier in a registration under paragraph (1) shall not
    apply until the date that the identifier system is specified by
    the Secretary under the preceding sentence.
      (c) Every person upon first engaging in the manufacture,
    preparation, propagation, compounding, or processing of a drug
    or drugs or a device or devices in any establishment which he
    owns or operates in any State shall immediately register with
    the Secretary--
              (1) with respect to drugs, the information described
            under subsection (b)(1); and
              (2) with respect to devices, the information
            described under subsection (b)(2)..
      (d) Every person duly registered in accordance with the
    foregoing subsections of this section shall immediately
    register with the Secretary any additional establishment which
    he owns or operates in any State and in which he begins the
    manufacture, preparation, propagation, compounding, or
    processing of a drug or drugs or a device or devices.
      (e) The Secretary may assign a registration number to any
    person or any establishment registered in accordance with this
    section. The Secretary may also assign a listing number to each
    drug or class of drugs listed under subsection (j). Any number
    assigned pursuant to the preceding sentence shall be the same
    as that assigned pursuant to the National Drug Code. The
    Secretary may by regulation prescribe a uniform system for the
    identification of devices intended for human use and may
    require that persons who are required to list such devices
    pursuant to subsection (j) shall list such devices in
    accordance with such system.
      (f) The Secretary shall make available for inspection, to any
    person so requesting, any registration filed pursuant to this
    section; except that any list submitted pursuant to paragraph
    (3) of subsection (j) and the information accompanying any list
    or notice filed under paragraph (1) or (2) of that subsection
    shall be exempt from such inspection unless the Secretary finds
    that such an exemption would be inconsistent with protection of
    the public health.
      (g) The foregoing subsections of this section shall not apply
    to--
              (1) pharmacies which maintain establishments in
            conformance with any applicable local laws regulating
            the practice of pharmacy and medicine and which are
            regularly engaged in dispensing prescription drugs or
            devices, upon prescriptions of practitioners licensed
            to administer such drugs or devices to patients under
            the care of such practitioners in the course of their
            professional practice, and which do not manufacture,
            prepare, propagate, compound, or process drugs or
            devices for sale other than in the regular course of
            their business of dispensing or selling drugs or
            devices at retail;
              (2) practitioners licensed by law to prescribe or
            administer drugs or devices and who manufacture,
            prepare, propagate, compound, or process drugs or
            devices solely for use in the course of their
            professional practice;
              (3) persons who manufacture, prepare, propagate,
            compound, or process drugs or devices solely for use in
            research, teaching, or chemical analysis and not for
            sale;
              (4) any distributor who acts as a wholesale
            distributor of devices, and who does not manufacture,
            repackage, process, or relabel a device; or
              (5) such other classes of persons as the Secretary
            may by regulation exempt from the application of this
            section upon a finding that registration by such
            classes of persons in accordance with this section is
            not necessary for the protection of the public health.
    In this subsection, the term ``wholesale distributor'' means
    any person (other than the manufacturer or the initial
    importer) who distributes a device from the original place of
    manufacture to the person who makes the final delivery or sale
    of the device to the ultimate consumer or user.
      (h) Inspections.--
              (1) In general.--Every establishment that is required
            to be registered with the Secretary under this section
            shall be subject to inspection pursuant to section 704.
              (2) Risk-based schedule for devices.--
                      (A) In general.--The Secretary, acting
                    through one or more officers or employees duly
                    designated by the Secretary, shall inspect
                    establishments described in paragraph (1) that
                    are engaged in the manufacture, propagation,
                    compounding, or processing of a device or
                    devices (referred to in this subsection as
                    ``device establishments'') in accordance with a
                    risk-based schedule established by the
                    Secretary.
                      (B) Factors and considerations.--In
                    establishing the risk-based schedule under
                    subparagraph (A), the Secretary shall--
                              (i) apply, to the extent applicable
                            for device establishments, the factors
                            identified in paragraph (4); and
                              (ii) consider the participation of
                            the device establishment, as
                            applicable, in international device
                            audit programs in which the United
                            States participates or the United
                            States recognizes for purposes of
                            inspecting device establishments.
              (3) Risk-based schedule for drugs.--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, preparation, propagation,
            compounding, or processing of a drug or drugs (referred
            to in this subsection as ``drug establishments'') in
            accordance with a risk-based schedule established by
            the Secretary.
              (4) Risk factors.--In establishing a risk-based
            schedule under paragraph (2) or (3), the Secretary
            shall inspect establishments according to the known
            safety risks of such establishments, which shall be
            based on the following factors:
                      (A) The compliance history of the
                    establishment.
                      (B) The record, history, and nature of
                    recalls linked to the establishment.
                      (C) The inherent risk of the drug or device
                    manufactured, prepared, propagated, compounded,
                    or processed at the establishment.
                      (D) The inspection frequency and history of
                    the establishment, including whether the
                    establishment has been inspected pursuant to
                    section 704 within the last 4 years.
                      (E) Whether the establishment has been
                    inspected by a foreign government or an agency
                    of a foreign government recognized under
                    section 809.
                      (F) The compliance history of establishments
                    in the country or region in which the
                    establishment is located that are subject to
                    regulation under this Act, including the
                    history of violations related to products
                    exported from such country or region that are
                    subject to such regulation.
                      [(F)] (G) Any other criteria deemed necessary
                    and appropriate by the Secretary for purposes
                    of allocating inspection resources.
              (5) Effect of status.--In determining the risk
            associated with an establishment for purposes of
            establishing a risk-based schedule under paragraph (3),
            the Secretary shall not consider whether the drugs
            manufactured, prepared, propagated, compounded, or
            processed by such establishment are drugs described in
            section 503(b).
              (6) Annual report on inspections of establishments.--
            Beginning in 2014, not later than May 1 of each year,
            the Secretary shall make available on the Internet Web
            site of the Food and Drug Administration a report
            regarding--
                      (A)(i) the number of domestic and foreign
                    establishments registered pursuant to this
                    section in the previous calendar year; and
                      (ii) the number of such domestic
                    establishments and the number of such foreign
                    establishments that the Secretary inspected in
                    the previous calendar year;
                      (B) with respect to establishments that
                    manufacture, prepare, propagate, compound, or
                    process an active ingredient of a drug or a
                    finished drug product, the number of each such
                    type of establishment; and
                      (C) the percentage of the budget of the Food
                    and Drug Administration used to fund the
                    inspections described under subparagraph (A).
      (i)(1) Every person who owns or operates any establishment
    within any foreign country engaged in the manufacture,
    preparation, propagation, compounding, or processing of a drug
    or device that is imported or offered for import into the
    United States shall, through electronic means in accordance
    with the criteria of the Secretary--
              (A) upon first engaging in any such activity,
            immediately submit a registration to the Secretary that
            includes--
                      (i) with respect to drugs, the name and place
                    of business of such person, all such
                    establishments, the unique facility identifier
                    of each such establishment, a point of contact
                    e-mail address, the name of the United States
                    agent of each such establishment, the name of
                    each importer of such drug in the United States
                    that is known to the establishment, and the
                    name of each person who imports or offers for
                    import such drug to the United States for
                    purposes of importation; and
                      (ii) with respect to devices, the name and
                    place of business of the establishment, the
                    name of the United States agent for the
                    establishment, the name of each importer of
                    such device in the United States that is known
                    to the establishment, and the name of each
                    person who imports or offers for import such
                    device to the United States for purposes of
                    importation; and
              (B) each establishment subject to the requirements of
            subparagraph (A) shall thereafter register with the
            Secretary during the period beginning on October 1 and
            ending on December 31 of each year.
      (2) The establishment shall also provide the information
    required by subsection (j).
      (3) The Secretary is authorized to enter into cooperative
    arrangements with officials of foreign countries to ensure that
    adequate and effective means are available for purposes of
    determining, from time to time, whether drugs or devices
    manufactured, prepared, propagated, compounded, or processed by
    an establishment described in paragraph (1), if imported or
    offered for import into the United States, shall be refused
    admission on any of the grounds set forth in section 801(a).
      (4) The Secretary shall specify the unique facility
    identifier system that shall be used by registrants under
    paragraph (1) with respect to drugs. The requirement to include
    a unique facility identifier in a registration under paragraph
    (1) with respect to drugs shall not apply until the date that
    the identifier system is specified by the Secretary under the
    preceding sentence.
      (j)(1) Every person who registers with the Secretary under
    subsection (b), (c), (d), or (i) shall, at the time of
    registration under any such subsection, file with the Secretary
    a list of all drugs and a list of all devices and a brief
    statement of the basis for believing that each device included
    in the list is a device rather than a drug (with each drug and
    device in each list listed by its established name (as defined
    in section 502(e)) and by any proprietary name) which are being
    manufactured, prepared, propagated, compounded, or processed by
    him for commercial distribution and which he has not included
    in any list of drugs or devices filed by him with the Secretary
    under this paragraph or paragraph (2) before such time of
    registration. Such list shall be prepared in such form and
    manner as the Secretary may prescribe and shall be accompanied
    by--
              (A) in the case of a drug contained in the applicable
            list and subject to section 505 or 512, or a device
            intended for human use contained in the applicable list
            with respect to which a performance standard has been
            established under section 514 or which is subject to
            section 515, a reference to the authority for the
            marketing of such drug or device and a copy of all
            labeling for such drug or device;
              (B) in the case of any other drug or device contained
            in an applicable list--
                      (i) which drug is subject to section
                    503(b)(1), or which device is a restricted
                    device, a copy of all labeling for such drug or
                    device, a representative sampling of
                    advertisements for such drug or device, and,
                    upon request made by the Secretary for good
                    cause, a copy of all advertisements for a
                    particular drug product or device, or
                      (ii) which drug is not subject to section
                    503(b)(1) or which device is not a restricted
                    device, the label and package insert for such
                    drug or device and a representative sampling of
                    any other labeling for such drug or device;
              (C) in the case of any drug contained in an
            applicable list which is described in subparagraph (B),
            a quantitative listing of its active ingredient or
            ingredients, except that with respect to a particular
            drug product the Secretary may require the submission
            of a quantitative listing of all ingredients if he
            finds that such submission is necessary to carry out
            the purposes of this Act;
              (D) if the registrant filing a list has determined
            that a particular drug product or device contained in
            such list is not subject to section 505 or 512, or the
            particular device contained in such list is not subject
            to a performance standard established under section 514
            or to section 515 or is not a restricted device, a
            brief statement of the basis upon which the registrant
            made such determination if the Secretary requests such
            a statement with respect to that particular drug
            product or device; and
              (E) in the case of a drug contained in the applicable
            list, the name and place of business of each
            manufacturer of an excipient of the listed drug with
            which the person listing the drug conducts business,
            including all establishments used in the production of
            such excipient, the unique facility identifier of each
            such establishment, and a point of contact e-mail
            address for each such excipient manufacturer.
      (2) Each person who registers with the Secretary under this
    section shall report to the Secretary, with regard to drugs
    once during the month of June of each year and once during the
    month of December of each year, and with regard to devices once
    each year during the period beginning on October 1 and ending
    on December 31, the following information:
              (A) A list of each drug or device introduced by the
            registrant for commercial distribution which has not
            been included in any list previously filed by him with
            the Secretary under this subparagraph or paragraph (1)
            of this subsection. A list under this subparagraph
            shall list a drug or device by its established name (as
            defined in section 502(e)) and by any proprietary name
            it may have and shall be accompanied by the other
            information required by paragraph (1).
              (B) If since the date the registrant last made a
            report under this paragraph (or if he has not made a
            report under this paragraph, since the effective date
            of this subsection) he has discontinued the
            manufacture, preparation, propagation, compounding, or
            processing for commercial distribution of a drug or
            device included in a list filed by him under
            subparagraph (A) or paragraph (1); notice of such
            discontinuance, the date of such discontinuance, and
            the identity (by established name (as defined in
            section 502(e)) and by any proprietary name) of such
            drug or device.
              (C) If since the date the registrant reported
            pursuant to subparagraph (B) a notice of discontinuance
            he has resumed the manufacture, preparation,
            propagation, compounding, or processing for commercial
            distribution of the drug or device with respect to
            which such notice of discontinuance was reported;
            notice of such resumption, the date of such resumption,
            the identity of such drug or device (by established
            name (as defined in section 502(e)) and by any
            proprietary name), and the other information required
            by paragraph (1), unless the registrant has previously
            reported such resumption to the Secretary pursuant to
            this subparagraph.
              (D) Any material change in any information previously
            submitted pursuant to this paragraph or paragraph (1).
              (3)(A) Each person who registers with the Secretary
            under this section with regard to a drug shall report
            annually to the Secretary on the amount of each drug
            listed under paragraph (1) that was manufactured,
            prepared, propagated, compounded, or processed by such
            person for commercial distribution. Such information
            may be required to be submitted in an electronic format
            as determined by the Secretary. The Secretary may
            require that information required to be reported under
            this paragraph be submitted at the time a public health
            emergency is declared by the Secretary under section
            319 of the Public Health Service Act.
              (B) By order of the Secretary, certain biological
            products or categories of biological products regulated
            under section 351 of the Public Health Service Act may
            be exempt from some or all of the reporting
            requirements under subparagraph (A), if the Secretary
            determines that applying such reporting requirements to
            such biological products or categories of biological
            products is not necessary to protect the public health.
      (4) The Secretary may also require each registrant under this
    section to submit a list of each drug product which (A) the
    registrant is manufacturing, preparing, propagating,
    compounding, or processing for commercial distribution, and (B)
    contains a particular ingredient. The Secretary may not require
    the submission of such a list unless he has made a finding that
    the submission of such a list is necessary to carry out the
    purposes of this Act.
      (5) The Secretary shall require persons subject to this
    subsection to use, for purposes of this subsection, the unique
    facility identifier systems specified under subsections (b)(3)
    and (i)(4) with respect to drugs. Such requirement shall not
    apply until the date that the identifier system under
    subsection (b)(3) or (i)(4), as applicable, is specified by the
    Secretary.
      (k) Each person who is required to register under this
    section and who proposes to begin the introduction or delivery
    for introduction into interstate commerce for commercial
    distribution of a device intended for human use shall, at least
    ninety days before making such introduction or delivery, report
    to the Secretary or person who is accredited under section
    523(a) (in such form and manner as the Secretary shall by
    regulation prescribe)--
              (1) the class in which the device is classified under
            section 513 or if such person determines that the
            device is not classified under such section, a
            statement of that determination and the basis for such
            person's determination that the device is or is not so
            classified, and
              (2) action taken by such person to comply with
            requirements under section 514 or 515 which are
            applicable to the device.
    A notification submitted under this subsection that contains
    clinical trial data for an applicable device clinical trial (as
    defined in section 402(j)(1) of the Public Health Service Act)
    shall be accompanied by the certification required under
    section 402(j)(5)(B) of such Act. Such certification shall not
    be considered an element of such notification.
      (l)(1) A report under subsection (k) is not required for a
    device intended for human use that is exempted from the
    requirements of this subsection under subsection (m) or is
    within a type that has been classified into class I under
    section 513. The exception established in the preceding
    sentence does not apply to any class I device that is intended
    for a use which is of substantial importance in preventing
    impairment of human health, or to any class I device that
    presents a potential unreasonable risk of illness or injury.
      (2) Not later than 120 calendar days after the date of
    enactment of the 21st Century Cures Act and at least once every
    5 years thereafter, as the Secretary determines appropriate,
    the Secretary shall identify, through publication in the
    Federal Register, any type of class I device that the Secretary
    determines no longer requires a report under subsection (k) to
    provide reasonable assurance of safety and effectiveness. Upon
    such publication--
              (A) each type of class I device so identified shall
            be exempt from the requirement for a report under
            subsection (k); and
              (B) the classification regulation applicable to each
            such type of device shall be deemed amended to
            incorporate such exemption.
      (m)(1) The Secretary shall--
              (A) not later than 90 days after the date of
            enactment of the 21st Century Cures Act and at least
            once every 5 years thereafter, as the Secretary
            determines appropriate--
                      (i) publish in the Federal Register a notice
                    that contains a list of each type of class II
                    device that the Secretary determines no longer
                    requires a report under subsection (k) to
                    provide reasonable assurance of safety and
                    effectiveness; and
                      (ii) provide for a period of not less than 60
                    calendar days for public comment beginning on
                    the date of the publication of such notice; and
              (B) not later than 210 calendar days after the date
            of enactment of the 21st Century Cures Act, publish in
            the Federal Register a list representing the
            Secretary's final determination with respect to the
            devices contained in the list published under
            subparagraph (A).
      (2) Beginning on the date that is 1 calendar day after the
    date of publication of the final list under paragraph (1)(B),
    the Secretary may exempt a class II device from the requirement
    to submit a report under subsection (k), upon the Secretary's
    own initiative or a petition of an interested person, if the
    Secretary determines that such report is not necessary to
    assure the safety and effectiveness of the device. The
    Secretary shall publish in the Federal Register notice of the
    intent of the Secretary to exempt the device, or of the
    petition, and provide a 60-calendar-day period for public
    comment. Within 120 days after the issuance of the notice in
    the Federal Register, the Secretary shall publish an order in
    the Federal Register that sets forth the final determination of
    the Secretary regarding the exemption of the device that was
    the subject of the notice. If the Secretary fails to respond to
    a petition within 180 days of receiving it, the petition shall
    be deemed to be granted.
      (3) Upon the publication of the final list under paragraph
    (1)(B)--
              (A) each type of class II device so listed shall be
            exempt from the requirement for a report under
            subsection (k); and
              (B) the classification regulation applicable to each
            such type of device shall be deemed amended to
            incorporate such exemption.
      (n)(1) The Secretary shall review the report required in
    subsection (k) and make a determination under section 513(f)(1)
    not later than 90 days after receiving the report.
              (2)(A) Not later than 18 months after the date of
            enactment of this paragraph, 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 regarding
            when a premarket notification under subsection (k)
            should be submitted for a modification or change to a
            legally marketed device. The report shall include the
            Secretary's interpretation of the following terms:
            ``could significantly affect the safety or
            effectiveness of the device'', ``a significant change
            or modification in design, material, chemical
            composition, energy source, or manufacturing process'',
            and ``major change or modification in the intended use
            of the device''. The report also shall discuss possible
            processes for industry to use to determine whether a
            new submission under subsection (k) is required and
            shall analyze how to leverage existing quality system
            requirements to reduce premarket burden, facilitate
            continual device improvement, and provide reasonable
            assurance of safety and effectiveness of modified
            devices. In developing such report, the Secretary shall
            consider the input of interested stakeholders.
              (B) The Secretary shall withdraw the Food and Drug
            Administration draft guidance entitled ``Guidance for
            Industry and FDA Staff--510(k) Device Modifications:
            Deciding When to Submit a 510(k) for a Change to an
            Existing Device'', dated July 27, 2011, and shall not
            use this draft guidance as part of, or for the basis
            of, any premarket review or any compliance or
            enforcement decisions or actions. The Secretary shall
            not issue--
                      (i) any draft guidance or proposed regulation
                    that addresses when to submit a premarket
                    notification submission for changes and
                    modifications made to a manufacturer's
                    previously cleared device before the receipt by
                    the Committee on Energy and Commerce of the
                    House of Representatives and the Committee on
                    Health, Education, Labor, and Pensions of the
                    Senate of the report required in subparagraph
                    (A); and
                      (ii) any final guidance or regulation on that
                    topic for one year after date of receipt of
                    such report by the Committee on Energy and
                    Commerce of the House of Representatives and
                    the Committee on Health, Education, Labor, and
                    Pensions of the Senate.
              (C) The Food and Drug Administration guidance
            entitled ``Deciding When to Submit a 510(k) for a
            Change to an Existing Device'', dated January 10, 1997,
            shall be in effect until the subsequent issuance of
            guidance or promulgation, if appropriate, of a
            regulation described in subparagraph (B), and the
            Secretary shall interpret such guidance in a manner
            that is consistent with the manner in which the
            Secretary has interpreted such guidance since 1997.
      (o)(1) With respect to reprocessed single-use devices for
    which reports are required under subsection (k):
              (A) The Secretary shall identify such devices or
            types of devices for which reports under such
            subsection must, in order to ensure that the device is
            substantially equivalent to a predicate device, include
            validation data, the types of which shall be specified
            by the Secretary, regarding cleaning and sterilization,
            and functional performance demonstrating that the
            single-use device will remain substantially equivalent
            to its predicate device after the maximum number of
            times the device is reprocessed as intended by the
            person submitting the premarket notification. Within
            six months after enactment of this subsection, the
            Secretary shall publish in the Federal Register a list
            of the types so identified, and shall revise the list
            as appropriate. Reports under subsection (k) for
            devices or types of devices within a type included on
            the list are, upon publication of the list, required to
            include such validation data.
              (B) In the case of each report under subsection (k)
            that was submitted to the Secretary before the
            publication of the initial list under subparagraph (A),
            or any revision thereof, and was for a device or type
            of device included on such list, the person who
            submitted the report under subsection (k) shall submit
            validation data as described in subparagraph (A) to the
            Secretary not later than nine months after the
            publication of the list. During such nine-month period,
            the Secretary may not take any action under this Act
            against such device solely on the basis that the
            validation data for the device have not been submitted
            to the Secretary. After the submission of the
            validation data to the Secretary, the Secretary may not
            determine that the device is misbranded under section
            502(o) or adulterated under section 501(f)(1)(B), or
            take action against the device under section 301(p) for
            failure to provide any information required by
            subsection (k) until (i) the review is terminated by
            withdrawal of the submission of the report under
            subsection (k); (ii) the Secretary finds the data to be
            acceptable and issues a letter; or (iii) the Secretary
            determines that the device is not substantially
            equivalent to a predicate device. Upon a determination
            that a device is not substantially equivalent to a
            predicate device, or if such submission is withdrawn,
            the device can no longer be legally marketed.
              (C) In the case of a report under subsection (k) for
            a device identified under subparagraph (A) that is of a
            type for which the Secretary has not previously
            received a report under such subsection, the Secretary
            may, in advance of revising the list under subparagraph
            (A) to include such type, require that the report
            include the validation data specified in subparagraph
            (A).
              (D) Section 502(o) applies with respect to the
            failure of a report under subsection (k) to include
            validation data required under subparagraph (A).
      (2) With respect to critical or semi-critical reprocessed
    single-use devices that, under subsection (l) or (m), are
    exempt from the requirement of submitting reports under
    subsection (k):
              (A) The Secretary shall identify such devices or
            types of devices for which such exemptions should be
            terminated in order to provide a reasonable assurance
            of the safety and effectiveness of the devices. The
            Secretary shall publish in the Federal Register a list
            of the devices or types of devices so identified, and
            shall revise the list as appropriate. The exemption for
            each device or type included on the list is terminated
            upon the publication of the list. For each report under
            subsection (k) submitted pursuant to this subparagraph
            the Secretary shall require the validation data
            described in paragraph (1)(A).
              (B) For each device or type of device included on the
            list under subparagraph (A), a report under subsection
            (k) shall be submitted to the Secretary not later than
            15 months after the publication of the initial list, or
            a revision of the list, whichever terminates the
            exemption for the device. During such 15-month period,
            the Secretary may not take any action under this Act
            against such device solely on the basis that such
            report has not been submitted to the Secretary. After
            the submission of the report to the Secretary the
            Secretary may not determine that the device is
            misbranded under section 502(o) or adulterated under
            section 501(f)(1)(B), or take action against the device
            under section 301(p) for failure to provide any
            information required by subsection (k) until (i) the
            review is terminated by withdrawal of the submission;
            (ii) the Secretary determines by order that the device
            is substantially equivalent to a predicate device; or
            (iii) the Secretary determines by order that the device
            is not substantially equivalent to a predicate device.
            Upon a determination that a device is not substantially
            equivalent to a predicate device, the device can no
            longer be legally marketed.
              (C) In the case of semi-critical devices, the initial
            list under subparagraph (A) shall be published not
            later than 18 months after the effective date of this
            subsection. In the case of critical devices, the
            initial list under such subparagraph shall be published
            not later than six months after such effective date.
              (D) Section 502(o) applies with respect to the
            failure to submit a report under subsection (k) that is
            required pursuant to subparagraph (A), including a
            failure of the report to include validation data
            required in such subparagraph.
              (E) The termination under subparagraph (A) of an
            exemption under subsection (l) or (m) for a critical or
            semi-critical reprocessed single-use device does not
            terminate the exemption under subsection (l) or (m) for
            the original device.
      (p) Electronic Registration and Listing.--
              (1) In general.--Registrations and listings under
            this section (including the submission of updated
            information) shall be submitted to the Secretary by
            electronic means unless the Secretary grants a request
            for waiver of such requirement because use of
            electronic means is not reasonable for the person
            requesting such waiver.
              (2) Electronic database.--Not later than 2 years
            after the Secretary specifies a unique facility
            identifier system under subsections (b) and (i), the
            Secretary shall maintain an electronic database, which
            shall not be subject to inspection under subsection
            (f), populated with the information submitted as
            described under paragraph (1) that--
                      (A) enables personnel of the Food and Drug
                    Administration to search the database by any
                    field of information submitted in a
                    registration described under paragraph (1), or
                    combination of such fields; and
                      (B) uses the unique facility identifier
                    system to link with other relevant databases
                    within the Food and Drug Administration,
                    including the database for submission of
                    information under section 801(r).
              (3) Risk-based information and coordination.--The
            Secretary shall ensure the accuracy and coordination of
            relevant Food and Drug Administration databases in
            order to identify and inform risk-based inspections
            under section 510(h).
      (q) Reusable Medical Devices.--
              (1) In general.--Not later than 180 days after the
            date of enactment of the 21st Century Cures Act, the
            Secretary shall identify and publish a list of reusable
            device types for which reports under subsection (k) are
            required to include--
                      (A) instructions for use, which have been
                    validated in a manner specified by the
                    Secretary; and
                      (B) validation data, the types of which shall
                    be specified by the Secretary;
            regarding cleaning, disinfection, and sterilization,
            and for which a substantial equivalence determination
            may be based.
              (2) Revision of list.--The Secretary shall revise the
            list under paragraph (2), as the Secretary determines
            appropriate, with notice in the Federal Register.
              (3) Content of reports.--Reports under subsection (k)
            that are submitted after the publication of the list
            described in paragraph (1), for devices or types of
            devices included on such list, shall include such
            instructions for use and validation data.

               *       *       *       *       *       *       *

                classification of devices intended for human use

                                 Device Classes

      Sec. 513. (a)(1) There are established the following classes
    of devices intended for human use:
              (A) Class I, General Controls.--
                      (i) A device for which the controls
                    authorized by or under section 501, 502, 510,
                    516, 518, 519, or 520 or any combination of
                    such sections are sufficient to provide
                    reasonable assurance of the safety and
                    effectiveness of the device.
                      (ii) A device for which insufficient
                    information exists to determine that the
                    controls referred to in clause (i) are
                    sufficient to provide reasonable assurance of
                    the safety and effectiveness of the device or
                    to establish special controls to provide such
                    assurance, but because it--
                              (I) is not purported or represented
                            to be for a use in supporting or
                            sustaining human life or for a use
                            which is of substantial importance in
                            preventing impairment of human health,
                            and
                              (II) does not present a potential
                            unreasonable risk of illness or injury,
                    is to be regulated by the controls referred to
                    in clause (i).
              (B) Class ii, special controls.--A device which
            cannot be classified as a class I device because the
            general controls by themselves are insufficient to
            provide reasonable assurance of the safety and
            effectiveness of the device, and for which there is
            sufficient information to establish special controls to
            provide such assurance, including the promulgation of
            performance standards, postmarket surveillance, patient
            registries, development and dissemination of guidelines
            (including guidelines for the submission of clinical
            data in premarket notification submissions in
            accordance with section 510(k)), recommendations, and
            other appropriate actions as the Secretary deems
            necessary to provide such assurance. For a device that
            is purported or represented to be for a use in
            supporting or sustaining human life, the Secretary
            shall examine and identify the special controls, if
            any, that are necessary to provide adequate assurance
            of safety and effectiveness and describe how such
            controls provide such assurance.
              (C) Class III, Premarket Approval.--A device which
            because--
                      (i) it (I) cannot be classified as a class I
                    device because insufficient information exists
                    to determine that the application of general
                    controls are sufficient to provide reasonable
                    assurance of the safety and effectiveness of
                    the device, and (II) cannot be classified as a
                    class II device because insufficient
                    information exists to determine that the
                    special controls described in subparagraph (B)
                    would provide reasonable assurance of its
                    safety and effectiveness, and
                      (ii)(I) is purported or represented to be for
                    a use in supporting or sustaining human life or
                    for a use which is of substantial importance in
                    preventing impairment of human health, or
                      (II) presents a potential unreasonable risk
                    of illness or injury,
            is to be subject, in accordance with section 515, to
            premarket approval to provide reasonable assurance of
            its safety and effectiveness.
    If there is not sufficient information to establish a
    performance standard for a device to provide reasonable
    assurance of its safety and effectiveness, the Secretary may
    conduct such activities as may be necessary to develop or
    obtain such information.
      (2) For purposes of this section and sections 514 and 515,
    the safety and effectiveness of a device are to be determined--
              (A) with respect to the persons for whose use the
            device is represented or intended,
              (B) with respect to the conditions of use prescribed,
            recommended, or suggested in the labeling of the
            device, and
              (C) weighing any probable benefit to health from the
            use of the device against any probable risk of injury
            or illness from such use.
      (3)(A) Except as authorized by subparagraph (B), the
    effectiveness of a device is, for purposes of this section and
    sections 514 and 515, to be determined, in accordance with
    regulations promulgated by the Secretary, on the basis of well-
    controlled investigations, including 1 or more clinical
    investigations where appropriate, by experts qualified by
    training and experience to evaluate the effectiveness of the
    device, from which investigations it can fairly and responsibly
    be concluded by qualified experts that the device will have the
    effect it purports or is represented to have under the
    conditions of use prescribed, recommended, or suggested in the
    labeling of the device.
      (B) If the Secretary determines that there exists valid
    scientific evidence (other than evidence derived from
    investigations described in subparagraph (A))--
              (i) which is sufficient to determine the
            effectiveness of a device, and
              (ii) from which it can fairly and responsibly be
            concluded by qualified experts that the device will
            have the effect it purports or is represented to have
            under the conditions of use prescribed, recommended, or
            suggested in the labeling of the device,
    then, for purposes of this section and sections 514 and 515,
    the Secretary may authorize the effectiveness of the device to
    be determined on the basis of such evidence.
      (C) In making a determination of a reasonable assurance of
    the effectiveness of a device for which an application under
    section 515 has been submitted, the Secretary shall consider
    whether the extent of data that otherwise would be required for
    approval of the application with respect to effectiveness can
    be reduced through reliance on postmarket controls.
      (D)(i) The Secretary, upon the written request of any person
    intending to submit an application under section 515, shall
    meet with such person to determine the type of valid scientific
    evidence (within the meaning of subparagraphs (A) and (B)) that
    will be necessary to demonstrate for purposes of approval of an
    application the effectiveness of a device for the conditions of
    use proposed by such person. The written request shall include
    a detailed description of the device, a detailed description of
    the proposed conditions of use of the device, a proposed plan
    for determining whether there is a reasonable assurance of
    effectiveness, and, if available, information regarding the
    expected performance from the device. Within 30 days after such
    meeting, the Secretary shall specify in writing the type of
    valid scientific evidence that will provide a reasonable
    assurance that a device is effective under the conditions of
    use proposed by such person.
      (ii) Any clinical data, including one or more well-controlled
    investigations, specified in writing by the Secretary for
    demonstrating a reasonable assurance of device effectiveness
    shall be specified as result of a determination by the
    Secretary that such data are necessary to establish device
    effectiveness. The Secretary shall consider, in consultation
    with the applicant, the least burdensome appropriate means of
    evaluating device effectiveness that would have a reasonable
    likelihood of resulting in approval.
      (iii) For purposes of clause (ii), the term ``necessary''
    means the minimum required information that would support a
    determination by the Secretary that an application provides
    reasonable assurance of the effectiveness of the device.
      (iv) Nothing in this subparagraph shall alter the criteria
    for evaluating an application for premarket approval of a
    device.
      (v) The determination of the Secretary with respect to the
    specification of valid scientific evidence under clauses (i)
    and (ii) shall be binding upon the Secretary, unless such
    determination by the Secretary could be contrary to the public
    health.

                     Classification; Classification Panels

      (b)(1) For purposes of--
              (A) determining which devices intended for human use
            should be subject to the requirements of general
            controls, performance standards, or premarket approval,
            and
              (B) providing notice to the manufacturers and
            importers of such devices to enable them to prepare for
            the application of such requirements to devices
            manufactured or imported by them,
    the Secretary shall classify all such devices (other than
    devices classified by subsection (f)) into the classes
    established by subsection (a). For the purpose of securing
    recommendations with respect to the classification of devices,
    the Secretary shall establish panels of experts or use panels
    of experts established before the date of the enactment of this
    section, or both. Section 14 of the Federal Advisory Committee
    Act shall not apply to the duration of a panel established
    under this paragraph.
      (2) The Secretary shall appoint to each panel established
    under paragraph (1) persons who are qualified by training and
    experience to evaluate the safety and effectiveness of the
    devices to be referred to the panel and who, to the extent
    feasible, possess skill in the use of, or experience in the
    development, manufacture, or utilization of, such devices. The
    Secretary shall make appointments to each panel so that each
    panel shall consist of members with adequately diversified
    expertise in such fields as clinical and administrative
    medicine, engineering, biological and physical sciences, and
    other related professions. In addition, each panel shall
    include as nonvoting members a representative of consumer
    interests and a representative of interests of the device
    manufacturing industry. Scientific, trade, and consumer
    organizations shall be afforded an opportunity to nominate
    individuals for appointment to the panels. No individual who is
    in the regular full-time employ of the United States and
    engaged in the administration of this Act may be a member of
    any panel. The Secretary shall designate one of the members of
    each panel to serve as chairman thereof.
      (3) Panel members (other than officers or employees of the
    United States), while attending meetings or conferences of a
    panel or otherwise engaged in its business, shall be entitled
    to receive compensation at rates to be fixed by the Secretary,
    but not at rates exceeding the daily equivalent of the rate in
    effect for grade GS-18 of the General Schedule, for each day so
    engaged, including traveltime; and while so serving away from
    their homes or regular places of business each member may be
    allowed travel expenses (including per diem in lieu of
    subsistence) as authorized by section 5703 of title 5, United
    States Code, for persons in the Government service employed
    intermittently.
      (4) The Secretary shall furnish each panel with adequate
    clerical and other necessary assistance.
      (5)(A) Classification panels covering each type of device
    shall be scheduled to meet at such times as may be appropriate
    for the Secretary to meet applicable statutory deadlines.
      (B) When a device is specifically the subject of review by a
    classification panel, the Secretary shall--
              (i) ensure that adequate expertise is represented on
            the classification panel to assess--
                      (I) the disease or condition which the device
                    is intended to cure, treat, mitigate, prevent,
                    or diagnose; and
                      (II) the technology of the device; and
              (ii) provide an opportunity for the person whose
            device is specifically the subject of panel review to
            provide recommendations on the expertise needed among
            the voting members of the panel.
      (C) For purposes of subparagraph (B)(i), the term ``adequate
    expertise'' means that the membership of the classification
    panel includes--
              (i) two or more voting members, with a specialty or
            other expertise clinically relevant to the device under
            review; and
              (ii) at least one voting member who is knowledgeable
            about the technology of the device.
      (D) The Secretary shall provide an annual opportunity for
    patients, representatives of patients, and sponsors of medical
    devices that may be specifically the subject of a review by a
    classification panel to provide recommendations for individuals
    with appropriate expertise to fill voting member positions on
    classification panels.
      (6)(A) Any person whose device is specifically the subject of
    review by a classification panel shall have--
              (i) the same access to data and information submitted
            to a classification panel (except for data and
            information that are not available for public
            disclosure under section 552 of title 5, United States
            Code) as the Secretary;
              (ii) the opportunity to submit, for review by a
            classification panel, information that is based on the
            data or information provided in the application
            submitted under section 515 by the person, which
            information shall be submitted to the Secretary for
            prompt transmittal to the classification panel; and
              (iii) the same opportunity as the Secretary to
            participate in meetings of the panel, including,
            subject to the discretion of the panel chairperson, by
            designating a representative who will be provided a
            time during the panel meeting to address the panel for
            the purpose of correcting misstatements of fact or
            providing clarifying information, and permitting the
            person or representative to call on experts within the
            person's organization to address such specific issues
            in the time provided.
      (B)(i) Any meeting of a classification panel with respect to
    the review of a device shall--
              (I) provide adequate time for initial presentations
            by the person whose device is specifically the subject
            of such review and by the Secretary; and
              (II) encourage free and open participation by all
            interested persons.
      (ii) Following the initial presentations described in clause
    (i), the panel may--
              (I) pose questions to a designated representative
            described in subparagraph (A)(iii); and
              (II) consider the responses to such questions in the
            panel's review of the device.
      (7) After receiving from a classification panel the
    conclusions and recommendations of the panel on a matter that
    the panel has reviewed, the Secretary shall review the
    conclusions and recommendations, shall make a final decision on
    the matter in accordance with section 515(d)(2), and shall
    notify the affected persons of the decision in writing and, if
    the decision differs from the conclusions and recommendations
    of the panel, shall include the reasons for the difference.
      (8) A classification panel under this subsection shall not be
    subject to the annual chartering and annual report requirements
    of the Federal Advisory Committee Act.

                Classification Panel Organization and Operation

      (c)(1) The Secretary shall organize the panels according to
    the various fields of clinical medicine and fundamental
    sciences in which devices intended for human use are used. The
    Secretary shall refer a device to be classified under this
    section to an appropriate panel established or authorized to be
    used under subsection (b) for its review and for its
    recommendation respecting the classification of the device. The
    Secretary shall by regulation prescribe the procedure to be
    followed by the panels in making their reviews and
    recommendations. In making their reviews of devices, the
    panels, to the maximum extent practicable, shall provide an
    opportunity for interested persons to submit data and views on
    the classification of the devices.
      (2)(A) Upon completion of a panel's review of a device
    referred to it under paragraph (1), the panel shall, subject to
    subparagraphs (B) and (C), submit to the Secretary its
    recommendation for the classification of the device. Any such
    recommendation shall (i) contain (I) a summary of the reasons
    for the recommendation, (II) a summary of the data upon which
    the recommendation is based, and (III) an identification of the
    risks to health (if any) presented by the device with respect
    to which the recommendation is made, and (ii) to the extent
    practicable, include a recommendation for the assignment of a
    priority for the application of the requirements of section 514
    or 515 to a device recommended to be classified in class II or
    class III.
      (B) A recommendation of a panel for the classification of a
    device in class I shall include a recommendation as to whether
    the device should be exempted from the requirements of section
    510, 519, or 520(f).
      (C) In the case of a device which has been referred under
    paragraph (1) to a panel, and which--
              (i) is intended to be implanted in the human body or
            is purported or represented to be for a use in
            supporting or sustaining human life, and
              (ii)(I) has been introduced or delivered for
            introduction into interstate commerce for commercial
            distribution before the date of enactment of this
            section, or
              (II) is within a type of device which was so
            introduced or delivered before such date and is
            substantially equivalent to another device within that
            type,
    such panel shall recommend to the Secretary that the device be
    classified in class III unless the panel determines that
    classification of the device in such class is not necessary to
    provide reasonable assurance of its safety and effectiveness.
    If a panel does not recommend that such a device be classified
    in class III, it shall in its recommendation to the Secretary
    for the classification of the device set forth the reasons for
    not recommending classification of the device in such class.
      (3) The panels shall submit to the Secretary within one year
    of the date funds are first appropriated for the implementation
    of this section their recommendations respecting all devices of
    a type introduced or delivered for introduction into interstate
    commerce for commercial distribution before the date of the
    enactment of this section.

                                 Classification

      (d)(1) Upon receipt of a recommendation from a panel
    respecting a device, the Secretary shall publish in the Federal
    Register the panel's recommendation and a proposed regulation
    classifying such device and shall provide interested persons an
    opportunity to submit comments on such recommendation and the
    proposed regulation. After reviewing such comments, the
    Secretary shall, subject to paragraph (2), by regulation
    classify such device.
      (2)(A) A regulation under paragraph (1) classifying a device
    in class I shall prescribe which, if any, of the requirements
    of section 510, 519 or 520(f) shall not apply to the device. A
    regulation which makes a requirement of section 510, 519, or
    520(f) inapplicable to a device shall be accompanied by a
    statement of the reasons of the Secretary for making such
    requirement inapplicable.
      (B) A device described in subsection (c)(2)(C) shall be
    classified in class III unless the Secretary determines that
    classification of the device in such class is not necessary to
    provide reasonable assurance of its safety and effectiveness. A
    proposed regulation under paragraph (1) classifying such a
    device in a class other than class III shall be accompanied by
    a full statement of the reasons of the Secretary (and
    supporting documentation and data) for not classifying such
    device in such class and an identification of the risks to
    health (if any) presented by such device.
      (3) In the case of devices classified in class II and devices
    classified under this subsection in class III and described in
    section 515(b)(1) the Secretary may establish priorities which,
    in his discretion, shall be used in applying sections 514 and
    515, as appropriate, to such devices.

                             Classification Changes

      (e)(1)(A)(i) Based on new information respecting a device,
    the Secretary may, upon the initiative of the Secretary or upon
    petition of an interested person, change the classification of
    such device, and revoke, on account of the change in
    classification, any regulation or requirement in effect under
    section 514 or 515 with respect to such device, by
    administrative order published in the Federal Register
    following publication of a proposed reclassification order in
    the Federal Register, a meeting of a device classification
    panel described in subsection (b), and consideration of
    comments to a public docket, notwithstanding subchapter II of
    chapter 5 of title 5, United States Code. The proposed
    reclassification order published in the Federal Register shall
    set forth the proposed reclassification, and a substantive
    summary of the valid scientific evidence concerning the
    proposed reclassification, including--
              (I) the public health benefit of the use of the
            device, and the nature and, if known, incidence of the
            risk of the device;
              (II) in the case of a reclassification from class II
            to class III, why general controls pursuant to
            subsection (a)(1)(A) and special controls pursuant to
            subsection (a)(1)(B) together are not sufficient to
            provide a reasonable assurance of safety and
            effectiveness for such device; and
              (III) in the case of reclassification from class III
            to class II, why general controls pursuant to
            subsection (a)(1)(A) and special controls pursuant to
            subsection (a)(1)(B) together are sufficient to provide
            a reasonable assurance of safety and effectiveness for
            such device.
      (ii) An order under this subsection changing the
    classification of a device from class III to class II may
    provide that such classification shall not take effect until
    the effective date of a performance standard established under
    section 514 for such device.
      (B) Authority to issue such administrative order shall not be
    delegated below the Director of the Center for Devices and
    Radiological Health, acting in consultation with the
    Commissioner.
      (2) By an order issued under paragraph (1), the Secretary may
    change the classification of a device from class III--
              (A) to class II if the Secretary determines that
            special controls would provide reasonable assurance of
            the safety and effectiveness of the device and that
            general controls would not provide reasonable assurance
            of the safety and effectiveness of the device, or
              (B) to class I if the Secretary determines that
            general controls would provide reasonable assurance of
            the safety and effectiveness of the device.

         Initial Classification and Reclassification of Certain Devices

      (f)(1) Any device intended for human use which was not
    introduced or delivered for introduction into interstate
    commerce for commercial distribution before the date of the
    enactment of this section is classified in class III unless--
              (A) the device--
                      (i) is within a type of device (I) which was
                    introduced or delivered for introduction into
                    interstate commerce for commercial distribution
                    before such date and which is to be classified
                    pursuant to subsection (b), or (II) which was
                    not so introduced or delivered before such date
                    and has been classified in class I or II, and
                      (ii) is substantially equivalent to another
                    device within such type;
              (B) the Secretary in response to a petition submitted
            under paragraph (3) has classified such device in class
            I or II; or
              (C) the device is classified pursuant to a request
            submitted under paragraph (2).
    A device classified in class III under this paragraph shall be
    classified in that class until the effective date of an order
    of the Secretary under paragraph (2) or (3) classifying the
    device in class I or II.
      (2)(A)(i) Any person who submits a report under section
    510(k) for a type of device that has not been previously
    classified under this Act, and that is classified into class
    III under paragraph (1), may request, after receiving written
    notice of such a classification, the Secretary to classify the
    device.
      (ii) In lieu of submitting a report under section 510(k) and
    submitting a request for classification under clause (i) for a
    device, if a person determines there is no legally marketed
    device upon which to base a determination of substantial
    equivalence (as defined in subsection (i)), a person may submit
    a request under this clause for the Secretary to classify the
    device.
      (iii) Upon receipt of a request under clause (i) or (ii), the
    Secretary shall classify the device subject to the request
    under the criteria set forth in subparagraphs (A) through (C)
    of subsection (a)(1) within 120 days.
      (iv) Notwithstanding clause (iii), the Secretary may decline
    to undertake a classification request submitted under clause
    (ii) if the Secretary identifies a legally marketed device that
    could provide a reasonable basis for review of substantial
    equivalence under paragraph (1), or when the Secretary
    determines that the device submitted is not of low to moderate
    risk or that general controls would be inadequate to control
    the risks and special controls to mitigate the risks cannot be
    developed.
      (v) The person submitting the request for classification
    under this subparagraph may recommend to the Secretary a
    classification for the device and shall, if recommending
    classification in class II, include in the request an initial
    draft proposal for applicable special controls, as described in
    subsection (a)(1)(B), that are necessary, in conjunction with
    general controls, to provide reasonable assurance of safety and
    effectiveness and a description of how the special controls
    provide such assurance. Any such request shall describe the
    device and provide detailed information and reasons for the
    recommended classification.
      (B)(i) The Secretary shall by written order classify the
    device involved. Such classification shall be the initial
    classification of the device for purposes of paragraph (1) and
    any device classified under this paragraph shall be a predicate
    device for determining substantial equivalence under paragraph
    (1).
      (ii) A device that remains in class III under this
    subparagraph shall be deemed to be adulterated within the
    meaning of section 501(f)(1)(B) until approved under section
    515 or exempted from such approval under section 520(g).
      (C) Within 30 days after the issuance of an order classifying
    a device under this paragraph, the Secretary shall publish a
    notice in the Federal Register announcing such classification.
      (3)(A) The Secretary may initiate the reclassification of a
    device classified into class III under paragraph (1) of this
    subsection or the manufacturer or importer of a device
    classified under paragraph (1) may petition the Secretary (in
    such form and manner as he shall prescribe) for the issuance of
    an order classifying the device in class I or class II. Within
    thirty days of the filing of such a petition, the Secretary
    shall notify the petitioner of any deficiencies in the petition
    which prevent the Secretary from making a decision on the
    petition.
      (B)(i) Upon determining that a petition does not contain any
    deficiency which prevents the Secretary from making a decision
    on the petition, the Secretary may for good cause shown refer
    the petition to an appropriate panel established or authorized
    to be used under subsection (b). A panel to which such a
    petition has been referred shall not later than ninety days
    after the referral of the petition make a recommendation to the
    Secretary respecting approval or denial of the petition. Any
    such recommendation shall contain (I) a summary of the reasons
    for the recommendation, (II) a summary of the data upon which
    the recommendation is based, and (III) an identification of the
    risks to health (if any) presented by the device with respect
    to which the petition was filed. In the case of a petition for
    a device which is intended to be implanted in the human body or
    which is purported or represented to be for a use in supporting
    or sustaining human life, the panel shall recommend that the
    petition be denied unless the panel determines that the
    classification in class III of the device is not necessary to
    provide reasonable assurance of its safety and effectiveness.
    If the panel recommends that such petition be approved, it
    shall in its recommendation to the Secretary set forth its
    reasons for such recommendation.
      (ii) The requirements of paragraphs (1) and (2) of subsection
    (c) (relating to opportunities for submission of data and views
    and recommendations respecting priorities and exemptions from
    sections 510, 519, and 520(f)) shall apply with respect to
    consideration by panels of petitions submitted under
    subparagraph (A).
      (C)(i) Within ninety days from the date the Secretary
    receives the recommendation of a panel respecting a petition
    (but not later than 210 days after the filing of such petition)
    the Secretary shall by order deny or approve the petition. If
    the Secretary approves the petition, the Secretary shall order
    the classification of the device into class I or class II in
    accordance with the criteria prescribed by subsection (a)(1)(A)
    or (a)(1)(B). In the case of a petition for a device which is
    intended to be implanted in the human body or which is
    purported or represented to be for a use in supporting or
    sustaining human life, the Secretary shall deny the petition
    unless the Secretary determines that the classification in
    class III of the device is not necessary to provide reasonable
    assurance of its safety and effectiveness. An order approving
    such petition shall be accompanied by a full statement of the
    reasons of the Secretary (and supporting documentation and
    data) for approving the petition and an identification of the
    risks to health (if any) presented by the device to which such
    order applies.
      (ii) The requirements of paragraphs (1) and (2)(A) of
    subsection (d) (relating to publication of recommendations,
    opportunity for submission of comments, and exemption from
    sections 510, 519, and 520(f)) shall apply with respect to
    action by the Secretary on petitions submitted under
    subparagraph (A).
      (4) If a manufacturer reports to the Secretary under section
    510(k) that a device is substantially equivalent to another
    device--
              (A) which the Secretary has classified as a class III
            device under subsection (b),
              (B) which was introduced or delivered for
            introduction into interstate commerce for commercial
            distribution before December 1, 1990, and
              (C) for which no final regulation requiring premarket
            approval has been promulgated under section 515(b),
    the manufacturer shall certify to the Secretary that the
    manufacturer has conducted a reasonable search of all
    information known or otherwise available to the manufacturer
    respecting such other device and has included in the report
    under section 510(k) a summary of and a citation to all adverse
    safety and effectiveness data respecting such other device and
    respecting the device for which the section 510(k) report is
    being made and which has not been submitted to the Secretary
    under section 519. The Secretary may require the manufacturer
    to submit the adverse safety and effectiveness data described
    in the report.
      (5) The Secretary may not withhold a determination of the
    initial classification of a device under paragraph (1) because
    of a failure to comply with any provision of this Act unrelated
    to a substantial equivalence decision, including a finding that
    the facility in which the device is manufactured is not in
    compliance with good manufacturing requirements as set forth in
    regulations of the Secretary under section 520(f) (other than a
    finding that there is a substantial likelihood that the failure
    to comply with such regulations will potentially present a
    serious risk to human health).
      (6)(A) Subject to the succeeding subparagraphs of this
    paragraph, the Secretary shall, by written order, classify an
    accessory under this section based on the risks of the
    accessory when used as intended and the level of regulatory
    controls necessary to provide a reasonable assurance of safety
    and effectiveness of the accessory, notwithstanding the
    classification of any other device with which such accessory is
    intended to be used.
      (B) The classification of any accessory distinct from another
    device by regulation or written order issued prior to December
    13, 2016, shall continue to apply unless and until the
    accessory is reclassified by the Secretary, notwithstanding the
    classification of any other device with which such accessory is
    intended to be used. Nothing in this paragraph shall preclude
    the Secretary's authority to initiate the classification of an
    accessory through regulation or written order, as appropriate.
      (C)(i) In the case of a device intended to be used with an
    accessory, where the accessory has been included in an
    application for premarket approval of such device under section
    515 or a report under section 510(k) for clearance of such
    device and the Secretary has not classified such accessory
    distinctly from another device in accordance with subparagraph
    (A), the person filing the application or report (as
    applicable) at the time such application or report is filed--
              (I) may include a written request for the proper
            classification of the accessory pursuant to
            subparagraph (A);
              (II) shall include in any such request such
            information as may be necessary for the Secretary to
            evaluate, based on the least burdensome approach, the
            appropriate class for the accessory under subsection
            (a); and
              (III) shall, if the request under subclause (I) is
            requesting classification of the accessory in class II,
            include in the application an initial draft proposal
            for special controls, if special controls would be
            required pursuant to subsection (a)(1)(B).
      (ii) The Secretary's response under section 515(d) or section
    510(n) (as applicable) to an application or report described in
    clause (i) shall also contain the Secretary's granting or
    denial of the request for classification of the accessory
    involved.
      (iii) The Secretary's evaluation of an accessory under clause
    (i) shall constitute an order establishing a new classification
    for such accessory for the specified intended use or uses of
    such accessory and for any accessory with the same intended use
    or uses as such accessory.
      (D) For accessories that have been granted marketing
    authorization as part of a submission for another device with
    which the accessory involved is intended to be used, through an
    application for such other device under section 515(c), a
    report under section 510(k), or a request for classification
    under paragraph (2) of this subsection, the following shall
    apply:
              (i) Not later than the date that is one year after
            the date of enactment of the FDA Reauthorization Act of
            2017 and at least once every 5 years thereafter, and as
            the Secretary otherwise determines appropriate,
            pursuant to this paragraph, the Secretary shall publish
            in the Federal Register a notice proposing a list of
            such accessories that the Secretary determines may be
            suitable for a distinct classification in class I and
            the proposed regulations for such classifications. In
            developing such list, the Secretary shall consider
            recommendations from sponsors of device submissions and
            other stakeholders for accessories to be included on
            such list. The notices shall provide for a period of
            not less than 60 calendar days for public comment.
            Within 180 days after the end of the comment period,
            the Secretary shall publish in the Federal Register a
            final action classifying such suitable accessories into
            class I.
              (ii) A manufacturer or importer of an accessory that
            has been granted such marketing authorization may
            submit to the Secretary a written request for the
            appropriate classification of the accessory based on
            the risks and appropriate level of regulatory controls
            as described in subparagraph (A), and shall, if the
            request is requesting classification of the accessory
            in class II, include in the submission an initial draft
            proposal for special controls, if special controls
            would be required pursuant to subsection (a)(1)(B).
            Such request shall include such information as may be
            necessary for the Secretary to evaluate, based on the
            least burdensome approach, the appropriate class for
            the accessory under subsection (a). The Secretary shall
            provide an opportunity for a manufacturer or importer
            to meet with appropriate personnel of the Food and Drug
            Administration to discuss the appropriate
            classification of such accessory prior to submitting a
            written request under this clause for classification of
            the accessory.
              (iii) The Secretary shall respond to a request made
            under clause (ii) not later than 85 calendar days after
            receiving such request by issuing a written order
            classifying the accessory or denying the request. If
            the Secretary does not agree with the recommendation
            for classification submitted by the manufacturer or
            importer, the response shall include a detailed
            description and justification for such determination.
            Within 30 calendar days after granting such a request,
            the Secretary shall publish a notice in the Federal
            Register announcing such response.
      (E) Nothing in this paragraph may be construed as precluding
    a manufacturer of an accessory of a new type from using the
    classification process described in subsection (f)(2) to obtain
    classification of such accessory in accordance with the
    criteria and requirements set forth in that subsection.

                                  Information

      (g) Within sixty days of the receipt of a written request of
    any person for information respecting the class in which a
    device has been classified or the requirements applicable to a
    device under this Act, the Secretary shall provide such person
    a written statement of the classification (if any) of such
    device and the requirements of this Act applicable to the
    device.

                                  Definitions

      (h) For purposes of this section and sections 501, 510, 514,
    515, 516, 519, and 520--
              (1) a reference to ``general controls'' is a
            reference to the controls authorized by or under
            sections 501, 502, 510, 516, 518, 519, and 520,
              (2) a reference to ``class I,''``class II,'' or
            ``class III'' is a reference to a class of medical
            devices described in subparagraph (A), (B), or (C) of
            subsection (a)(1), and
              (3) a reference to a ``panel under section 513'' is a
            reference to a panel established or authorized to be
            used under this section.

                            Substantial Equivalence

      (i)(1)(A) For purposes of determinations of substantial
    equivalence under subsection (f) and section 520(l), the term
    ``substantially equivalent'' or ``substantial equivalence''
    means, with respect to a device being compared to a predicate
    device, that the device has the same intended use as the
    predicate device and that the Secretary by order has found that
    the device--
              (i) has the same technological characteristics as the
            predicate device, or
              (ii)(I) has different technological characteristics
            and the information submitted that the device is
            substantially equivalent to the predicate device
            contains information, including appropriate clinical or
            scientific data if deemed necessary by the Secretary or
            a person accredited under section 523, that
            demonstrates that the device is as safe and effective
            as a legally marketed device, and (II) does not raise
            different questions of safety and effectiveness than
            the predicate device.
      (B) For purposes of subparagraph (A), the term ``different
    technological characteristics'' means, with respect to a device
    being compared to a predicate device, that there is a
    significant change in the materials, design, energy source, or
    other features of the device from those of the predicate
    device.
      (C) To facilitate reviews of reports submitted to the
    Secretary under section 510(k), the Secretary shall consider
    the extent to which reliance on postmarket controls may
    expedite the classification of devices under subsection (f)(1)
    of this section.
      (D)(i) Whenever the Secretary requests information to
    demonstrate that devices with differing technological
    characteristics are substantially equivalent, the Secretary
    shall only request information that is necessary to making
    substantial equivalence determinations. In making such request,
    the Secretary shall consider the least burdensome means of
    demonstrating substantial equivalence and request information
    accordingly.
      (ii) For purposes of clause (i), the term ``necessary'' means
    the minimum required information that would support a
    determination of substantial equivalence between a new device
    and a predicate device.
      (iii) Nothing in this subparagraph shall alter the standard
    for determining substantial equivalence between a new device
    and a predicate device.
      (E)(i) Any determination by the Secretary of the intended use
    of a device shall be based upon the proposed labeling submitted
    in a report for the device under section 510(k). However, when
    determining that a device can be found substantially equivalent
    to a legally marketed device, the director of the
    organizational unit responsible for regulating devices (in this
    subparagraph referred to as the ``Director'') may require a
    statement in labeling that provides appropriate information
    regarding a use of the device not identified in the proposed
    labeling if, after providing an opportunity for consultation
    with the person who submitted such report, the Director
    determines and states in writing--
              (I) that there is a reasonable likelihood that the
            device will be used for an intended use not identified
            in the proposed labeling for the device; and
              (II) that such use could cause harm.
      (ii) Such determination shall--
              (I) be provided to the person who submitted the
            report within 10 days from the date of the notification
            of the Director's concerns regarding the proposed
            labeling;
              (II) specify the limitations on the use of the device
            not included in the proposed labeling; and
              (III) find the device substantially equivalent if the
            requirements of subparagraph (A) are met and if the
            labeling for such device conforms to the limitations
            specified in subclause (II).
      (iii) The responsibilities of the Director under this
    subparagraph may not be delegated.
      (F) Not later than 270 days after the date of the enactment
    of the Food and Drug Administration Modernization Act of 1997,
    the Secretary shall issue guidance specifying the general
    principles that the Secretary will consider in determining when
    a specific intended use of a device is not reasonably included
    within a general use of such device for purposes of a
    determination of substantial equivalence under subsection (f)
    or section 520(l).
      (2) A device may not be found to be substantially equivalent
    to a predicate device that has been removed from the market at
    the initiative of the Secretary or that has been determined to
    be misbranded or adulterated by a judicial order.
      (3)(A) As part of a submission under section 510(k)
    respecting a device, the person required to file a premarket
    notification under such section shall provide an adequate
    summary of any information respecting safety and effectiveness
    or state that such information will be made available upon
    request by any person.
      (B) Any summary under subparagraph (A) respecting a device
    shall contain detailed information regarding data concerning
    adverse health effects and shall be made available to the
    public by the Secretary within 30 days of the issuance of a
    determination that such device is substantially equivalent to
    another device.
      (j) Training and Oversight of Least Burdensome
    Requirements.--
              (1) The Secretary shall--
                      (A) ensure that each employee of the Food and
                    Drug Administration who is involved in the
                    review of premarket submissions, including
                    supervisors, receives training regarding the
                    meaning and implementation of the least
                    burdensome requirements under subsections
                    (a)(3)(D) and (i)(1)(D) of this section and
                    section 515(c)(5); and
                      (B) periodically assess the implementation of
                    the least burdensome requirements, including
                    the employee training under subparagraph (A),
                    to ensure that the least burdensome
                    requirements are fully and consistently
                    applied.
              (2) Not later than 18 months after the date of
            enactment of the 21st Century Cures Act, the ombudsman
            for any organizational unit of the Food and Drug
            Administration responsible for the premarket review of
            devices shall--
                      (A) conduct an audit of the training
                    described in paragraph (1)(A), including the
                    effectiveness of such training in implementing
                    the least burdensome requirements;
                      (B) include in such audit interviews of
                    persons who are representatives of the device
                    industry regarding their experiences in the
                    device premarket review process, including with
                    respect to the application of least burdensome
                    concepts to premarket review and
                    decisionmaking;
                      (C) include in such audit a list of the
                    measurement tools the Secretary uses to assess
                    the implementation of the least burdensome
                    requirements, including under paragraph (1)(B)
                    and section 517A(a)(3), and may also provide
                    feedback on the effectiveness of such tools in
                    the implementation of the least burdensome
                    requirements;
                      (D) summarize the findings of such audit in a
                    final audit report; and
                      (E) within 30 calendar days of completion of
                    such final audit report, make such final audit
                    report available--
                              (i) 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
                              (ii) on the Internet website of the
                            Food and Drug Administration.
      (k) For a device authorized for emergency use under section
    564 for which, in accordance with section 564(m), the Secretary
    has deemed a laboratory examination or procedure associated
    with such device to be in the category of examinations and
    procedures described in section 353(d)(3) of the Public Health
    Service Act, the sponsor of such device may, when submitting a
    request for classification under section 513(f)(2), submit a
    single submission containing--
              (1) the information needed for such a request; and
              (2) sufficient information to enable the Secretary to
            determine whether such laboratory examination or
            procedure satisfies the criteria to be categorized
            under section 353(d)(3) of the Public Health Service
            Act.

                             performance standards

                            Provisions of Standards

      Sec. 514. (a)(1) The special controls required by section
    513(a)(1)(B) shall include performance standards for a class II
    device if the Secretary determines that a performance standard
    is necessary to provide reasonable assurance of the safety and
    effectiveness of the device. A class III device may also be
    considered a class II device for purposes of establishing a
    standard for the device under subsection (b) if the device has
    been reclassified as a class II device under an administrative
    order under section 513(e) (or a regulation promulgated under
    such section prior to the date of enactment of the Food and
    Drug Administration Safety and Innovation Act) but such order
    (or regulation) provides that the reclassification is not to
    take effect until the effective date of such a standard for the
    device.
      (2) A performance standard established under subsection (b)
    for a device--
              (A) shall include provisions to provide reasonable
            assurance of its safe and effective performance;
              (B) shall, where necessary to provide reasonable
            assurance of its safe and effective performance,
            include--
                      (i) provisions respecting the construction,
                    components, ingredients, and properties of the
                    device and its compatibility with power systems
                    and connections to such systems,
                      (ii) provisions for the testing (on a sample
                    basis or, if necessary, on an individual basis)
                    of the device or, if it is determined that no
                    other more practicable means are available to
                    the Secretary to assure the conformity of the
                    device to the standard, provisions for the
                    testing (on a sample basis or, if necessary, on
                    an individual basis) by the Secretary or by
                    another person at the direction of the
                    Secretary,
                      (iii) provisions for the measurement of the
                    performance characteristics of the device,
                      (iv) provisions requiring that the results of
                    each or of certain of the tests of the device
                    required to be made under clause (ii) show that
                    the device is in conformity with the portions
                    of the standard for which the test or tests
                    were required, and
                      (v) a provision requiring that the sale and
                    distribution of the device be restricted but
                    only to the extent that the sale and
                    distribution of a device may be restricted
                    under a regulation under section 520(e); and
              (C) shall, where appropriate, require the use and
            prescribe the form and content of labeling for the
            proper installation, maintenance, operation, and use of
            the device.
      (3) The Secretary shall provide for periodic evaluation of
    performance standards established under subsection (b) to
    determine if such standards should be changed to reflect new
    medical, scientific, or other technological data.
      (4) In carrying out his duties under this subsection and
    subsection (b), the Secretary shall, to the maximum extent
    practicable--
              (A) use personnel, facilities, and other technical
            support available in other Federal agencies,
              (B) consult with other Federal agencies concerned
            with standard-setting and other nationally or
            internationally recognized standard-setting entities,
            and
              (C) invite appropriate participation, through joint
            or other conferences, workshops, or other means, by
            informed persons representative of scientific,
            professional, industry, or consumer organizations who
            in his judgment can make a significant contribution.

                          Establishment of a Standard

      (b)(1)(A) The Secretary shall publish in the Federal Register
    a notice of proposed rulemaking for the establishment,
    amendment, or revocation of any performance standard for a
    device.
      (B) A notice of proposed rulemaking for the establishment or
    amendment of a performance standard for a device shall--
              (i) set forth a finding with supporting justification
            that the performance standard is appropriate and
            necessary to provide reasonable assurance of the safety
            and effectiveness of the device,
              (ii) set forth proposed findings with respect to the
            risk of illness or injury that the performance standard
            is intended to reduce or eliminate,
              (iii) invite interested persons to submit to the
            Secretary, within 30 days of the publication of the
            notice, requests for changes in the classification of
            the device pursuant to section 513(e) based on new
            information relevant to the classification, and
              (iv) invite interested persons to submit an existing
            performance standard for the device, including a draft
            or proposed performance standard, for consideration by
            the Secretary.
      (C) A notice of proposed rulemaking for the revocation of a
    performance standard shall set forth a finding with supporting
    justification that the performance standard is no longer
    necessary to provide reasonable assurance of the safety and
    effectiveness of a device.
      (D) The Secretary shall provide for a comment period of not
    less than 60 days.
      (2) If, after publication of a notice in accordance with
    paragraph (1), the Secretary receives a request for a change in
    the classification of the device, the Secretary shall, within
    60 days of the publication of the notice, after consultation
    with the appropriate panel under section 513, either deny the
    request or give notice of an intent to initiate such change
    under section 513(e).
      (3)(A) After the expiration of the period for comment on a
    notice of proposed rulemaking published under paragraph (1)
    respecting a performance standard and after consideration of
    such comments and any report from an advisory committee under
    paragraph (5), the Secretary shall (i) promulgate a regulation
    establishing a performance standard and publish in the Federal
    Register findings on the matters referred to in paragraph (1),
    or (ii) publish a notice terminating the proceeding for the
    development of the standard together with the reasons for such
    termination. If a notice of termination is published, the
    Secretary shall (unless such notice is issued because the
    device is a banned device under section 516) initiate a
    proceeding under section 513(e) to reclassify the device
    subject to the proceeding terminated by such notice.
      (B) A regulation establishing a performance standard shall
    set forth the date or dates upon which the standard shall take
    effect, but no such regulation may take effect before one year
    after the date of its publication unless (i) the Secretary
    determines that an earlier effective date is necessary for the
    protection of the public health and safety, or (ii) such
    standard has been established for a device which, effective
    upon the effective date of the standard, has been reclassified
    from class III to class II. Such date or dates shall be
    established so as to minimize, consistent with the public
    health and safety, economic loss to, and disruption or
    dislocation of, domestic and international trade.
      (4)(A) The Secretary, upon his own initiative or upon
    petition of an interested person may by regulation, promulgated
    in accordance with the requirements of paragraphs (1), (2), and
    (3)(B) of this subsection, amend or revoke a performance
    standard.
      (B) The Secretary may declare a proposed amendment of a
    performance standard to be effective on and after its
    publication in the Federal Register and until the effective
    date of any final action taken on such amendment if he
    determines that making it so effective is in the public
    interest. A proposed amendment of a performance standard made
    so effective under the preceding sentence may not prohibit,
    during the period in which it is so effective, the introduction
    or delivery for introduction into interstate commerce of a
    device which conforms to such standard without the change or
    changes provided by such proposed amendment.
      (5)(A) The Secretary--
              (i) may on his own initiative refer a proposed
            regulation for the establishment, amendment, or
            revocation of a performance standard, or
              (ii) shall, upon the request of an interested person
            which demonstrates good cause for referral and which is
            made before the expiration of the period for submission
            of comments on such proposed regulation refer such
            proposed regulation,
    to an advisory committee of experts, established pursuant to
    subparagraph (B) for a report and recommendation with respect
    to any matter involved in the proposed regulation which
    requires the exercise of scientific judgment. If a proposed
    regulation is referred under this subparagraph to an advisory
    committee, the Secretary shall provide the advisory committee
    with the data and information on which such proposed regulation
    is based. The advisory committee shall, within sixty days of
    the referral of a proposed regulation and after independent
    study of the data and information furnished to it by the
    Secretary and other data and information before it, submit to
    the Secretary a report and recommendation respecting such
    regulation, together with all underlying data and information
    and a statement of the reason or basis for the recommendation.
    A copy of such report and recommendation shall be made public
    by the Secretary.
      (B) The Secretary shall establish advisory committees (which
    may not be panels under section 513) to receive referrals under
    subparagraph (A). The Secretary shall appoint as members of any
    such advisory committee persons qualified in the subject matter
    to be referred to the committee and of appropriately
    diversified professional background, except that the Secretary
    may not appoint to such a committee any individual who is in
    the regular full-time employ of the United States and engaged
    in the administration of this Act. Each such committee shall
    include as nonvoting members a representative of consumer
    interests and a representative of interests of the device
    manufacturing industry. Members of an advisory committee who
    are not officers or employees of the United States, while
    attending conferences or meetings of their committee or
    otherwise serving at the request of the Secretary, shall be
    entitled to receive compensation at rates to be fixed by the
    Secretary, which rates may not exceed the daily equivalent of
    the rate in effect for grade GS-18 of the General Schedule, for
    each day (including traveltime) they are so engaged; and while
    so serving away from their homes or regular places of business
    each member may be allowed travel expenses, including per diem
    in lieu of subsistence, as authorized by section 5703 of title
    5 of the United States Code for persons in the Government
    service employed intermittently. The Secretary shall designate
    one of the members of each advisory committee to serve as
    chairman thereof. The Secretary shall furnish each advisory
    committee with clerical and other assistance, and shall by
    regulation prescribe the procedures to be followed by each such
    committee in acting on referrals made under subparagraph (A).

                           Recognition of a Standard

      (c)(1)(A) In addition to establishing a performance standard
    under this section, the Secretary shall, by publication in the
    Federal Register (or, with respect to a susceptibility test
    interpretive criteria standard under section 511A, by posting
    on the Interpretive Criteria Website in accordance with such
    section), recognize all or part of an appropriate standard
    established by a nationally or internationally recognized
    standard development organization for which a person may submit
    a declaration of conformity in order to meet a premarket
    submission requirement or other requirement under this Act to
    which such standard is applicable.
      (B) If a person elects to use a standard recognized by the
    Secretary under subparagraph (A) to meet the requirements
    described in such subparagraph, the person shall provide a
    declaration of conformity to the Secretary that certifies that
    the device is in conformity with such standard. A person may
    elect to use data, or information, other than data required by
    a standard recognized under subparagraph (A) to meet any
    requirement regarding devices under this Act.
      (C)(i) Any person may submit a request for recognition under
    subparagraph (A) of all or part of an appropriate standard
    established by a nationally or internationally recognized
    standard organization.
      (ii) Not later than 60 calendar days after the Secretary
    receives such a request, the Secretary shall--
              (I) make a determination to recognize all, part, or
            none of the standard that is the subject of the
            request; and
              (II) issue to the person who submitted such request a
            response in writing that states the Secretary's
            rationale for that determination, including the
            scientific, technical, regulatory, or other basis for
            such determination.
      (iii) The Secretary shall make a response issued under clause
    (ii)(II) publicly available, in such a manner as the Secretary
    determines appropriate.
      (iv) The Secretary shall take such actions as may be
    necessary to implement all or part of a standard recognized
    under clause (ii)(I), in accordance with subparagraph (A).
      (D) The Secretary shall make publicly available, in such
    manner as the Secretary determines appropriate, the rationale
    for recognition under subparagraph (A) of all, part, or none of
    a standard, including the scientific, technical, regulatory, or
    other basis for the decision regarding such recognition.
      (2) The Secretary may withdraw such recognition of a standard
    through publication of a notice in the Federal Register if the
    Secretary determines that the standard is no longer appropriate
    for meeting a requirement regarding devices under this Act.
      (3)(A) Subject to subparagraph (B), the Secretary shall
    accept a declaration of conformity that a device is in
    conformity with a standard recognized under paragraph (1)
    unless the Secretary finds--
              (i) that the data or information submitted to support
            such declaration does not demonstrate that the device
            is in conformity with the standard identified in the
            declaration of conformity; or
              (ii) that the standard identified in the declaration
            of conformity is not applicable to the particular
            device under review.
      (B) The Secretary may request, at any time, the data or
    information relied on by the person to make a declaration of
    conformity with respect to a standard recognized under
    paragraph (1).
      (C) A person making a declaration of conformity with respect
    to a standard recognized under paragraph (1) shall maintain the
    data and information demonstrating conformity of the device to
    the standard for a period of two years after the date of the
    classification or approval of the device by the Secretary or a
    period equal to the expected design life of the device,
    whichever is longer.
      (4) The Secretary shall provide to all employees of the Food
    and Drug Administration who review premarket submissions for
    devices periodic training on the concept and use of recognized
    standards for purposes of meeting a premarket submission
    requirement or other applicable requirement under this Act,
    including standards relevant to an employee's area of device
    review.
      [(d) Pilot Accreditation Scheme for Conformity Assessment.--
              [(1) In general.--The Secretary shall establish a
            pilot program under which--
                      [(A) testing laboratories may be accredited,
                    by accreditation bodies meeting criteria
                    specified by the Secretary, to assess the
                    conformance of a device with certain standards
                    recognized under this section; and
                      [(B) subject to paragraph (2), determinations
                    by testing laboratories so accredited that a
                    device conforms with such standard or standards
                    shall be accepted by the Secretary for purposes
                    of demonstrating such conformity under this
                    section unless the Secretary finds that a
                    particular such determination shall not be so
                    accepted.
              [(2) Secretarial review of accredited laboratory
            determinations.--The Secretary may--
                      [(A) review determinations by testing
                    laboratories accredited pursuant to this
                    subsection, including by conducting periodic
                    audits of such determinations or processes of
                    accredited bodies or testing laboratories and,
                    following such review, taking additional
                    measures under this Act, such as suspension or
                    withdrawal of accreditation of such testing
                    laboratory under paragraph (1)(A) or requesting
                    additional information with respect to such
                    device, as the Secretary determines
                    appropriate; and
                      [(B) if the Secretary becomes aware of
                    information materially bearing on safety or
                    effectiveness of a device assessed for
                    conformity by a testing laboratory so
                    accredited, take such additional measures under
                    this Act as the Secretary determines
                    appropriate, such as suspension or withdrawal
                    of accreditation of such testing laboratory
                    under paragraph (1)(A), or requesting
                    additional information with regard to such
                    device.
              [(3) Implementation and reporting.--
                      [(A) Public meeting.--The Secretary shall
                    publish in the Federal Register a notice of a
                    public meeting to be held no later than
                    September 30, 2018, to discuss and obtain input
                    and recommendations from stakeholders regarding
                    the goals and scope of, and a suitable
                    framework and procedures and requirements for,
                    the pilot program under this subsection.
                      [(B) Pilot program guidance.--The Secretary
                    shall--
                              [(i) not later than September 30,
                            2019, issue draft guidance regarding
                            the goals and implementation of the
                            pilot program under this subsection;
                            and
                              [(ii) not later than September 30,
                            2021, issue final guidance with respect
                            to the implementation of such program.
                      [(C) Pilot program initiation.--Not later
                    than September 30, 2020, the Secretary shall
                    initiate the pilot program under this
                    subsection.
                      [(D) Report.--The Secretary shall make
                    available on the internet website of the Food
                    and Drug Administration an annual report on the
                    progress of the pilot program under this
                    subsection.
              [(4) Sunset.--As of October 1, 2022--
                      [(A) the authority for accreditation bodies
                    to accredit testing laboratories pursuant to
                    paragraph (1)(A) shall cease to have force or
                    effect;
                      [(B) the Secretary--
                              [(i) may not accept a determination
                            pursuant to paragraph (1)(B) made by a
                            testing laboratory after such date; and
                              [(ii) may accept such a determination
                            made prior to such date;
                      [(C) except for purposes of accepting a
                    determination described in subparagraph
                    (B)(ii), the Secretary shall not continue to
                    recognize the accreditation of testing
                    laboratories accredited under paragraph (1)(A);
                    and
                      [(D) the Secretary may take actions in
                    accordance with paragraph (2) with respect to
                    the determinations made prior to such date and
                    recognition of the accreditation of testing
                    laboratories pursuant to determinations made
                    prior to such date.]
      (d) Accreditation Scheme for Conformity Assessment.--
              (1) In general.--The Secretary shall establish a
            program under which--
                      (A) testing laboratories meeting criteria
                    specified in guidance by the Secretary may be
                    accredited by accreditation bodies meeting
                    criteria specified in guidance by the
                    Secretary, to conduct testing to support the
                    assessment of the conformity of a device to
                    certain standards recognized under this
                    section; and
                      (B) subject to paragraph (2), results from
                    tests conducted to support the assessment of
                    conformity of devices as described in
                    subparagraph (A) conducted by testing
                    laboratories accredited pursuant to this
                    subsection shall be accepted by the Secretary
                    for purposes of demonstrating such conformity
                    unless the Secretary finds that certain results
                    of such tests should not be so accepted.
              (2) Secretarial review of accredited laboratory
            results.--The Secretary may--
                      (A) review the results of tests conducted by
                    testing laboratories accredited pursuant to
                    this subsection, including by conducting
                    periodic audits of such results or of the
                    processes of accredited bodies or testing
                    laboratories;
                      (B) following such review, take additional
                    measures under this Act, as the Secretary
                    determines appropriate, such as--
                              (i) suspension or withdrawal of
                            accreditation of a testing laboratory
                            or recognition of an accreditation body
                            under paragraph (1)(A); or
                              (ii) requesting additional
                            information with respect to a device;
                            and
                      (C) if the Secretary becomes aware of
                    information materially bearing on the safety or
                    effectiveness of a device for which an
                    assessment of conformity was supported by
                    testing conducted by a testing laboratory
                    accredited under this subsection, take such
                    additional measures under this Act, as the
                    Secretary determines appropriate, such as--
                              (i) suspension or withdrawal of
                            accreditation of a testing laboratory
                            or recognition of an accreditation body
                            under paragraph (1)(A); or
                              (ii) requesting additional
                            information with regard to such device.
              (3) Implementation and reporting.--
                      (A) Pilot program transition.--After
                    September 30, 2023, the pilot program
                    previously initiated under this subsection, as
                    in effect prior to the date of enactment of the
                    Medical Device User Fee Amendments of 2022,
                    shall be considered to be completed, and the
                    Secretary may continue operating a program
                    consistent with this subsection.
                      (B) 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.

               *       *       *       *       *       *       *

                                 banned devices

                                  General Rule

      Sec. 516. (a) Whenever the Secretary finds, on the basis of
    all available data and information, that--
              (1) a device intended for human use presents
            substantial deception or an unreasonable and
            substantial risk of illness or injury for one or more
            intended use; and
              (2) in the case of substantial deception or an
            unreasonable and substantial risk of illness or injury
            which the Secretary determined could be corrected or
            eliminated by labeling or change in labeling and with
            respect to which the Secretary provided written notice
            to the manufacturer specifying the deception or risk of
            illness or injury, the labeling or change in labeling
            to correct the deception or eliminate or reduce such
            risk, and the period within which such labeling or
            change in labeling was to be done, such labeling or
            change in labeling was not done within such period;
    he may initiate a proceeding to promulgate a regulation to make
    such device a banned device for any such intended use or uses.
    A device that is banned for one or more intended uses is not a
    legally marketed device under section 1006 when intended for
    such use or uses.

                             Special Effective Date

      (b) The Secretary may declare a proposed regulation under
    subsection (a) to be effective upon its publication in the
    Federal Register and until the effective date of any final
    action taken respecting such regulation if (1) he determines,
    on the basis of all available data and information, that the
    deception or risk of illness or injury associated with the use
    of the device which is subject to the regulation presents an
    unreasonable, direct, and substantial danger to the health of
    individuals, and (2) before the date of the publication of such
    regulation, the Secretary notifies the manufacturer of such
    device that such regulation is to be made so effective. If the
    Secretary makes a proposed regulation so effective, he shall,
    as expeditiously as possible, give interested persons prompt
    notice of his action under this subsection, provide reasonable
    opportunity for an informal hearing on the proposed regulation,
    and either affirm, modify, or revoke such proposed regulation.
      (c) Specific Device Banned.--Electrical stimulation devices
    that apply a noxious electrical stimulus to a person's skin
    intended to reduce or cease self-injurious behavior or
    aggressive behavior are deemed to be banned devices, as
    described in subsection (a).
      (d) Reversal by Regulation.--Devices banned under this
    section are banned devices unless or until the Secretary
    promulgates a regulation to make such devices or use of such
    devices no longer banned based on a finding that such devices
    or use of such devices does not present substantial deception
    or an unreasonable and substantial risk of illness or injury,
    or that such risk can be corrected or eliminated by labeling.

               *       *       *       *       *       *       *

    general provisions respecting control of devices intended for human use

                                  General Rule

      Sec. 520. (a) Any requirement authorized by or under section
    501, 502, 510, or 519 applicable to a device intended for human
    use shall apply to such device until the applicability of the
    requirement to the device has been changed by action taken
    under section 513, 514, or 515 or under subsection (g) of this
    section, and any requirement established by or under section
    501, 502, 510, or 519 which is inconsistent with a requirement
    imposed on such device under section 514 or 515 or under
    subsection (g) of this section shall not apply to such device.
      (b) Custom Devices.--
              (1) In general.--The requirements of sections 514 and
            515 shall not apply to a device that--
                      (A) is created or modified in order to comply
                    with the order of an individual physician or
                    dentist (or any other specially qualified
                    person designated under regulations promulgated
                    by the Secretary after an opportunity for an
                    oral hearing);
                      (B) in order to comply with an order
                    described in subparagraph (A), necessarily
                    deviates from an otherwise applicable
                    performance standard under section 514 or
                    requirement under section 515;
                      (C) is not generally available in the United
                    States in finished form through labeling or
                    advertising by the manufacturer, importer, or
                    distributor for commercial distribution;
                      (D) is designed to treat a unique pathology
                    or physiological condition that no other device
                    is domestically available to treat;
                      (E)(i) is intended to meet the special needs
                    of such physician or dentist (or other
                    specially qualified person so designated) in
                    the course of the professional practice of such
                    physician or dentist (or other specially
                    qualified person so designated); or
                      (ii) is intended for use by an individual
                    patient named in such order of such physician
                    or dentist (or other specially qualified person
                    so designated);
                      (F) is assembled from components or
                    manufactured and finished on a case-by-case
                    basis to accommodate the unique needs of
                    individuals described in clause (i) or (ii) of
                    subparagraph (E); and
                      (G) may have common, standardized design
                    characteristics, chemical and material
                    compositions, and manufacturing processes as
                    commercially distributed devices.
              (2) Limitations.--Paragraph (1) shall apply to a
            device only if--
                      (A) such device is for the purpose of
                    treating a sufficiently rare condition, such
                    that conducting clinical investigations on such
                    device would be impractical;
                      (B) production of such device under paragraph
                    (1) is limited to no more than 5 units per year
                    of a particular device type, provided that such
                    replication otherwise complies with this
                    section; and
                      (C) the manufacturer of such device notifies
                    the Secretary on an annual basis, in a manner
                    prescribed by the Secretary, of the manufacture
                    of such device.
              (3) Guidance.--Not later than 2 years after the date
            of enactment of this section, the Secretary shall issue
            final guidance on replication of multiple devices
            described in paragraph (2)(B).

                                 Trade Secrets

      (c) Any information reported to or otherwise obtained by the
    Secretary or his representative under section 513, 514, 515,
    516, 518, 519, or 704 or under subsection (f) or (g) of this
    section which is exempt from disclosure pursuant to subsection
    (a) of section 552 of title 5, United States Code, by reason of
    subsection (b)(4) of such section shall be considered
    confidential and shall not be disclosed and may not be used by
    the Secretary as the basis for the reclassification of a device
    from class III to class II or class I or as the basis for the
    establishment or amendment of a performance standard under
    section 514 for a device reclassified from class III to class
    II, except (1) in accordance with subsection (h), and (2) that
    such information may be disclosed to other officers or
    employees concerned with carrying out this Act or when relevant
    in any proceeding under this Act (other than section 513 or 514
    thereof).

                              Notices and Findings

      (d) Each notice of proposed rulemaking under section 513,
    514, 515, 516, 518, or 519, or under this section, any other
    notice which is published in the Federal Register with respect
    to any other action taken under any such section and which
    states the reasons for such action, and each publication of
    findings required to be made in connection with rulemaking
    under any such section shall set forth--
              (1) the manner in which interested persons may
            examine data and other information on which the notice
            or findings is based, and
              (2) the period within which interested persons may
            present their comments on the notice or findings
            (including the need therefor) orally or in writing,
            which period shall be at least sixty days but may not
            exceed ninety days unless the time is extended by the
            Secretary by a notice published in the Federal Register
            stating good cause therefor.

                               Restricted Devices

      (e)(1) The Secretary may by regulation require that a device
    be restricted to sale, distribution, or use--
              (A) only upon the written or oral authorization of a
            practitioner licensed by law to administer or use such
            device, or
              (B) upon such other conditions as the Secretary may
            prescribe in such regulation,
    if, because of its potentiality for harmful effect or the
    collateral measures necessary to its use, the Secretary
    determines that there cannot otherwise be reasonable assurance
    of its safety and effectiveness. No condition prescribed under
    subparagraph (B) may restrict the use of a device to persons
    with specific training or experience in its use or to persons
    for use in certain facilities unless the Secretary determines
    that such a restriction is required for the safe and effective
    use of the device. No such condition may exclude a person from
    using a device solely because the person does not have the
    training or experience to make him eligible for certification
    by a certifying board recognized by the American Board of
    Medical Specialties or has not been certified by such a Board.
    A device subject to a regulation under this subsection is a
    restricted device.
      (2) The label of a restricted device shall bear such
    appropriate statements of the restrictions required by a
    regulation under paragraph (1) as the Secretary may in such
    regulation prescribe.

                    Good Manufacturing Practice Requirements

      (f)(1)(A) The Secretary may, in accordance with subparagraph
    (B), prescribe regulations requiring that the methods used in,
    and the facilities and controls used for, the manufacture, pre-
    production design validation (including a process to assess the
    performance of a device but not including an evaluation of the
    safety or effectiveness of a device), packing, storage, and
    installation of a device conform to current good manufacturing
    practice, as prescribed in such regulations, to assure that the
    device will be safe and effective and otherwise in compliance
    with this Act.
      (B) Before the Secretary may promulgate any regulation under
    subparagraph (A) he shall--
              (i) afford the advisory committee established under
            paragraph (3) an opportunity to submit recommendations
            to him with respect to the regulation proposed to be
            promulgated;
              (ii) afford opportunity for an oral hearing; and
              (iii) ensure that such regulation conforms, to the
            extent practicable, with internationally recognized
            standards defining quality systems, or parts of the
            standards, for medical devices.
    The Secretary shall provide the advisory committee a reasonable
    time to make its recommendation with respect to proposed
    regulations under subparagraph (A).
      (2)(A) Any person subject to any requirement prescribed by
    regulations under paragraph (1) may petition the Secretary for
    an exemption or variance from such requirement. Such a petition
    shall be submitted to the Secretary in such form and manner as
    he shall prescribe and shall--
              (i) in the case of a petition for an exemption from a
            requirement, set forth the basis for the petitioner's
            determination that compliance with the requirement is
            not required to assure that the device will be safe and
            effective and otherwise in compliance with this Act,
              (ii) in the case of a petition for a variance from a
            requirement, set forth the methods proposed to be used
            in, and the facilities and controls proposed to be used
            for, the manufacture, packing, storage, and
            installation of the device in lieu of the methods,
            facilities, and controls prescribed by the requirement,
            and
              (iii) contain such other information as the Secretary
            shall prescribe.
      (B) The Secretary may refer to the advisory committee
    established under paragraph (3) any petition submitted under
    subparagraph (A). The advisory committee shall report its
    recommendations to the Secretary with respect to a petition
    referred to it within sixty days of the date of the petition's
    referral. Within sixty days after--
              (i) the date the petition was submitted to the
            Secretary under subparagraph (A), or
              (ii) if the petition was referred to an advisory
            committee, the expiration of the sixty-day period
            beginning on the date the petition was referred to the
            advisory committee,
    whichever occurs later, the Secretary shall by order either
    deny the petition or approve it.
      (C) The Secretary may approve--
              (i) a petition for an exemption for a device from a
            requirement if he determines that compliance with such
            requirement is not required to assure that the device
            will be safe and effective and otherwise in compliance
            with this Act, and
              (ii) a petition for a variance for a device from a
            requirement if he determines that the methods to be
            used in, and the facilities and controls to be used
            for, the manufacture, packing, storage, and
            installation of the device in lieu of the methods,
            controls, and facilities prescribed by the requirement
            are sufficient to assure that the device will be safe
            and effective and otherwise in compliance with this
            Act.
    An order of the Secretary approving a petition for a variance
    shall prescribe such conditions respecting the methods used in,
    and the facilities and controls used for, the manufacture,
    packing, storage, and installation of the device to be granted
    the variance under the petition as may be necessary to assure
    that the device will be safe and effective and otherwise in
    compliance with this Act.
      (D) After the issuance of an order under subparagraph (B)
    respecting a petition, the petitioner shall have an opportunity
    for an informal hearing on such order.
      (3) The Secretary shall establish an advisory committee for
    the purpose of advising and making recommendations to him with
    respect to regulations proposed to be promulgated under
    paragraph (1)(A) and the approval or disapproval of petitions
    submitted under paragraph (2). The advisory committee shall be
    composed of nine members as follows:
              (A) Three of the members shall be appointed from
            persons who are officers or employees of any State or
            local government or of the Federal Government.
              (B) Two of the members shall be appointed from
            persons who are representative of interests of the
            device manufacturing industry; two of the members shall
            be appointed from persons who are representative of the
            interests of physicians and other health professionals;
            and two of the members shall be representative of the
            interests of the general public.
    Members of the advisory committee who are not officers or
    employees of the United States, while attending conferences or
    meetings of the committee or otherwise engaged in its business,
    shall be entitled to receive compensation at rates to be fixed
    by the Secretary, which rates may not exceed the daily
    equivalent of the rate in effect for grade GS-18 of the General
    Schedule, for each day (including traveltime) they are so
    engaged; and while so serving away from their homes or regular
    places of business each member may be allowed travel expenses,
    including per diem in lieu of subsistence, as authorized by
    section 5703 of title 5 of the United States Code for persons
    in the Government service employed intermittently. The
    Secretary shall designate one of the members of the advisory
    committee to serve as its chairman. The Secretary shall furnish
    the advisory committee with clerical and other assistance.
    Section 14 of the Federal Advisory Committee Act shall not
    apply with respect to the duration of the advisory committee
    established under this paragraph.

                 Exemption for Devices for Investigational Use

      (g)(1) It is the purpose of this subsection to encourage to
    the extent consistent with the protection of the public health
    and safety and with ethical standards, the discovery and
    development of useful devices intended for human use and to
    that end to maintain optimum freedom for scientific
    investigators in their pursuit of that purpose.
      (2)(A) The Secretary shall, within the one hundred and
    twenty-day period beginning on the date of the enactment of
    this section, by regulation prescribe procedures and conditions
    under which devices intended for human use may upon application
    be granted an exemption from the requirements of section 502,
    510, 514, 515, 516, 519, or 721 or subsection (e) or (f) of
    this section or from any combination of such requirements to
    permit the investigational use of such devices by experts
    qualified by scientific training and experience to investigate
    the safety and effectiveness of such devices.
      (B) The conditions prescribed pursuant to subparagraph (A)
    shall include the following:
              (i) A requirement that an application be submitted to
            the Secretary before an exemption may be granted and
            that the application be submitted in such form and
            manner as the Secretary shall specify.
              (ii) A requirement that the person applying for an
            exemption for a device assure the establishment and
            maintenance of such records, and the making of such
            reports to the Secretary of safety or effectiveness
            data obtained as a result of the investigational use of
            the device during the exemption, as the Secretary
            determines will enable him to assure compliance with
            such conditions, review the progress of the
            investigation, and evaluate the safety and
            effectiveness of the device.
              (iii) Such other requirements as the Secretary may
            determine to be necessary for the protection of the
            public health and safety.
      (C) Procedures and conditions prescribed pursuant to
    subparagraph (A) for an exemption may appropriately vary
    depending on (i) the scope and duration of clinical testing to
    be conducted under such exemption, (ii) the number of human
    subjects that are to be involved in such testing, (iii) the
    need to permit changes to be made in the device subject to the
    exemption during testing conducted in accordance with a
    clinical testing plan required under paragraph (3)(A), and (iv)
    whether the clinical testing of such device is for the purpose
    of developing data to obtain approval for the commercial
    distribution of such device.
      (3) Procedures and conditions prescribed pursuant to
    paragraph (2)(A) shall require, as a condition to the exemption
    of any device to be the subject of testing involving human
    subjects, that the person applying for the exemption--
              (A) submit a plan for any proposed clinical testing
            of the device and a report of prior investigations of
            the device (including, where appropriate, tests on
            animals) adequate to justify the proposed clinical
            testing--
                      (i) to the institutional review committee
                    established in accordance with regulations of
                    the Secretary to supervise clinical testing of
                    devices in the facilities where the proposed
                    clinical testing is to be conducted, or
                      (ii) to the Secretary, if--
                              (I) no such committee exists, or
                              (II) the Secretary finds that the
                            process of review by such committee is
                            inadequate (whether or not the plan for
                            such testing has been approved by such
                            committee),
            for review for adequacy to justify the commencement of
            such testing; and, unless the plan and report are
            submitted to the Secretary, submit to the Secretary a
            summary of the plan and a report of prior
            investigations of the device (including, where
            appropriate, tests on animals);
              (B) promptly notify the Secretary (under such
            circumstances and in such manner as the Secretary
            prescribes) of approval by an institutional review
            committee of any clinical testing plan submitted to it
            in accordance with subparagraph (A);
              (C) in the case of a device to be distributed to
            investigators for testing, obtain signed agreements
            from each of such investigators that any testing of the
            device involving human subjects will be under such
            investigator's supervision and in accordance with
            subparagraph (D) and submit such agreements to the
            Secretary; and
              (D) assure that informed consent will be obtained
            from each human subject (or his representative) of
            proposed clinical testing involving such device, except
            where, subject to such conditions as the Secretary may
            prescribe--
                      (i) the proposed clinical testing poses no
                    more than minimal risk to the human subject and
                    includes appropriate safeguards to protect the
                    rights, safety, and welfare of the human
                    subject; or
                      (ii) the investigator conducting or
                    supervising the proposed clinical testing of
                    the device determines in writing that there
                    exists a life threatening situation involving
                    the human subject of such testing which
                    necessitates the use of such device and it is
                    not feasible to obtain informed consent from
                    the subject and there is not sufficient time to
                    obtain such consent from his representative.
    The determination required by subparagraph (D)(ii) shall be
    concurred in by a licensed physician who is not involved in the
    testing of the human subject with respect to which such
    determination is made unless immediate use of the device is
    required to save the life of the human subject of such testing
    and there is not sufficient time to obtain such concurrence.
      (4)(A) An application, submitted in accordance with the
    procedures prescribed by regulations under paragraph (2), for
    an exemption for a device (other than an exemption from section
    516) shall be deemed approved on the thirtieth day after the
    submission of the application to the Secretary unless on or
    before such day the Secretary by order disapproves the
    application and notifies the applicant of the disapproval of
    the application.
      (B) The Secretary may disapprove an application only if he
    finds that the investigation with respect to which the
    application is submitted does not conform to procedures and
    conditions prescribed under regulations under paragraph (2).
    Such a notification shall contain the order of disapproval and
    a complete statement of the reasons for the Secretary's
    disapproval of the application and afford the applicant
    opportunity for an informal hearing on the disapproval order.
      (C) Consistent with paragraph (1), the Secretary shall not
    disapprove an application under this subsection because the
    Secretary determines that--
              (i) the investigation may not support a substantial
            equivalence or de novo classification determination or
            approval of the device;
              (ii) the investigation may not meet a requirement,
            including a data requirement, relating to the approval
            or clearance of a device; or
              (iii) an additional or different investigation may be
            necessary to support clearance or approval of the
            device.
      (5) The Secretary may by order withdraw an exemption granted
    under this subsection for a device if the Secretary determines
    that the conditions applicable to the device under this
    subsection for such exemption are not met. Such an order may be
    issued only after opportunity for an informal hearing, except
    that such an order may be issued before the provision of an
    opportunity for an informal hearing if the Secretary determines
    that the continuation of testing under the exemption with
    respect to which the order is to be issued will result in an
    unreasonable risk to the public health.
      (6)(A) Not later than 1 year after the date of the enactment
    of the Food and Drug Administration Modernization Act of 1997,
    the Secretary shall by regulation establish, with respect to a
    device for which an exemption under this subsection is in
    effect, procedures and conditions that, without requiring an
    additional approval of an application for an exemption or the
    approval of a supplement to such an application, permit--
              (i) developmental changes in the device (including
            manufacturing changes) that do not constitute a
            significant change in design or in basic principles of
            operation and that are made in response to information
            gathered during the course of an investigation; and
              (ii) changes or modifications to clinical protocols
            that do not affect--
                      (I) the validity of data or information
                    resulting from the completion of an approved
                    protocol, or the relationship of likely patient
                    risk to benefit relied upon to approve a
                    protocol;
                      (II) the scientific soundness of an
                    investigational plan submitted under paragraph
                    (3)(A); or
                      (III) the rights, safety, or welfare of the
                    human subjects involved in the investigation.
      (B) Regulations under subparagraph (A) shall provide that a
    change or modification described in such subparagraph may be
    made if--
              (i) the sponsor of the investigation determines, on
            the basis of credible information (as defined by the
            Secretary) that the applicable conditions under
            subparagraph (A) are met; and
              (ii) the sponsor submits to the Secretary, not later
            than 5 days after making the change or modification, a
            notice of the change or modification.
      (7)(A) In the case of a person intending to investigate the
    safety or effectiveness of a class III device or any
    implantable device, the Secretary shall ensure that the person
    has an opportunity, prior to submitting an application to the
    Secretary or to an institutional review committee, to submit to
    the Secretary, for review, an investigational plan (including a
    clinical protocol). If the applicant submits a written request
    for a meeting with the Secretary regarding such review, the
    Secretary shall, not later than 30 days after receiving the
    request, meet with the applicant for the purpose of reaching
    agreement regarding the investigational plan (including a
    clinical protocol). The written request shall include a
    detailed description of the device, a detailed description of
    the proposed conditions of use of the device, a proposed plan
    (including a clinical protocol) for determining whether there
    is a reasonable assurance of effectiveness, and, if available,
    information regarding the expected performance from the device.
      (B) Any agreement regarding the parameters of an
    investigational plan (including a clinical protocol) that is
    reached between the Secretary and a sponsor or applicant shall
    be reduced to writing and made part of the administrative
    record by the Secretary. Any such agreement shall not be
    changed, except--
              (i) with the written agreement of the sponsor or
            applicant; or
              (ii) pursuant to a decision, made in accordance with
            subparagraph (C) by the director of the office in which
            the device involved is reviewed, that a substantial
            scientific issue essential to determining the safety or
            effectiveness of the device involved has been
            identified.
      (C) A decision under subparagraph (B)(ii) by the director
    shall be in writing, and may be made only after the Secretary
    has provided to the sponsor or applicant an opportunity for a
    meeting at which the director and the sponsor or applicant are
    present and at which the director documents the scientific
    issue involved.
      (8)(A) At any time, the Secretary may prohibit the sponsor of
    an investigation from conducting the investigation (referred to
    in this paragraph as a ``clinical hold'') if the Secretary
    makes a determination described in subparagraph (B). The
    Secretary shall specify the basis for the clinical hold,
    including the specific information available to the Secretary
    which served as the basis for such clinical hold, and confirm
    such determination in writing.
      (B) For purposes of subparagraph (A), a determination
    described in this subparagraph with respect to a clinical hold
    is a determination that--
              (i) the device involved represents an unreasonable
            risk to the safety of the persons who are the subjects
            of the clinical investigation, taking into account the
            qualifications of the clinical investigators,
            information about the device, the design of the
            clinical investigation, the condition for which the
            device is to be investigated, and the health status of
            the subjects involved; or
              (ii) the clinical hold should be issued for such
            other reasons as the Secretary may by regulation
            establish.
      (C) Any written request to the Secretary from the sponsor of
    an investigation that a clinical hold be removed shall receive
    a decision, in writing and specifying the reasons therefor,
    within 30 days after receipt of such request. Any such request
    shall include sufficient information to support the removal of
    such clinical hold.
      (9)(A)(i) In order for a device in a clinical study for which
    submission of an application for an investigational device
    exemption is required to be exempt under this subsection, the
    sponsor of such study shall submit to the Secretary in such
    application a diversity action plan in the form and manner
    specified in the guidance required by section 524B.
      (ii) In order for a device in a clinical study for which
    submission of an application for an investigational device
    exemption is not required, except for a device being studied as
    described in section 812.2(c) of title 21, Code of Federal
    Regulations (or successor regulations), to be exempt under this
    subsection, the sponsor of such study shall develop and
    implement a diversity action plan. Such diversity action plan
    shall be submitted to the Secretary in any premarket
    notification under section 510(k), request for classification
    under section 513(f)(2), or application for premarket approval
    under section 515 for such device.
      (B) A diversity action plan under clause (i) or (ii) of
    subparagraph (A) shall include--
              (i) the sponsor's goals for enrollment in the
            clinical study;
              (ii) the sponsor's rationale for such goals; and
              (iii) an explanation of how the sponsor intends to
            meet such goals.
      (C) The Secretary may waive the requirement in subparagraph
    (A) or (B) if the Secretary determines that a waiver is
    necessary based on what is known about the prevalence of the
    disease in terms of the patient population that may use the
    device.
      (D) No diversity action plan shall be required for a
    submission described in section 561.

                Release of Safety and Effectiveness Information

      (h)(1) The Secretary shall promulgate regulations under which
    a detailed summary of information respecting the safety and
    effectiveness of a device which information was submitted to
    the Secretary and which was the basis for--
              (A) an order under section 515(d)(1)(A) approving an
            application for premarket approval for the device or
            denying approval of such an application or an order
            under section 515(e) withdrawing approval of such an
            application for the device,
              (B) an order under section 515(f)(6)(A) revoking an
            approved protocol for the device, an order under
            section 515(f)(6)(B) declaring a protocol for the
            device completed or not completed, or an order under
            section 515(f)(7) revoking the approval of the device,
            or
              (C) an order approving an application under
            subsection (g) for an exemption for the device from
            section 516 or an order disapproving, or withdrawing
            approval of, an application for an exemption under such
            subsection for the device,
    shall be made available to the public upon issuance of the
    order. Summaries of information made available pursuant to this
    paragraph respecting a device shall include information
    respecting any adverse effects on health of the device.
      (2) The Secretary shall promulgate regulations under which
    each advisory committee established under section 515(g)(2)(B)
    shall make available to the public a detailed summary of
    information respecting the safety and effectiveness of a device
    which information was submitted to the advisory committee and
    which was the basis for its recommendation to the Secretary
    made pursuant to section 515(g)(2)(A). A summary of information
    upon which such a recommendation is based shall be made
    available pursuant to this paragraph only after the issuance of
    the order with respect to which the recommendation was made and
    each summary shall include information respecting any adverse
    effect on health of the device subject to such order.
      (3) Except as provided in paragraph (4), any information
    respecting a device which is made available pursuant to
    paragraph (1) or (2) of this subsection (A) may not be used to
    establish the safety or effectiveness of another device for
    purposes of this Act by any person other than the person who
    submitted the information so made available, and (B) shall be
    made available subject to subsection (c) of this section.
      (4)(A) Subject to subparagraph (C), any information contained
    in an application for premarket approval filed with the
    Secretary pursuant to section 515(c) (including information
    from clinical and preclinical tests or studies that demonstrate
    the safety and effectiveness of a device, but excluding
    descriptions of methods of manufacture and product composition
    and other trade secrets) shall be available, 6 years after the
    application has been approved by the Secretary, for use by the
    Secretary in--
              (i) approving another device;
              (ii) determining whether a product development
            protocol has been completed, under section 515 for
            another device;
              (iii) establishing a performance standard or special
            control under this Act; or
              (iv) classifying or reclassifying another device
            under section 513 and subsection (l)(2).
      (B) The publicly available detailed summaries of information
    respecting the safety and effectiveness of devices required by
    paragraph (1)(A) shall be available for use by the Secretary as
    the evidentiary basis for the agency actions described in
    subparagraph (A).
      (C) No information contained in an application for premarket
    approval filed with the Secretary pursuant to section 515(c)
    may be used to approve or clear any application submitted under
    section 515 or 510(k) or to classify a product under section
    513(f)(2) for a combination product containing as a constituent
    part an approved drug (as defined in section 503(g)(5)(B))
    unless--
              (i) the application includes the certification or
            statement referenced in section 503(g)(5)(A);
              (ii) the applicant provides notice as described in
            section 503(g)(5)(A); and
              (iii) the Secretary's approval of such application is
            subject to the provisions in section 503(g)(5)(C).

                 Proceedings of Advisory Panels and Committees

      (i) Each panel under section 513 and each advisory committee
    established under section 514(b)(5)(B) or 515(g) or under
    subsection (f) of this section shall make and maintain a
    transcript of any proceeding of the panel or committee. Each
    such panel and committee shall delete from any transcript made
    pursuant to this subsection information which under subsection
    (c) of this section is to be considered confidential.

                           Traceability Requirements

      (j) Except as provided in section 519(e), no regulation under
    this Act may impose on a type or class of device requirements
    for the traceability of such type or class of device unless
    such requirements are necessary to assure the protection of the
    public health.

                            Research and Development

      (k) The Secretary may enter into contracts for research,
    testing, and demonstrations respecting devices and may obtain
    devices for research, testing, and demonstration purposes
    without regard to sections 3648 and 3709 of the Revised
    Statutes (31 U.S.C. 529, 41 U.S.C. 5).

          Transitional Provisions for Devices Considered as New Drugs

      (l)(1) Any device intended for human use--
              (A) for which on the date of enactment of the Medical
            Device Amendments of 1976 (hereinafter in this
            subsection referred to as the ``enactment date'') an
            approval of an application submitted under section
            505(b) was in effect;
              (B) for which such an application was filed on or
            before the enactment date and with respect to which
            application no order of approval or refusing to approve
            had been issued on such date under subsection (c) or
            (d) of such section;
              (C) for which on the enactment date an exemption
            under subsection (i) of such section was in effect;
              (D) which is within a type of device described in
            subparagraph (A), (B), or (C) and is substantially
            equivalent to another device within that type;
              (E) which the Secretary in a notice published in the
            Federal Register before the enactment date has declared
            to be a new drug subject to section 505; or
              (F) with respect to which on the enactment date an
            action is pending in a United States court under
            section 302, 303, or 304 for an alleged violation of a
            provision of section 301 which enforces a requirement
            of section 505 or for an alleged violation of section
            505(a),
    is classified in class III unless the Secretary in response to
    a petition submitted under paragraph (2) has classified such
    device in class I or II.
      (2) The Secretary may initiate the reclassification of a
    device classified into class III under paragraph (1) of this
    subsection or the manufacturer or importer of a device
    classified under paragraph (1) may petition the Secretary (in
    such form and manner as he shall prescribe) for the issuance of
    an order classifying the device in class I or class II. Within
    thirty days of the filing of such a petition, the Secretary
    shall notify the petitioner of any deficiencies in the petition
    which prevent the Secretary from making a decision on the
    petition. Except as provided in paragraph (3)(D)(ii), within
    one hundred and eighty days after the filing of a petition
    under this paragraph, the Secretary shall, after consultation
    with the appropriate panel under section 513, by order either
    deny the petition or order the classification, in accordance
    with the criteria prescribed by section 513(a)(1)(A) or
    513(a)(1)(B), of the device in class I or class II.
      (3)(A) In the case of a device which is described in
    paragraph (1)(A) and which is in class III--
              (i) such device shall on the enactment date be
            considered a device with an approved application under
            section 515, and
              (ii) the requirements applicable to such device
            before the enactment date under section 505 shall
            continue to apply to such device until changed by the
            Secretary as authorized by this Act.
      (B) In the case of a device which is described in paragraph
    (1)(B) and which is in class III, an application for such
    device shall be considered as having been filed under section
    515 on the enactment date. The period in which the Secretary
    shall act on such application in accordance with section
    515(d)(1) shall be one hundred and eighty days from the
    enactment date (or such greater period as the Secretary and the
    applicant may agree upon after the Secretary has made the
    finding required by section 515(d)(1)(B)(i)) less the number of
    days in the period beginning on the date an application for
    such device was filed under section 505 and ending on the
    enactment date. After the expiration of such period such device
    is required, unless exempt under subsection (g), to have in
    effect an approved application under section 515.
      (C) A device which is described in paragraph (1)(C) and which
    is in class III shall be considered a new drug until the
    expiration of the ninety-day period beginning on the date of
    the promulgation of regulations under subsection (g) of this
    section. After the expiration of such period such device is
    required, unless exempt under subsection (g), to have in effect
    an approved application under section 515.
      (D)(i) Except as provided in clauses (ii) and (iii), a device
    which is described in subparagraph (D), (E), or (F) of
    paragraph (1) and which is in class III is required, unless
    exempt under subsection (g) of this section, to have on and
    after sixty days after the enactment date in effect an approved
    application under section 515.
      (ii) If--
              (I) a petition is filed under paragraph (2) for a
            device described in subparagraph (D), (E), or (F) of
            paragraph (1), or
              (II) an application for premarket approval is filed
            under section 515 for such a device,
    within the sixty-day period beginning on the enactment date (or
    within such greater period as the Secretary, after making the
    finding required under section 515(d)(1)(B), and the petitioner
    or applicant may agree upon), the Secretary shall act on such
    petition or application in accordance with paragraph (2) or
    section 515 except that the period within which the Secretary
    must act on the petition or application shall be within the one
    hundred and twenty-day period beginning on the date the
    petition or application is filed. If such a petition or
    application is filed within such sixty-day (or greater) period,
    clause (i) of this subparagraph shall not apply to such device
    before the expiration of such one hundred and twenty-day
    period, or if such petition is denied or such application is
    denied approval, before the date of such denial, whichever
    occurs first.
      (iii) In the case of a device which is described in
    subparagraph (E) of paragraph (1), which the Secretary in a
    notice published in the Federal Register after March 31, 1976,
    declared to be a new drug subject to section 505, and which is
    in class III--
              (I) the device shall, after eighteen months after the
            enactment date, have in effect an approved application
            under section 515 unless exempt under subsection (g) of
            this section, and
              (II) the Secretary may, during the period beginning
            one hundred and eighty days after the enactment date
            and ending eighteen months after such date, restrict
            the use of the device to investigational use by experts
            qualified by scientific training and experience to
            investigate the safety and effectiveness of such
            device, and to investigational use in accordance with
            the requirements applicable under regulations under
            subsection (g) of this section to investigational use
            of devices granted an exemption under such subsection.
    If the requirements under subsection (g) of this section are
    made applicable to the investigational use of such a device,
    they shall be made applicable in such a manner that the device
    shall be made reasonably available to physicians meeting
    appropriate qualifications prescribed by the Secretary.
      (5)(A) Before December 1, 1991, the Secretary shall by order
    require manufacturers of devices described in paragraph (1),
    which are subject to revision of classification under
    subparagraph (B), to submit to the Secretary a summary of and
    citation to any information known or otherwise available to the
    manufacturers respecting the devices, including adverse safety
    or effectiveness information which has not been submitted under
    section 519. The Secretary may require a manufacturer to submit
    the adverse safety or effectiveness data for which a summary
    and citation were submitted, if such data are available to the
    manufacturer.
      (B) Except as provided in subparagraph (C), after the
    issuance of an order under subparagraph (A) but before December
    1, 1992, the Secretary shall publish a regulation in the
    Federal Register for each device which is classified in class
    III under paragraph (1) revising the classification of the
    device so that the device is classified into class I or class
    II, unless the regulation requires the device to remain in
    class III. In determining whether to revise the classification
    of a device or to require a device to remain in class III, the
    Secretary shall apply the criteria set forth in section 513(a).
    Before the publication of a regulation requiring a device to
    remain in class III or revising its classification, the
    Secretary shall publish a proposed regulation respecting the
    classification of a device under this subparagraph and provide
    an opportunity for the submission of comments on any such
    regulation. No regulation under this subparagraph requiring a
    device to remain in class III or revising its classification
    may take effect before the expiration of 90 days from the date
    of the publication in the Federal Register of the proposed
    regulation.
      (C) The Secretary may by notice published in the Federal
    Register extend the period prescribed by subparagraph (B) for a
    device for an additional period not to exceed 1 year.

                         Humanitarian Device Exemption

      (m)(1) To the extent consistent with the protection of the
    public health and safety and with ethical standards, it is the
    purpose of this subsection to encourage the discovery and use
    of devices intended to benefit patients in the treatment and
    diagnosis of diseases or conditions that affect not more than
    8,000 individuals in the United States.
      (2) The Secretary may grant a request for an exemption from
    the effectiveness requirements of sections 514 and 515 for a
    device for which the Secretary finds that--
              (A) the device is designed to treat or diagnose a
            disease or condition that affects not more than 8,000
            individuals in the United States,
              (B) the device would not be available to a person
            with a disease or condition referred to in subparagraph
            (A) unless the Secretary grants such an exemption and
            there is no comparable device, other than under this
            exemption, available to treat or diagnose such disease
            or condition, and
              (C) the device will not expose patients to an
            unreasonable or significant risk of illness or injury
            and the probable benefit to health from the use of the
            device outweighs the risk of injury or illness from its
            use, taking into account the probable risks and
            benefits of currently available devic or alternative
            forms of treatment.
    The request shall be in the form of an application submitted to
    the Secretary and such application shall include the
    certification required under section 402(j)(5)(B) of the Public
    Health Service Act (which shall not be considered an element of
    such application). Not later than 75 days after the date of the
    receipt of the application, the Secretary shall issue an order
    approving or denying the application.
      (3) Except as provided in paragraph (6), no person granted an
    exemption under paragraph (2) with respect to a device may sell
    the device for an amount that exceeds the costs of research and
    development, fabrication, and distribution of the device.
      (4) Devices granted an exemption under paragraph (2) may only
    be used--
              (A) in facilities in which clinical testing of
            devices is supervised by an institutional review
            committee established in accordance with the
            regulations of the Secretary; and
              (B) if, before the use of a device, an institutional
            review committee or an appropriate local committee
            approves the use in the treatment or diagnosis of a
            disease or condition referred to in paragraph (2)(A),
            unless a physician determines in an emergency situation
            that approval from an institutional review committee or
            an appropriate local committee can not be obtained in
            time to prevent serious harm or death to a patient.
    In a case described in subparagraph (B) in which a physician
    uses a device without an approval from an institutional review
    committee or an appropriate local committee, the physician
    shall, after the use of the device, notify the chairperson of
    the institutional review committee or an appropriate local
    committee of such use. Such notification shall include the
    identification of the patient involved, the date on which the
    device was used, and the reason for the use.
      (5) The Secretary may require a person granted an exemption
    under paragraph (2) to demonstrate continued compliance with
    the requirements of this subsection if the Secretary believes
    such demonstration to be necessary to protect the public
    health, if the Secretary has reason to believe that the
    requirements of paragraph (6) are no longer met, or if the
    Secretary has reason to believe that the criteria for the
    exemption are no longer met. If the person granted an exemption
    under paragraph (2) fails to demonstrate continued compliance
    with the requirements of this subsection, the Secretary may
    suspend or withdraw the exemption from the effectiveness
    requirements of sections 514 and 515 for a humanitarian device
    only after providing notice and an opportunity for an informal
    hearing.
      (6)(A) Except as provided in subparagraph (D), the
    prohibition in paragraph (3) shall not apply with respect to a
    person granted an exemption under paragraph (2) if each of the
    following conditions apply:
              (i) The device with respect to which the exemption is
            granted--
                      (I) is intended for the treatment or
                    diagnosis of a disease or condition that occurs
                    in pediatric patients or in a pediatric
                    subpopulation, and such device is labeled for
                    use in pediatric patients or in a pediatric
                    subpopulation in which the disease or condition
                    occurs; or
                      (II) is intended for the treatment or
                    diagnosis of a disease or condition that does
                    not occur in pediatric patients or that occurs
                    in pediatric patients in such numbers that the
                    development of the device for such patients is
                    impossible, highly impracticable, or unsafe.
              (ii) During any calendar year, the number of such
            devices distributed during that year under each
            exemption granted under this subsection does not exceed
            the annual distribution number for such device. In this
            paragraph, the term ``annual distribution number''
            means the number of such devices reasonably needed to
            treat, diagnose, or cure a population of 8,000
            individuals in the United States. The Secretary shall
            determine the annual distribution number when the
            Secretary grants such exemption.
              (iii) Such person immediately notifies the Secretary
            if the number of such devices distributed during any
            calendar year exceeds the annual distribution number
            referred to in clause (ii).
              (iv) The request for such exemption is submitted on
            or before October 1, [2022] 2027.
      (B) The Secretary may inspect the records relating to the
    number of devices distributed during any calendar year of a
    person granted an exemption under paragraph (2) for which the
    prohibition in paragraph (3) does not apply.
      (C) A person may petition the Secretary to modify the annual
    distribution number determined by the Secretary under
    subparagraph (A)(ii) with respect to a device if additional
    information arises, and the Secretary may modify such annual
    distribution number.
      (D) If a person notifies the Secretary, or the Secretary
    determines through an inspection under subparagraph (B), that
    the number of devices distributed during any calendar year
    exceeds the annual distribution number, as required under
    subparagraph (A)(iii), and modified under subparagraph (C), if
    applicable, then the prohibition in paragraph (3) shall apply
    with respect to such person for such device for any sales of
    such device after such notification.
      (E)(i) In this subsection, the term ``pediatric patients''
    means patients who are 21 years of age or younger at the time
    of the diagnosis or treatment.
      (ii) In this subsection, the term ``pediatric subpopulation''
    means 1 of the following populations:
              (I) Neonates.
              (II) Infants.
              (III) Children.
              (IV) Adolescents.
      (7) The Secretary shall refer any report of an adverse event
    regarding a device described in paragraph (6)(A)(i)(I) for
    which the prohibition under paragraph (3) does not apply
    pursuant to paragraph (6)(A) that the Secretary receives to the
    Office of Pediatric Therapeutics, established under section 6
    of the Best Pharmaceuticals for Children Act (Public Law 107-
    109). In considering the report, the Director of the Office of
    Pediatric Therapeutics, in consultation with experts in the
    Center for Devices and Radiological Health, shall provide for
    periodic review of the report by the Pediatric Advisory
    Committee, including obtaining any recommendations of such
    committee regarding whether the Secretary should take action
    under this Act in response to the report.
      (8) The Secretary, acting through the Office of Pediatric
    Therapeutics and the Center for Devices and Radiological
    Health, shall provide for an annual review by the Pediatric
    Advisory Committee of all devices described in paragraph
    (6)(A)(i)(I) to ensure that the exemption under paragraph (2)
    remains appropriate for the pediatric populations for which it
    is granted.

                     Regulation of Contact Lens as Devices

      (n)(1) All contact lenses shall be deemed to be devices under
    section 201(h).
      (2) Paragraph (1) shall not be construed as bearing on or
    being relevant to the question of whether any product other
    than a contact lens is a device as defined by section 201(h) or
    a drug as defined by section 201(g).
      (o) Regulation of Medical and Certain Decisions Support
    Software.--
              (1) The term device, as defined in section 201(h),
            shall not include a software function that is
            intended--
                      (A) for administrative support of a health
                    care facility, including the processing and
                    maintenance of financial records, claims or
                    billing information, appointment schedules,
                    business analytics, information about patient
                    populations, admissions, practice and inventory
                    management, analysis of historical claims data
                    to predict future utilization or cost-
                    effectiveness, determination of health benefit
                    eligibility, population health management, and
                    laboratory workflow;
                      (B) for maintaining or encouraging a healthy
                    lifestyle and is unrelated to the diagnosis,
                    cure, mitigation, prevention, or treatment of a
                    disease or condition;
                      (C) to serve as electronic patient records,
                    including patient-provided information, to the
                    extent that such records are intended to
                    transfer, store, convert formats, or display
                    the equivalent of a paper medical chart, so
                    long as--
                              (i) such records were created,
                            stored, transferred, or reviewed by
                            health care professionals, or by
                            individuals working under supervision
                            of such professionals;
                              (ii) such records are part of health
                            information technology that is
                            certified under section 3001(c)(5) of
                            the Public Health Service Act; and
                              (iii) such function is not intended
                            to interpret or analyze patient
                            records, including medical image data,
                            for the purpose of the diagnosis, cure,
                            mitigation, prevention, or treatment of
                            a disease or condition;
                      (D) for transferring, storing, converting
                    formats, or displaying clinical laboratory test
                    or other device data and results, findings by a
                    health care professional with respect to such
                    data and results, general information about
                    such findings, and general background
                    information about such laboratory test or other
                    device, unless such function is intended to
                    interpret or analyze clinical laboratory test
                    or other device data, results, and findings; or
                      (E) unless the function is intended to
                    acquire, process, or analyze a medical image or
                    a signal from an in vitro diagnostic device or
                    a pattern or signal from a signal acquisition
                    system, for the purpose of--
                              (i) displaying, analyzing, or
                            printing medical information about a
                            patient or other medical information
                            (such as peer-reviewed clinical studies
                            and clinical practice guidelines);
                              (ii) supporting or providing
                            recommendations to a health care
                            professional about prevention,
                            diagnosis, or treatment of a disease or
                            condition; and
                              (iii) enabling such health care
                            professional to independently review
                            the basis for such recommendations that
                            such software presents so that it is
                            not the intent that such health care
                            professional rely primarily on any of
                            such recommendations to make a clinical
                            diagnosis or treatment decision
                            regarding an individual patient.
              (2) In the case of a product with multiple functions
            that contains--
                      (A) at least one software function that meets
                    the criteria under paragraph (1) or that
                    otherwise does not meet the definition of
                    device under section 201(h); and
                      (B) at least one function that does not meet
                    the criteria under paragraph (1) and that
                    otherwise meets the definition of a device
                    under section 201(h),
            the Secretary shall not regulate the software function
            of such product described in subparagraph (A) as a
            device. Notwithstanding the preceding sentence, when
            assessing the safety and effectiveness of the device
            function or functions of such product described in
            subparagraph (B), the Secretary may assess the impact
            that the software function or functions described in
            subparagraph (A) have on such device function or
            functions.
              (3)(A) Notwithstanding paragraph (1), a software
            function described in subparagraph (C), (D), or (E) of
            paragraph (1) shall not be excluded from the definition
            of device under section 201(h) if--
                      (i) the Secretary makes a finding that use of
                    such software function would be reasonably
                    likely to have serious adverse health
                    consequences; and
                      (ii) the software function has been
                    identified in a final order issued by the
                    Secretary under subparagraph (B).
              (B) Subparagraph (A) shall apply only if the
            Secretary--
                      (i) publishes a notification and proposed
                    order in the Federal Register;
                      (ii) includes in such notification the
                    Secretary's finding, including the rationale
                    and identification of the evidence on which
                    such finding was based, as described in
                    subparagraph (A)(i); and
                      (iii) provides for a period of not less than
                    30 calendar days for public comment before
                    issuing a final order or withdrawing such
                    proposed order.
              (C) In making a finding under subparagraph (A)(i)
            with respect to a software function, the Secretary
            shall consider--
                      (i) the likelihood and severity of patient
                    harm if the software function were to not
                    perform as intended;
                      (ii) the extent to which the software
                    function is intended to support the clinical
                    judgment of a health care professional;
                      (iii) whether there is a reasonable
                    opportunity for a health care professional to
                    review the basis of the information or
                    treatment recommendation provided by the
                    software function; and
                      (iv) the intended user and user environment,
                    such as whether a health care professional will
                    use a software function of a type described in
                    subparagraph (E) of paragraph (1).
              (4) Nothing in this subsection shall be construed as
            limiting the authority of the Secretary to--
                      (A) exercise enforcement discretion as to any
                    device subject to regulation under this Act;
                      (B) regulate software used in the manufacture
                    and transfusion of blood and blood components
                    to assist in the prevention of disease in
                    humans; or
                      (C) regulate software as a device under this
                    Act if such software meets the criteria under
                    section 513(a)(1)(C).
      (p) Diagnostic Imaging Devices Intended for Use With Contrast
    Agents.--
              (1) In general.--The Secretary may, subject to the
            succeeding provisions of this subsection, approve an
            application (or a supplement to such an application)
            submitted under section 515 with respect to an
            applicable medical imaging device, or, in the case of
            an applicable medical imaging device for which a
            notification is submitted under section 510(k), may
            make a substantial equivalence determination with
            respect to an applicable medical imaging device, or may
            grant a request submitted under section 513(f)(2) for
            an applicable medical imaging device, if such
            application, notification, or request involves the use
            of a contrast agent that is not--
                      (A) in a concentration, rate of
                    administration, or route of administration that
                    is different from those described in the
                    approved labeling of the contrast agent, except
                    that the Secretary may approve such
                    application, make such substantial equivalence
                    determination, or grant such request if the
                    Secretary determines that such differences in
                    concentration, rate of administration, or route
                    of administration exist but do not adversely
                    affect the safety and effectiveness of the
                    contrast agent when used with the device;
                      (B) in a region, organ, or system of the body
                    that is different from those described in the
                    approved labeling of the contrast agent, except
                    that the Secretary may approve such
                    application, make such substantial equivalence
                    determination, or grant such request if the
                    Secretary determines that such differences in
                    region, organ, or system of the body exist but
                    do not adversely affect the safety and
                    effectiveness of the contrast agent when used
                    with the device;
                      (C) in a patient population that is different
                    from those described in the approved labeling
                    of the contrast agent, except that the
                    Secretary may approve such application, make
                    such substantial equivalence determination, or
                    grant such request if the Secretary determines
                    such differences in patient population exist
                    but do not adversely affect the safety and
                    effectiveness of the contrast agent when used
                    with the device; or
                      (D) in an imaging modality that is different
                    from those described in the approved labeling
                    of the contrast agent.
              (2) Premarket review.--The agency center charged with
            premarket review of devices shall have primary
            jurisdiction with respect to the review of an
            application, notification, or request described in
            paragraph (1). In conducting such review, such agency
            center may--
                      (A) consult with the agency center charged
                    with the premarket review of drugs or
                    biological products; and
                      (B) review information and data provided to
                    the Secretary by the sponsor of a contrast
                    agent in an application submitted under section
                    505 of this Act or section 351 of the Public
                    Health Service Act, so long as the sponsor of
                    such contrast agent has provided to the sponsor
                    of the applicable medical imaging device that
                    is the subject of such review a right of
                    reference and the application is submitted in
                    accordance with this subsection.
              (3) Applicable requirements.--An application
            submitted under section 515, a notification submitted
            under section 510(k), or a request submitted under
            section 513(f)(2), as described in paragraph (1), with
            respect to an applicable medical imaging device shall
            be subject to the requirements of such respective
            section. Such application, notification, or request
            shall only be subject to the requirements of this Act
            applicable to devices.
              (4) Definitions.--For purposes of this subsection--
                      (A) the term ``applicable medical imaging
                    device'' means a device intended to be used in
                    conjunction with a contrast agent (or class of
                    contrast agents) for an imaging use that is not
                    described in the approved labeling of such
                    contrast agent (or the approved labeling of any
                    contrast agent in the same class as such
                    contrast agent); and
                      (B) the term ``contrast agent'' means a drug
                    that is approved under section 505 or licensed
                    under section 351 of the Public Health Service
                    Act, is intended for use in conjunction with an
                    applicable medical imaging device, and--
                              (i) is a diagnostic
                            radiopharmaceutical, as defined in
                            section 315.2 and 601.31 of title 21,
                            Code of Federal Regulations (or any
                            successor regulations); or
                              (ii) is a diagnostic agent that
                            improves the visualization of structure
                            or function within the body by
                            increasing the relative difference in
                            signal intensity within the target
                            tissue, structure, or fluid.
      (q) Regulation of Over-the-Counter Hearing Aids.--
              (1) Definition.--
                      (A) In general.--In this subsection, the term
                    ``over-the-counter hearing aid'' means a device
                    that--
                              (i) uses the same fundamental
                            scientific technology as air conduction
                            hearing aids (as defined in section
                            874.3300 of title 21, Code of Federal
                            Regulations) (or any successor
                            regulation) or wireless air conduction
                            hearing aids (as defined in section
                            874.3305 of title 21, Code of Federal
                            Regulations) (or any successor
                            regulation);
                              (ii) is intended to be used by adults
                            age 18 and older to compensate for
                            perceived mild to moderate hearing
                            impairment;
                              (iii) through tools, tests, or
                            software, allows the user to control
                            the over-the-counter hearing aid and
                            customize it to the user's hearing
                            needs;
                              (iv) may--
                                      (I) use wireless technology;
                                    or
                                      (II) include tests for self-
                                    assessment of hearing loss; and
                              (v) is available over-the-counter,
                            without the supervision, prescription,
                            or other order, involvement, or
                            intervention of a licensed person, to
                            consumers through in-person
                            transactions, by mail, or online.
                      (B) Exception.--Such term does not include a
                    personal sound amplification product intended
                    to amplify sound for nonhearing impaired
                    consumers in situations including hunting and
                    bird-watching.
              (2) Regulation.--An over-the-counter hearing aid
            shall be subject to the regulations promulgated in
            accordance with section 709(b) of the FDA
            Reauthorization Act of 2017 and shall be exempt from
            sections 801.420 and 801.421 of title 21, Code of
            Federal Regulations (or any successor regulations).

               *       *       *       *       *       *       *

    SEC. 523. ACCREDITED PERSONS.

      (a) In General.--
              (1) Review and classification of devices.--Not later
            than 1 year after the date of the enactment of the Food
            and Drug Administration Modernization Act of 1997, the
            Secretary shall, subject to paragraph (3), accredit
            persons for the purpose of reviewing reports submitted
            under section 510(k) and making recommendations to the
            Secretary regarding the initial classification of
            devices under section 513(f)(1).
              (2) Requirements regarding review.--
                      (A) In general.--In making a recommendation
                    to the Secretary under paragraph (1), an
                    accredited person shall notify the Secretary in
                    writing of the reasons for the recommendation.
                      (B) Time period for review.--Not later than
                    30 days after the date on which the Secretary
                    is notified under subparagraph (A) by an
                    accredited person with respect to a
                    recommendation of an initial classification of
                    a device, the Secretary shall make a
                    determination with respect to the initial
                    classification.
                      (C) Special rule.--The Secretary may change
                    the initial classification under section
                    513(f)(1) that is recommended under paragraph
                    (1) by an accredited person, and in such case
                    shall provide to such person, and the person
                    who submitted the report under section 510(k)
                    for the device, a statement explaining in
                    detail the reasons for the change.
              (3) Certain devices.--
                      (A) In general.--An accredited person may not
                    be used to perform a review of--
                              (i) a class III device;
                              (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) Designation for review.--The Secretary
                    shall--
                              (i) issue draft guidance on the
                            factors the Secretary will use in
                            determining whether a class I or class
                            II device type, or subset of such
                            device types, is eligible for review by
                            an accredited person, including--
                                      (I) the risk of the device
                                    type, or subset of such device
                                    type; and
                                      (II) whether the device type,
                                    or subset of such device type,
                                    is permanently implantable,
                                    life sustaining, or life
                                    supporting, and whether there
                                    is a detailed public health
                                    justification for permitting
                                    the review by an accredited
                                    person of such device type or
                                    subset;
                              (ii) not later than 24 months after
                            the date on which the Secretary issues
                            such draft guidance, finalize such
                            guidance; and
                              (iii) beginning on the date such
                            guidance is finalized, designate and
                            post on the internet website of the
                            Food and Drug Administration, an
                            updated list of class I and class II
                            device types, or subsets of such device
                            types, and the Secretary's
                            determination with respect to whether
                            each such device type, or subset of a
                            device type, is eligible or not
                            eligible for review by an accredited
                            person under this section based on the
                            factors described in clause (i).
                      (C) Interim rule.--Until the date on which
                    the updated list is designated and posted in
                    accordance with subparagraph (B)(iii), the list
                    in effect on the date of enactment the Medical
                    Device User Fee Amendments of 2017 shall be in
                    effect.
      (b) Accreditation.--
              (1) Programs.--The Secretary shall provide for such
            accreditation through programs administered by the Food
            and Drug Administration, other government agencies, or
            by other qualified nongovernment organizations.
              (2) Accreditation.--
                      (A) In general.--Not later than 180 days
                    after the date of the enactment of the Food and
                    Drug Administration Modernization Act of 1997,
                    the Secretary shall establish and publish in
                    the Federal Register criteria to accredit or
                    deny accreditation to persons who request to
                    perform the duties specified in subsection (a).
                    The Secretary shall respond to a request for
                    accreditation within 60 days of the receipt of
                    the request. The accreditation of such person
                    shall specify the particular activities under
                    subsection (a) for which such person is
                    accredited.
                      (B) Withdrawal of accreditation.--The
                    Secretary may suspend or withdraw accreditation
                    of any person accredited under this paragraph,
                    after providing notice and an opportunity for
                    an informal hearing, when such person is
                    substantially not in compliance with the
                    requirements of this section or poses a threat
                    to public health or fails to act in a manner
                    that is consistent with the purposes of this
                    section.
                      (C) Performance auditing.--To ensure that
                    persons accredited under this section will
                    continue to meet the standards of
                    accreditation, the Secretary shall--
                              (i) make onsite visits on a periodic
                            basis to each accredited person to
                            audit the performance of such person;
                            and
                              (ii) take such additional measures as
                            the Secretary determines to be
                            appropriate.
                      (D) Periodic reaccreditation.--
                              (i) Period.--Subject to suspension or
                            withdrawal under subparagraph (B), any
                            accreditation under this section shall
                            be valid for a period of 3 years after
                            its issuance.
                              (ii) Response to reaccreditation
                            request.--Upon the submission of a
                            request by an accredited person for
                            reaccreditation under this section, the
                            Secretary shall approve or deny such
                            request not later than 60 days after
                            receipt of the request.
                              (iii) Criteria.--Not later than 120
                            days after the date of the enactment of
                            this subparagraph, the Secretary shall
                            establish and publish in the Federal
                            Register criteria to reaccredit or deny
                            reaccreditation to persons under this
                            section. The reaccreditation of persons
                            under this section shall specify the
                            particular activities under subsection
                            (a), and the devices, for which such
                            persons are reaccredited.
              (3) Qualifications.--An accredited person shall, at a
            minimum, meet the following requirements:
                      (A) Such person may not be an employee of the
                    Federal Government.
                      (B) Such person shall be an independent
                    organization which is not owned or controlled
                    by a manufacturer, supplier, or vendor of
                    devices and which has no organizational,
                    material, or financial affiliation with such a
                    manufacturer, supplier, or vendor.
                      (C) Such person shall be a legally
                    constituted entity permitted to conduct the
                    activities for which it seeks accreditation.
                      (D) Such person shall not engage in the
                    design, manufacture, promotion, or sale of
                    devices.
                      (E) The operations of such person shall be in
                    accordance with generally accepted professional
                    and ethical business practices.
                      (F) 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--
                              (i) certify that reported information
                            accurately reflects data reviewed;
                              (ii) limit work to that for which
                            competence and capacity are available;
                              (iii) treat information received,
                            records, reports, and recommendations
                            as proprietary information;
                              (iv) promptly respond and attempt to
                            resolve complaints regarding its
                            activities for which it is accredited;
                            and
                              (v) protect against the use, in
                            carrying out subsection (a) with
                            respect to a device, of any officer or
                            employee of the person who has a
                            financial conflict of interest
                            regarding the device, and annually make
                            available to the public disclosures of
                            the extent to which the person, and the
                            officers and employees of the person,
                            have maintained compliance with
                            requirements under this clause relating
                            to financial conflicts of interest.
              (4) Selection of accredited persons.--The Secretary
            shall provide each person who chooses to use an
            accredited person to receive a section 510(k) report a
            panel of at least two or more accredited persons from
            which the regulated person may select one for a
            specific regulatory function.
              (5) Compensation of accredited persons.--Compensation
            for an accredited person shall be determined by
            agreement between the accredited person and the person
            who engages the services of the accredited person, and
            shall be paid by the person who engages such services.
      (c) Duration.--The authority provided by this section
    terminates October 1, [2022] 2027.

               *       *       *       *       *       *       *

    SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS.

      (a) In General.--If the Secretary designates a drug under
    section 505E(d) as a qualified infectious disease product, then
    the Secretary shall give priority review to the first
    application submitted for approval for such drug under section
    505(b) of this Act or section 351(a) of the Public Health
    Service Act that requires clinical data (other than
    bioavailability studies) to demonstrate safety or
    effectiveness.
      (b) Construction.--Nothing in this section shall prohibit the
    Secretary from giving priority review to a human drug
    application or efficacy supplement submitted for approval under
    section 505(b) that otherwise meets the criteria for the
    Secretary to grant priority review.

    SEC. 524B. GUIDANCE ON DIVERSITY ACTION PLANS FOR CLINICAL STUDIES.

      (a) In General.--The Secretary shall issue guidance relating
    to--
              (1) the format and content of the diversity action
            plans required by sections 505(i)(5) and 520(g)(9)
            pertaining to the sponsor's goals for clinical study
            enrollment, disaggregated by age group, sex, race,
            geographic location, socioeconomic status, and
            ethnicity, including with respect to--
                      (A) the rationale for the sponsor's
                    enrollment goals, which may include--
                              (i) the estimated prevalence or
                            incidence in the United States of the
                            disease or condition for which the drug
                            or device is being developed or
                            investigated, if such estimated
                            prevalence or incidence is known or can
                            be determined based on available data;
                              (ii) what is known about the disease
                            or condition for which the drug or
                            device is being developed or
                            investigated;
                              (iii) any relevant pharmacokinetic or
                            pharmacogenomic data;
                              (iv) what is known about the patient
                            population for such disease or
                            condition, including, to the extent
                            data is available--
                                      (I) demographic information,
                                    including age group, sex, race,
                                    geographic location,
                                    socioeconomic status, and
                                    ethnicity;
                                      (II) non-demographic factors,
                                    including co-morbidities
                                    affecting the patient
                                    population; and
                                      (III) potential barriers to
                                    enrolling diverse participants,
                                    such as patient population
                                    size, geographic location, and
                                    socioeconomic status; and
                              (v) any other data or information
                            relevant to selecting appropriate
                            enrollment goals, disaggregated by
                            demographic subgroup, such as the
                            inclusion of pregnant and lactating
                            women;
                      (B) an explanation for how the sponsor
                    intends to meet such goals, including
                    demographic-specific outreach and enrollment
                    strategies, study-site selection, clinical
                    study inclusion and exclusion practices, and
                    any diversity training for study personnel; and
                      (C) procedures for the public posting of key
                    information from the diversity action plan that
                    would be useful to patients and providers on
                    the sponsor's website, as appropriate; and
              (2) how sponsors should include in regular reports to
            the Secretary--
                      (A) the sponsor's progress in meeting the
                    goals referred to in paragraph (1)(A); and
                      (B) if the sponsor does not expect to meet
                    such goals--
                              (i) any updates needed to be made to
                            a diversity action plan referred to in
                            paragraph (1) to help meet such goals;
                            and
                              (ii) the sponsor's reasons for why
                            the sponsor does not expect to meet
                            such goals.
      (b) Issuance.--The Secretary shall--
              (1) not later than 12 months after the date of
            enactment of this section, issue new draft guidance or
            update existing draft guidance described in subsection
            (a); and
              (2) not later than 9 months after closing the comment
            period on such draft guidance, finalize such guidance.

    SEC. 524C. ENSURING CYBERSECURITY OF DEVICES.

      (a) In General.--For purposes of ensuring cybersecurity
    throughout the lifecycle of a cyber device, any person who
    submits a premarket submission for the cyber device shall
    include such information as the Secretary may require to ensure
    that the cyber device meets such cybersecurity requirements as
    the Secretary determines to be appropriate to demonstrate a
    reasonable assurance of safety and effectiveness, including at
    a minimum the cybersecurity requirements under subsection (b).
      (b) Cybersecurity Requirements.--At a minimum, the
    manufacturer of a cyber device shall meet the following
    cybersecurity requirements:
              (1) The manufacturer shall have a plan to
            appropriately monitor, identify, and address in a
            reasonable time postmarket cybersecurity
            vulnerabilities and exploits, including coordinated
            vulnerability disclosure and procedures.
              (2) The manufacturer shall design, develop, and
            maintain processes and procedures to ensure the device
            and related systems are cybersecure, and shall make
            available updates and patches to the cyber device and
            related systems throughout the lifecycle of the cyber
            device to address--
                      (A) on a reasonably justified regular cycle,
                    known unacceptable vulnerabilities; and
                      (B) as soon as possible out of cycle,
                    critical vulnerabilities that could cause
                    uncontrolled risks.
              (3) The manufacturer shall provide in the labeling of
            the cyber device a software bill of materials,
            including commercial, open-source, and off-the-shelf
            software components.
              (4) The manufacturer shall comply with such other
            requirements as the Secretary may require to
            demonstrate reasonable assurance of the safety and
            effectiveness of the device for purposes of
            cybersecurity, which the Secretary may require by an
            order published in the Federal Register.
      (c) Substantial Equivalence.--In making a determination of
    substantial equivalence under section 513(i) for a cyber
    device, the Secretary may--
              (1) find that cybersecurity information for the cyber
            device described in the relevant premarket submission
            in the cyber device's use environment is inadequate;
            and
              (2) issue a nonsubstantial equivalence determination
            based on this finding.
      (d) Definition.--In this section:
              (1) Cyber device.--The term ``cyber device'' means a
            device that--
                      (A) includes software, including software as
                    or in a device;
                      (B) has the ability to connect to the
                    internet; or
                      (C) contains any such technological
                    characteristics that could be vulnerable to
                    cybersecurity threats.
              (2) Lifecycle of the cyber device.--The term
            ``lifecycle of the cyber device'' includes the
            postmarket lifecycle of the cyber device.
              (3) Premarket submission.--The term ``premarket
            submission'' means any submission under section 510(k),
            513, 515(c), 515(f), or 520(m).
      (e) Exemption.--The Secretary may identify devices or types
    of devices that are exempt from meeting the cybersecurity
    requirements established by this section and regulations
    promulgated pursuant to this section. The Secretary shall
    publish in the Federal Register, and update, as appropriate, a
    list of the devices and types of devices so identified by the
    Secretary.

    Subchapter B--Drugs for Rare Diseases or Conditions

               *       *       *       *       *       *       *

              protection for drugs for rare diseases or conditions

      Sec. 527. (a) Except as provided in subsection (b), if the
    Secretary--
              (1) approves an application filed pursuant to section
            505, or
              (2) issues a license under section 351 of the Public
            Health Service Act
    for a drug designated under section 526 for a rare disease or
    condition, the Secretary may not approve another application
    under section 505 or issue another license under section 351 of
    the Public Health Service Act for the same drug for the [same
    disease or condition] same approved indication or use within
    such rare disease or condition for a person who is not the
    holder of such approved application or of such license until
    the expiration of seven years from the date of the approval of
    the approved application or the issuance of the license.
    Section 505(c)(2) does not apply to the refusal to approve an
    application under the preceding sentence.
      (b) 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]
    same indication or use for which the Secretary has approved or
    licensed such drug if--
              (1) the Secretary finds, after providing the holder
            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 the availability of sufficient
            quantities of the drug to meet the needs of persons
            [with the disease or condition for which the drug was
            designated] for whom the drug is indicated; or
              (2) the holder provides the Secretary in writing the
            consent of such holder for the approval of other
            applications or the issuance of other licenses before
            the expiration of such seven-year period.
      (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] same indication or use
            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.
              (3) Applicability.--This subsection applies to any
            drug designated under section 526 for which an
            application was approved under section 505 of this Act
            or licensed under section 351 of the Public Health
            Service Act after the date of enactment of the FDA
            Reauthorization Act of 2017, regardless of the date on
            which such drug was designated under section 526.
      (d) Regulations.--The Secretary may promulgate regulations
    for the implementation of subsection (c). Beginning on the date
    of enactment of the FDA Reauthorization Act of 2017, until such
    time as the Secretary promulgates regulations in accordance
    with this subsection, the Secretary may apply any definitions
    set forth in regulations that were promulgated prior to such
    date of enactment, to the extent such definitions are not
    inconsistent with the terms of this section, as amended by such
    Act.
      (e) Demonstration of Clinical Superiority Standard.--To
    assist sponsors in demonstrating clinical superiority as
    described in subsection (c), the Secretary--
              (1) upon the designation of any drug under section
            526, shall notify the sponsor of such drug in writing
            of the basis for the designation, including, as
            applicable, any plausible hypothesis offered by the
            sponsor and relied upon by the Secretary that the drug
            is clinically superior to a previously approved drug;
            and
              (2) upon granting exclusive approval or licensure
            under subsection (a) on the basis of a demonstration of
            clinical superiority as described in subsection (c),
            shall publish a summary of the clinical superiority
            findings.

               *       *       *       *       *       *       *

    Subchapter E--General Provisions Relating to Drugs and Devices

               *       *       *       *       *       *       *

    SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

      (a) Establishment.--The Secretary, acting through the
    Commissioner of Food and Drugs, may enter into collaborative
    agreements, to be known as Critical Path Public-Private
    Partnerships, with one or more eligible entities to implement
    the Critical Path Initiative of the Food and Drug
    Administration by developing innovative, collaborative projects
    in research, education, and outreach for the purpose of
    fostering medical product innovation, enabling the acceleration
    of medical product development, manufacturing, and
    translational therapeutics, and enhancing medical product
    safety.
      (b) Eligible Entity.--In this section, the term ``eligible
    entity'' means an entity that meets each of the following:
              (1) The entity is--
                      (A) an institution of higher education (as
                    such term is defined in section 101 of the
                    Higher Education Act of 1965) or a consortium
                    of such institutions; or
                      (B) an organization described in section
                    501(c)(3) of the Internal Revenue Code of 1986
                    and exempt from tax under section 501(a) of
                    such Code.
              (2) The entity has experienced personnel and clinical
            and other technical expertise in the biomedical
            sciences, which may include graduate training programs
            in areas relevant to priorities of the Critical Path
            Initiative.
              (3) The entity demonstrates to the Secretary's
            satisfaction that the entity is capable of--
                      (A) developing and critically evaluating
                    tools, methods, and processes--
                              (i) to increase efficiency,
                            predictability, and productivity of
                            medical product development; and
                              (ii) to more accurately identify the
                            benefits and risks of new and existing
                            medical products;
                      (B) establishing partnerships, consortia, and
                    collaborations with health care practitioners
                    and other providers of health care goods or
                    services; pharmacists; pharmacy benefit
                    managers and purchasers; health maintenance
                    organizations and other managed health care
                    organizations; health care insurers; government
                    agencies; patients and consumers; manufacturers
                    of prescription drugs, biological products,
                    diagnostic technologies, and devices; and
                    academic scientists; and
                      (C) securing funding for the projects of a
                    Critical Path Public-Private Partnership from
                    Federal and nonfederal governmental sources,
                    foundations, and private individuals.
      (c) Funding.--The Secretary may not enter into a
    collaborative agreement under subsection (a) unless the
    eligible entity involved provides an assurance that the entity
    will not accept funding for a Critical Path Public-Private
    Partnership project from any organization that manufactures or
    distributes products regulated by the Food and Drug
    Administration unless the entity provides assurances in its
    agreement with the Food and Drug Administration that the
    results of the Critical Path Public-Private Partnership project
    will not be influenced by any source of funding.
      (d) Annual Report.--Not later than 18 months after the date
    of the enactment of this section, and annually thereafter, the
    Secretary, in collaboration with the parties to each Critical
    Path Public-Private Partnership, shall submit 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--
              (1) reviewing the operations and activities of the
            Partnerships in the previous year; and
              (2) addressing such other issues relating to this
            section as the Secretary determines to be appropriate.
      (e) Definition.--In this section, the term ``medical
    product'' includes a drug, a biological product as defined in
    section 351 of the Public Health Service Act, a device, and any
    combination of such products.
      (f) Authorization of Appropriations.--To carry out this
    section, there is authorized to be appropriated [$6,000,000 for
    each of fiscal years 2018 through 2022] $10,000,000 for each of
    fiscal years 2023 through 2027.

    SEC. 566A. EMERGING TECHNOLOGY PROGRAM.

      (a) Program Establishment.--
              (1) In general.--The Secretary shall establish a
            program to support the adoption of, and improve the
            development of, innovative approaches to drug product
            design and manufacturing.
              (2) Actions.--In carrying out the program under
            paragraph (1), the Secretary may--
                      (A) facilitate and increase communication
                    between public and private entities, consortia,
                    and individuals with respect to innovative drug
                    product design and manufacturing;
                      (B) solicit information regarding, and
                    conduct or support research on, innovative
                    approaches to drug product design and
                    manufacturing;
                      (C) convene meetings with representatives of
                    industry, academia, other Federal agencies,
                    international agencies, and other interested
                    persons, as appropriate;
                      (D) convene working groups to support drug
                    product design and manufacturing research and
                    development;
                      (E) support education and training for
                    regulatory staff and scientists related to
                    innovative approaches to drug product design
                    and manufacturing;
                      (F) advance regulatory science related to the
                    development and review of innovative approaches
                    to drug product design and manufacturing;
                      (G) convene or participate in working groups
                    to support the harmonization of international
                    regulatory requirements related to innovative
                    approaches to drug product design and
                    manufacturing; and
                      (H) award grants or contracts to carry out or
                    support the program under paragraph (1).
              (3) Grants and contracts.--To seek a grant or
            contract under this section, an entity shall submit an
            application--
                      (A) in such form and manner as the Secretary
                    may require; and
                      (B) containing such information as the
                    Secretary may require, including a description
                    of--
                              (i) how the entity will conduct the
                            activities to be supported through the
                            grant or contract; and
                              (ii) how such activities will further
                            research and development related to, or
                            adoption of, innovative approaches to
                            drug product design and manufacturing.
      (b) Guidance.--The Secretary shall--
              (1) issue or update guidance to help facilitate the
            adoption of, and advance the development of, innovative
            approaches to drug product design and manufacturing;
            and
              (2) include in such guidance descriptions of--
                      (A) any regulatory requirements related to
                    the development or review of technologies
                    related to innovative approaches to drug
                    product design and manufacturing, including
                    updates and improvements to such technologies
                    after product approval; and
                      (B) data that can be used to demonstrate the
                    identity, safety, purity, and potency of drugs
                    manufactured using such technologies.
      (c) Report to Congress.--Not later than 4 years after the
    date of enactment of this section, 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--
              (1) an annual accounting of the allocation of funds
            made available to carry out this section;
              (2) a description of how Food and Drug Administration
            staff were utilized to carry out this section and, as
            applicable, any challenges or limitations related to
            staffing;
              (3) the number of public meetings held or
            participated in by the Food and Drug Administration
            pursuant to this section, including meetings convened
            as part of a working group described in subparagraph
            (D) or (G) of subsection (a)(2), and the topics of each
            such meeting; and
              (4) the number of drug products approved or licensed,
            after the date of enactment of this section, using an
            innovative approach to drug product design and
            manufacturing.
      (d) Authorization of Appropriations.--To carry out this
    section, there is authorized to be appropriated $20,000,000 for
    each fiscal year 2023 through 2027.

               *       *       *       *       *       *       *

    SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES, TARGETED
                        THERAPIES, AND GENETIC TARGETING OF TREATMENTS.

      (a) In General.--For the purpose of promoting the efficiency
    of and informing the review by the Food and Drug Administration
    of new drugs and biological products for rare diseases and
    drugs and biological products that are genetically targeted,
    the following shall apply:
              (1) Consultation with stakeholders.--Consistent with
            sections X.C and IX.E.4 of the PDUFA Reauthorization
            Performance Goals and Procedures Fiscal Years 2013
            through 2017, as referenced in the letters described in
            section 101(b) of the Prescription Drug User Fee
            Amendments of 2012, the Secretary shall ensure that
            opportunities exist, at a time the Secretary determines
            appropriate, for consultations with stakeholders on the
            topics described in subsection (b).
              (2) Consultation with external experts.--
                      (A) In general.--The Secretary shall develop
                    and maintain a list of external experts who,
                    because of their special expertise, are
                    qualified to provide advice on rare disease
                    issues, including topics described in
                    subsection (b). The Secretary may, when
                    appropriate to address a specific regulatory
                    question, consult such external experts on
                    issues related to the review of new drugs and
                    biological products for rare diseases and drugs
                    and biological products that are genetically
                    targeted, including the topics described in
                    subsection (b), when such consultation is
                    necessary because the Secretary lacks the
                    specific scientific, medical, or technical
                    expertise necessary for the performance of the
                    Secretary's regulatory responsibilities and the
                    necessary expertise can be provided by the
                    external experts.
                      (B) External experts.--For purposes of
                    subparagraph (A), external experts are
                    individuals who possess scientific or medical
                    training that the Secretary lacks with respect
                    to one or more rare diseases.
                      (C) Small population studies.--The external
                    experts on the list maintained pursuant to
                    subparagraph (A) may include experts on the
                    science of small population studies.
      (b) Topics for Consultation.--Topics for consultation
    pursuant to this section may include--
              (1) rare diseases;
              (2) the severity of rare diseases;
              (3) the unmet medical need associated with rare
            diseases;
              (4) the willingness and ability of individuals with a
            rare disease to participate in clinical trials;
              (5) an assessment of the benefits and risks of
            therapies to treat rare diseases;
              (6) the general design of clinical trials for rare
            disease populations and subpopulations; and
              (7) the demographics and the clinical description of
            patient populations.
      (c) Classification as Special Government Employees.--The
    external experts who are consulted under this section may be
    considered special government employees, as defined under
    section 202 of title 18, United States Code.
      (d) Protection of Confidential Information and Trade
    Secrets.--
              (1) Rule of construction.--Nothing in this section
            shall be construed to alter the protections offered by
            laws, regulations, and policies governing disclosure of
            confidential commercial or trade secret information,
            and any other information exempt from disclosure
            pursuant to section 552(b) of title 5, United States
            Code, as such provisions would be applied to
            consultation with individuals and organizations prior
            to the date of enactment of this section.
              (2) Consent required for disclosure.--The Secretary
            shall not disclose confidential commercial or trade
            secret information to an expert consulted under this
            section without the written consent of the sponsor
            unless the expert is a special government employee (as
            defined under section 202 of title 18, United States
            Code) or the disclosure is otherwise authorized by law.
      (e) Other Consultation.--Nothing in this section shall be
    construed to limit the ability of the Secretary to consult with
    individuals and organizations as authorized prior to the date
    of enactment of this section.
      (f) No Right or Obligation.--
              (1) No right to consultation.--Nothing in this
            section shall be construed to create a legal right for
            a consultation on any matter or require the Secretary
            to meet with any particular expert or stakeholder.
              (2) No altering of goals.--Nothing in this section
            shall be construed to alter agreed upon goals and
            procedures identified in the letters described in
            section 101(b) of the Prescription Drug User Fee
            Amendments of 2012.
              (3) No change to number of review cycles.--Nothing in
            this section is intended to increase the number of
            review cycles as in effect before the date of enactment
            of this section.
      (g) No Delay in Product Review.--
              (1) In general.--Prior to a consultation with an
            external expert, as described in this section, relating
            to an investigational new drug application under
            section 505(i), a new drug application under section
            505(b), or a biologics license application under
            section 351 of the Public Health Service Act, the
            Director of the Center for Drug Evaluation and Research
            or the Director of the Center for Biologics Evaluation
            and Research (or appropriate Division Director), as
            appropriate, shall determine that--
                      (A) such consultation will--
                              (i) facilitate the Secretary's
                            ability to complete the Secretary's
                            review; and
                              (ii) address outstanding deficiencies
                            in the application; or
                      (B) the sponsor authorized such consultation.
              (2) Limitation.--The requirements of this subsection
            shall apply only in instances where the consultation is
            undertaken solely under the authority of this section.
            The requirements of this subsection shall not apply to
            any consultation initiated under any other authority.

               *       *       *       *       *       *       *

                         CHAPTER VII--GENERAL AUTHORITY

    Subchapter A--General Administrative Provisions

               *       *       *       *       *       *       *

    SEC. 703. RECORDS.

      (a) In General.--For the purpose of enforcing the provisions
    of this Act, carriers engaged in interstate commerce, and
    persons receiving food, drugs, devices, tobacco products, or
    cosmetics in interstate commerce or holding such articles so
    received, shall, upon the request of an officer or employee
    duly designated by the Secretary, permit such officer or
    employee, at reasonable times, to have access to and to copy
    all records showing the movement in interstate commerce of any
    food, drug, device, tobacco product, or cosmetic, or the
    holding thereof during or after such movement, and the
    quantity, shipper, and consignee thereof; and it shall be
    unlawful for any such carrier or person to fail to permit such
    access to and copying of any such record so requested when such
    request is accompanied by a statement in writing specifying the
    nature or kind of food, drug, device, tobacco product, or
    cosmetic to which such request relates, except that evidence
    obtained under this section, or any evidence which is directly
    or indirectly derived from such evidence, shall not be used in
    a criminal prosecution of the person from whom obtained, and
    except that carriers shall not be subject to the other
    provisions of this Act by reason of their receipt, carriage,
    holding, or delivery of food, drugs, devices, tobacco products,
    or cosmetics in the usual course of business as carriers,
    except as provided in subsection (b).
      (b) Food Transportation Records.--A shipper, carrier by motor
    vehicle or rail vehicle, receiver, or other person subject to
    section 416 shall, on request of an officer or employee
    designated by the Secretary, permit the officer or employee, at
    reasonable times, to have access to and to copy all records
    that the Secretary requires to be kept under section
    416(c)(1)(E).
      (c) Applicability.--The limitations on the Secretary's use of
    evidence obtained under this section, or any evidence which is
    directly or indirectly derived from such evidence, in a
    criminal prosecution of the person from whom such evidence was
    obtained shall not apply to evidence, including records or
    other information, obtained under authorities other than this
    section, unless such limitations are specifically incorporated
    by reference in such other authorities.

                               factory inspection

      Sec. 704. (a)(1) For purposes of enforcement of this Act,
    officers or employees duly designated by the Secretary, upon
    presenting appropriate credentials and a written notice to the
    owner, operator, or agent in charge, are authorized (A) to
    enter, at reasonable times, any factory, warehouse, or
    establishment in which food, drugs, devices, tobacco products,
    or cosmetics are manufactured, processed, packed, or held, for
    introduction into interstate commerce or after such
    introduction, or to enter any vehicle, being used to transport
    or hold such food, drugs, devices, tobacco products, or
    cosmetics in interstate commerce; and (B) to inspect, at
    reasonable times and within reasonable limits and in a
    reasonable manner, such factory, warehouse, establishment, or
    vehicle and all pertinent equipment, finished and unfinished
    materials, containers, and labeling therein. In the case of any
    person (excluding farms and restaurants) who manufactures,
    processes, packs, transports, distributes, holds, or imports
    foods, the inspection shall extend to all records and other
    information described in section 414, when the standard for
    records inspection under paragraph (1) or (2) of section 414(a)
    applies, subject to the limitations established in section
    414(d). In the case of any factory, warehouse, establishment,
    or consulting laboratory in which prescription drugs,
    nonprescription drugs intended for human use, [restricted
    devices] devices, or tobacco products are manufactured,
    processed, packed, or held, inspection shall extend to all
    things therein (including records, files, papers, processes,
    controls, and facilities) bearing on whether prescription
    drugs, nonprescription drugs intended for human use,
    [restricted devices] devices, or tobacco products which are
    adulterated or misbranded within the meaning of this Act, or
    which may not be manufactured, introduced into interstate
    commerce, or sold, or offered for sale by reason of any
    provision of this Act, have been or are being manufactured,
    processed, packed, transported, or held in any such place, or
    otherwise bearing on violation of this Act. No inspection
    authorized by the preceding sentence or by paragraph (3) shall
    extend to financial data, sales data other than shipment data,
    pricing data, personnel data (other than data as to
    qualifications of technical and professional personnel
    performing functions subject to this Act), and research data
    (other than data relating to new drugs, antibiotic drugs,
    devices, and tobacco products and subject to reporting and
    inspection under regulations lawfully issued pursuant to
    section 505 (i) or (k), section 519, section 520(g), or chapter
    IX and data relating to other drugs, devices, or tobacco
    products which in the case of a new drug would be subject to
    reporting or inspection under lawful regulations issued
    pursuant to section 505(j)). A separate notice shall be given
    for each such inspection, but a notice shall not be required
    for each entry made during the period covered by the
    inspection. Each such inspection shall be commenced and
    completed with reasonable promptness.
      (2) The provisions of the third sentence of paragraph (1)
    shall not apply to--
              (A) pharmacies which maintain establishments in
            conformance with any applicable local laws regulating
            the practice of pharmacy and medicine and which are
            regularly engaged in dispensing prescription drugs or
            devices, upon prescriptions of practitioners licensed
            to administer such drugs or devices to patients under
            the care of such practitioners in the course of their
            professional practice, and which do not, either through
            a subsidiary or otherwise, manufacture, prepare,
            propagate, compound, or process drugs or devices for
            sale other than in the regular course of their business
            of dispensing or selling drugs or devices at retail;
              (B) practitioners licensed by law to prescribe or
            administer drugs, or prescribe or use devices, as the
            case may be, and who manufacture, prepare, propagate,
            compound, or process drugs, or manufacture or process
            devices solely for use in the course of their
            professional practice;
              (C) persons who manufacture, prepare, propagate,
            compound, or process drugs, or manufacture or process
            devices solely for use in research, teaching, or
            chemical analysis and not for sale;
              (D) such other classes of persons as the Secretary
            may by regulation exempt from the application of this
            section upon a finding that inspection as applied to
            such classes of persons in accordance with this section
            is not necessary for the protection of the public
            health.
      (3) An officer or employee making an inspection under
    paragraph (1) for purposes of enforcing the requirements of
    section 412 applicable to infant formulas shall be permitted,
    at all reasonable times, to have access to and to copy and
    verify any records--
              (A) bearing on whether the infant formula
            manufactured or held in the facility inspected meets
            the requirements of section 412, or
              (B) required to be maintained under section 412.
      (4)(A) Any records or other information that the Secretary
    may inspect under this section from a person that owns or
    operates [an establishment that is engaged in the manufacture,
    preparation, propagation, compounding, or processing of a drug]
    an establishment that is engaged in the manufacture,
    preparation, propagation, compounding, or processing of a drug
    or device, or that is subject to inspection under paragraph
    (5)(C), shall, upon the request of the Secretary, be provided
    to the Secretary by such person, in advance of or in lieu of an
    inspection, within a reasonable timeframe, within reasonable
    limits, and in a reasonable manner, and in either electronic or
    physical form, at the expense of such person. The Secretary's
    request shall include a sufficient description of the records
    requested and a rationale for requesting such records or other
    information in advance of, or in lieu of, an inspection.
      (B) Upon receipt of the records requested under subparagraph
    (A), the Secretary shall provide to the person confirmation of
    receipt.
      (C) The Secretary may rely on any records or other
    information that the Secretary may inspect under this section
    to satisfy requirements that may pertain to a preapproval or
    risk-based surveillance inspection, or to resolve deficiencies
    identified during such inspections, if applicable and
    appropriate.
      [(C)] (D) Nothing in this paragraph supplants the authority
    of the Secretary to conduct inspections otherwise permitted
    under this Act in order to ensure compliance with this Act.
              (5) Bioresearch monitoring inspections.--
                      (A) In general.--The Secretary may, to ensure
                    the accuracy and reliability of studies and
                    records or other information described in
                    subparagraph (B) and to assess compliance with
                    applicable requirements under this Act or the
                    Public Health Service Act, enter sites and
                    facilities specified in subparagraph (C) in
                    order to inspect such records or other
                    information.
                      (B) Information subject to inspection.--An
                    inspection under this paragraph shall extend to
                    all records and other information related to
                    the studies and submissions described in
                    subparagraph (E), including records and
                    information related to the conduct, results,
                    and analyses of, and the protection of human
                    and animal trial participants participating in,
                    such studies.
                      (C) Sites and facilities subject to
                    inspection.--
                              (i) Sites and facilities described.--
                            The sites and facilities subject to
                            inspection by the Secretary under this
                            paragraph are those owned or operated
                            by a person described in clause (ii)
                            and which are (or were) utilized by
                            such person in connection with--
                                      (I) developing an application
                                    or other submission to the
                                    Secretary under this Act or the
                                    Public Health Service Act
                                    related to marketing
                                    authorization for a product
                                    described in paragraph (1);
                                      (II) preparing, conducting,
                                    or analyzing the results of a
                                    study described in subparagraph
                                    (E); or
                                      (III) holding any records or
                                    other information described in
                                    subparagraph (B).
                              (ii) Persons described.--A person
                            described in this clause is--
                                      (I) the sponsor of an
                                    application or submission
                                    specified in subparagraph (E);
                                      (II) a person engaged in any
                                    activity described in clause
                                    (i) on behalf of such a
                                    sponsor, through a contract,
                                    grant, or other business
                                    arrangement with such sponsor;
                                      (III) an institutional review
                                    board, or other individual or
                                    entity, engaged by contract,
                                    grant, or other business
                                    arrangement with a nonsponsor
                                    in preparing, collecting, or
                                    analyzing records or other
                                    information described in
                                    subparagraph (B); or
                                      (IV) any person not otherwise
                                    described in this clause that
                                    conducts, or has conducted, a
                                    study described in subparagraph
                                    (E) yielding records or other
                                    information described in
                                    subparagraph (B).
                      (D) Conditions of inspection.--
                              (i) Access to information subject to
                            inspection.--Subject to clause (ii), an
                            entity that owns or operates any site
                            or facility subject to inspection under
                            this paragraph shall provide the
                            Secretary with access to records and
                            other information described in
                            subparagraph (B) that is held by or
                            under the control of such entity,
                            including--
                                      (I) permitting the Secretary
                                    to record or copy such
                                    information for purposes of
                                    this paragraph;
                                      (II) providing the Secretary
                                    with access to any electronic
                                    information system utilized by
                                    such entity to hold, process,
                                    analyze, or transfer any
                                    records or other information
                                    described in subparagraph (B);
                                    and
                                      (III) permitting the
                                    Secretary to inspect the
                                    facilities, equipment, written
                                    procedures, processes, and
                                    conditions through which
                                    records or other information
                                    described in subparagraph (B)
                                    is or was generated, held,
                                    processed, analyzed, or
                                    transferred.
                              (ii) No effect on applicability of
                            provisions for protection of
                            proprietary information or trade
                            secrets.--Nothing in clause (i) shall
                            negate, supersede, or otherwise affect
                            the applicability of provisions, under
                            this or any other Act, preventing or
                            limiting the disclosure of confidential
                            commercial information or other
                            information considered proprietary or
                            trade secret.
                              (iii) Reasonableness of
                            inspections.--An inspection under this
                            paragraph shall be conducted at
                            reasonable times and within reasonable
                            limits and in a reasonable manner.
                      (E) Studies and submissions described.--The
                    studies and submissions described in this
                    subparagraph are each of the following:
                              (i) Clinical and nonclinical studies
                            submitted to the Secretary in support
                            of, or otherwise related to,
                            applications and other submissions to
                            the Secretary under this Act or the
                            Public Health Service Act for marketing
                            authorization of a product described in
                            paragraph (1).
                              (ii) Postmarket safety activities
                            conducted under this Act or the Public
                            Health Service Act.
                              (iii) Any other clinical
                            investigation of--
                                      (I) a drug subject to section
                                    505 or 512 of this Act or
                                    section 351 of the Public
                                    Health Service Act; or
                                      (II) a device subject to
                                    section 520(g).
                              (iv) Any other submissions made under
                            this Act or the Public Health Service
                            Act with respect to which the Secretary
                            determines an inspection under this
                            paragraph is warranted in the interest
                            of public health.
                      (F) Clarification.--This paragraph clarifies
                    the authority of the Secretary to conduct
                    inspections of the type described in this
                    paragraph and shall not be construed as a basis
                    for inferring that, prior to the date of
                    enactment of this paragraph, the Secretary
                    lacked the authority to conduct such
                    inspections, including under this Act or the
                    Public Health Service Act.
      (b)(1) Upon completion of any such inspection of a factory,
    warehouse, consulting laboratory, or other establishment, and
    prior to leaving the premises, the officer or employee making
    the inspection shall give to the owner, operator, or agent in
    charge a report in writing setting forth any conditions or
    practices observed by him which, in his judgment, indicate that
    any food, drug, device, tobacco product, or cosmetic in such
    establishment (A) consists in whole or in part of any filthy,
    putrid, or decomposed substance, or (B) has been prepared,
    packed, or held under insanitary conditions whereby it may have
    become contaminated with filth, or whereby it may have been
    rendered injurious to health. A copy of such report shall be
    sent promptly to the Secretary.
      (2) In carrying out this subsection with respect to any
    establishment manufacturing a drug approved under subsection
    (c) or (j) of section 505 for which a notification has been
    submitted in accordance with section 506C is, or has been in
    the last 5 years, listed on the drug shortage list under
    section 506E, or that is described in section 505(j)(11)(A), a
    copy of the report shall be sent promptly to the appropriate
    offices of the Food and Drug Administration with expertise
    regarding drug shortages.
      (c) If the officer or employee making any such inspection of
    a factory, warehouse, or other establishment has obtained any
    sample in the course of the inspection, upon completion of the
    inspection and prior to leaving the premises he shall give to
    the owner, operator, or agent in charge a receipt describing
    the samples obtained.
      (d) Whenever in the course of any such inspection of a
    factory or other establishment where food is manufactured,
    processed, or packed, the officer or employee making the
    inspection obtains a sample of any such food, and an analysis
    is made of such sample for the purpose of ascertaining whether
    such food consists in whole or in part of any filthy, putrid,
    or decomposed substance, or is otherwise unfit for food, a copy
    of the results of such analysis shall be furnished promptly to
    the owner, operator, or agent in charge.
      (e) Every person required under section 519 or 520(g) to
    maintain records and every person who is in charge or custody
    of such records shall, upon request of an officer or employee
    designated by the Secretary, permit such officer or employee at
    all reasonable times to have access to, and to copy and verify,
    such records.
      (f)(1) An accredited person described in paragraph (3) shall
    maintain records documenting the training qualifications of the
    person and the employees of the person, the procedures used by
    the person for handling confidential information, the
    compensation arrangements made by the person, and the
    procedures used by the person to identify and avoid conflicts
    of interest. Upon the request of an officer or employee
    designated by the Secretary, the person shall permit the
    officer or employee, at all reasonable times, to have access
    to, to copy, and to verify, the records.
      (2) Within 15 days after the receipt of a written request
    from the Secretary to an accredited person described in
    paragraph (3) for copies of records described in paragraph (1),
    the person shall produce the copies of the records at the place
    designated by the Secretary.
      (3) For purposes of paragraphs (1) and (2), an accredited
    person described in this paragraph is a person who--
              (A) is accredited under subsection (g); or
              (B) is accredited under section 523.
      (g)(1) The Secretary shall, subject to the provisions of this
    subsection, accredit persons for the purpose of conducting
    inspections of establishments that manufacture, prepare,
    propagate, compound, or process class II or class III devices,
    which inspections are required under section 510(h) or are
    inspections of such establishments required to register under
    section 510(i). The owner or operator of such an establishment
    that is eligible under paragraph (6) may, from the list
    published under paragraph (4), select an accredited person to
    conduct such inspections.
      (2) The Secretary shall publish in the Federal Register
    criteria to accredit or deny accreditation to persons who
    request to perform the duties specified in paragraph (1).
    Thereafter, the Secretary shall inform those requesting
    accreditation, within 60 days after the receipt of such
    request, whether the request for accreditation is adequate for
    review, and the Secretary shall promptly act on the request for
    accreditation. Any resulting accreditation shall state that
    such person is accredited to conduct inspections at device
    establishments identified in paragraph (1). The accreditation
    of such person shall specify the particular activities under
    this subsection for which such person is accredited.
      (3) An accredited person shall, at a minimum, meet the
    following requirements:
              (A) Such person may not be an employee of the Federal
            Government.
              (B) Such person shall be an independent organization
            which is not owned or controlled by a manufacturer,
            supplier, or vendor of articles regulated under this
            Act and which has no organizational, material, or
            financial affiliation (including a consultative
            affiliation) with such a manufacturer, supplier, or
            vendor.
              (C) Such person shall be a legally constituted entity
            permitted to conduct the activities for which it seeks
            accreditation.
              (D) Such person shall not engage in the design,
            manufacture, promotion, or sale of articles regulated
            under this Act.
              (E) The operations of such person shall be in
            accordance with generally accepted professional and
            ethical business practices, and such person shall agree
            in writing that at a minimum the person will--
                      (i) certify that reported information
                    accurately reflects data reviewed, inspection
                    observations made, other matters that relate to
                    or may influence compliance with this Act, and
                    recommendations made during an inspection or at
                    an inspection's closing meeting;
                      (ii) limit work to that for which competence
                    and capacity are available;
                      (iii) treat information received, records,
                    reports, and recommendations as confidential
                    commercial or financial information or trade
                    secret information, except such information may
                    be made available to the Secretary;
                      (iv) promptly respond and attempt to resolve
                    complaints regarding its activities for which
                    it is accredited; and
                      (v) protect against the use, in carrying out
                    paragraph (1), of any officer or employee of
                    the accredited person who has a financial
                    conflict of interest regarding any product
                    regulated under this Act, and annually make
                    available to the public disclosures of the
                    extent to which the accredited person, and the
                    officers and employees of the person, have
                    maintained compliance with requirements under
                    this clause relating to financial conflicts of
                    interest.
              (F) Such person shall notify the Secretary of any
            withdrawal, suspension, restriction, or expiration of
            certificate of conformance with the quality systems
            standard referred to in paragraph (7) for any device
            establishment that such person inspects under this
            subsection not later than 30 days after such
            withdrawal, suspension, restriction, or expiration.
              (G) Such person may conduct audits to establish
            conformance with the quality systems standard referred
            to in paragraph (7).
      (4) The Secretary shall publish on the Internet site of the
    Food and Drug Administration a list of persons who are
    accredited under paragraph (2). Such list shall be updated to
    ensure that the identity of each accredited person, and the
    particular activities for which the person is accredited, is
    known to the public. The updating of such list shall be no
    later than one month after the accreditation of a person under
    this subsection or the suspension or withdrawal of
    accreditation, or the modification of the particular activities
    for which the person is accredited.
      (5)(A) To ensure that persons accredited under this
    subsection continue to meet the standards of accreditation, the
    Secretary shall (i) audit the performance of such persons on a
    periodic basis through the review of inspection reports and
    inspections by persons designated by the Secretary to evaluate
    the compliance status of a device establishment and the
    performance of accredited persons, and (ii) take such
    additional measures as the Secretary determines to be
    appropriate.
      (B) The Secretary may withdraw accreditation of any person
    accredited under paragraph (2), after providing notice and an
    opportunity for an informal hearing, when such person is
    substantially not in compliance with the standards of
    accreditation, poses a threat to public health, fails to act in
    a manner that is consistent with the purposes of this
    subsection, or where the Secretary determines that there is a
    financial conflict of interest in the relationship between the
    accredited person and the owner or operator of a device
    establishment that the accredited person has inspected under
    this subsection. The Secretary may suspend the accreditation of
    such person during the pendency of the process under the
    preceding sentence.
      (6)(A) Subject to subparagraphs (B) and (C), a device
    establishment is eligible for inspection by persons accredited
    under paragraph (2) if the following conditions are met:
              (i) The Secretary classified the results of the most
            recent inspection of the establishment as ``no action
            indicated'' or ``voluntary action indicated''.
              (ii) With respect to inspections of the establishment
            to be conducted by an accredited person, the owner or
            operator of the establishment submits to the Secretary
            a notice that--
                      (I) provides the date of the last inspection
                    of the establishment by the Secretary and the
                    classification of that inspection;
                      (II) states the intention of the owner or
                    operator to use an accredited person to conduct
                    inspections of the establishment;
                      (III) identifies the particular accredited
                    person the owner or operator intends to select
                    to conduct such inspections; and
                      (IV) includes a certification that, with
                    respect to the devices that are manufactured,
                    prepared, propagated, compounded, or processed
                    in the establishment--
                              (aa) at least 1 of such devices is
                            marketed in the United States; and
                              (bb) at least 1 of such devices is
                            marketed, or is intended to be
                            marketed, in 1 or more foreign
                            countries, 1 of which countries
                            certifies, accredits, or otherwise
                            recognizes the person accredited under
                            paragraph (2) and identified under
                            subclause (III) as a person authorized
                            to conduct inspections of device
                            establishments.
      (B)(i) Except with respect to the requirement of subparagraph
    (A)(i), a device establishment is deemed to have clearance to
    participate in the program and to use the accredited person
    identified in the notice under subparagraph (A)(ii) for
    inspections of the establishment unless the Secretary, not
    later than 30 days after receiving such notice, issues a
    response that--
              (I) denies clearance to participate as provided under
            subparagraph (C); or
              (II) makes a request under clause (ii).
      (ii) The Secretary may request from the owner or operator of
    a device establishment in response to the notice under
    subparagraph (A)(ii) with respect to the establishment, or from
    the particular accredited person identified in such notice--
              (I) compliance data for the establishment in
            accordance with clause (iii)(I); or
              (II) information concerning the relationship between
            the owner or operator of the establishment and the
            accredited person identified in such notice in
            accordance with clause (iii)(II).
    The owner or operator of the establishment, or such accredited
    person, as the case may be, shall respond to such a request not
    later than 60 days after receiving such request.
      (iii)(I) The compliance data to be submitted by the owner or
    operator of a device establishment in response to a request
    under clause (ii)(I) are data describing whether the quality
    controls of the establishment have been sufficient for ensuring
    consistent compliance with current good manufacturing practice
    within the meaning of section 501(h) and with other applicable
    provisions of this Act. Such data shall include complete
    reports of inspectional findings regarding good manufacturing
    practice or other quality control audits that, during the
    preceding 2-year period, were conducted at the establishment by
    persons other than the owner or operator of the establishment,
    together with all other compliance data the Secretary deems
    necessary. Data under the preceding sentence shall demonstrate
    to the Secretary whether the establishment has facilitated
    consistent compliance by promptly correcting any compliance
    problems identified in such inspections.
      (II) A request to an accredited person under clause (ii)(II)
    may not seek any information that is not required to be
    maintained by such person in records under subsection (f)(1).
      (iv) A device establishment is deemed to have clearance to
    participate in the program and to use the accredited person
    identified in the notice under subparagraph (A)(ii) for
    inspections of the establishment unless the Secretary, not
    later than 60 days after receiving the information requested
    under clause (ii), issues a response that denies clearance to
    participate as provided under subparagraph (C).
      (C)(i) The Secretary may deny clearance to a device
    establishment if the Secretary has evidence that the
    certification under subparagraph (A)(ii)(IV) is untrue and the
    Secretary provides to the owner or operator of the
    establishment a statement summarizing such evidence.
      (ii) The Secretary may deny clearance to a device
    establishment if the Secretary determines that the
    establishment has failed to demonstrate consistent compliance
    for purposes of subparagraph (B)(iii)(I) and the Secretary
    provides to the owner or operator of the establishment a
    statement of the reasons for such determination.
      (iii)(I) The Secretary may reject the selection of the
    accredited person identified in the notice under subparagraph
    (A)(ii) if the Secretary provides to the owner or operator of
    the establishment a statement of the reasons for such
    rejection. Reasons for the rejection may include that the
    establishment or the accredited person, as the case may be, has
    failed to fully respond to the request, or that the Secretary
    has concerns regarding the relationship between the
    establishment and such accredited person.
      (II) If the Secretary rejects the selection of an accredited
    person by the owner or operator of a device establishment, the
    owner or operator may make an additional selection of an
    accredited person by submitting to the Secretary a notice that
    identifies the additional selection. Clauses (i) and (ii) of
    subparagraph (B), and subclause (I) of this clause, apply to
    the selection of an accredited person through a notice under
    the preceding sentence in the same manner and to the same
    extent as such provisions apply to a selection of an accredited
    person through a notice under subparagraph (A)(ii).
      (iv) In the case of a device establishment that is denied
    clearance under clause (i) or (ii) or with respect to which the
    selection of the accredited person is rejected under clause
    (iii), the Secretary shall designate a person to review the
    statement of reasons, or statement summarizing such evidence,
    as the case may be, of the Secretary under such clause if,
    during the 30-day period beginning on the date on which the
    owner or operator of the establishment receives such statement,
    the owner or operator requests the review. The review shall
    commence not later than 30 days after the owner or operator
    requests the review, unless the Secretary and the owner or
    operator otherwise agree.
      (7)(A) Persons accredited under paragraph (2) to conduct
    inspections shall record in writing their inspection
    observations and shall present the observations to the device
    establishment's designated representative and describe each
    observation. Additionally, such accredited person shall prepare
    an inspection report in a form and manner designated by the
    Secretary to conduct inspections, taking into consideration the
    goals of international harmonization of quality systems
    standards. Any official classification of the inspection shall
    be determined by the Secretary.
      (B) At a minimum, an inspection report under subparagraph (A)
    shall identify the persons responsible for good manufacturing
    practice compliance at the inspected device establishment, the
    dates of the inspection, the scope of the inspection, and shall
    describe in detail each observation identified by the
    accredited person, identify other matters that relate to or may
    influence compliance with this Act, and describe any
    recommendations during the inspection or at the inspection's
    closing meeting.
      (C) An inspection report under subparagraph (A) shall be sent
    to the Secretary and to the designated representative of the
    inspected device establishment at the same time, but under no
    circumstances later than three weeks after the last day of the
    inspection. The report to the Secretary shall be accompanied by
    all written inspection observations previously provided to the
    designated representative of the establishment.
      (D) Any statement or representation made by an employee or
    agent of a device establishment to a person accredited under
    paragraph (2) to conduct inspections shall be subject to
    section 1001 of title 18, United States Code.
      (E) If at any time during an inspection by an accredited
    person the accredited person discovers a condition that could
    cause or contribute to an unreasonable risk to the public
    health, the accredited person shall immediately notify the
    Secretary of the identification of the device establishment
    subject to inspection and such condition.
      (F) For the purpose of setting risk-based inspectional
    priorities, the Secretary shall accept voluntary submissions of
    reports of audits assessing conformance with appropriate
    quality systems standards set by the International Organization
    for Standardization (ISO) and identified by the Secretary in
    public notice. If the owner or operator of an establishment
    elects to submit audit reports under this subparagraph, the
    owner or operator shall submit all such audit reports with
    respect to the establishment during the preceding 2-year
    periods.
      (8) Compensation for an accredited person shall be determined
    by agreement between the accredited person and the person who
    engages the services of the accredited person, and shall be
    paid by the person who engages such services.
      (9) Nothing in this subsection affects the authority of the
    Secretary to inspect any device establishment pursuant to this
    Act.
      (10)(A) For fiscal year 2005 and each subsequent fiscal year,
    no device establishment may be inspected during the fiscal year
    involved by a person accredited under paragraph (2) if--
              (i) of the amounts appropriated for salaries and
            expenses of the Food and Drug Administration for the
            preceding fiscal year (referred to in this subparagraph
            as the ``first prior fiscal year''), the amount
            obligated by the Secretary for inspections of device
            establishments by the Secretary was less than the
            adjusted base amount applicable to such first prior
            fiscal year; and
              (ii) of the amounts appropriated for salaries and
            expenses of the Food and Drug Administration for the
            fiscal year preceding the first prior fiscal year
            (referred to in this subparagraph as the ``second prior
            fiscal year''), the amount obligated by the Secretary
            for inspections of device establishments by the
            Secretary was less than the adjusted base amount
            applicable to such second prior fiscal year.
      (B)(i) Subject to clause (ii), the Comptroller General of the
    United States shall determine the amount that was obligated by
    the Secretary for fiscal year 2002 for compliance activities of
    the Food and Drug Administration with respect to devices
    (referred to in this subparagraph as the ``compliance
    budget''), and of such amount, the amount that was obligated
    for inspections by the Secretary of device establishments
    (referred to in this subparagraph as the ``inspection
    budget'').
      (ii) For purposes of determinations under clause (i), the
    Comptroller General shall not include in the compliance budget
    or the inspection budget any amounts obligated for inspections
    of device establishments conducted as part of the process of
    reviewing applications under section 515.
      (iii) Not later than March 31, 2003, the Comptroller General
    shall complete the determinations required in this subparagraph
    and submit to the Secretary and the Congress a report
    describing the findings made through such determinations.
      (C) For purposes of this paragraph:
              (i) The term ``base amount'' means the inspection
            budget determined under subparagraph (B) for fiscal
            year 2002.
              (ii) The term ``adjusted base amount'', in the case
            of applicability to fiscal year 2003, means an amount
            equal to the base amount increased by 5 percent.
              (iii) The term ``adjusted base amount'', with respect
            to applicability to fiscal year 2004 or any subsequent
            fiscal year, means the adjusted base amount applicable
            to the preceding year increased by 5 percent.
      (11) The authority provided by this subsection terminates on
    October 1, [2022] 2027.
      (12) No later than four years after the enactment of this
    subsection the Comptroller General shall report 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) the number of inspections conducted by accredited
            persons pursuant to this subsection and the number of
            inspections conducted by Federal employees pursuant to
            section 510(h) and of device establishments required to
            register under section 510(i);
              (B) the number of persons who sought accreditation
            under this subsection, as well as the number of persons
            who were accredited under this subsection;
              (C) the reasons why persons who sought accreditation,
            but were denied accreditation, were denied;
              (D) the number of audits conducted by the Secretary
            of accredited persons, the quality of inspections
            conducted by accredited persons, whether accredited
            persons are meeting their obligations under this Act,
            and whether the number of audits conducted is
            sufficient to permit these assessments;
              (E) whether this subsection is achieving the goal of
            ensuring more information about device establishment
            compliance is being presented to the Secretary, and
            whether that information is of a quality consistent
            with information obtained by the Secretary pursuant to
            inspections conducted by Federal employees;
              (F) whether this subsection is advancing efforts to
            allow device establishments to rely upon third-party
            inspections for purposes of compliance with the laws of
            foreign governments; and
              (G) whether the Congress should continue, modify, or
            terminate the program under this subsection.
      (13) The Secretary shall include in the annual report
    required under section 1003(g) the names of all accredited
    persons and the particular activities under this subsection for
    which each such person is accredited and the name of each
    accredited person whose accreditation has been withdrawn during
    the year.
      (14) Notwithstanding any provision of this subsection, this
    subsection does not have any legal effect on any agreement
    described in section 803(b) between the Secretary and a foreign
    country.
      (15)(A) Notwithstanding any other provision of this
    subsection, the Secretary may recognize auditing organizations
    that are recognized by organizations established by governments
    to facilitate international harmonization for purposes of
    conducting inspections of--
              (i) establishments that manufacture, prepare,
            propagate, compound, or process devices (other than
            types of devices licensed under section 351 of the
            Public Health Service Act), as required under section
            510(h); or
              (ii) establishments required to register pursuant to
            section 510(i).
      (B) Nothing in this paragraph affects--
              (i) the authority of the Secretary to inspect any
            device establishment pursuant to this Act; or
              (ii) the authority of the Secretary to determine the
            official classification of an inspection.
      (h)(1) In the case of inspections other than for-cause
    inspections, the Secretary shall review processes and standards
    applicable to inspections of domestic and foreign device
    establishments in effect as of the date of the enactment of
    this subsection, and update such processes and standards
    through the adoption of uniform processes and standards
    applicable to such inspections. Such uniform processes and
    standards shall provide for--
              (A) exceptions to such processes and standards, as
            appropriate;
              (B) announcing the inspection of the establishment
            within a reasonable time before such inspection occurs,
            including by providing to the owner, operator, or agent
            in charge of the establishment a notification regarding
            the type and nature of the inspection;
              (C) a reasonable estimate of the timeframe for the
            inspection, an opportunity for advance communications
            between the officers or employees carrying out the
            inspection under subsection (a)(1) and the owner,
            operator, or agent in charge of the establishment
            concerning appropriate working hours during the
            inspection, and, to the extent feasible, advance notice
            of some records that will be requested; and
              (D) regular communications during the inspection with
            the owner, operator, or agent in charge of the
            establishment regarding inspection status, which may be
            recorded by either party with advance notice and mutual
            consent.
      (2)(A) The Secretary shall, with respect to a request
    described in subparagraph (B), provide nonbinding feedback with
    respect to such request not later than 45 days after the
    Secretary receives such request.
      (B) A request described in this subparagraph is a request for
    feedback--
              (i) that is made by the owner, operator, or agent in
            charge of such establishment in a timely manner; and
              (ii) with respect to actions proposed to be taken by
            a device establishment in a response to a report
            received by such establishment pursuant to subsection
            (b) that involve a public health priority, that
            implicate systemic or major actions, or relate to
            emerging safety issues (as determined by the
            Secretary).
      (3) Nothing in this subsection affects the authority of the
    Secretary to conduct inspections otherwise permitted under this
    Act in order to ensure compliance with this Act.

               *       *       *       *       *       *       *

    SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND PROFESSIONAL
                        PERSONNEL.

      (a) In General.--The Secretary may, notwithstanding title 5,
    United States Code, governing appointments in the competitive
    service, appoint outstanding and qualified candidates to
    scientific, technical, or professional positions that support
    the development, review, and regulation of [medical products]
    products regulated by the Food and Drug Administration. Such
    positions shall be within the competitive service.
      (b) Compensation.--
              (1) In general.--Notwithstanding any other provision
            of law, including any requirement with respect to
            General Schedule pay rates under subchapter III of
            chapter 53 of title 5, United States Code, and
            consistent with the requirements of paragraph (2), the
            Commissioner of Food and Drugs may determine and set--
                      (A) the annual rate of pay of any individual
                    appointed under subsection (a); and
                      (B) for purposes of retaining qualified
                    employees, the annual rate of pay for any
                    qualified scientific, technical, or
                    professional personnel appointed to a position
                    described in subsection (a) before the date of
                    enactment of the 21st Century Cures Act.
              (2) Limitation.--The annual rate of pay established
            pursuant to paragraph (1) may not exceed the amount of
            annual compensation (excluding expenses) specified in
            section 102 of title 3, United States Code.
              (3) Public availability.--The annual rate of pay
            provided to an individual in accordance with this
            section shall be publicly available information.
      (c) Rule of Construction.--The authorities under this section
    shall not be construed to affect the authority provided under
    section 714.
      [(d) Report on Workforce Planning.--
              [(1) In general.--Not later than 18 months after the
            date of enactment of the 21st Century Cures Act, the
            Secretary shall submit a report on workforce planning
            to the Committee on Health, Education, Labor, and
            Pensions of the Senate and the Committee on Energy and
            Commerce of the House of Representatives that examines
            the extent to which the Food and Drug Administration
            has a critical need for qualified individuals for
            scientific, technical, or professional positions,
            including--
                      [(A) an analysis of the workforce needs at
                    the Food and Drug Administration and the
                    Secretary's strategic plan for addressing such
                    needs, including through use of the authority
                    under this section; and
                      [(B) a recruitment and retention plan for
                    hiring qualified scientific, technical, and
                    professional candidates, which may include the
                    use of--
                              [(i) recruitment through
                            nongovernmental recruitment or
                            placement agencies;
                              [(ii) recruitment through academic
                            institutions;
                              [(iii) recruitment or hiring bonuses,
                            if applicable;
                              [(iv) recruitment using targeted
                            direct hiring authorities; and
                              [(v) retention of qualified
                            scientific, technical, and professional
                            employees using the authority under
                            this section, or other applicable
                            authorities of the Secretary.
              [(2) Recommendations.--The report under paragraph (1)
            may include the recommendations of the Commissioner of
            Food and Drugs that would help the Food and Drug
            Administration to better recruit and retain qualified
            individuals for scientific, technical, or professional
            positions at the agency.]
      (d) Agency-wide Strategic Workforce Plan.--
              (1) In general.--Not later than 1 year after the date
            of enactment of the Food and Drug Amendments of 2022,
            the Commissioner of Food and Drugs shall develop and
            begin implementation of an agency-wide strategic
            workforce plan at the Food and Drug Administration,
            which shall include--
                      (A) agency-wide human capital goals and
                    strategies;
                      (B) performance measures, benchmarks, or
                    other elements to facilitate the monitoring and
                    evaluation of the progress made toward such
                    goals and the effectiveness of such strategies;
                    and
                      (C) a process for updating such plan based on
                    timely and relevant information on an ongoing
                    basis.
              (2) Report to congress.--Not later than 18 months
            after the date of enactment of the Food and Drug
            Amendments of 2022, 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 describing
            the plan under paragraph (1) and the status of its
            implementation.

               *       *       *       *       *       *       *

    Subchapter C--Fees

               *       *       *       *       *       *       *

                         PART 2--FEES RELATING TO DRUGS

    SEC. 735. DEFINITIONS.

       For purposes of this part:
              (1) The term ``human drug application'' means an
            application for--
                      (A) approval of a new drug submitted under
                    section 505(b), or
                      (B) licensure of a biological product under
                    subsection (a) of section 351 of the Public
                    Health Service Act.
            Such term does not include a supplement to such an
            application, does not include an application with
            respect to whole blood or a blood component for
            transfusion, does not include an application with
            respect to a bovine blood product for topical
            application licensed before September 1, 1992, [an
            allergenic extract product, or] does not include an
            application with respect to an allergenic extract
            product licensed before October 1, 2022, does not
            include an application with respect to a standardized
            allergenic extract product submitted pursuant to a
            notification to the applicant from the Secretary
            regarding the existence of a potency test that measures
            the allergenic activity of an allergenic extract
            product licensed by the applicant before October 1,
            2022, does not include an application with respect to
            an in vitro diagnostic biologic product licensed under
            section 351 of the Public Health Service Act, does not
            include an application with respect to a large volume
            parenteral drug product approved before September 1,
            1992, does not include an application for a licensure
            of a biological product for further manufacturing use
            only, and does not include an application or supplement
            submitted by a State or Federal Government entity for a
            drug that is not distributed commercially. Such term
            does include an application for licensure, as described
            in subparagraph (B), of a large volume biological
            product intended for single dose injection for
            intravenous use or infusion.
              (2) The term ``supplement'' means a request to the
            Secretary to approve a change in a human drug
            application which has been approved.
              [(3) The term] (3)(A) The term  ``prescription drug
            product'' means a specific strength or potency of a
            drug in final dosage form--
                              [(A)] (i) for which a human drug
                            application has been approved,
                              [(B)] (ii) which may be dispensed
                            only under prescription pursuant to
                            section 503(b), and
                              [(C)] (iii) which is on the list of
                            products described in section
                            505(j)(7)(A) (not including the
                            discontinued section of such list) or
                            is on a list created and maintained by
                            the Secretary of products approved
                            under human drug applications under
                            section 351 of the Public Health
                            Service Act (not including the
                            discontinued section of such list).
             [Such term does not include whole blood]
              (B) Such term does not include whole blood  or a
            blood component for transfusion, does not include a
            bovine blood product for topical application licensed
            before September 1, 1992, [an allergenic extract
            product,] an allergenic extract product licensed before
            October 1, 2022, a standardized allergenic extract
            product submitted pursuant to a notification to the
            applicant from the Secretary regarding the existence of
            a potency test that measures the allergenic activity of
            an allergenic extract product licensed by the applicant
            before October 1, 2022, or an in vitro diagnostic
            biologic product licensed under section 351 of the
            Public Health Service Act. Such term does not include a
            biological product that is licensed for further
            manufacturing use only, and does not include a drug
            that is not distributed commercially and is the subject
            of an application or supplement submitted by a State or
            Federal Government entity. Such term does include a
            large volume biological product intended for single
            dose injection for intravenous use or infusion.
                      (C)(i) If a written request to place a
                    product in the discontinued section of either
                    of the lists referenced in subparagraph
                    (A)(iii) is submitted to the Secretary on
                    behalf of an applicant, and the request
                    identifies the date the product is withdrawn
                    from sale, then for purposes of assessing the
                    prescription drug program fee under section
                    736(a)(2), the Secretary shall consider such
                    product to have been included in the
                    discontinued section on the later of--
                              (I) the date such request was
                            received; or
                              (II) if the product will be withdrawn
                            from sale on a future date, such future
                            date when the product is withdrawn from
                            sale.
                      (ii) For purposes of this subparagraph, a
                    product shall be considered withdrawn from sale
                    once the applicant has ceased its own
                    distribution of the product, whether or not the
                    applicant has ordered recall of all previously
                    distributed lots of the product, except that a
                    routine, temporary interruption in supply shall
                    not render a product withdrawn from sale.
              (4) The term ``final dosage form'' means, with
            respect to a prescription drug product, a finished
            dosage form which is approved for administration to a
            patient without substantial further manufacturing (such
            as capsules, tablets, or lyophilized products before
            reconstitution).
              (5) The term ``prescription drug establishment''
            means a foreign or domestic place of business which is
            at one general physical location consisting of one or
            more buildings all of which are within five miles of
            each other and at which one or more prescription drug
            products are manufactured in final dosage form. For
            purposes of this paragraph, the term ``manufactured''
            does not include packaging.
              (6) The term ``process for the review of human drug
            applications'' means the following activities of the
            Secretary with respect to the review of human drug
            applications and supplements:
                      (A) The activities necessary for the review
                    of human drug applications and supplements.
                      (B) The issuance of action letters which
                    approve human drug applications or which set
                    forth in detail the specific deficiencies in
                    such applications and, where appropriate, the
                    actions necessary to place such applications in
                    condition for approval.
                      (C) The inspection of prescription drug
                    establishments and other facilities undertaken
                    as part of the Secretary's review of pending
                    human drug applications and supplements.
                      (D) Activities necessary for the review of
                    applications for licensure of establishments
                    subject to section 351 of the Public Health
                    Service Act and for the release of lots of
                    biologics under such section.
                      (E) Monitoring of research conducted in
                    connection with the review of human drug
                    applications.
                      (F) Postmarket safety activities with respect
                    to drugs approved under human drug applications
                    or supplements, including the following
                    activities:
                              (i) Collecting, developing, and
                            reviewing safety information on
                            approved drugs, including adverse event
                            reports.
                              (ii) Developing and using improved
                            adverse-event data-collection systems,
                            including information technology
                            systems.
                              (iii) Developing and using improved
                            analytical tools to assess potential
                            safety problems, including access to
                            external data bases.
                              (iv) Implementing and enforcing
                            section 505(o) (relating to
                            postapproval studies and clinical
                            trials and labeling changes) and
                            section 505(p) (relating to risk
                            evaluation and mitigation strategies).
                              (v) Carrying out section 505(k)(5)
                            (relating to adverse event reports and
                            postmarket safety activities).
              (7) The term ``costs of resources allocated for the
            process for the review of human drug applications''
            means the expenses in connection with the process for
            the review of human drug applications for--
                      (A) officers and employees of the Food and
                    Drug Administration, contractors of the Food
                    and Drug Administration, advisory committees,
                    and costs related to such officers, employees,
                    and committees and to contracts with such
                    contractors,
                      (B) management of information, and the
                    acquisition, maintenance, and repair of
                    computer resources,
                      (C) leasing, maintenance, renovation, and
                    repair of facilities and acquisition,
                    maintenance, and repair of fixtures, furniture,
                    scientific equipment, and other necessary
                    materials and supplies, and
                      (D) collecting fees under section 736 and
                    accounting for resources allocated for the
                    review of human drug applications and
                    supplements.
              (8) The term ``adjustment factor'' applicable to a
            fiscal year is the Consumer Price Index for all urban
            consumers (all items; United States city average) for
            October of the preceding fiscal year divided by such
            Index for October 1996.
              (9) The term ``person'' includes an affiliate
            thereof.
              (10) The term ``active'', with respect to a
            commercial investigational new drug application, means
            such an application to which information was submitted
            during the relevant period.
              (11) The term ``affiliate'' means a business entity
            that has a relationship with a second business entity
            if, directly or indirectly--
                      (A) one business entity controls, or has the
                    power to control, the other business entity; or
                      (B) a third party controls, or has power to
                    control, both of the business entities.
              (12) The term ``skin-test diagnostic product''--
                      (A) means a product--
                              (i) for prick, scratch, intradermal,
                            or subcutaneous administration;
                              (ii) expected to produce a limited,
                            local reaction at the site of
                            administration (if positive), rather
                            than a systemic effect;
                              (iii) not intended to be a preventive
                            or therapeutic intervention; and
                              (iv) intended to detect an immediate-
                            or delayed-type skin hypersensitivity
                            reaction to aid in the diagnosis of--
                                      (I) an allergy to an
                                    antimicrobial agent;
                                      (II) an allergy that is not
                                    to an antimicrobial agent, if
                                    the diagnostic product was
                                    authorized for marketing prior
                                    to October 1, 2022; or
                                      (III) infection with fungal
                                    or mycobacterial pathogens; and
                      (B) includes positive and negative controls
                    required to interpret the results of a product
                    described in subparagraph (A).

    SEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES.

      (a) Types of Fees.--Beginning in [fiscal year 2018] fiscal
    year 2023, the Secretary shall assess and collect fees in
    accordance with this section as follows:
              (1) Human drug application fee.--
                      (A) In general.--Each person that submits, on
                    or after September 1, 1992, a human drug
                    application shall be subject to a fee as
                    follows:
                              (i) A fee established under
                            subsection [(c)(5)] (c)(6) for a human
                            drug application for which clinical
                            data (other than bioavailability or
                            bioequivalence studies) with respect to
                            safety or effectiveness are required
                            for approval.
                              (ii) A fee established under
                            subsection [(c)(5)] (c)(6) 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. Such fee shall
                            be half of the amount of the fee
                            established under clause (i).
                      (B) Payment.--The fee required by
                    subparagraph (A) shall be due upon submission
                    of the application.
                      (C) Exception for previously filed
                    application.--If a human drug application was
                    submitted by a person that paid the fee for
                    such application, was accepted for filing, and
                    was not approved or was withdrawn prior to
                    approval (without a waiver), the submission of
                    a human drug application for the same product
                    by the same person (or the person's licensee,
                    assignee, or successor) shall not be subject to
                    a fee under subparagraph (A).
                      (D) Refund of fee if application refused for
                    filing or withdrawn before filing.--The
                    Secretary shall refund 75 percent of the fee
                    paid under subparagraph (B) for any application
                    which is refused for filing or withdrawn
                    without a waiver before filing.
                      (E) Fees for applications previously refused
                    for filing or withdrawn before filing.--A human
                    drug application that was submitted but was
                    refused for filing, or was withdrawn before
                    being accepted or refused for filing, shall be
                    subject to the full fee under subparagraph (A)
                    upon being resubmitted or filed over protest,
                    unless the fee is waived or reduced under
                    subsection (d).
                      (F) Exception for designated orphan drug.--A
                    human drug application for a prescription drug
                    product that has been designated as a drug for
                    a rare disease or condition pursuant to section
                    526 shall not be subject to a fee under
                    subparagraph (A), unless the human drug
                    application includes an indication for other
                    than a rare disease or condition.
                      (G) Refund of fee if application withdrawn.--
                    If an application is withdrawn after the
                    application was filed, the Secretary may refund
                    the fee or a portion of the fee if no
                    substantial work was performed on the
                    application after the application was filed.
                    The Secretary shall have the sole discretion to
                    refund a fee or a portion of the fee under this
                    subparagraph. A determination by the Secretary
                    concerning a refund under this paragraph shall
                    not be reviewable.
                      (H) Exception for skin-test diagnostic
                    products.--A human drug application for a skin-
                    test diagnostic product shall not be subject to
                    a fee under subparagraph (A).
              (2) Prescription drug program fee.--
                      (A) In general.--[Except as provided in
                    subparagraphs (B) and (C)]
                              (i) Fee._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)] subsection (c)(6)
                            for each prescription drug product that
                            is identified in such a human drug
                            application approved as of October 1 of
                            such fiscal year. Such fee shall be due
                            on the later of the first business day
                            on or after October 1 of each fiscal
                            year or the first business day after
                            the enactment of an appropriations Act
                            providing for the collection and
                            obligation of fees for such fiscal year
                            under this section. Such fee shall be
                            paid only once for each product for a
                            fiscal year in which the fee is
                            payable.
                              (ii) Special rule.--If a drug product
                            that is identified in a human drug
                            application approved as of October 1 of
                            a fiscal year is not a prescription
                            drug product as of that date because
                            the drug product is in the discontinued
                            section of a list referenced in section
                            735(3)(A)(iii), and on any subsequent
                            day during such fiscal year the drug
                            product is a prescription drug product,
                            then except as provided in
                            subparagraphs (B) and (C), each person
                            who is named as the applicant in a
                            human drug application with respect to
                            such product, and who, after September
                            1, 1992, had pending before the
                            Secretary a human drug application or
                            supplement with respect to such
                            product, shall pay the annual
                            prescription drug program fee
                            established for a fiscal year under
                            subsection (c)(6) for such prescription
                            drug product. Such fee shall be due on
                            the last business day of such fiscal
                            year and shall be paid only once for
                            each such product for a fiscal year in
                            which the fee is payable.
                      [(B) Exception for certain prescription drug
                    products.--A prescription drug program fee
                    shall not be assessed for a prescription drug
                    product under subparagraph (A) if such product
                    is--
                              [(i) identified on the list compiled
                            under section 505(j)(7) with a potency
                            described in terms of per 100 mL;
                              [(ii) the same product as another
                            product that--
                                      [(I) was approved under an
                                    application filed under section
                                    505(b) or 505(j); and
                                      [(II) is not in the list of
                                    discontinued products compiled
                                    under section 505(j)(7);
                              [(iii) the same product as another
                            product that was approved under an
                            abbreviated application filed under
                            section 507 (as in effect on the day
                            before the date of enactment of the
                            Food and Drug Administration
                            Modernization Act of 1997); or
                              [(iv) the same product as another
                            product that was approved under an
                            abbreviated new drug application
                            pursuant to regulations in effect prior
                            to the implementation of the Drug Price
                            Competition and Patent Term Restoration
                            Act of 1984.]
                      (B) Exception for certain prescription drug
                    products.--A prescription drug program fee
                    shall not be assessed for a prescription drug
                    product under subparagraph (A) if such product
                    is--
                              (i) a large volume parenteral product
                            (a sterile aqueous drug product
                            packaged in a single-dose container
                            with a volume greater than or equal to
                            100 mL, not including powders for
                            reconstitution or pharmacy bulk
                            packages) identified on the list
                            compiled under section 505(j)(7);
                              (ii) pharmaceutically equivalent (as
                            defined in section 314.3 of title 21,
                            Code of Federal Regulations (or any
                            successor regulation)) to another
                            product on the list of products
                            compiled under section 505(j)(7) (not
                            including the discontinued section of
                            such list); or
                              (iii) a skin-test diagnostic product.
                      (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.
      (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.]
              (1) In general.--For each of the fiscal years 2023
            through 2027, 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 strategic
                    hiring and retention adjustment for the fiscal
                    year (as determined under subsection (c)(2));
                      (D) the dollar amount equal to the capacity
                    planning adjustment for the fiscal year (as
                    determined under subsection (c)(3));
                      (E) the dollar amount equal to the operating
                    reserve adjustment for the fiscal year, if
                    applicable (as determined under subsection
                    (c)(4));
                      (F) the dollar amount equal to the additional
                    direct cost adjustment for the fiscal year (as
                    determined under subsection (c)(5)); and
                      (G) additional dollar amounts for each fiscal
                    year as follows:
                              (i) $65,773,693 for fiscal year 2023.
                              (ii) $25,097,671 for fiscal year
                            2024.
                              (iii) $14,154,169 for fiscal year
                            2025.
                              (iv) $4,864,860 for fiscal year 2026.
                              (v) $1,314,620 for fiscal year 2027.
              (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).]
              (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 2023, $1,151,522,958; and
                      (B) for fiscal years 2024 through 2027, 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)(4) or
                    (c)(5).
      (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]
                            Washington-Arlington-Alexandria, DC-VA-
                            MD-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) Strategic hiring and retention adjustment.--For
            each fiscal year, after the annual base revenue
            established in subsection (b)(1)(A) is adjusted for
            inflation in accordance with paragraph (1), the
            Secretary shall further increase the fee revenue and
            fees by the following amounts:
                      (A) For fiscal year 2023, $9,000,000.
                      (B) For each of fiscal years 2024 through
                    2027, $4,000,000.
              [ (2) Capacity planning adjustment.--
                      [(A) In general.--For each fiscal year, after
                    the annual base revenue established in
                    subsection (b)(1)(A) is adjusted for inflation
                    in accordance with paragraph (1), such revenue
                    shall be adjusted further for such fiscal year,
                    in accordance with this paragraph, to reflect
                    changes in the resource capacity needs of the
                    Secretary for the process for the review of
                    human drug applications.
                      [(B) Interim methodology.--
                              [(i) In general.--Until the capacity
                            planning methodology described in
                            subparagraph (C) is effective, the
                            adjustment under this paragraph for a
                            fiscal year shall be based on the
                            product of--
                                      [(I) the annual base revenue
                                    for such year, as adjusted for
                                    inflation under paragraph (1);
                                    and
                                      [(II) the adjustment
                                    percentage under clause (ii).
                              [(ii) Adjustment percentage.--The
                            adjustment percentage under this clause
                            for a fiscal year is the weighted
                            change in the 3-year average ending in
                            the most recent year for which data are
                            available, over the 3-year average
                            ending in the previous year, for--
                                      [(I) the total number of
                                    human drug applications,
                                    efficacy supplements, and
                                    manufacturing supplements
                                    submitted to the Secretary;
                                      [(II) the total number of
                                    active commercial
                                    investigational new drug
                                    applications; and
                                      [(III) the total number of
                                    formal meetings scheduled by
                                    the Secretary, and written
                                    responses issued by the
                                    Secretary in lieu of such
                                    formal meetings, as identified
                                    in section I.H of the letters
                                    described in section 101(b) of
                                    the Prescription Drug User Fee
                                    Amendments of 2017.
                      [(C) Capacity planning methodology.--
                              [(i) Development; evaluation and
                            report.--The Secretary shall obtain,
                            through a contract with an independent
                            accounting or consulting firm, a report
                            evaluating options and recommendations
                            for a new methodology to accurately
                            assess changes in the resource and
                            capacity needs of the process for the
                            review of human drug applications. The
                            capacity planning methodological
                            options and recommendations presented
                            in such report shall utilize and be
                            informed by personnel time reporting
                            data as an input. The report shall be
                            published for public comment no later
                            than the end of fiscal year 2020.
                              [(ii) Establishment and
                            implementation.--After review of the
                            report described in clause (i) and any
                            public comments thereon, the Secretary
                            shall establish a capacity planning
                            methodology for purposes of this
                            paragraph, which shall--
                                      [(I) replace the interim
                                    methodology under subparagraph
                                    (B);
                                      [(II) incorporate such
                                    approaches and attributes as
                                    the Secretary determines
                                    appropriate; and
                                      [(III) be effective beginning
                                    with the first fiscal year for
                                    which fees are set after such
                                    capacity planning methodology
                                    is established.
                      [(D) Limitation.--Under no circumstances
                    shall an adjustment under this paragraph result
                    in fee revenue for a fiscal year that is less
                    than the sum of the amounts under subsections
                    (b)(1)(A) (the annual base revenue for the
                    fiscal year) and (b)(1)(B) (the dollar amount
                    of the inflation adjustment for the fiscal
                    year).
                      [(E) Publication in federal register.--The
                    Secretary shall publish in the Federal Register
                    notice under paragraph (5) of the fee revenue
                    and fees resulting from the adjustment and the
                    methodologies under this paragraph.]
              (3) Capacity planning adjustment.--
                      (A) In general.--For each fiscal year, after
                    the annual base revenue established in
                    subsection (b)(1)(A) is adjusted in accordance
                    with paragraphs (1) and (2), 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) Methodology.--For purposes of this
                    paragraph, the Secretary shall employ the
                    capacity planning methodology utilized by the
                    Secretary in setting fees for fiscal year 2021,
                    as described in the notice titled
                    ``Prescription Drug User Fee Rates for Fiscal
                    Year 2021'' published in the Federal Register
                    on August 3, 2020 (85 Fed. Reg. 46651). The
                    workload categories used in applying such
                    methodology in forecasting shall include only
                    the activities described in that notice and, as
                    feasible, additional activities that are also
                    directly related to the direct review of
                    applications and supplements, including
                    additional formal meeting types, the direct
                    review of postmarketing commitments and
                    requirements, the direct review of risk
                    evaluation and mitigation strategies, and the
                    direct review of annual reports for approved
                    prescription drug products. Subject to the
                    exceptions in the preceding sentence, the
                    Secretary shall not include as workload
                    categories in applying such methodology in
                    forecasting any non-core review activities,
                    including those activities that the Secretary
                    referenced for potential future use in such
                    notice but did not utilize in setting fees for
                    fiscal year 2021.
                      (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)(1)(A) (the annual base revenue for the
                    fiscal year), (b)(1)(B) (the dollar amount of
                    the inflation adjustment for the fiscal year),
                    and (b)(1)(C) (the dollar amount of the
                    strategic hiring and retention adjustment for
                    the fiscal year).
                      (D) Publication in federal register.--The
                    Secretary shall publish in the Federal Register
                    notice under paragraph (6) of the fee revenue
                    and fees resulting from the adjustment and the
                    methodologies under this paragraph.
              [(3)] (4) Operating reserve adjustment.--
                      [(A) Increase.--For fiscal year 2018 and
                    subsequent fiscal years, the Secretary may, in
                    addition to adjustments under paragraphs (1)
                    and (2), further increase the fee revenue and
                    fees if such an adjustment is necessary to
                    provide for not more than 14 weeks of operating
                    reserves of carryover user fees for the process
                    for the review of human drug applications.]
                      (A) Increase.--For fiscal year 2023 and
                    subsequent fiscal years, the Secretary shall,
                    in addition to adjustments under paragraphs
                    (1), (2), and (3), further increase the fee
                    revenue and fees if such an adjustment is
                    necessary to provide for operating reserves of
                    carryover user fees for the process for the
                    review of human drug applications for each
                    fiscal year in at least the following amounts:
                              (i) For fiscal year 2023, at least 8
                            weeks of operating reserves.
                              (ii) For fiscal year 2024, at least 9
                            weeks of operating reserves.
                              (iii) For fiscal year 2025 and
                            subsequent fiscal years, at least 10
                            weeks of operating reserves.
                      (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)] paragraph
                    (6) 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) Additional direct cost adjustment.--
                      (A) Increase.--The Secretary shall, in
                    addition to adjustments under paragraphs (1),
                    (2), (3), and (4), further increase the fee
                    revenue and fees--
                              (i) for fiscal year 2023, by
                            $44,386,150; and
                              (ii) for each of fiscal years 2024
                            through 2027, by the amount set forth
                            in clauses (i) through (iv) of
                            subparagraph (B), as applicable,
                            multiplied by the Consumer Price Index
                            for urban consumers (Washington-
                            Arlington-Alexandria, DC-VA-MD-WV; Not
                            Seasonally Adjusted; All Items; Annual
                            Index) for the most recent year of
                            available data, divided by such Index
                            for 2021.
                      (B) Applicable amounts.--The amounts referred
                    to in subparagraph (A)(ii) are the following:
                              (i) For fiscal year 2024,
                            $60,967,993.
                              (ii) For fiscal year 2025,
                            $35,799,314.
                              (iii) For fiscal year 2026, $35,799,
                            314.
                              (iv) For fiscal year 2027,
                            $35,799,314.
              [(5)] (6) Annual fee setting.--The Secretary shall,
            not later than 60 days before the start of each fiscal
            year that begins after [September 30, 2017] September
            30, 2022--
                      (A) establish, for each such fiscal year,
                    human drug application fees and prescription
                    drug program fees under subsection (a), based
                    on the revenue amounts established under
                    subsection (b) and the adjustments provided
                    under this subsection; and
                      (B) publish such fee revenue and fees in the
                    Federal Register.
              [(6)] (7) 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.--
              (1) In general.--The Secretary shall grant to a
            person who is named as the applicant in a human drug
            application a waiver from or a reduction of one or more
            fees assessed to that person under subsection (a) where
            the Secretary finds that--
                      (A) such waiver or reduction is necessary to
                    protect the public health,
                      (B) the assessment of the fee would present a
                    significant barrier to innovation because of
                    limited resources available to such person or
                    other circumstances, or
                      (C) the applicant involved is a small
                    business submitting its first human drug
                    application to the Secretary for review.
              (2) Considerations.--In determining whether to grant
            a waiver or reduction of a fee under paragraph (1), the
            Secretary shall consider only the circumstances and
            assets of the applicant involved and any affiliate of
            the applicant.
              (3) Rules relating to small businesses.--
                      (A) Definition.--In paragraph (1)(C), the
                    term ``small business'' means an entity that
                    has fewer than 500 employees, including
                    employees of affiliates, and that does not have
                    a drug product that has been approved under a
                    human drug application and introduced or
                    delivered for introduction into interstate
                    commerce.
                      (B) Waiver of application fee.--The Secretary
                    shall waive under paragraph (1)(C) the
                    application fee for the first human drug
                    application that a small business or its
                    affiliate submits to the Secretary for review.
                    After a small business or its affiliate is
                    granted such a waiver, the small business or
                    its affiliate shall pay application fees for
                    all subsequent human drug applications
                    submitted to the Secretary for review in the
                    same manner as an entity that does not qualify
                    as a small business.
      (e) Effect of Failure To Pay Fees.--A human drug application
    or supplement submitted by a person subject to fees under
    subsection (a) shall be considered incomplete and shall not be
    accepted for filing by the Secretary until all such fees owed
    by such person have been paid.
      (f) Limitations.--
              (1) In general.--Fees under subsection (a) shall be
            refunded for a fiscal year beginning after fiscal year
            1997 unless appropriations for salaries and expenses of
            the Food and Drug Administration for such fiscal year
            (excluding the amount of fees appropriated for such
            fiscal year) are equal to or greater than the amount of
            appropriations for the salaries and expenses of the
            Food and Drug Administration for the fiscal year 1997
            (excluding the amount of fees appropriated for such
            fiscal year) multiplied by the adjustment factor
            applicable to the fiscal year involved.
              (2) Authority.--If the Secretary does not assess fees
            under subsection (a) during any portion of a fiscal
            year because of paragraph (1) and if at a later date in
            such fiscal year the Secretary may assess such fees,
            the Secretary may assess and collect such fees, without
            any modification in the rate, for human drug
            applications and prescription drug program fees at any
            time in such fiscal year notwithstanding the provisions
            of subsection (a) relating to the date fees are to be
            paid.
              (3) Limitation.--Beginning on October 1, 2023, the
            authorities under section 735(7)(C) shall include only
            expenditures for leasing and necessary scientific
            equipment.
      (g) Crediting and Availability of Fees.--
              (1) In general.--Subject to paragraph (2)(C), fees
            authorized under subsection (a) shall be collected and
            available for obligation only to the extent and in the
            amount provided in advance in appropriations Acts. Such
            fees are authorized to remain available until expended.
            Such sums as may be necessary may be transferred from
            the Food and Drug Administration salaries and expenses
            appropriation account without fiscal year limitation to
            such appropriation account for salaries and expenses
            with such fiscal year limitation. The sums transferred
            shall be available solely for the process for the
            review of human drug applications.
              (2) Collections and appropriation acts.--
                      (A) In general.--The fees authorized by this
                    section--
                              (i) subject to subparagraph (C),
                            shall be collected and available in
                            each fiscal year in an amount not to
                            exceed the amount specified in
                            appropriation Acts, or otherwise made
                            available for obligation, for such
                            fiscal year, and
                              (ii) shall be available to defray
                            increases in the costs of the resources
                            allocated for the process for the
                            review of human drug applications
                            (including increases in such costs for
                            an additional number of full-time
                            equivalent positions in the Department
                            of Health and Human Services to be
                            engaged in such process) over such
                            costs, excluding costs paid from fees
                            collected under this section, for
                            fiscal year 1997 multiplied by the
                            adjustment factor.
                      (B) Compliance.--The Secretary shall be
                    considered to have met the requirements of
                    subparagraph (A)(ii) in any fiscal year if the
                    costs funded by appropriations and allocated
                    for the process for the review of human drug
                    applications--
                              (i) are not more than 3 percent below
                            the level specified in subparagraph
                            (A)(ii); or
                              (ii)(I) are more than 3 percent below
                            the level specified in subparagraph
                            (A)(ii), and fees assessed for the
                            fiscal year following the subsequent
                            fiscal year are decreased by the amount
                            in excess of 3 percent by which such
                            costs fell below the level specified in
                            such subparagraph; and
                              (II) such costs are not more than 5
                            percent below the level specified in
                            such subparagraph.
                      (C) Provision for early payments.--Payment of
                    fees authorized under this section for a fiscal
                    year, prior to the due date for such fees, may
                    be accepted by the Secretary in accordance with
                    authority provided in advance in a prior year
                    appropriations Act.
              (3) Authorization of appropriations.--For each of the
            [fiscal years 2018 through 2022] fiscal years 2023
            through 2027, there is authorized to be appropriated
            for fees under this section an amount equal to the
            total revenue amount determined under subsection (b)
            for the fiscal year, as adjusted or otherwise affected
            under subsection (c).
      (h) Collection of Unpaid Fees.--In any case where the
    Secretary does not receive payment of a fee assessed under
    subsection (a) within 30 days after it is due, such fee shall
    be treated as a claim of the United States Government subject
    to subchapter II of chapter 37 of title 31, United States Code.
      [(i) Written Requests for Waivers, Reductions, and Refunds.--
    To qualify for consideration for a waiver or reduction under
    subsection (d), or for a refund of any fee collected in
    accordance with subsection (a), a person shall submit to the
    Secretary a written request for such waiver, reduction, or
    refund not later than 180 days after such fee is due.]
      (i) Written Requests for Waivers, Reductions, Exemptions, and
    Returns; Disputes Concerning Fees.--To qualify for
    consideration for a waiver or reduction under subsection (d),
    an exemption under subsection (k), or the return of any fee
    paid under this section, including if the fee is claimed to
    have been paid in error, a person shall--
              (1) not later than 180 days after such fee is due,
            submit to the Secretary a written request justifying
            such waiver, reduction, exemption, or return; and
              (2) include in the request any legal authorities
            under which the request is made.
      (j) Construction.--This section may not be construed to
    require that the number of full-time equivalent positions in
    the Department of Health and Human Services, for officers,
    employers, and advisory committees not engaged in the process
    of the review of human drug applications, be reduced to offset
    the number of officers, employees, and advisory committees so
    engaged.
      (k) Orphan Drugs.--
              (1) Exemption.--A drug designated under section 526
            for a rare disease or condition and approved under
            section 505 or under section 351 of the Public Health
            Service Act shall be exempt from prescription drug
            program fees under this section, if the drug meets all
            of the following conditions:
                      (A) The drug meets the public health
                    requirements contained in this Act as such
                    requirements are applied to requests for
                    waivers for prescription drug program fees.
                      (B) The drug is owned or licensed and is
                    marketed by a company that had less than
                    $50,000,000 in gross worldwide revenue [during
                    the previous year] as determined under
                    paragraph (2).
              [(2) Evidence of qualification.--An exemption under
            paragraph (1) applies with respect to a drug only if
            the applicant involved submits a certification that its
            gross annual revenues did not exceed $50,000,000 for
            the preceding 12 months before the exemption was
            requested.]
              (2) Evidence of qualification.--An exemption under
            paragraph (1) applies with respect to a drug only if
            the applicant involved submits a certification that the
            applicant's gross annual revenues did not exceed
            $50,000,000 for the last calendar year ending prior to
            the fiscal year for which the exemption is requested.
            Such certification shall be supported by--
                      (A) tax returns submitted to the United
                    States Internal Revenue Service; or
                      (B) as necessary, other appropriate financial
                    information.

               *       *       *       *       *       *       *

    SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS.

      (a) Performance Report.--
              (1) In general.--[Beginning with fiscal year 2018,
            not] Not later than 120 days after the end of each
            fiscal year for which fees are collected under this
            part, the Secretary shall prepare and 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 concerning--
                      (A) the progress of the Food and Drug
                    Administration in achieving the goals
                    identified in the letters described in section
                    101(b) of the [Prescription Drug User Fee
                    Amendments of 2017] Prescription Drug User Fee
                    Amendments of 2022 during such fiscal year and
                    the future plans of the Food and Drug
                    Administration for meeting the goals, including
                    the status of the independent assessment
                    described in such letters; and
                      (B) the progress of the Center for Drug
                    Evaluation and Research and the Center for
                    Biologics Evaluation and Research in achieving
                    the goals, and future plans for meeting the
                    goals, including, for each review division--
                              (i) the number of original standard
                            new drug applications and biologics
                            license applications filed per fiscal
                            year for each review division;
                              (ii) the number of original priority
                            new drug applications and biologics
                            license applications filed per fiscal
                            year for each review division;
                              (iii) the number of standard efficacy
                            supplements filed per fiscal year for
                            each review division;
                              (iv) the number of priority efficacy
                            supplements filed per fiscal year for
                            each review division;
                              (v) the number of applications filed
                            for review under accelerated approval
                            per fiscal year for each review
                            division;
                              (vi) the number of applications filed
                            for review as fast track products per
                            fiscal year for each review division;
                              (vii) the number of applications
                            filed for orphan-designated products
                            per fiscal year for each review
                            division; and
                              (viii) the number of breakthrough
                            designations for a fiscal year for each
                            review division.
              (2) Inclusion.--The report under this subsection for
            a fiscal year shall include information on all previous
            cohorts for which the Secretary has not given a
            complete response on all human drug applications and
            supplements in the cohort.
              (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] Not later than 30
                    calendar days after the end of each quarter of
                    each fiscal year for which fees are collected
                    under this part, the Secretary shall post the
                    data described in subparagraph (B) on the
                    internet website of the Food and Drug
                    Administration for such quarter and on a
                    cumulative basis for such fiscal year, and may
                    remove duplicative data from the annual
                    performance report under this subsection.
                      (B) Data.--The Secretary shall post the
                    following data in accordance with subparagraph
                    (A):
                              (i) The number and titles of draft
                            and final guidance on topics related to
                            the process for the review of human
                            drug applications, and whether such
                            guidances were issued as required by
                            statute or pursuant to a commitment
                            under the letters described in section
                            101(b) of the [Prescription Drug User
                            Fee Amendments of 2017] Prescription
                            Drug User Fee Amendments of 2022.
                              (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] Prescription Drug User Fee
                            Amendments of 2022.
                              (iii) The number of new drug
                            applications and biological licensing
                            applications approved.
                              (iv) The number of new drug
                            applications and biological licensing
                            applications filed.
                              (v) For fiscal years 2023 and 2024,
                            of the meeting requests from sponsors
                            for which the Secretary has determined
                            that a face-to-face meeting is
                            appropriate, the number of face-to-face
                            meetings requested by sponsors to be
                            conducted in person (in such manner as
                            the Secretary shall prescribe on the
                            internet website of the Food and Drug
                            Administration), and the number of such
                            in-person meetings granted by the
                            Secretary.
              (4) Rationale for pdufa program changes.--[Beginning
            with fiscal year 2020, the] 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] Prescription Drug
                    User Fee Amendments of 2022 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.
              (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] Prescription Drug
                            User Fee Amendments of 2022 for the
                            applicable fiscal year.
                      (B) Relevant data to determine whether the
                    Center for Drug Evaluation and Research and the
                    Center for Biologics Evaluation and Research
                    have met performance enhancement goals
                    identified in the letters described in section
                    101(b) of the [Prescription Drug User Fee
                    Amendments of 2017] Prescription Drug User Fee
                    Amendments of 2022 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] Prescription Drug User Fee
                    Amendments of 2022.
      (b) Fiscal Report.--[Beginning with fiscal year 2018, not]
    Not later than 120 days after the end of each fiscal year for
    which fees are collected under this part, the Secretary shall
    prepare and submit to the Committee on Energy and Commerce of
    the House of Representatives and the Committee on Health,
    Education, Labor, and Pensions of the Senate a report on the
    implementation of the authority for such fees during such
    fiscal year and the use, by the Food and Drug Administration,
    of the fees collected for such fiscal year.
      (c) Corrective Action Report.--[Beginning with fiscal year
    2018, for] For each fiscal year for which fees are collected
    under this part, the Secretary shall prepare and submit a
    corrective action report to the Committee on Energy and
    Commerce and the Committee on Appropriations of the House of
    Representatives and the Committee on Health, Education, Labor,
    and Pensions and the Committee on Appropriations of the Senate.
    The report shall include the following information, as
    applicable:
              (1) Goals met.--For each fiscal year, if the
            Secretary determines, based on the analysis under
            subsection (a)(5), that each of the goals identified in
            the letters described in section 101(b) of the
            [Prescription Drug User Fee Amendments of 2017]
            Prescription Drug User Fee Amendments of 2022 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]
            Prescription Drug User Fee Amendments of 2022 for the
            applicable fiscal year that the Secretary determines to
            not have been met, the corrective action report shall
            include--
                      (A) a detailed justification for such
                    determination and a description, as applicable,
                    of the types of circumstances and trends under
                    which human drug applications that missed the
                    review goal time were approved during the first
                    cycle review, or application review goals were
                    missed; and
                      (B) with respect to performance enhancement
                    goals that were not achieved, a description of
                    efforts the Food and Drug Administration has
                    put in place for the fiscal year in which the
                    report is submitted to improve the ability of
                    such agency to meet each such goal for the such
                    fiscal year.
      (d) Enhanced Communication.--
              (1) Communications with congress.--Each fiscal year,
            as applicable and requested, representatives from the
            Centers with expertise in the review of human drugs
            shall meet with representatives from the Committee on
            Health, Education, Labor, and Pensions of the Senate
            and the Committee on Energy and Commerce of the House
            of Representatives to report on the contents described
            in the reports under this section.
              (2) Participation in congressional hearing.--Each
            fiscal year, as applicable and requested,
            representatives from the Food and Drug Administration
            shall participate in a public hearing before the
            Committee on Health, Education, Labor, and Pensions of
            the Senate and the Committee on Energy and Commerce of
            the House of Representatives, to report on the contents
            described in the reports under this section. Such
            hearing shall occur not later than 120 days after the
            end of each fiscal year for which fees are collected
            under this part.
      (e) Public Availability.--The Secretary shall make the
    reports required under subsections (a) and (b) available to the
    public on the Internet Web site of the Food and Drug
    Administration.
      (f) Reauthorization.--
              (1) Consultation.--In developing recommendations to
            present to the Congress with respect to the goals, and
            plans for meeting the goals, for the process for the
            review of human drug applications for the first 5
            fiscal years after [fiscal year 2022] fiscal year 2027,
            and for the reauthorization of this part for such
            fiscal years, the Secretary shall consult with--
                      (A) the Committee on Energy and Commerce of
                    the House of Representatives;
                      (B) the Committee on Health, Education,
                    Labor, and Pensions of the Senate;
                      (C) scientific and academic experts;
                      (D) health care professionals;
                      (E) representatives of patient and consumer
                    advocacy groups; and
                      (F) the regulated industry.
              (2) Prior public input.--Prior to beginning
            negotiations with the regulated industry on the
            reauthorization of this part, the Secretary shall--
                      (A) publish a notice in the Federal Register
                    requesting public input on the reauthorization;
                      (B) hold a public meeting at which the public
                    may present its views on the reauthorization,
                    including specific suggestions for changes to
                    the goals referred to in subsection (a);
                      (C) provide a period of 30 days after the
                    public meeting to obtain written comments from
                    the public suggesting changes to this part; and
                      (D) publish the comments on the Food and Drug
                    Administration's Internet Web site.
              (3) Periodic consultation.--Not less frequently than
            once every month during negotiations with the regulated
            industry, the Secretary shall hold discussions with
            representatives of patient and consumer advocacy groups
            to continue discussions of their views on the
            reauthorization and their suggestions for changes to
            this part as expressed under paragraph (2).
              (4) Public review of recommendations.--After
            negotiations with the regulated industry, the Secretary
            shall--
                      (A) present the recommendations developed
                    under paragraph (1) to the Congressional
                    committees specified in such paragraph;
                      (B) publish such recommendations in the
                    Federal Register;
                      (C) provide for a period of 30 days for the
                    public to provide written comments on such
                    recommendations;
                      (D) hold a meeting at which the public may
                    present its views on such recommendations; and
                      (E) after consideration of such public views
                    and comments, revise such recommendations as
                    necessary.
              (5) Transmittal of recommendations.--Not later than
            [January 15, 2022] January 15, 2027, the Secretary
            shall transmit to the Congress the revised
            recommendations under paragraph (4), a summary of the
            views and comments received under such paragraph, and
            any changes made to the recommendations in response to
            such views and comments.
              (6) Minutes of negotiation meetings.--
                      (A) Public availability.--Before presenting
                    the recommendations developed under paragraphs
                    (1) through (5) to the Congress, the Secretary
                    shall make publicly available, on the public
                    Web site of the Food and Drug Administration,
                    minutes of all negotiation meetings conducted
                    under this subsection between the Food and Drug
                    Administration and the regulated industry.
                      (B) Content.--The minutes described under
                    subparagraph (A) shall summarize any
                    substantive proposal made by any party to the
                    negotiations as well as significant
                    controversies or differences of opinion during
                    the negotiations and their resolution.

               *       *       *       *       *       *       *

                        PART 3--FEES RELATING TO DEVICES

    SEC. 737. DEFINITIONS.

       For purposes of this part:
              (1) The term ``premarket application'' means--
                      (A) an application for approval of a device
                    submitted under section 515(c) or section 351
                    of the Public Health Service Act; or
                      (B) a product development protocol described
                    in section 515(f).
            Such term does not include a supplement, a premarket
            report, or a premarket notification submission.
              (2) The term ``premarket report'' means a report
            submitted under section 515(c)(2).
              (3) The term ``premarket notification submission''
            means a report submitted under section 510(k).
              (4)(A) The term ``supplement'', with respect to a
            panel-track supplement, a 180-day supplement, a real-
            time supplement, or an efficacy supplement, means a
            request to the Secretary to approve a change in a
            device for which--
                      (i) an application or report has been
                    approved under section 515(d), or an
                    application has been approved under section 351
                    of the Public Health Service Act; or
                      (ii) a notice of completion has become
                    effective under section 515(f).
              (B) The term ``panel-track supplement'' means a
            supplement to an approved premarket application or
            premarket report under section 515 that requests a
            significant change in design or performance of the
            device, or a new indication for use of the device, and
            for which substantial clinical data are necessary to
            provide a reasonable assurance of safety and
            effectiveness.
              (C) The term ``180-day supplement'' means a
            supplement to an approved premarket application or
            premarket report under section 515 that is not a panel-
            track supplement and requests a significant change in
            components, materials, design, specification, software,
            color additives, or labeling.
              (D) The term ``real-time supplement'' means a
            supplement to an approved premarket application or
            premarket report under section 515 that requests a
            minor change to the device, such as a minor change to
            the design of the device, software, sterilization, or
            labeling, and for which the applicant has requested and
            the agency has granted a meeting or similar forum to
            jointly review and determine the status of the
            supplement.
              (E) The term ``efficacy supplement'' means a
            supplement to an approved premarket application under
            section 351 of the Public Health Service Act that
            requires substantive clinical data.
              (5) The term ``30-day notice'' means a notice under
            section 515(d)(5) that is limited to a request to make
            modifications to manufacturing procedures or methods of
            manufacture affecting the safety and effectiveness of
            the device.
              (6) The term ``request for classification
            information'' means a request made under section 513(g)
            for information respecting the class in which a device
            has been classified or the requirements applicable to a
            device.
              (7) The term ``annual fee'', for periodic reporting
            concerning a class III device, means the annual fee
            associated with periodic reports required by a
            premarket application approval order.
              (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.
              (9) The term ``process for the review of device
            applications'' means the following activities of the
            Secretary with respect to the review of premarket
            applications, premarket reports, supplements, [and
            premarket notification submissions] premarket
            notification submissions, and de novo classification
            requests:
                      (A) The activities necessary for the review
                    of premarket applications, premarket reports,
                    supplements, and premarket notification
                    submissions.
                      (B) The issuance of action letters that allow
                    the marketing of devices or which set forth in
                    detail the specific deficiencies in such
                    applications, reports, supplements, or
                    submissions and, where appropriate, the actions
                    necessary to place them in condition for
                    approval.
                      (C) The inspection of manufacturing
                    establishments and other facilities undertaken
                    as part of the Secretary's review of pending
                    premarket applications, premarket reports, and
                    supplements.
                      (D) Monitoring of research conducted in
                    connection with the review of such
                    applications, reports, supplements, [and
                    submissions] submissions, and requests.
                      (E) Review of device applications subject to
                    section 351 of the Public Health Service Act
                    for an investigational new drug application
                    under section 505(i) or for an investigational
                    device exemption under section 520(g) and
                    activities conducted in anticipation of the
                    submission of such applications under section
                    505(i) or 520(g).
                      (F) The development of guidance, policy
                    documents, or regulations to improve the
                    process for the review of premarket
                    applications, premarket reports, supplements,
                    [and premarket notification submissions]
                    premarket notification submissions, and de novo
                    classification requests.
                      (G) The development of voluntary test
                    methods, consensus standards, or mandatory
                    performance standards under section 514 in
                    connection with the review of such
                    applications, reports, supplements, [or
                    submissions] submissions, or requests and
                    related activities.
                      (H) The provision of technical assistance to
                    device manufacturers in connection with the
                    submission of such applications, reports,
                    supplements, [or submissions] submissions, or
                    requests.
                      (I) Any activity undertaken under section 513
                    or 515(i) in connection with the initial
                    classification or reclassification of a device
                    or under section 515(b) in connection with any
                    requirement for approval of a device.
                      (J) Evaluation of postmarket studies required
                    as a condition of an approval of a premarket
                    application or premarket report under section
                    515 or a premarket application under section
                    351 of the Public Health Service Act.
                      (K) Compiling, developing, and reviewing
                    information on relevant devices to identify
                    safety and effectiveness issues for devices
                    subject to premarket applications, premarket
                    reports, supplements, [or premarket
                    notification submissions] premarket
                    notification submissions, or de novo
                    classification requests.
              (10) The term ``costs of resources allocated for the
            process for the review of device applications'' means
            the expenses in connection with the process for the
            review of device applications for--
                      (A) officers and employees of the Food and
                    Drug Administration, contractors of the Food
                    and Drug Administration, advisory committees,
                    and costs related to such officers, employees,
                    and committees and to contracts with such
                    contractors;
                      (B) management of information, and the
                    acquisition, maintenance, and repair of
                    computer resources;
                      (C) leasing, maintenance, renovation, and
                    repair of facilities and acquisition,
                    maintenance, and repair of fixtures, furniture,
                    scientific equipment, and other necessary
                    materials and supplies; and
                      (D) collecting fees and accounting for
                    resources allocated for the review of premarket
                    applications, premarket reports, supplements,
                    submissions, and de novo classification
                    requests.
              (11) The term ``adjustment factor'' applicable to a
            fiscal year is the Consumer Price Index for all urban
            consumers (all items; United States city average) for
            October of the preceding fiscal year divided by such
            Index for October [2016] 2021.
              (12) The term ``person'' includes an affiliate
            thereof.
              (13) The term ``affiliate'' means a business entity
            that has a relationship with a second business entity
            (whether domestic or international) if, directly or
            indirectly--
                      (A) one business entity controls, or has the
                    power to control, the other business entity; or
                      (B) a third party controls, or has power to
                    control, both of the business entities.
              (14) The term ``establishment subject to a
            registration fee'' means an establishment that is
            registered (or is required to register) with the
            Secretary under section 510 because such establishment
            is engaged in the manufacture, preparation,
            propagation, compounding, or processing of a device.

    SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES.

      (a) Types of Fees.--
              (1) In general.--Beginning in [fiscal year 2018]
            fiscal year 2023, the Secretary shall assess and
            collect fees in accordance with this section.
              (2) Premarket application, premarket report,
            supplement, and submission fee, and annual fee for
            periodic reporting concerning a class iii device.--
                      (A) In general.--Except as provided in
                    subparagraph (B) and subsections (d) and (e)
                    each person who submits any of the following,
                    on or after [October 1, 2017] October 1, 2022,
                    shall be subject to a fee established under
                    subsection (c) for the fiscal year involved in
                    accordance with the following:
                              (i) A premarket application.
                              (ii) For a premarket report, a fee
                            equal to the fee that applies under
                            clause (i).
                              (iii) For a panel track supplement, a
                            fee equal to [75 percent] 80 percent of
                            the fee that applies under clause (i).
                              (iv) For a 180-day supplement, a fee
                            equal to 15 percent of the fee that
                            applies under clause (i).
                              (v) For a real-time supplement, a fee
                            equal to 7 percent of the fee that
                            applies under clause (i).
                              (vi) For a 30-day notice, a fee equal
                            to 1.6 percent of the fee that applies
                            under clause (i).
                              (vii) For an efficacy supplement, a
                            fee equal to the fee that applies under
                            clause (i).
                              (viii) For a premarket notification
                            submission, a fee equal to [3.4
                            percent] 4.5 percent of the fee that
                            applies under clause (i).
                              (ix) For a request for classification
                            information, a fee equal to 1.35
                            percent of the fee that applies under
                            clause (i).
                              (x) For periodic reporting concerning
                            a class III device, an annual fee equal
                            to 3.5 percent of the fee that applies
                            under clause (i).
                              (xi) For a de novo classification
                            request, a fee equal to 30 percent of
                            the fee that applies under clause (i).
                      (B) Exceptions.--
                              (i) Humanitarian device exemption.--
                            An application under section 520(m) is
                            not subject to any fee under
                            subparagraph (A).
                              (ii) Further manufacturing use.--No
                            fee shall be required under
                            subparagraph (A) for the submission of
                            a premarket application under section
                            351 of the Public Health Service Act
                            for a product licensed for further
                            manufacturing use only.
                              (iii) State or federal government
                            sponsors.--No fee shall be required
                            under subparagraph (A) for a premarket
                            application, premarket report,
                            supplement, [or premarket notification
                            submission] premarket notification
                            submission, or de novo classification
                            request submitted by a State or Federal
                            Government entity unless the device
                            involved is to be distributed
                            commercially.
                              (iv) Premarket notifications by third
                            parties.--No fee shall be required
                            under subparagraph (A) for a premarket
                            notification submission reviewed by an
                            accredited person pursuant to section
                            523.
                              (v) Pediatric conditions of use.--
                                      (I) In general.--No fee shall
                                    be required under subparagraph
                                    (A) for a premarket
                                    application, premarket report,
                                    premarket notification
                                    submission, or de novo
                                    classification request if the
                                    proposed conditions of use for
                                    the device involved are solely
                                    for a pediatric population. No
                                    fee shall be required under
                                    such subparagraph for a
                                    supplement if the sole purpose
                                    of the supplement is to propose
                                    conditions of use for a
                                    pediatric population.
                                      (II) Subsequent proposal of
                                    adult conditions of use.--In
                                    the case of a person who
                                    submits a premarket application
                                    or premarket report for which,
                                    under subclause (I), a fee
                                    under subparagraph (A) is not
                                    required, any supplement to
                                    such application that proposes
                                    conditions of use for any adult
                                    population is subject to the
                                    fee that applies under such
                                    subparagraph for a premarket
                                    application.
                      (C) Payment.--The fee required by
                    subparagraph (A) shall be due upon submission
                    of the premarket application, premarket report,
                    supplement, premarket notification submission,
                    30-day notice, request for classification
                    information, [or periodic reporting concerning
                    a class III device] periodic reporting
                    concerning a class III device, or de novo
                    classification request. Applicants submitting
                    portions of applications pursuant to section
                    515(c)(4) shall pay such fees upon submission
                    of the first portion of such applications.
                      (D) Refunds.--
                              (i) Application refused for filing.--
                            The Secretary shall refund 75 percent
                            of the fee paid under subparagraph (A)
                            for any application, report, or
                            supplement that is refused for filing.
                              (ii) Application withdrawn before
                            filing.--The Secretary shall refund 75
                            percent of the fee paid under
                            subparagraph (A) for any application,
                            report, or supplement that is withdrawn
                            prior to the filing decision of the
                            Secretary.
                              (iii) Application withdrawn before
                            first action.--After receipt of a
                            request for a refund of the fee paid
                            under subparagraph (A) for a premarket
                            application, premarket report, or
                            supplement that is withdrawn after
                            filing but before a first action, the
                            Secretary may return some or all of the
                            fee. The amount of refund, if any,
                            shall be based on the level of effort
                            already expended on the review of such
                            application, report, or supplement.
                              (iv) Modular applications withdrawn
                            before first action.--The Secretary
                            shall refund 75 percent of the
                            application fee paid for an application
                            submitted under section 515(c)(4) that
                            is withdrawn before a second portion is
                            submitted and before a first action on
                            the first portion.
                              (v) Later withdrawn modular
                            applications.--If an application
                            submitted under section 515(c)(4) is
                            withdrawn after a second or subsequent
                            portion is submitted but before any
                            first action, the Secretary may return
                            a portion of the fee. The amount of
                            refund, if any, shall be based on the
                            level of effort already expended on the
                            review of the portions submitted.
                              (vi) Sole discretion to refund.--The
                            Secretary shall have sole discretion to
                            refund a fee or portion of the fee
                            under clause (iii) or (v). A
                            determination by the Secretary
                            concerning a refund under clause (iii)
                            or (v) shall not be reviewable.
              (3) Annual establishment registration fee.--
                      (A) In general.--Except as provided in
                    subparagraph (B), each establishment subject to
                    a registration fee shall be subject to a fee
                    for each initial or annual registration under
                    section 510 beginning with its registration for
                    fiscal year 2008.
                      (B) Exception.--No fee shall be required
                    under subparagraph (A) for an establishment
                    operated by a State or Federal governmental
                    entity or an Indian tribe (as defined in the
                    Indian Self Determination and Educational
                    Assistance Act), unless a device manufactured
                    by the establishment is to be distributed
                    commercially.
                      (C) Payment.--The fee required under
                    subparagraph (A) shall be due once each fiscal
                    year, upon the later of--
                              (i) the initial or annual
                            registration (as applicable) of the
                            establishment under section 510; 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 year under
                            this section.
      (b) Fee Amounts.--
              (1) In general.--Subject to subsections (c), (d),
            (e), and (h), for each of fiscal years [2018 through
            2022] 2023 through 2027, 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]
    ----------------------------------------------------------------------------------------------------------------

              (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 2023  Year 2024  Year 2025  Year 2026  Year 2027
    ----------------------------------------------------------------------------------------------------------------
    Premarket Application....................................   $425,000   $435,000   $445,000   $455,000   $470,000
    Establishment Registration...............................     $6,250     $6,875     $7,100     $7,575     $8,465
    ----------------------------------------------------------------------------------------------------------------

              [(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.]
              (3) Total revenue amounts specified.--For purposes of
            paragraph (1), the total revenue amounts specified in
            this paragraph are as follows:
                      (A) $312,606,000 for fiscal year 2023.
                      (B) $335,750,000 for fiscal year 2024.
                      (C) $350,746,400 for fiscal year 2025.
                      (D) $366,486,300 for fiscal year 2026.
                      (E) $418,343,000 for fiscal year 2027.
      (c) Annual Fee Setting; Adjustments.--
              (1) In general.--The Secretary shall, 60 days before
            the start of each fiscal year after September 30,
            [2017] 2022, establish fees under subsection (a), based
            on amounts specified under subsection (b) and the
            adjustments provided under this subsection, and publish
            such fees, and the rationale for any adjustments to
            such fees, in the Federal Register.
              (2) Inflation adjustments.--
                      (A) Adjustment to total revenue amounts.--For
                    fiscal year [2018] 2023 and each subsequent
                    fiscal year, the Secretary shall adjust the
                    total revenue amount specified in subsection
                    (b)(3) for such fiscal year by multiplying such
                    amount by the applicable inflation adjustment
                    under subparagraph (B) for such year.
                      (B) Applicable inflation adjustment.--The
                    applicable inflation adjustment for [fiscal
                    year 2018] fiscal year 2023 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] fiscal year
                            2022.
                      (C) Base inflation adjustment.--
                              (i) In general.--Subject to further
                            adjustment under clause (ii), the base
                            inflation adjustment for a fiscal year
                            is the sum of one plus--
                                      (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 0.60; and
                                      (II) the average annual
                                    percent change that occurred in
                                    the Consumer Price Index for
                                    urban consumers ([Washington-
                                    Baltimore, DC-MD-VA-WV]
                                    Washington-Arlington-
                                    Alexandria, DC-VA-MD-WV; Not
                                    Seasonally Adjusted; All items;
                                    Annual Index) for the first 3
                                    years of the preceding 4 years
                                    of available data multiplied by
                                    0.40.
                              (ii) Limitations.--For purposes of
                            subparagraph (B), if the base inflation
                            adjustment for a fiscal year under
                            clause (i)--
                                      (I) is less than 1, such
                                    adjustment shall be considered
                                    to be equal to 1; or
                                      (II) is greater than 1.04,
                                    such adjustment shall be
                                    considered to be equal to 1.04.
                      (D) Adjustment to base fee amounts.--For each
                    of [fiscal years 2018 through 2022] fiscal
                    years 2023 through 2027, the Secretary shall--
                              (i) adjust the base fee amounts
                            specified in subsection (b)(2) for such
                            fiscal year by multiplying such amounts
                            by the applicable inflation adjustment
                            under subparagraph (B) for such year;
                            and
                              (ii) if the Secretary determines
                            necessary, increase (in addition to the
                            adjustment under clause (i)) such base
                            fee amounts, on a uniform proportionate
                            basis, to generate the total revenue
                            amounts under subsection (b)(3), as
                            adjusted for inflation under
                            subparagraph (A).
              (3) Volume-based adjustments to establishment
            registration base fees.--For each of fiscal years [2018
            through 2022] 2023 through 2027, after the base fee
            amounts specified in subsection (b)(2) are adjusted
            under paragraph (2)(D), the base establishment
            registration fee amounts specified in such subsection
            shall be increased, as the Secretary estimates is
            necessary in order for total fee collections for such
            fiscal year to generate the total revenue amounts, as
            adjusted under paragraph (2).
              (4) Performance improvement adjustment.--
                      (A) In general.--For each of fiscal years
                    2025 through 2027, after the adjustments under
                    paragraphs (2) and (3), the base establishment
                    registration fee amounts for such fiscal year
                    shall be increased to reflect changes in the
                    resource needs of the Secretary due to improved
                    review performance goals for the process for
                    the review of device applications identified in
                    the letters described in section 201(b) of the
                    Medical Device User Fee Amendments of 2022, as
                    the Secretary determines necessary to achieve
                    an increase in total fee collections for such
                    fiscal year equal to the following amounts:
                              (i) For fiscal year 2025, the product
                            of--
                                      (I) the amount determined
                                    under subparagraph (B)(i)(I);
                                    and
                                      (II) the applicable inflation
                                    adjustment under paragraph
                                    (2)(B) for such fiscal year.
                              (ii) For fiscal year 2026, the
                            product of--
                                      (I) the sum of the amounts
                                    determined under subparagraphs
                                    (B)(i)(II), (B)(ii)(I), and
                                    (B)(iii)(I); and
                                      (II) the applicable inflation
                                    adjustment under paragraph
                                    (2)(B) for such fiscal year.
                              (iii) For fiscal year 2027, the
                            product of--
                                      (I) the sum of the amounts
                                    determined under subparagraphs
                                    (B)(i)(III), (B)(ii)(II), and
                                    (B)(iii)(II); and
                                      (II) the applicable inflation
                                    adjustment under paragraph
                                    (2)(B) for such fiscal year.
                      (B) Amounts.--
                              (i) Pre-submission amount.--For
                            purposes of subparagraph (A), with
                            respect to the pre-submission written
                            feedback goal, the amounts determined
                            under this subparagraph are as follows:
                                      (I) For fiscal year 2025,
                                    $15,396,600 if such goal for
                                    fiscal year 2023 is met.
                                      (II) For fiscal year 2026:
                                              (aa) $15,396,600 if
                                            such goal for fiscal
                                            year 2023 is met and
                                            such goal for fiscal
                                            year 2024 is not met.
                                              (bb) $36,792,200 if
                                            such goal for fiscal
                                            year 2024 is met.
                                      (III) For fiscal year 2027:
                                              (aa) $15,396,600 if
                                            such goal for fiscal
                                            year 2023 is met and
                                            such goal for each of
                                            fiscal years 2024 and
                                            2025 is not met.
                                              (bb) $36,792,200 if
                                            such goal for fiscal
                                            year 2024 is met and
                                            such goal for fiscal
                                            year 2025 is not met.
                                              (cc) $40,572,600 if
                                            such goal for fiscal
                                            year 2025 is met.
                              (ii) De novo classification amount.--
                            For purposes of subparagraph (A), with
                            respect to the de novo decision goal,
                            the amounts determined under this
                            subparagraph are as follows:
                                      (I) For fiscal year 2026,
                                    $6,323,500 if such goal for
                                    fiscal year 2023 is met.
                                      (II) For fiscal year 2027:
                                              (aa) $6,323,500 if
                                            such goal for fiscal
                                            year 2023 is met and
                                            such goal for fiscal
                                            year 2024 is not met.
                                              (bb) $11,765,400 if
                                            such goal for fiscal
                                            year 2024 is met.
                              (iii) Premarket notification and
                            premarket approval amount.--For
                            purposes of subparagraph (A), with
                            respect to the 510(k) decision goal,
                            510(k) shared outcome total time to
                            decision goal, PMA decision goal, and
                            PMA shared outcome total time to
                            decision goal, the amounts determined
                            under this subparagraph are as follows:
                                      (I) For fiscal year 2026,
                                    $1,020,000 if the four goals
                                    for fiscal year 2023 are met.
                                      (II) For fiscal year 2027:
                                              (aa) $1,020,000 if
                                            the four goals for
                                            fiscal year 2023 are
                                            met and one or more of
                                            the four goals for
                                            fiscal year 2024 are
                                            not met.
                                              (bb) $3,906,000 if
                                            the four goals for
                                            fiscal year 2024 are
                                            met.
                      (C) Performance calculation.--For purposes of
                    this paragraph, performance of the goals listed
                    in subparagraph (D) shall be determined as
                    specified in the letters described in section
                    201(b) of the Medical Device User Fee
                    Amendments of 2022 and based on data available
                    as of the following dates:
                              (i) The performance of the pre-
                            submission written feedback goal shall
                            be based on data available as of--
                                      (I) for fiscal year 2023,
                                    March 31, 2024;
                                      (II) for fiscal year 2024,
                                    March 31, 2025; and
                                      (III) for fiscal year 2025,
                                    March 31, 2026.
                              (ii) The performance of the de novo
                            decision goal, 510(k) decision goal,
                            510(k) shared outcome total time to
                            decision goal, PMA decision goal, and
                            PMA shared outcome total time to
                            decision goal shall be based on data
                            available as of--
                                      (I) for fiscal year 2023,
                                    March 31, 2025; and
                                      (II) for fiscal year 2024,
                                    March 31, 2026.
                      (D) Goals defined.--For purposes of this
                    paragraph, the terms ``pre-submission written
                    feedback goal'', ``de novo decision goal'',
                    ``510(k) decision goal'', ``510(k) shared
                    outcome total time to decision goal'', ``PMA
                    decision goal'', and ``PMA shared outcome total
                    time to decision goal'' refer to the goals
                    identified by the same names in the letters
                    described in section 201(b) of the Medical
                    Device User Fee Amendments of 2022.
              (5) Hiring adjustment.--
                      (A) In general.--For each of fiscal years
                    2025 through 2027, after the adjustments under
                    paragraphs (2), (3), and (4), if applicable, if
                    the number of hires to support the process for
                    the review of device applications falls below
                    the thresholds specified in subparagraph (B)
                    for the applicable fiscal years, the base
                    establishment registration fee amounts shall be
                    decreased as the Secretary determines necessary
                    to achieve a reduction in total fee collections
                    equal to the hiring adjustment amount under
                    subparagraph (C).
                      (B) Thresholds.--The thresholds specified in
                    this subparagraph are as follows:
                              (i) For fiscal year 2025, the
                            threshold is 123 hires for fiscal year
                            2023.
                              (ii) For fiscal year 2026, the
                            threshold is 38 hires for fiscal year
                            2024.
                              (iii) For fiscal year 2027, the
                            threshold is--
                                      (I) 22 hires for fiscal year
                                    2025 if the base establishment
                                    registration fees are not
                                    increased by the amount
                                    determined under paragraph
                                    (4)(A)(i); or
                                      (II) 75 hires for fiscal year
                                    2025 if such fees are so
                                    increased.
                      (C) Hiring adjustment amount.--The hiring
                    adjustment amount for fiscal year 2025 and each
                    subsequent fiscal year is the product of--
                              (i) the number of hires by which the
                            hiring goal specified in subparagraph
                            (D) for the fiscal year before the
                            prior fiscal year was not met;
                              (ii) $72,877; and
                              (iii) the applicable inflation
                            adjustment under paragraph (2)(B) for
                            the fiscal year for which the hiring
                            goal was not met.
                      (D) Hiring goals.--The hiring goals for each
                    of fiscal years 2023 through 2025 are as
                    follows:
                              (i) For fiscal year 2023, 144 hires.
                              (ii) For fiscal year 2024, 42 hires.
                              (iii) For fiscal year 2025:
                                      (I) 24 hires if the base
                                    establishment registration fees
                                    are not increased by the amount
                                    determined under paragraph
                                    (4)(A)(i).
                                      (II) 83 hires if the base
                                    establishment registration fees
                                    are increased by the amount
                                    determined under paragraph
                                    (4)(A)(i).
                      (E) Number of hires.--For purposes of this
                    paragraph, the number of hires shall be
                    determined by the Secretary as set forth in the
                    letters described in section 201(b) of the
                    Medical Device User Fee Amendments of 2022.
              (6) Operating reserve adjustment.--
                      (A) In general.--For each of fiscal years
                    2023 through 2027, after the adjustments under
                    paragraphs (2), (3), (4), and (5), if
                    applicable, if the Secretary has operating
                    reserves of carryover user fees for the process
                    for the review of device applications in excess
                    of the designated amount in subparagraph (B),
                    the Secretary shall decrease the base
                    establishment registration fee amounts to
                    provide for not more than such designated
                    amount of operating reserves.
                      (B) Designated amount.--Subject to
                    subparagraph (C), for each fiscal year, the
                    designated amount in this subparagraph is equal
                    to the sum of--
                              (i) 13 weeks of operating reserves of
                            carryover user fees; and
                              (ii) 1 month of operating reserves
                            maintained pursuant to paragraph (8).
                      (C) Excluded amount.--For the period of
                    fiscal years 2023 through 2026, a total amount
                    equal to $118,000,000 shall not be considered
                    part of the designated amount under
                    subparagraph (B) and shall not be subject to
                    the decrease under subparagraph (A).
              [(4)] (7) 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 device applications.
              [(5)] (8) Supplement.--
                      (A) In general.--The Secretary may use
                    unobligated carryover balances from fees
                    collected in previous fiscal years to ensure
                    that sufficient fee revenues are available in
                    that fiscal year, so long as the Secretary
                    maintains unobligated carryover balances of not
                    less than 1 month of operating reserves for the
                    first month of the next fiscal year.
                      (B) Notice to congress.--Not later than 14
                    days before the Secretary anticipates the use
                    of funds described in subparagraph (A), the
                    Secretary shall provide notice to the Committee
                    on Health, Education, Labor, and Pensions and
                    the Committee on Appropriations of the Senate
                    and the Committee on Energy and Commerce and
                    the Committee on Appropriations of the House of
                    Representatives.
      (d) Small Businesses; Fee Waiver and Fee Reduction Regarding
    Premarket Approval Fees.--
              (1) In general.--The Secretary shall grant a waiver
            of the fee required under subsection (a) for one
            premarket application, or one premarket report, where
            the Secretary finds that the applicant involved is a
            small business submitting its first premarket
            application to the Secretary, or its first premarket
            report, respectively, for review. For the purposes of
            this paragraph, the term ``small business'' means an
            entity that reported $30,000,000 or less of gross
            receipts or sales in its most recent Federal income tax
            return for a taxable year, including such returns of
            all of its affiliates. In addition, for subsequent
            premarket applications, premarket reports, and
            supplements where the Secretary finds that the
            applicant involved is a small business, the fees
            specified in clauses (i) through (vii) and clauses
            (ix), (x), and (xi) of subsection (a)(2)(A) may be paid
            at a reduced rate in accordance with paragraph (2)(C).
              (2) Rules relating to premarket approval fees.--
                      (A) Definition.--For purposes of this
                    paragraph, the term ``small business'' means an
                    entity that reported $100,000,000 or less of
                    gross receipts or sales in its most recent
                    Federal income tax return for a taxable year,
                    including such returns of all of its
                    affiliates.
                      (B) Evidence of qualification.--
                              (i) In general.--An applicant shall
                            pay the higher fees established by the
                            Secretary each year unless the
                            applicant submits evidence that it
                            qualifies for a waiver of the fee or
                            the lower fee rate.
                              (ii) Firms submitting tax returns to
                            the united states internal revenue
                            service.--The applicant shall support
                            its claim that it meets the definition
                            under subparagraph (A) by submission of
                            a copy of its most recent Federal
                            income tax return for a taxable year,
                            and a copy of such returns of its
                            affiliates, which show an amount of
                            gross sales or receipts that is less
                            than the maximum established in
                            subparagraph (A). The applicant, and
                            each of such affiliates, shall certify
                            that the information provided is a true
                            and accurate copy of the actual tax
                            forms they submitted to the Internal
                            Revenue Service. If no tax forms are
                            submitted for any affiliate, the
                            applicant shall certify that the
                            applicant has no affiliates.
                              (iii) Firms not submitting tax
                            returns to the united states internal
                            revenue service.--In the case of an
                            applicant that has not previously
                            submitted a Federal income tax return,
                            the applicant and each of its
                            affiliates shall demonstrate that it
                            meets the definition under subparagraph
                            (A) by submission of a signed
                            certification, in such form as the
                            Secretary may direct through a notice
                            published in the Federal Register, that
                            the applicant or affiliate meets the
                            criteria for a small business and a
                            certification, in English, from the
                            national taxing authority, if extant,
                            of the country in which the applicant
                            or, if applicable, affiliate is
                            headquartered. The certification from
                            such taxing authority shall bear the
                            official seal of such taxing authority
                            and shall provide the applicant's or
                            affiliate's gross receipts or sales for
                            the most recent year in both the local
                            currency of such country and in United
                            States dollars, the exchange rate used
                            in converting such local currency to
                            dollars, and the dates during which
                            these receipts or sales were collected.
                            The applicant shall also submit a
                            statement signed by the head of the
                            applicant's firm or by its chief
                            financial officer that the applicant
                            has submitted certifications for all of
                            its affiliates, or that the applicant
                            has no affiliates.
                      (C) Reduced fees.--Where the Secretary finds
                    that the applicant involved meets the
                    definition under subparagraph (A), the fees
                    established under subsection (c)(1) may be paid
                    at a reduced rate of--
                              (i) 25 percent of the fee established
                            under such subsection for a premarket
                            application, a premarket report, a
                            supplement, periodic reporting
                            concerning a class III device, or a de
                            novo classification request; and
                              (ii) 50 percent of the fee
                            established under such subsection for a
                            30-day notice or a request for
                            classification information.
                      (D) Request for fee waiver or reduction.--An
                    applicant seeking a fee waiver or reduction
                    under this subsection shall submit supporting
                    information to the Secretary at least 60 days
                    before the fee is required pursuant to
                    subsection (a). The decision of the Secretary
                    regarding whether an entity qualifies for such
                    a waiver or reduction is not reviewable.
      (e) Small Businesses; Fee Reduction Regarding Premarket
    Notification Submissions.--
              (1) In general.--For fiscal year 2008 and each
            subsequent fiscal year, where the Secretary finds that
            the applicant involved is a small business, the fee
            specified in subsection (a)(2)(A)(viii) may be paid at
            a reduced rate in accordance with paragraph (2)(C).
              (2) Rules relating to premarket notification
            submissions.--
                      (A) Definition.--For purposes of this
                    subsection, the term ``small business'' means
                    an entity that reported $100,000,000 or less of
                    gross receipts or sales in its most recent
                    Federal income tax return for a taxable year,
                    including such returns of all of its
                    affiliates.
                      (B) Evidence of qualification.--
                              (i) In general.--An applicant shall
                            pay the higher fees established by the
                            Secretary each year unless the
                            applicant submits evidence that it
                            qualifies for the lower fee rate.
                              (ii) Firms submitting tax returns to
                            the united states internal revenue
                            service.--The applicant shall support
                            its claim that it meets the definition
                            under subparagraph (A) by submission of
                            a copy of its most recent Federal
                            income tax return for a taxable year,
                            and a copy of such returns of its
                            affiliates, which show an amount of
                            gross sales or receipts that is less
                            than the maximum established in
                            subparagraph (A). The applicant, and
                            each of such affiliates, shall certify
                            that the information provided is a true
                            and accurate copy of the actual tax
                            forms they submitted to the Internal
                            Revenue Service. If no tax forms are
                            submitted for any affiliate, the
                            applicant shall certify that the
                            applicant has no affiliates.
                              (iii) Firms not submitting tax
                            returns to the united states internal
                            revenue service.--In the case of an
                            applicant that has not previously
                            submitted a Federal income tax return,
                            the applicant and each of its
                            affiliates shall demonstrate that it
                            meets the definition under subparagraph
                            (A) by submission of a signed
                            certification, in such form as the
                            Secretary may direct through a notice
                            published in the Federal Register, that
                            the applicant or affiliate meets the
                            criteria for a small business and a
                            certification, in English, from the
                            national taxing authority, if extant,
                            of the country in which the applicant
                            or, if applicable, affiliate is
                            headquartered. The certification from
                            such taxing authority shall bear the
                            official seal of such taxing authority
                            and shall provide the applicant's or
                            affiliate's gross receipts or sales for
                            the most recent year in both the local
                            currency of such country and in United
                            States dollars, the exchange rate used
                            in converting such local currency to
                            dollars, and the dates during which
                            these receipts or sales were collected.
                            The applicant shall also submit a
                            statement signed by the head of the
                            applicant's firm or by its chief
                            financial officer that the applicant
                            has submitted certifications for all of
                            its affiliates, or that the applicant
                            has no affiliates.
                      (C) Reduced fees.--For fiscal year 2008 and
                    each subsequent fiscal year, where the
                    Secretary finds that the applicant involved
                    meets the definition under subparagraph (A),
                    the fee for a premarket notification submission
                    may be paid at 25 percent of the fee that
                    applies under subsection (a)(2)(A)(viii), and
                    as established under subsection (c)(1).
                      (D) Request for reduction.--An applicant
                    seeking a fee reduction under this subsection
                    shall submit supporting information to the
                    Secretary at least 60 days before the fee is
                    required pursuant to subsection (a). The
                    decision of the Secretary regarding whether an
                    entity qualifies for such a reduction is not
                    reviewable.
      (f) Effect of Failure To Pay Fees.--
              (1) No acceptance of submissions.--A premarket
            application, premarket report, supplement, premarket
            notification submission, 30-day notice, request for
            classification information, periodic reporting
            concerning a class III device, or de novo
            classification request submitted by a person subject to
            fees under subsections (a)(2) and (a)(3) shall be
            considered incomplete and shall not be accepted by the
            Secretary until all such fees owed by such person have
            been paid.
              (2) No registration.--Registration information
            submitted under section 510 by an establishment subject
            to a registration fee shall be considered incomplete
            and shall not be accepted by the Secretary until the
            registration fee under subsection (a)(3) owed for the
            establishment has been paid. Until the fee is paid and
            the registration is complete, the establishment is
            deemed to have failed to register in accordance with
            section 510.
      (g) Conditions.--
              (1) Performance goals; termination of program.--With
            respect to the amount that, under the salaries and
            expenses account of the Food and Drug Administration,
            is appropriated for a fiscal year for devices and
            radiological products, fees may not be assessed under
            subsection (a) for the fiscal year, and the Secretary
            is not expected to meet any performance goals
            identified for the fiscal year, if--
                      (A) the amount so appropriated for the fiscal
                    year, excluding the amount of fees appropriated
                    for the fiscal year, is more than 1 percent
                    less than [$320,825,000] $398,566,000
                    multiplied by the adjustment factor applicable
                    to such fiscal year; or
                      (B) fees were not assessed under subsection
                    (a) for the previous fiscal year.
              (2) Authority.--If the Secretary does not assess fees
            under subsection (a) during any portion of a fiscal
            year because of paragraph (1) and if at a later date in
            such fiscal year the Secretary may assess such fees,
            the Secretary may assess and collect such fees, without
            any modification in the rate for premarket
            applications, supplements, premarket reports, premarket
            notification submissions, 30-day notices, requests for
            classification information, periodic reporting
            concerning a class III device, de novo classification
            requests, and establishment registrations at any time
            in such fiscal year, notwithstanding the provisions of
            subsection (a) relating to the date fees are to be
            paid.
              (3) Limitation.--Beginning on October 1, 2023, the
            authorities under section 737(9)(C) shall include only
            leasing and necessary scientific equipment.
      (h) Crediting and Availability of Fees.--
              (1) In general.--Subject to paragraph (2)(C), fees
            authorized under subsection (a) shall be collected and
            available for obligation only to the extent and in the
            amount provided in advance in appropriation Acts. Such
            fees are authorized to be appropriated to remain
            available until expended. Such sums as may be necessary
            may be transferred from the Food and Drug
            Administration salaries and expenses appropriation
            account without fiscal year limitation to such
            appropriation account for salaries and expenses with
            such fiscal year limitation. The sums transferred shall
            be available solely for the process for the review of
            device applications.
              (2) Collections and appropriation acts.--
                      (A) In general.--The fees authorized by this
                    section--
                              (i) subject to subparagraph (C),
                            shall be collected and available in
                            each fiscal year in an amount not to
                            exceed the amount specified in
                            appropriation Acts, or otherwise made
                            available for obligation, for such
                            fiscal year, and
                              (ii) shall be available to defray
                            increases in the costs of the resources
                            allocated for the process for the
                            review of device applications
                            (including increases in such costs for
                            an additional number of full-time
                            equivalent positions in the Department
                            of Health and Human Services to be
                            engaged in such process) over such
                            costs, excluding costs paid from fees
                            collected under this section, for
                            fiscal year 2009 multiplied by the
                            adjustment factor.
                      (B) Compliance.--
                              (i) In general.--The Secretary shall
                            be considered to have met the
                            requirements of subparagraph (A)(ii) in
                            any fiscal year if the costs funded by
                            appropriations and allocated for the
                            process for the review of device
                            applications--
                              (I) are not more than 3 percent below
                            the level specified in subparagraph
                            (A)(ii); or
                              (II)(aa) are more than 3 percent
                            below the level specified in
                            subparagraph (A)(ii), and fees assessed
                            for a subsequent fiscal year are
                            decreased by the amount in excess of 3
                            percent by which such costs fell below
                            the level specified in such
                            subparagraph; and
                              (bb) such costs are not more than 5
                            percent below the level specified in
                            such subparagraph.
                              (ii) More than 5 percent.--To the
                            extent such costs are more than 5
                            percent below the specified level in
                            subparagraph (A)(ii), fees may not be
                            collected under this section for that
                            fiscal year.
                      (C) Provision for early payments.--Payment of
                    fees authorized under this section for a fiscal
                    year, prior to the due date for such fees, may
                    be accepted by the Secretary in accordance with
                    authority provided in advance in a prior year
                    appropriations Act.
              [(3) Authorizations of appropriations.--For each of
            the fiscal years 2018 through 2022, there is authorized
            to be appropriated for fees under this section an
            amount equal to the total revenue amount specified
            under subsection (b)(3) for the fiscal year, as
            adjusted under subsection (c).]
              (3) Authorization of appropriations.--
                      (A) In general.--For each of fiscal years
                    2023 through 2027, there is authorized to be
                    appropriated for fees under this section an
                    amount equal to the revenue amount determined
                    under subparagraph (B), less the amount of
                    reductions determined under subparagraph (C).
                      (B) Revenue amount.--For purposes of this
                    paragraph, the revenue amount for each fiscal
                    year is the sum of--
                              (i) the total revenue amount under
                            subsection (b)(3) for the fiscal year,
                            as adjusted under paragraphs (2) and
                            (3) of subsection (c); and
                              (ii) the performance improvement
                            adjustment amount for the fiscal year
                            under subsection (c)(4), if applicable.
                      (C) Reductions.--For purposes of this
                    paragraph, the amount of reductions for each
                    fiscal year is the sum of--
                              (i) the hiring adjustment amount for
                            the fiscal year under subsection
                            (c)(5), if applicable; and
                              (ii) the operating reserve adjustment
                            amount for the fiscal year under
                            subsection (c)(6), if applicable.
      (i) Collection of Unpaid Fees.--In any case where the
    Secretary does not receive payment of a fee assessed under
    subsection (a) within 30 days after it is due, such fee shall
    be treated as a claim of the United States Government subject
    to subchapter II of chapter 37 of title 31, United States Code.
      (j) Written Requests for Refunds.--To qualify for
    consideration for a refund under subsection (a)(2)(D), a person
    shall submit to the Secretary a written request for such refund
    not later than 180 days after such fee is due.
      (k) Construction.--This section may not be construed to
    require that the number of full-time equivalent positions in
    the Department of Health and Human Services, for officers,
    employees, and advisory committees not engaged in the process
    of the review of device applications, be reduced to offset the
    number of officers, employees, and advisory committees so
    engaged.

    SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS.

      (a) Reports.--
              (1) Performance report.--
                              (A) In general.--
                                      (i) General requirements.--
                                    Beginning with [fiscal year
                                    2018] fiscal year 2023, for
                                    each fiscal year for which fees
                                    are collected under this part,
                                    the Secretary shall prepare and
                                    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 annual reports
                                    concerning the progress of the
                                    Food and Drug Administration in
                                    achieving the goals identified
                                    in the letters described in
                                    section 201(b) of the [Medical
                                    Device User Fee Amendments of
                                    2017] Medical Device User Fee
                                    Amendments of 2022 during such
                                    fiscal year and the future
                                    plans of the Food and Drug
                                    Administration for meeting the
                                    goals.
                                      (ii) Additional
                                    information.--Beginning with
                                    [fiscal year 2018] fiscal year
                                    2023, the annual report under
                                    this subparagraph shall include
                                    the progress of the Center for
                                    Devices and Radiological Health
                                    in achieving the goals, and
                                    future plans for meeting the
                                    goals, including--
                                              (I) the number of
                                            premarket applications
                                            filed under section 515
                                            per fiscal year for
                                            each review division;
                                              (II) the number of
                                            reports submitted under
                                            section 510(k) per
                                            fiscal year for each
                                            review division; and
                                              (III) the number of
                                            expedited development
                                            and priority review
                                            designations under
                                            section 515C per fiscal
                                            year.
                                      (iii) Real time reporting.--
                                              (I) In general.--Not
                                            later than 30 calendar
                                            days after the end of
                                            the second quarter of
                                            [fiscal year 2018]
                                            fiscal year 2023, 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] Medical
                                                    Device User Fee
                                                    Amendments of
                                                    2022; 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] Medical
                                                    Device User Fee
                                                    Amendments of
                                                    2022.
                                      (iv) Rationale for mdufa
                                    program changes.--Beginning
                                    with [fiscal year 2020] fiscal
                                    year 2023, 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]
                                            Medical Device User Fee
                                            Amendments of 2022 and
                                            the number of full time
                                            equivalents funded by
                                            budget authority at the
                                            Food and Drug
                                            Administration by each
                                            division within the
                                            Center for Devices and
                                            Radiological Health,
                                            the Center for
                                            Biologics Evaluation
                                            and Research, the
                                            Office of Regulatory
                                            Affairs, and the Office
                                            of the Commissioner;
                                              (II) data, analysis,
                                            and discussion of the
                                            changes in the fee
                                            revenue amounts and
                                            costs for the process
                                            for the review of
                                            devices, including
                                            identifying drivers of
                                            such changes; and
                                              (III) for each of the
                                            Center for Devices and
                                            Radiological Health,
                                            the Center for
                                            Biologics Evaluation
                                            and Research, the
                                            Office of Regulatory
                                            Affairs, and the Office
                                            of the Commissioner,
                                            the number of employees
                                            for whom time reporting
                                            is required and the
                                            number of employees for
                                            whom time reporting is
                                            not required.
                                      [(iv)] (v) Analysis.--For
                                    each fiscal year, the Secretary
                                    shall include in the report
                                    under clause (i) an analysis of
                                    the following:
                                              (I) The difference
                                            between the aggregate
                                            number of premarket
                                            applications filed
                                            under section 515 and
                                            aggregate reports
                                            submitted under section
                                            510(k) and the
                                            aggregate number of
                                            major deficiency
                                            letters, not approvable
                                            letters, and denials
                                            for such applications
                                            issued by the agency,
                                            accounting for--
                                                      (aa) the
                                                    number of
                                                    applications
                                                    filed and
                                                    reports
                                                    submitted
                                                    during one
                                                    fiscal year for
                                                    which a
                                                    decision is not
                                                    scheduled to be
                                                    made until the
                                                    following
                                                    fiscal year;
                                                    and
                                                      (bb) the
                                                    aggregate
                                                    number of
                                                    applications
                                                    for each fiscal
                                                    year that did
                                                    not meet the
                                                    goals as
                                                    identified by
                                                    the letters
                                                    described in
                                                    section 201(b)
                                                    of the [Medical
                                                    Device User Fee
                                                    Amendments of
                                                    2017] Medical
                                                    Device User Fee
                                                    Amendments of
                                                    2022 for the
                                                    applicable
                                                    fiscal year.
                                              (II) Relevant data to
                                            determine whether the
                                            Center for Devices and
                                            Radiological Health has
                                            met performance
                                            enhancement goals
                                            identified by the
                                            letters described in
                                            section 201(b) of the
                                            [Medical Device User
                                            Fee Amendments of 2017]
                                            Medical Device User Fee
                                            Amendments of 2022 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]
                                            Medical Device User Fee
                                            Amendments of 2022.
                      (B) Publication.--With regard to information
                    to be reported by the Food and Drug
                    Administration to industry on a quarterly and
                    annual basis pursuant to the letters described
                    in section 201(b) of the [Medical Device User
                    Fee Amendments of 2017] Medical Device User Fee
                    Amendments of 2022, the Secretary shall make
                    such information publicly available on the
                    Internet Web site of the Food and Drug
                    Administration not later than 60 days after the
                    end of each quarter or 120 days after the end
                    of each fiscal year, respectively, to which
                    such information applies. This information
                    shall include the status of the independent
                    assessment identified in the letters described
                    in such section 201(b).
                      (C) Updates.--The Secretary shall include in
                    each report under subparagraph (A) information
                    on all previous cohorts for which the Secretary
                    has not given a complete response on all device
                    premarket applications and reports,
                    supplements, and premarket notifications in the
                    cohort.
              (2) Corrective action report.--Beginning with [fiscal
            year 2018] fiscal year 2023, for each fiscal year for
            which fees are collected under this part, the Secretary
            shall prepare and submit a corrective action report to
            the Committee on Energy and Commerce and the Committee
            on Appropriations of the House of Representatives and
            the Committee on Health, Education, Labor, and Pensions
            and the Committee on Appropriations of the Senate. The
            report shall include the following information, as
            applicable:
                      (A) Goals met.--For each fiscal year, if the
                    Secretary determines, based on the analysis
                    under paragraph (1)(A)(iv), that each of the
                    goals identified by the letters described in
                    section 201(b) of the [Medical Device User Fee
                    Amendments of 2017] Medical Device User Fee
                    Amendments of 2022 for the applicable fiscal
                    year have been met, the corrective action
                    report shall include recommendations on ways in
                    which the Secretary can improve and streamline
                    the medical device application review process.
                      (B) Goals missed.--For each of the goals
                    identified by the letters described in section
                    201(b) of the [Medical Device User Fee
                    Amendments of 2017] Medical Device User Fee
                    Amendments of 2022 for the applicable fiscal
                    year that the Secretary determines to not have
                    been met, the corrective action report shall
                    include--
                              (i) a justification for such
                            determination;
                              (ii) a description of the types of
                            circumstances, in the aggregate, under
                            which applications or reports submitted
                            under section 515 or notifications
                            submitted under section 510(k) missed
                            the review goal times but were approved
                            during the first cycle review, as
                            applicable;
                              (iii) a summary and any trends with
                            regard to the circumstances for which a
                            review goal was missed; and
                              (iv) the performance enhancement
                            goals that were not achieved during the
                            previous fiscal year and a description
                            of efforts the Food and Drug
                            Administration has put in place for the
                            fiscal year in which the report is
                            submitted to improve the ability of
                            such agency to meet each such goal for
                            the such fiscal year.
              (3) Enhanced communication.--
                      (A) Communications with congress.--Each
                    fiscal year, as applicable and requested,
                    representatives from the Centers with expertise
                    in the review of devices shall meet with
                    representatives from the Committee on Health,
                    Education, Labor, and Pensions of the Senate
                    and the Committee on Energy and Commerce of the
                    House of Representatives to report on the
                    contents described in the reports under this
                    section.
                      (B) Participation in congressional hearing.--
                    Each fiscal year, as applicable and requested,
                    representatives from the Food and Drug
                    Administration shall participate in a public
                    hearing before the Committee on Health,
                    Education, Labor, and Pensions of the Senate
                    and the Committee on Energy and Commerce of the
                    House of Representatives, to report on the
                    contents described in the reports under this
                    section. Such hearing shall occur not later
                    than 120 days after the end of each fiscal year
                    for which fees are collected under this part.
              (4) Fiscal report.--For fiscal years [2018 through
            2022] 2023 through 2027, not later than 120 days after
            the end of each fiscal year during which fees are
            collected under this part, the Secretary shall prepare
            and 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, a
            report on the implementation of the authority for such
            fees during such fiscal year and the use, by the Food
            and Drug Administration, of the fees collected during
            such fiscal year for which the report is made.
              (5) Public availability.--The Secretary shall make
            the reports required under paragraphs (1) and (2)
            available to the public on the Internet Web site of the
            Food and Drug Administration.
      (b) Reauthorization.--
              (1) Consultation.--In developing recommendations to
            present to Congress with respect to the goals, and
            plans for meeting the goals, for the process for the
            review of device applications for the first 5 fiscal
            years after fiscal year [2022] 2027, and for the
            reauthorization of this part for such fiscal years, the
            Secretary shall consult with--
                      (A) the Committee on Energy and Commerce of
                    the House of Representatives;
                      (B) the Committee on Health, Education,
                    Labor, and Pensions of the Senate;
                      (C) scientific and academic experts;
                      (D) health care professionals;
                      (E) representatives of patient and consumer
                    advocacy groups; and
                      (F) the regulated industry.
              (2) Prior public input.--Prior to beginning
            negotiations with the regulated industry on the
            reauthorization of this part, the Secretary shall--
                      (A) publish a notice in the Federal Register
                    requesting public input on the reauthorization;
                      (B) hold a public meeting at which the public
                    may present its views on the reauthorization,
                    including specific suggestions for changes to
                    the goals referred to in subsection (a)(1);
                      (C) provide a period of 30 days after the
                    public meeting to obtain written comments from
                    the public suggesting changes to this part; and
                      (D) publish the comments on the Food and Drug
                    Administration's Internet Web site.
              (3) Periodic consultation.--Not less frequently than
            once every month during negotiations with the regulated
            industry, the Secretary shall hold discussions with
            representatives of patient and consumer advocacy groups
            to continue discussions of their views on the
            reauthorization and their suggestions for changes to
            this part as expressed under paragraph (2).
              (4) Public review of recommendations.--After
            negotiations with the regulated industry, the Secretary
            shall--
                      (A) present the recommendations developed
                    under paragraph (1) to the Congressional
                    committees specified in such paragraph;
                      (B) publish such recommendations in the
                    Federal Register;
                      (C) provide for a period of 30 days for the
                    public to provide written comments on such
                    recommendations;
                      (D) hold a meeting at which the public may
                    present its views on such recommendations; and
                      (E) after consideration of such public views
                    and comments, revise such recommendations as
                    necessary.
              (5) Transmittal of recommendations.--Not later than
            January 15, [2022] 2027, the Secretary shall transmit
            to Congress the revised recommendations under paragraph
            (4), a summary of the views and comments received under
            such paragraph, and any changes made to the
            recommendations in response to such views and comments.
              (6) Minutes of negotiation meetings.--
                      (A) Public availability.--Before presenting
                    the recommendations developed under paragraphs
                    (1) through (5) to the Congress, the Secretary
                    shall make publicly available, on the public
                    Web site of the Food and Drug Administration,
                    minutes of all negotiation meetings conducted
                    under this subsection between the Food and Drug
                    Administration and the regulated industry.
                      (B) Content.--The minutes described under
                    subparagraph (A) shall summarize any
                    substantive proposal made by any party to the
                    negotiations as well as significant
                    controversies or differences of opinion during
                    the negotiations and their resolution.

               *       *       *       *       *       *       *

    PART 7--FEES RELATING TO GENERIC DRUGS

               *       *       *       *       *       *       *

    SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.

      (a) Types of Fees.--Beginning in [fiscal year 2018] fiscal
    year 2023, the Secretary shall assess and collect fees in
    accordance with this section as follows:
              (1) One-time backlog fee for abbreviated new drug
            applications pending on october 1, 2012.--
                      (A) In general.--Each person that owns an
                    abbreviated new drug application that is
                    pending on October 1, 2012, and that has not
                    received a tentative approval prior to that
                    date, shall be subject to a fee for each such
                    application, as calculated under subparagraph
                    (B).
                      (B) Method of fee amount calculation.--The
                    amount of each one-time backlog fee shall be
                    calculated by dividing $50,000,000 by the total
                    number of abbreviated new drug applications
                    pending on October 1, 2012, that have not
                    received a tentative approval as of that date.
                      (C) Notice.--Not later than October 31, 2012,
                    the Secretary shall publish in the Federal
                    Register a notice announcing the amount of the
                    fee required by subparagraph (A).
                      (D) Fee due date.--The fee required by
                    subparagraph (A) shall be due no later than 30
                    calendar days after the date of the publication
                    of the notice specified in subparagraph (C).
                      (E) Sunset.--This paragraph shall cease to be
                    effective October 1, 2022.
              (2) Drug master file fee.--
                      (A) In general.--Each person that owns a Type
                    II active pharmaceutical ingredient drug master
                    file that is referenced on or after October 1,
                    2012, in a generic drug submission by any
                    initial letter of authorization shall be
                    subject to a drug master file fee.
                      (B) One-time payment.--If a person has paid a
                    drug master file fee for a Type II active
                    pharmaceutical ingredient drug master file, the
                    person shall not be required to pay a
                    subsequent drug master file fee when that Type
                    II active pharmaceutical ingredient drug master
                    file is subsequently referenced in generic drug
                    submissions.
                      (C) Notice.--Not later than 60 days before
                    the start of each of fiscal years [2018 through
                    2022] 2023 through 2027, the Secretary shall
                    publish in the Federal Register the amount of
                    the drug master file fee established by this
                    paragraph for such fiscal year.
                      (D) Availability for reference.--
                              (i) In general.--Subject to
                            subsection (g)(2)(C), for a generic
                            drug submission to reference a Type II
                            active pharmaceutical ingredient drug
                            master file, the drug master file must
                            be deemed available for reference by
                            the Secretary.
                              (ii) Conditions.--A drug master file
                            shall be deemed available for reference
                            by the Secretary if--
                                      (I) the person that owns a
                                    Type II active pharmaceutical
                                    ingredient drug master file has
                                    paid the fee required under
                                    subparagraph (A) within 20
                                    calendar days after the
                                    applicable due date under
                                    subparagraph (E); and
                                      (II) the drug master file has
                                    not failed an initial
                                    completeness assessment by the
                                    Secretary, in accordance with
                                    criteria to be published by the
                                    Secretary.
                              (iii) List.--The Secretary shall make
                            publicly available on the Internet Web
                            site of the Food and Drug
                            Administration a list of the drug
                            master file numbers that correspond to
                            drug master files that have
                            successfully undergone an initial
                            completeness assessment, in accordance
                            with criteria to be published by the
                            Secretary, and are available for
                            reference.
                      (E) Fee due date.--
                              (i) In general.--Subject to clause
                            (ii), a drug master file fee shall be
                            due on the earlier of--
                                      (I) the date on which the
                                    first generic drug submission
                                    is submitted that references
                                    the associated Type II active
                                    pharmaceutical ingredient drug
                                    master file; or
                                      (II) the date on which the
                                    drug master file holder
                                    requests the initial
                                    completeness assessment.
                              (ii) Limitation.--No fee shall be due
                            under subparagraph (A) for a fiscal
                            year until the later of--
                                      (I) 30 calendar days after
                                    publication of the notice
                                    provided for in subparagraph
                                    (C); or
                                      (II) 30 calendar days after
                                    the date of enactment of an
                                    appropriations Act providing
                                    for the collection and
                                    obligation of fees for such
                                    year under this section.
              (3) Abbreviated new drug application filing fee.--
                      (A) In general.--Each applicant that submits,
                    on or after October 1, 2012, an abbreviated new
                    drug application shall be subject to a fee for
                    each such submission in the amount established
                    under subsection (d).
                      (B) Notice.--Not later than 60 days before
                    the start of each of fiscal years [2018 through
                    2022] 2023 through 2027, the Secretary shall
                    publish in the Federal Register the amount of
                    the fees under subparagraph (A) for such fiscal
                    year.
                      (C) Fee due date.--The fees required by
                    subparagraphs (A) and (F) shall be due no later
                    than the date of submission of the abbreviated
                    new drug application or prior approval
                    supplement for which such fee applies.
                      (D) Refund of fee if abbreviated new drug
                    application is not considered to have been
                    received, is withdrawn prior to being received,
                    or is no longer received.--
                              (i) Applications not considered to
                            have been received and applications
                            withdrawn prior to being received.--The
                            Secretary shall refund 75 percent of
                            the fee paid under subparagraph (A) for
                            any abbreviated new drug application
                            that the Secretary considers not to
                            have been received within the meaning
                            of section 505(j)(5)(A) for a cause
                            other than failure to pay fees, or that
                            has been withdrawn prior to being
                            received within the meaning of section
                            505(j)(5)(A).
                              (ii) Applications no longer
                            received.--The Secretary shall refund
                            100 percent of the fee paid under
                            subparagraph (A) for any abbreviated
                            new drug application if the Secretary
                            initially receives the application
                            under section 505(j)(5)(A) and
                            subsequently determines that an
                            exclusivity period for a listed drug
                            should have prevented the Secretary
                            from receiving such application, such
                            that the abbreviated new drug
                            application is no longer received
                            within the meaning of section
                            505(j)(5)(A).
                      (E) Fee for an application the secretary
                    considers not to have been received, or that
                    has been withdrawn.--An abbreviated new drug
                    application that was submitted on or after
                    October 1, 2012, and that the Secretary
                    considers not to have been received, or that
                    has been withdrawn, shall, upon resubmission of
                    the application or a subsequent new submission
                    following the applicant's withdrawal of the
                    application, be subject to a full fee under
                    subparagraph (A).
                      (F) Additional fee for active pharmaceutical
                    ingredient information not included by
                    reference to type ii active pharmaceutical
                    ingredient drug master file.--An applicant that
                    submits a generic drug submission on or after
                    October 1, 2017, shall pay a fee, in the amount
                    determined under subsection (d)(2), in addition
                    to the fee required under subparagraph (A),
                    if--
                              (i) such submission contains
                            information concerning the manufacture
                            of an active pharmaceutical ingredient
                            at a facility by means other than
                            reference by a letter of authorization
                            to a Type II active pharmaceutical drug
                            master file; and
                              (ii) a fee in the amount equal to the
                            drug master file fee established in
                            paragraph (2) has not been previously
                            paid with respect to such information.
              (4) Generic drug facility fee and active
            pharmaceutical ingredient facility fee.--
                      (A) In general.--Facilities identifiedin at
                    least one generic drug submission that is
                    approved to produce a finished dosage form of a
                    human generic drug or an active pharmaceutical
                    ingredient contained in a human generic drug
                    shall be subject to fees as follows:
                              (i) Generic drug facility.--Each
                            person that owns a facility which is
                            identified in at least one generic drug
                            submission that is approved to produce
                            one or more finished dosage forms of a
                            human generic drug shall be assessed an
                            annual fee for each such facility.
                              (ii) Active pharmaceutical ingredient
                            facility.--Each person that owns a
                            facility which 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 generic drug submission, shall
                            be assessed an annual fee for each such
                            facility.
                              (iii) Facilities producing both
                            active pharmaceutical ingredients and
                            finished dosage forms.--Each person
                            that owns a facility identified, or
                            intended to be identified, in at least
                            one generic drug submission that is
                            pending or approved to produce both one
                            or more finished dosage forms subject
                            to clause (i) and one or more active
                            pharmaceutical ingredients subject to
                            clause (ii) shall be subject only to
                            the fee attributable to the manufacture
                            of the finished dosage forms for that
                            facility.
                      (B) Amount.--The amount of fees established
                    under subparagraph (A) shall be established
                    under subsection (d).
                      (C) Notice.--Within the timeframe specified
                    in subsection (d)(1), the Secretary shall
                    publish in the Federal Register the amount of
                    the fees under subparagraph (A) for such fiscal
                    year.
                      (D) Fee due date.--For each of fiscal years
                    [2018 through 2022] 2023 through 2027, 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.
              (5) Generic drug applicant program fee.--
                      (A) In general.--A generic drug applicant
                    program fee shall be assessed annually as
                    described in subsection (b)(2)(E).
                      (B) Amount.--The amount of fees established
                    under subparagraph (A) shall be established
                    under subsection (d).
                      (C) Notice.--Within the timeframe specified
                    in subsection (d)(1), the Secretary shall
                    publish in the Federal Register the amount of
                    the fees under subparagraph (A) for such fiscal
                    year.
                      (D) Fee due date.--For each of fiscal years
                    [2018 through 2022] 2023 through 2027, 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.
              (6) Date of submission.--For purposes of this Act, a
            generic drug submission or Type II pharmaceutical
            master file is deemed to be ``submitted'' to the Food
            and Drug Administration--
                      (A) if it is submitted via a Food and Drug
                    Administration electronic gateway, on the day
                    when transmission to that electronic gateway is
                    completed, except that a submission or master
                    file that arrives on a weekend, Federal
                    holiday, or day when the Food and Drug
                    Administration office that will review that
                    submission is not otherwise open for business
                    shall be deemed to be submitted on the next day
                    when that office is open for business; or
                      (B) if it is submitted in physical media
                    form, on the day it arrives at the appropriate
                    designated document room of the Food and Drug
                    Administration.
      (b) Fee Revenue Amounts.--
              (1) In general.--
                      (A) Fiscal year [2018] 2023.--For fiscal year
                    [2018] 2023, fees under subsection (a) shall be
                    established to generate a total estimated
                    revenue amount under such subsection of
                    [$493,600,000] $582,500,000.
                      [(B) Fiscal years 2019 through 2022.--For
                    each of the fiscal years 2019 through 2022,
                    fees under paragraphs (2) through (5) of
                    subsection (a) shall be established to generate
                    a total estimated revenue amount under such
                    subsection that is equal to $493,600,000, as
                    adjusted pursuant to subsection (c).]
                      (B) Fiscal years 2024 through 2027.--
                              (i) In general.--For each of the
                            fiscal years 2024 through 2027, fees
                            under paragraphs (2) through (5) of
                            subsection (a) shall be established to
                            generate a total estimated revenue
                            amount under such subsection that is
                            equal to the base revenue amount for
                            the fiscal year under clause (ii), as
                            adjusted pursuant to subsection (c).
                              (ii) Base revenue amount.--The base
                            revenue amount for a fiscal year
                            referred to in clause (i) is equal to
                            the total revenue amount established
                            under this paragraph for the previous
                            fiscal year, not including any
                            adjustments made for such previous
                            fiscal year under subsection (c)(3).
              (2) Types of fees.--In establishing fees under
            paragraph (1) to generate the revenue amounts specified
            in such paragraph for a fiscal year, such fees shall be
            derived from the fees under paragraphs (2) through (5)
            of subsection (a) as follows:
                      (A) Five percent shall be derived from fees
                    under subsection (a)(2) (relating to drug
                    master files).
                      (B) Thirty-three percent shall be derived
                    from fees under subsection (a)(3) (relating to
                    abbreviated new drug applications).
                      (C) Twenty percent shall be derived from fees
                    under subsection (a)(4)(A)(i) (relating to
                    generic drug facilities). The amount of the fee
                    for a contract manufacturing organization
                    facility shall be equal to [one-third the
                    amount] twenty-four percent 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) [Seven percent] Six percent shall be
                    derived from fees under subsection
                    (a)(4)(A)(ii) (relating to active
                    pharmaceutical ingredient facilities). 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, including its territories
                    and possessions.
                      (E)(i) [Thirty-five percent] Thirty-six
                    percent shall be derived from fees under
                    subsection (a)(5) (relating to generic drug
                    applicant program fees). For purposes of this
                    subparagraph, if a person has affiliates, a
                    single program fee shall be assessed with
                    respect to that person, including its
                    affiliates, and may be paid by that person or
                    any one of its affiliates. The Secretary shall
                    determine the fees as follows:
                              (I) If a person (including its
                            affiliates) owns at least one but not
                            more than 5 approved abbreviated new
                            drug applications on the due date for
                            the fee under this subsection, the
                            person (including its affiliates) shall
                            be assessed a small business generic
                            drug applicant program fee equal to
                            one-tenth of the large size operation
                            generic drug applicant program fee.
                              (II) If a person (including its
                            affiliates) owns at least 6 but not
                            more than 19 approved abbreviated new
                            drug applications on the due date for
                            the fee under this subsection, the
                            person (including its affiliates) shall
                            be assessed a medium size operation
                            generic drug applicant program fee
                            equal to two-fifths of the large size
                            operation generic drug applicant
                            program fee.
                              (III) If a person (including its
                            affiliates) owns 20 or more approved
                            abbreviated new drug applications on
                            the due date for the fee under this
                            subsection, the person (including its
                            affiliates) shall be assessed a large
                            size operation generic drug applicant
                            program fee.
                      (ii) For purposes of this subparagraph, an
                    abbreviated new drug application shall be
                    deemed not to be approved if the applicant has
                    submitted a written request for withdrawal of
                    approval of such abbreviated new drug
                    application by April 1 of the previous fiscal
                    year.
      (c) Adjustments.--
              (1) Inflation adjustment.--For fiscal year [2019]
            2024 and subsequent fiscal years, the revenues
            established in subsection (b) shall be adjusted by the
            Secretary by notice, published in the Federal Register,
            for a fiscal year, [to equal the product of the total
            revenues established in such notice for the prior
            fiscal year multiplied] to equal the base revenue
            amount for the fiscal year (as specified in subsection
            (b)(1)(B)) multiplied by an amount equal to the sum
            of--
                      (A) one;
                      (B) 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 human generic
                    drug activities for the first 3 years of the
                    preceding 4 fiscal years; and
                      (C) the average annual percent change that
                    occurred in the Consumer Price Index for urban
                    consumers ([Washington-Baltimore, DC-MD-VA-WV]
                    Washington-Arlington-Alexandria, DC-VA-MD-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 human generic drug activities for the first
                    3 years of the preceding 4 fiscal years.
              [(2) Final year adjustment.--For fiscal year 2022,
            the Secretary may, in addition to adjustments under
            paragraph (1), further increase the fee revenues and
            fees established in subsection (b) if such an
            adjustment is necessary to provide for not more than 3
            months of operating reserves of carryover user fees for
            human generic drug activities for the first 3 months of
            fiscal year 2023. If such an adjustment is necessary,
            the rationale for the amount of the increase shall be
            contained in the annual notice establishing fee
            revenues and fees for fiscal year 2022. If the
            Secretary has carryover balances for such activities in
            excess of 3 months of such operating reserves, the
            adjustment under this subparagraph shall not be made.]
              (2) Capacity planning adjustment.--
                      (A) In general.--Beginning with fiscal year
                    2024, 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, in accordance with
                    this paragraph, to reflect changes in the
                    resource capacity needs of the Secretary for
                    human generic drug activities.
                      (B) Capacity planning methodology.--The
                    Secretary shall establish a capacity planning
                    methodology for purposes of this paragraph,
                    which shall--
                              (i) be derived from the methodology
                            and recommendations made in the report
                            titled ``Independent Evaluation of the
                            GDUFA Resource Capacity Planning
                            Adjustment Methodology: Evaluation and
                            Recommendations'' announced in the
                            Federal Register on August 3, 2020;
                              (ii) incorporate approaches and
                            attributes determined appropriate by
                            the Secretary, including approaches and
                            attributes made in such report, except
                            that in incorporating such approaches
                            and attributes the workload categories
                            used in forecasting resources shall
                            only be the workload categories
                            specified in section VIII.B.2.e. of the
                            letters described in section 301(b) of
                            the Generic Drug User Fee Amendments of
                            2022; and
                              (iii) be effective beginning with
                            fiscal year 2024.
                      (C) Limitations.--
                              (i) In general.--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 subsection
                            (b)(1)(B)(ii) (the base revenue amount
                            for the fiscal year) and paragraph (1)
                            (the dollar amount of the inflation
                            adjustment for the fiscal year).
                              (ii) Percentage limitation.--An
                            adjustment under this paragraph shall
                            not exceed three percent of the sum
                            described in clause (i) for the fiscal
                            year, except that such limitation shall
                            be four percent if--
                                      (I) for purposes of a fiscal
                                    year 2024 adjustment, the
                                    Secretary determines that
                                    during the period from April 1,
                                    2021, through March 31, 2023--
                                              (aa) the total number
                                            of abbreviated new drug
                                            applications submitted
                                            was greater than or
                                            equal to 2,000; or
                                              (bb) thirty-five
                                            percent or more of
                                            abbreviated new drug
                                            applications submitted
                                            related to complex
                                            products (as that term
                                            is defined in section
                                            XI of the letters
                                            described in section
                                            301(b) of the Generic
                                            Drug User Fee
                                            Amendments of 2022);
                                      (II) for purposes of a fiscal
                                    year 2025 adjustment, the
                                    Secretary determines that
                                    during the period from April 1,
                                    2022, through March 31, 2024--
                                              (aa) the total number
                                            of abbreviated new drug
                                            applications submitted
                                            was greater than or
                                            equal to 2,300; or
                                              (bb) thirty-five
                                            percent or more of
                                            abbreviated new drug
                                            applications submitted
                                            related to complex
                                            products (as so
                                            defined);
                                      (III) for purposes of a
                                    fiscal year 2026 adjustment,
                                    the Secretary determines that
                                    during the period from April 1,
                                    2023, through March 31, 2025--
                                              (aa) the total number
                                            of abbreviated new drug
                                            applications submitted
                                            was greater than or
                                            equal to 2,300; or
                                              (bb) thirty-five
                                            percent or more of
                                            abbreviated new drug
                                            applications submitted
                                            related to complex
                                            products (as so
                                            defined); and
                                      (IV) for purposes of a fiscal
                                    year 2027 adjustment, the
                                    Secretary determines that
                                    during the period from April 1,
                                    2024, through March 31, 2026--
                                              (aa) the total number
                                            of abbreviated new drug
                                            applications submitted
                                            was greater than or
                                            equal to 2,300; or
                                              (bb) thirty-five
                                            percent or more of
                                            abbreviated new drug
                                            applications submitted
                                            related to complex
                                            products (as so
                                            defined).
                      (D) Publication in federal register.--The
                    Secretary shall publish in the Federal Register
                    notice referred to in subsection (a) the fee
                    revenue and fees resulting from the adjustment
                    and the methodology under this paragraph.
              (3) Operating reserve adjustment.--
                      (A) In general.--For fiscal year 2024 and
                    each subsequent fiscal year, the Secretary may,
                    in addition to adjustments under paragraphs (1)
                    and (2), further increase the fee revenue and
                    fees under this section for such fiscal year if
                    such an adjustment is necessary to provide
                    operating reserves of carryover user fees for
                    human generic drug activities for not more than
                    the number of weeks specified in subparagraph
                    (B) with respect to that fiscal year.
                      (B) Number of weeks.--The number of weeks
                    specified in this subparagraph is--
                              (i) 8 weeks for fiscal year 2024;
                              (ii) 9 weeks for fiscal year 2025;
                            and
                              (iii) 10 weeks for each of fiscal
                            year 2026 and 2027.
                      (C) Decrease.--If the Secretary has carryover
                    balances for human generic drug activities in
                    excess of 12 weeks of the operating reserves
                    referred to in subparagraph (A), the Secretary
                    shall decrease the fee revenue and fees
                    referred to in such subparagraph to provide for
                    not more than 12 weeks of such operating
                    reserves.
                      (D) Rationale for adjustment.--If an
                    adjustment under this paragraph 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 subsection (a) publishing
                    the fee revenue and fees for the fiscal year
                    involved.
      (d) Annual Fee Setting.--
              (1) Fiscal years [2018 through 2022] 2023 through
            2027.--Not [more than 60 days before the first day of
            each of fiscal years 2018 through 2022] later than 60
            days before the first day of each of fiscal years 2023
            through 2027, 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) Fee for active pharmaceutical ingredient
            information not included by reference to type ii active
            pharmaceutical ingredient drug master file.--In
            establishing the fee under paragraph (1), the amount of
            the fee under subsection (a)(3)(F) shall be determined
            by multiplying--
                      (A) the sum of--
                              (i) the total number of such active
                            pharmaceutical ingredients in such
                            submission; and
                              (ii) for each such ingredient that is
                            manufactured at more than one such
                            facility, the total number of such
                            additional facilities; and
                      (B) the amount equal to the drug master file
                    fee established in subsection (a)(2) for such
                    submission.
      (e) Limitations.--
              (1) In general.--The total amount of fees charged, as
            adjusted under subsection (c), for a fiscal year may
            not exceed the total costs for such fiscal year for the
            resources allocated for human generic drug activities.
              (2) Leasing and necessary equipment.--Beginning on
            October 1, 2023, the authorities under section
            744A(11)(C) shall include only leasing and necessary
            scientific equipment.
      (f) Identification of Facilities.--
              (1) Required submission of facility identification.--
            Each person that owns a facility described in
            subsection (a)(4)(A) or a site or organization required
            to be identified by paragraph (3) shall submit to the
            Secretary the information required under this
            subsection each year. Such information shall, for each
            fiscal year, be submitted, updated, or reconfirmed on
            or before June 1 of the previous fiscal year.
              (2) Information required to be submitted.--At a
            minimum, the submission required by paragraph (1) shall
            include for each such facility--
                      (A) identification of a facility identified
                    in an approved or pending generic drug
                    submission;
                      (B) whether the facility manufactures active
                    pharmaceutical ingredients or finished dosage
                    forms, or both;
                      (C) whether or not the facility is located
                    within the United States and its territories
                    and possessions;
                      (D) whether the facility manufactures
                    positron emission tomography drugs solely, or
                    in addition to other drugs;
                      (E) whether the facility manufactures drugs
                    that are not generic drugs; and
                      (F) whether the facility is a contract
                    manufacturing organization facility.
              (3) Certain sites and organizations.--
                      (A) In general.--Any person that owns or
                    operates a site or organization described in
                    subparagraph (B) shall submit to the Secretary
                    information concerning the ownership, name, and
                    address of the site or organization.
                      (B) Sites and organizations.--A site or
                    organization is described in this subparagraph
                    if it is identified in a generic drug
                    submission and is--
                              (i) a site in which a bioanalytical
                            study is conducted;
                              (ii) a clinical research
                            organization;
                              (iii) a contract analytical testing
                            site; or
                              (iv) a contract repackager site.
                      (C) Notice.--The Secretary may, by notice
                    published in the Federal Register, specify the
                    means and format for submission of the
                    information under subparagraph (A) and may
                    specify, as necessary for purposes of this
                    section, any additional information to be
                    submitted.
                      (D) Inspection authority.--The Secretary's
                    inspection authority under section 704(a)(1)
                    shall extend to all such sites and
                    organizations.
      (g) Effect of Failure To Pay Fees.--
              (1) Generic drug backlog fee.--Failure to pay the fee
            under subsection (a)(1) shall result in the Secretary
            placing the person that owns the abbreviated new drug
            application subject to that fee on a publicly available
            arrears list, such that no new abbreviated new drug
            applications or supplement submitted on or after
            October 1, 2012, from that person, or any affiliate of
            that person, will be received within the meaning of
            section 505(j)(5)(A) until such outstanding fee is
            paid. This paragraph shall cease to be effective on
            October 1, 2022.
              (2) Drug master file fee.--
                      (A) Failure to pay the fee under subsection
                    (a)(2) within 20 calendar days after the
                    applicable due date under subparagraph (E) of
                    such subsection (as described in subsection
                    (a)(2)(D)(ii)(I)) shall result in the Type II
                    active pharmaceutical ingredient drug master
                    file not being deemed available for reference.
                      (B)(i) Any generic drug submission submitted
                    on or after October 1, 2012, that references,
                    by a letter of authorization, a Type II active
                    pharmaceutical ingredient drug master file that
                    has not been deemed available for reference
                    shall not be received within the meaning of
                    section 505(j)(5)(A) unless the condition
                    specified in clause (ii) is met.
                      (ii) The condition specified in this clause
                    is that the fee established under subsection
                    (a)(2) has been paid within 20 calendar days of
                    the Secretary providing the notification to the
                    sponsor of the abbreviated new drug application
                    or supplement of the failure of the owner of
                    the Type II active pharmaceutical ingredient
                    drug master file to pay the drug master file
                    fee as specified in subparagraph (C).
                      (C)(i) If an abbreviated new drug application
                    or supplement to an abbreviated new drug
                    application references a Type II active
                    pharmaceutical ingredient drug master file for
                    which a fee under subsection (a)(2)(A) has not
                    been paid by the applicable date under
                    subsection (a)(2)(E), the Secretary shall
                    notify the sponsor of the abbreviated new drug
                    application or supplement of the failure of the
                    owner of the Type II active pharmaceutical
                    ingredient drug master file to pay the
                    applicable fee.
                      (ii) If such fee is not paid within 20
                    calendar days of the Secretary providing the
                    notification, the abbreviated new drug
                    application or supplement to an abbreviated new
                    drug application shall not be received within
                    the meaning of section 505(j)(5)(A).
              (3) Abbreviated new drug application fee [and prior
            approval supplement fee].--Failure to pay a fee under
            subparagraph (A) or (F) of subsection (a)(3) within 20
            calendar days of the applicable due date under
            subparagraph (C) of such subsection shall result in the
            abbreviated new drug application or the prior approval
            supplement to an abbreviated new drug application not
            being received within the meaning of section
            505(j)(5)(A) until such outstanding fee is paid.
              (4) Generic drug facility fee and active
            pharmaceutical ingredient facility fee.--
                      (A) In general.--Failure to pay the fee under
                    subsection (a)(4) within 20 calendar days of
                    the due date as specified in subparagraph (D)
                    of such subsection shall result in the
                    following:
                              (i) The Secretary shall place the
                            facility on a publicly available
                            arrears list, such that no new
                            abbreviated new drug application or
                            supplement submitted on or after
                            October 1, 2012, from the person that
                            is responsible for paying such fee, or
                            any affiliate of that person, will be
                            received within the meaning of section
                            505(j)(5)(A).
                              (ii) Any new generic drug submission
                            submitted on or after October 1, 2012,
                            that references such a facility shall
                            not be received, within the meaning of
                            section 505(j)(5)(A) if the outstanding
                            facility fee is not paid within 20
                            calendar days of the Secretary
                            providing the notification to the
                            sponsor of the failure of the owner of
                            the facility to pay the facility fee
                            under subsection (a)(4)(C).
                              (iii) All drugs or active
                            pharmaceutical ingredients manufactured
                            in such a facility or containing an
                            ingredient manufactured in such a
                            facility shall be deemed misbranded
                            under section 502(aa).
                      (B) Application of penalties.--The penalties
                    under this paragraph shall apply until the fee
                    established by subsection (a)(4) is paid or the
                    facility is removed from all generic drug
                    submissions that refer to the facility.
                      (C) Nonreceival for nonpayment.--
                              (i) Notice.--If an abbreviated new
                            drug application or supplement to an
                            abbreviated new drug application
                            submitted on or after October 1, 2012,
                            references a facility for which a
                            facility fee has not been paid by the
                            applicable date under subsection
                            (a)(4)(C), the Secretary shall notify
                            the sponsor of the generic drug
                            submission of the failure of the owner
                            of the facility to pay the facility
                            fee.
                              (ii) Nonreceival.--If the facility
                            fee is not paid within 20 calendar days
                            of the Secretary providing the
                            notification under clause (i), the
                            abbreviated new drug application or
                            supplement to an abbreviated new drug
                            application shall not be received
                            within the meaning of section
                            505(j)(5)(A).
              (5) Generic drug applicant program fee.--
                      (A) In general.--A person who fails to pay a
                    fee as required under subsection (a)(5) by the
                    date that is 20 calendar days after the due
                    date, as specified in subparagraph (D) of such
                    subsection, shall be subject to the following:
                              (i) The Secretary shall place the
                            person on a publicly available arrears
                            list.
                              (ii) Any abbreviated new drug
                            application submitted by the generic
                            drug applicant or an affiliate of such
                            applicant shall not be received, within
                            the meaning of section 505(j)(5)(A).
                              (iii) All drugs marketed pursuant to
                            any abbreviated new drug application
                            held by such applicant or an affiliate
                            of such applicant shall be deemed
                            misbranded under section 502(aa).
                      (B) Application of penalties.--The penalties
                    under subparagraph (A) shall apply until the
                    fee required under subsection (a)(5) is paid.
      (h) Limitations.--
              (1) In general.--Fees under subsection (a) shall be
            refunded for a fiscal year beginning after fiscal year
            2012, unless appropriations for salaries and expenses
            of the Food and Drug Administration for such fiscal
            year (excluding the amount of fees appropriated for
            such fiscal year) are equal to or greater than the
            amount of appropriations for the salaries and expenses
            of the Food and Drug Administration for fiscal year
            2009 (excluding the amount of fees appropriated for
            such fiscal year) multiplied by the adjustment factor
            (as defined in section 744A) applicable to the fiscal
            year involved.
              (2) Authority.--If the Secretary does not assess fees
            under subsection (a) during any portion of a fiscal
            year and if at a later date in such fiscal year the
            Secretary may assess such fees, the Secretary may
            assess and collect such fees, without any modification
            in the rate, at any time in such fiscal year
            notwithstanding the provisions of subsection (a)
            relating to the date fees are to be paid.
      (i) Crediting and Availability of Fees.--
              (1) In general.--Fees authorized under subsection (a)
            shall be collected and available for obligation only to
            the extent and in the amount provided in advance in
            appropriations Acts, subject to paragraph (2). Such
            fees are authorized to remain available until expended.
            Such sums as may be necessary may be transferred from
            the Food and Drug Administration salaries and expenses
            appropriation account without fiscal year limitation to
            such appropriation account for salaries and expenses
            with such fiscal year limitation. The sums transferred
            shall be available solely for human generic drug
            activities.
              (2) Collections and appropriation acts.--
                      (A) In general.--The fees authorized by this
                    section--
                              (i) subject to subparagraph (C),
                            shall be collected and available in
                            each fiscal year in an amount not to
                            exceed the amount specified in
                            appropriation Acts, or otherwise made
                            available for obligation for such
                            fiscal year; and
                              (ii) shall be available for a fiscal
                            year beginning after fiscal year 2012
                            to defray the costs of human generic
                            drug activities (including such costs
                            for an additional number of full-time
                            equivalent positions in the Department
                            of Health and Human Services to be
                            engaged in such activities), only if
                            the Secretary allocates for such
                            purpose an amount for such fiscal year
                            (excluding amounts from fees collected
                            under this section) no less than
                            $97,000,000 multiplied by the
                            adjustment factor defined in section
                            744A(3) applicable to the fiscal year
                            involved.
                      (B) Compliance.--The Secretary shall be
                    considered to have met the requirements of
                    subparagraph (A)(ii) in any fiscal year if the
                    costs funded by appropriations and allocated
                    for human generic activities are not more than
                    10 percent below the level specified in such
                    subparagraph.
                      (C) Provision for early payments.--Payment of
                    fees authorized under this section for a fiscal
                    year, prior to the due date for such fees, may
                    be accepted by the Secretary in accordance with
                    authority provided in advance in a prior year
                    appropriations Act.
              (3) Authorization of appropriations.--For each of the
            [fiscal years 2018 through 2022] fiscal years 2023
            through 2027, there is authorized to be appropriated
            for fees under this section an amount equivalent to the
            total revenue amount determined under subsection (b)
            for the fiscal year, as adjusted under subsection (c),
            if applicable, or as otherwise affected under paragraph
            (2) of this subsection.
      (j) Collection of Unpaid Fees.--In any case where the
    Secretary does not receive payment of a fee assessed under
    subsection (a) within 30 calendar days after it is due, such
    fee shall be treated as a claim of the United States Government
    subject to subchapter II of chapter 37 of title 31, United
    States Code.
      (k) Construction.--This section may not be construed to
    require that the number of full-time equivalent positions in
    the Department of Health and Human Services, for officers,
    employees, and advisory committees not engaged in human generic
    drug activities, be reduced to offset the number of officers,
    employees, and advisory committees so engaged.
      (l) Positron Emission Tomography Drugs.--
              (1) Exemption from fees.--Submission of an
            application for a positron emission tomography drug or
            active pharmaceutical ingredient for a positron
            emission tomography drug shall not require the payment
            of any fee under this section. Facilities that solely
            produce positron emission tomography drugs shall not be
            required to pay a facility fee as established in
            subsection (a)(4).
              (2) Identification requirement.--Facilities that
            produce positron emission tomography drugs or active
            pharmaceutical ingredients of such drugs are required
            to be identified pursuant to subsection (f).
      (m) Disputes Concerning Fees.--To qualify for the return of a
    fee claimed to have been paid in error under this section, a
    person shall submit to the Secretary a written request
    justifying such return within 180 calendar days after such fee
    was paid.
      (n) Substantially Complete Applications.--An abbreviated new
    drug application that is not considered to be received within
    the meaning of section 505(j)(5)(A) because of failure to pay
    an applicable fee under this provision within the time period
    specified in subsection (g) shall be deemed not to have been
    ``substantially complete'' on the date of its submission within
    the meaning of section 505(j)(5)(B)(iv)(II)(cc). An abbreviated
    new drug application that is not substantially complete on the
    date of its submission solely because of failure to pay an
    applicable fee under the preceding sentence shall be deemed
    substantially complete and received within the meaning of
    section 505(j)(5)(A) as of the date such applicable fee is
    received.
      (o) Information on Abbreviated New Drug Applications Owned by
    Applicants and Their Affiliates.--
              (1) In general.--By April 1 of each year, each person
            that owns an abbreviated new drug application, or a
            designated affiliate of such person, shall submit, on
            behalf of the person and the affiliates of such person,
            to the Secretary a list of--
                      (A) all approved abbreviated new drug
                    applications owned by such person; and
                      (B) if any affiliate of such person also owns
                    an abbreviated new drug application, all
                    affiliates that own any such abbreviated new
                    drug application and all approved abbreviated
                    new drug applications owned by any such
                    affiliate.
              (2) Format and method.--The Secretary shall specify
            in guidance the format and method for submission of
            lists under this subsection.

    SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.

      (a) Performance Report.--
              (1) General requirements.--[Beginning with fiscal
            year 2018, not] Not later than 120 days after the end
            of each fiscal year for which fees are collected under
            this part, the Secretary shall prepare and 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 concerning
            the progress of the Food and Drug Administration in
            achieving the goals identified in the letters described
            in section 301(b) of the [Generic Drug User Fee
            Amendments of 2017] Generic Drug User Fee Amendments of
            2022 during such fiscal year and the future plans of
            the Food and Drug Administration for meeting the goals.
              (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] Not later than 30
                    calendar days after the end of each quarter of
                    each fiscal year for which fees are collected
                    under this part, 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] Generic
                            Drug User Fee Amendments of 2022.
                              (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] Generic Drug User
                            Fee Amendments of 2022.
              (3) Rationale for gdufa program changes.--[Beginning
            with fiscal year 2020, the] 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] Generic Drug User Fee
                    Amendments of 2022 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.
              (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] Generic Drug User
                            Fee Amendments of 2022 for the
                            applicable fiscal year.
                      (B) Relevant data to determine whether the
                    Food and Drug Administration has met the
                    performance enhancement goals identified by the
                    letters described in section 301(b) of the
                    [Generic Drug User Fee Amendments of 2017]
                    Generic Drug User Fee Amendments of 2022 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] Generic Drug User Fee Amendments of
                    2022.
      (b) Fiscal Report.--[Beginning with fiscal year 2018, not]
    Not later than 120 days after the end of each fiscal year for
    which fees are collected under this part, the Secretary shall
    prepare and submit to the Committee on Energy and Commerce of
    the House of Representatives and the Committee on Health,
    Education, Labor, and Pensions of the Senate a report on the
    implementation of the authority for such fees during such
    fiscal year and the use, by the Food and Drug Administration,
    of the fees collected for such fiscal year.
      (c) Corrective Action Report.--[Beginning with fiscal year
    2018, for] For each fiscal year for which fees are collected
    under this part, the Secretary shall prepare and submit a
    corrective action report to the Committee on Energy and
    Commerce and the Committee on Appropriations of the House of
    Representatives and the Committee on Health, Education, Labor,
    and Pensions and the Committee on Appropriations of the Senate.
    The report shall include the following information, as
    applicable:
              (1) Goals met.--For each fiscal year, if the
            Secretary determines, based on the analysis under
            subsection (a)(4), that each of the goals identified by
            the letters described in section 301(b) of the [Generic
            Drug User Fee Amendments of 2017] Generic Drug User Fee
            Amendments of 2022 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] Generic Drug
            User Fee Amendments of 2022 for the applicable fiscal
            year that the Secretary determines to not have been
            met, the corrective action report shall include--
                      (A) a detailed justification for such
                    determination and a description, as applicable,
                    of the types of circumstances and trends under
                    which abbreviated new drug applications missed
                    the review goal times but were approved during
                    the first cycle review, or review goals were
                    missed; and
                      (B) with respect to performance enhancement
                    goals that were not achieved, a detailed
                    description of efforts the Food and Drug
                    Administration has put in place for the fiscal
                    year in which the report is submitted to
                    improve the ability of such agency to meet each
                    such goal for the such fiscal year.
      (d) Enhanced Communication.--
              (1) Communications with congress.--Each fiscal year,
            as applicable and requested, representatives from the
            Centers with expertise in the review of human drugs
            shall meet with representatives from the Committee on
            Health, Education, Labor, and Pensions of the Senate
            and the Committee on Energy and Commerce of the House
            of Representatives to report on the contents described
            in the reports under this section.
              (2) Participation in congressional hearing.--Each
            fiscal year, as applicable and requested,
            representatives from the Food and Drug Administration
            shall participate in a public hearing before the
            Committee on Health, Education, Labor, and Pensions of
            the Senate and the Committee on Energy and Commerce of
            the House of Representatives, to report on the contents
            described in the reports under this section. Such
            hearing shall occur not later than 120 days after the
            end of each fiscal year for which fees are collected
            under this part.
      (e) Public Availability.--The Secretary shall make the
    reports required under subsections (a) and (b) available to the
    public on the Internet Web site of the Food and Drug
    Administration.
      (f) Reauthorization.--
              (1) Consultation.--In developing recommendations to
            present to the Congress with respect to the goals, and
            plans for meeting the goals, for human generic drug
            activities for the first 5 fiscal years after [fiscal
            year 2022] fiscal year 2027, and for the
            reauthorization of this part for such fiscal years, the
            Secretary shall consult with--
                      (A) the Committee on Energy and Commerce of
                    the House of Representatives;
                      (B) the Committee on Health, Education,
                    Labor, and Pensions of the Senate;
                      (C) scientific and academic experts;
                      (D) health care professionals;
                      (E) representatives of patient and consumer
                    advocacy groups; and
                      (F) the generic drug industry.
              (2) Prior public input.--Prior to beginning
            negotiations with the generic drug industry on the
            reauthorization of this part, the Secretary shall--
                      (A) publish a notice in the Federal Register
                    requesting public input on the reauthorization;
                      (B) hold a public meeting at which the public
                    may present its views on the reauthorization,
                    including specific suggestions for changes to
                    the goals referred to in subsection (a);
                      (C) provide a period of 30 days after the
                    public meeting to obtain written comments from
                    the public suggesting changes to this part; and
                      (D) publish the comments on the Food and Drug
                    Administration's Internet Web site.
              (3) Periodic consultation.--Not less frequently than
            once every month during negotiations with the generic
            drug industry, the Secretary shall hold discussions
            with representatives of patient and consumer advocacy
            groups to continue discussions of their views on the
            reauthorization and their suggestions for changes to
            this part as expressed under paragraph (2).
              (4) Public review of recommendations.--After
            negotiations with the generic drug industry, the
            Secretary shall--
                      (A) present the recommendations developed
                    under paragraph (1) to the congressional
                    committees specified in such paragraph;
                      (B) publish such recommendations in the
                    Federal Register;
                      (C) provide for a period of 30 days for the
                    public to provide written comments on such
                    recommendations;
                      (D) hold a meeting at which the public may
                    present its views on such recommendations; and
                      (E) after consideration of such public views
                    and comments, revise such recommendations as
                    necessary.
              (5) Transmittal of recommendations.--Not later than
            [January 15, 2022] January 15, 2027, the Secretary
            shall transmit to the Congress the revised
            recommendations under paragraph (4), a summary of the
            views and comments received under such paragraph, and
            any changes made to the recommendations in response to
            such views and comments.
              (6) Minutes of negotiation meetings.--
                      (A) Public availability.--Before presenting
                    the recommendations developed under paragraphs
                    (1) through (5) to the Congress, the Secretary
                    shall make publicly available, on the Internet
                    Web site of the Food and Drug Administration,
                    minutes of all negotiation meetings conducted
                    under this subsection between the Food and Drug
                    Administration and the generic drug industry.
                      (B) Content.--The minutes described under
                    subparagraph (A) shall summarize any
                    substantive proposal made by any party to the
                    negotiations as well as significant
                    controversies or differences of opinion during
                    the negotiations and their resolution.

            PART 8--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

    SEC. 744G. DEFINITIONS.

       For purposes of this part:
              [(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.]
              (1) The term ``adjustment factor'' applicable to a
            fiscal year is the Consumer Price Index for urban
            consumers (Washington-Arlington-Alexandria, DC-VA-MD-
            WV; Not Seasonally Adjusted; All items; Annual Index)
            for September of the preceding fiscal year divided by
            such Index for September 2011.
              (2) The term ``affiliate'' means a business entity
            that has a relationship with a second business entity
            if, directly or indirectly--
                      (A) one business entity controls, or has the
                    power to control, the other business entity; or
                      (B) a third party controls, or has power to
                    control, both of the business entities.
              (3) The term ``biosimilar biological product''means a
            specific strength of a biological product in final
            dosage form for which a biosimilar biological product
            application has been approved.
              (4)(A) Subject to subparagraph (B), the term
            ``biosimilar biological product application'' means an
            application for licensure of a biological product under
            section 351(k) of the Public Health Service Act.
              (B) Such term does not include--
                      (i) a supplement to such an application;
                      (ii) an application filed under section
                    351(k) of the Public Health Service Act that
                    cites as the reference product a bovine blood
                    product for topical application licensed before
                    September 1, 1992, or a large volume parenteral
                    drug product approved before such date;
                      (iii) an application filed under section
                    351(k) of the Public Health Service Act with
                    respect to--
                              (I) whole blood or a blood component
                            for transfusion;
                              [(II) an allergenic extract product;]
                              [(III)] (II) an in vitro diagnostic
                            biological product; or
                              [(IV)] (III) a biological product for
                            further manufacturing use only; or
                      (iv) an application for licensure under
                    section 351(k) of the Public Health Service Act
                    that is submitted by a State or Federal
                    Government entity for a product that is not
                    distributed commercially.
              (5) The term ``biosimilar biological product
            development meeting'' means any meeting, other than a
            biosimilar initial advisory meeting, regarding the
            content of a development program, including a proposed
            design for, or data from, a study intended to support a
            biosimilar biological product application.
              (6) The term ``biosimilar biological product
            development program'' means the program under this part
            for expediting the process for the review of
            submissions in connection with biosimilar biological
            product development.
              (7)(A) The term ``biosimilar biological product
            establishment'' means a foreign or domestic place of
            business--
                      (i) that is at one general physical location
                    consisting of one or more buildings, all of
                    which are within 5 miles of each other; and
                      (ii) at which one or more biosimilar
                    biological products are manufactured in final
                    dosage form.
              (B) For purposes of subparagraph (A)(ii), the term
            ``manufactured'' does not include packaging.
              (8) The term ``biosimilar initial advisory
            meeting''--
                      (A) means a meeting, if requested, that is
                    limited to--
                              (i) a general discussion regarding
                            whether licensure under section 351(k)
                            of the Public Health Service Act may be
                            feasible for a particular product; and
                              (ii) if so, general advice on the
                            expected content of the development
                            program; and
                      (B) does not include any meeting that
                    involves substantive review of summary data or
                    full study reports.
              (9) The term ``costs of resources allocated for the
            process for the review of biosimilar biological product
            applications'' means the expenses in connection with
            the process for the review of biosimilar biological
            product applications for--
                      (A) officers and employees of the Food and
                    Drug Administration, contractors of the Food
                    and Drug Administration, advisory committees,
                    and costs related to such officers employees
                    and committees and to contracts with such
                    contractors;
                      (B) management of information, and the
                    acquisition, maintenance, and repair of
                    computer resources;
                      (C) leasing, maintenance, renovation, and
                    repair of facilities and acquisition,
                    maintenance, and repair of fixtures, furniture,
                    scientific equipment, and other necessary
                    materials and supplies; and
                      (D) collecting fees under section 744H and
                    accounting for resources allocated for the
                    review of submissions in connection with
                    biosimilar biological product development,
                    biosimilar biological product applications, and
                    supplements.
              (10) The term ``final dosage form'' means, with
            respect to a biosimilar biological product, a finished
            dosage form which is approved for administration to a
            patient without substantial further manufacturing (such
            as lyophilized products before reconstitution).
              (11) The term ``financial hold''--
                      (A) means an order issued by the Secretary to
                    prohibit the sponsor of a clinical
                    investigation from continuing the investigation
                    if the Secretary determines that the
                    investigation is intended to support a
                    biosimilar biological product application and
                    the sponsor has failed to pay any fee for the
                    product required under subparagraph (A), (B),
                    or (D) of section 744H(a)(1); and
                      (B) does not mean that any of the bases for a
                    ``clinical hold'' under section 505(i)(3) have
                    been determined by the Secretary to exist
                    concerning the investigation.
              (12) The term ``person'' includes an affiliate of
            such person.
              (13) The term ``process for the review of biosimilar
            biological product applications'' means the following
            activities of the Secretary with respect to the review
            of submissions in connection with biosimilar biological
            product development, biosimilar biological product
            applications, and supplements:
                      (A) The activities necessary for the review
                    of submissions in connection with biosimilar
                    biological product development, biosimilar
                    biological product applications, and
                    supplements.
                      (B) Actions related to submissions in
                    connection with biosimilar biological product
                    development, the issuance of action letters
                    which approve biosimilar biological product
                    applications or which set forth in detail the
                    specific deficiencies in such applications, and
                    where appropriate, the actions necessary to
                    place such applications in condition for
                    approval.
                      (C) The inspection of biosimilar biological
                    product establishments and other facilities
                    undertaken as part of the Secretary's review of
                    pending biosimilar biological product
                    applications and supplements.
                      (D) Activities necessary for the release of
                    lots of biosimilar biological products under
                    section 351(k) of the Public Health Service
                    Act.
                      (E) Monitoring of research conducted in
                    connection with the review of biosimilar
                    biological product applications.
                      (F) Postmarket safety activities with respect
                    to biologics approved under biosimilar
                    biological product applications or supplements,
                    including the following activities:
                              (i) Collecting, developing, and
                            reviewing safety information on
                            biosimilar biological products,
                            including adverse-event reports.
                              (ii) Developing and using improved
                            adverse-event data-collection systems,
                            including information technology
                            systems.
                              (iii) Developing and using improved
                            analytical tools to assess potential
                            safety problems, including access to
                            external data bases.
                              (iv) Implementing and enforcing
                            section 505(o) (relating to
                            postapproval studies and clinical
                            trials and labeling changes) and
                            section 505(p) (relating to risk
                            evaluation and mitigation strategies).
                              (v) Carrying out section 505(k)(5)
                            (relating to adverse-event reports and
                            postmarket safety activities).
              (14) The term ``supplement'' means a request to the
            Secretary to approve a change in a biosimilar
            biological product application which has been approved,
            including a supplement requesting that the Secretary
            determine that the biosimilar biological product meets
            the standards for interchangeability described in
            section 351(k)(4) of the Public Health Service Act.

    SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL PRODUCT
                        FEES.

      (a) Types of Fees.--Beginning in [fiscal year 2018] fiscal
    year 2023, the Secretary shall assess and collect fees in
    accordance with this section as follows:
              (1) Biosimilar biological product development program
            fees.--
                      (A) Initial biosimilar biological product
                    development fee.--
                              (i) In general.--Each person that
                            submits to the Secretary a meeting
                            request described under clause (ii) or
                            a clinical protocol for an
                            investigational new drug protocol
                            described under clause (iii) shall pay
                            for the product named in the meeting
                            request or the investigational new drug
                            application the initial biosimilar
                            biological product development fee
                            established under subsection (c)(5).
                              (ii) Meeting request.--The meeting
                            request described in this clause is a
                            request for a biosimilar biological
                            product development meeting for a
                            product.
                              (iii) Clinical protocol for ind.--A
                            clinical protocol for an
                            investigational new drug protocol
                            described in this clause is a clinical
                            protocol consistent with the provisions
                            of section 505(i), including any
                            regulations promulgated under section
                            505(i), (referred to in this section as
                            ``investigational new drug
                            application'') describing an
                            investigation that the Secretary
                            determines is intended to support a
                            biosimilar biological product
                            application for a product.
                              (iv) Due date.--The initial
                            biosimilar biological product
                            development fee shall be due by the
                            earlier of the following:
                                      (I) Not later than [5 days] 7
                                    days after the Secretary grants
                                    a request for a biosimilar
                                    biological product development
                                    meeting.
                                      (II) The date of submission
                                    of an investigational new drug
                                    application describing an
                                    investigation that the
                                    Secretary determines is
                                    intended to support a
                                    biosimilar biological product
                                    application.
                              (v) Transition rule.--Each person
                            that has submitted an investigational
                            new drug application prior to the date
                            of enactment of the Biosimilar User Fee
                            Act of 2012 shall pay the initial
                            biosimilar biological product
                            development fee by the earlier of the
                            following:
                                      (I) Not later than 60 days
                                    after the date of the enactment
                                    of the Biosimilar User Fee Act
                                    of 2012, if the Secretary
                                    determines that the
                                    investigational new drug
                                    application describes an
                                    investigation that is intended
                                    to support a biosimilar
                                    biological product application.
                                      (II) Not later than [5 days]
                                    7 days after the Secretary
                                    grants a request for a
                                    biosimilar biological product
                                    development meeting.
                      (B) Annual biosimilar biological product
                    development fee.--
                              (i) In general.--A person that pays
                            an initial biosimilar biological
                            product development fee for a product
                            shall pay for such product, beginning
                            in the fiscal year following the fiscal
                            year in which the initial biosimilar
                            biological product development fee was
                            paid, an annual fee established under
                            subsection (c)(5)for the biosimilar
                            biological product development program
                            (referred to in this section as
                            ``annual biosimilar biological product
                            development fee''), except where such
                            product (including, where applicable,
                            ownership of the relevant
                            investigational new drug application)
                            is transferred to a licensee, assignee,
                            or successor of such person, and
                            written notice of such transfer is
                            provided to the Secretary, in which
                            case such licensee, assignee, or
                            successor shall pay the annual
                            biosimilar biological product
                            development fee.
                              (ii) Due date.--The annual biosimilar
                            biological product development fee for
                            each fiscal year will 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.
                              (iii) Exception.--The annual
                            biosimilar biological product
                            development fee for each fiscal year
                            will be due on the date specified in
                            clause (ii), unless the person has--
                                      (I) submitted a marketing
                                    application for the biological
                                    product that was accepted for
                                    filing; [or]
                                      (II) discontinued
                                    participation in the biosimilar
                                    biological product development
                                    program for the product under
                                    subparagraph (C)[.]; or
                                      (III) been administratively
                                    removed from the biosimilar
                                    biological product development
                                    program for the product under
                                    subparagraph (E)(v).
                              (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] is subsequently
                            accepted for filing, the person may
                            request a refund equal to the annual
                            biosimilar biological product
                            development fee paid by the person for
                            the product for such fiscal year. To
                            qualify for consideration for a refund
                            under this clause, a person shall
                            submit to the Secretary a written
                            request for such refund not later than
                            180 days after the marketing
                            application is accepted for filing.
                      (C) Discontinuation of fee obligation.--A
                    person may discontinue participation in the
                    biosimilar biological product development
                    program for a product, effective October 1 of a
                    fiscal year, by, not later than August 1 of the
                    preceding fiscal year--
                              (i) if no investigational new drug
                            application concerning the product has
                            been submitted, submitting to the
                            Secretary a written declaration that
                            the person has no present intention of
                            further developing the product as a
                            biosimilar biological product; or
                              (ii) if an investigational new drug
                            application concerning the product has
                            been submitted, withdrawing the
                            investigational new drug application in
                            accordance with part 312 of title 21,
                            Code of Federal Regulations (or any
                            successor regulations).
                      [(D) Reactivation fee.--
                              [(i) In general.--A person that has
                            discontinued participation in the
                            biosimilar biological product
                            development program for a product under
                            subparagraph (C) shall, if the person
                            seeks to resume participation in such
                            program, pay a fee (referred to in this
                            section as ``reactivation fee'') by the
                            earlier of the following:
                                      [(I) Not later than 5 days
                                    after the Secretary grants a
                                    request by such person for a
                                    biosimilar biological product
                                    development meeting for the
                                    product (after the date on
                                    which such participation was
                                    discontinued).
                                      [(II) Upon the date of
                                    submission (after the date on
                                    which such participation was
                                    discontinued) by such person of
                                    an investigational new drug
                                    application describing an
                                    investigation that the
                                    Secretary determines is
                                    intended to support a
                                    biosimilar biological product
                                    application for that product.
                              [(ii) Application of annual fee.--A
                            person that pays a reactivation fee for
                            a product shall pay for such product,
                            beginning in the next fiscal year, the
                            annual biosimilar biological product
                            development fee under subparagraph
                            (B).]
                      (D) Reactivation fee.--
                              (i) In general.--A person that has
                            discontinued participation in the
                            biosimilar biological product
                            development program for a product under
                            subparagraph (C), or who has been
                            administratively removed from the
                            biosimilar biological product
                            development program for a product under
                            subparagraph (E)(v), shall, if the
                            person seeks to resume participation in
                            such program, pay all annual biosimilar
                            biological product development fees
                            previously assessed for such product
                            and still owed and a fee (referred to
                            in this section as ``reactivation
                            fee'') by the earlier of the following:
                                      (I) Not later than 7 days
                                    after the Secretary grants a
                                    request by such person for a
                                    biosimilar biological product
                                    development meeting for the
                                    product (after the date on
                                    which such participation was
                                    discontinued or the date of
                                    administrative removal, as
                                    applicable).
                                      (II) Upon the date of
                                    submission (after the date on
                                    which such participation was
                                    discontinued or the date of
                                    administrative removal, as
                                    applicable) by such person of
                                    an investigational new drug
                                    application describing an
                                    investigation that the
                                    Secretary determines is
                                    intended to support a
                                    biosimilar biological product
                                    application for that product.
                              (ii) Application of annual fee.--A
                            person that pays a reactivation fee for
                            a product shall pay for such product,
                            beginning in the next fiscal year, the
                            annual biosimilar biological product
                            development fee under subparagraph (B),
                            except where such product (including,
                            where applicable, ownership of the
                            relevant investigational new drug
                            application) is transferred to a
                            licensee, assignee, or successor of
                            such person, and written notice of such
                            transfer is provided to the Secretary,
                            in which case such licensee, assignee,
                            or successor shall pay the annual
                            biosimilar biological product
                            development fee.
                      (E) Effect of failure to pay fees.--
                              (i) No biosimilar biological product
                            development meetings.--If a person has
                            failed to pay an initial or annual
                            biosimilar biological product
                            development fee as required under
                            subparagraph (A) or (B), or a
                            reactivation fee as required under
                            subparagraph (D), the Secretary shall
                            not provide a biosimilar biological
                            product development meeting relating to
                            the product for which fees are owed.
                              (ii) No receipt of investigational
                            new drug applications.--Except in
                            extraordinary circumstances, the
                            Secretary shall not consider an
                            investigational new drug application to
                            have been received under section
                            505(i)(2) if--
                                      (I) the Secretary determines
                                    that the investigation is
                                    intended to support a
                                    biosimilar biological product
                                    application; and
                                      (II) the sponsor has failed
                                    to pay an initial or annual
                                    biosimilar biological product
                                    development fee for the product
                                    as required under subparagraph
                                    (A) or (B), or a reactivation
                                    fee as required under
                                    subparagraph (D).
                              (iii) Financial hold.--
                            Notwithstanding section 505(i)(2),
                            except in extraordinary circumstances,
                            the Secretary shall prohibit the
                            sponsor of a clinical investigation
                            from continuing the investigation if--
                                      (I) the Secretary determines
                                    that the investigation is
                                    intended to support a
                                    biosimilar biological product
                                    application; and
                                      (II) the sponsor has failed
                                    to pay an initial or annual
                                    biosimilar biological product
                                    development fee for the product
                                    as required under subparagraph
                                    (A) or (B), or a reactivation
                                    fee for the product as required
                                    under subparagraph (D).
                              (iv) No acceptance of biosimilar
                            biological product applications or
                            supplements.--If a person has failed to
                            pay an initial or annual biosimilar
                            biological product development fee as
                            required under subparagraph (A) or (B),
                            or a reactivation fee as required under
                            subparagraph (D), any biosimilar
                            biological product application or
                            supplement submitted by that person
                            shall be considered incomplete and
                            shall not be accepted for filing by the
                            Secretary until all such fees owed by
                            such person have been paid.
                              (v) Administrative removal from the
                            biosimilar biological product
                            development program.--If a person has
                            failed to pay an annual biosimilar
                            biological product development fee for
                            a product as required under
                            subparagraph (B) for a period of two
                            consecutive fiscal years, the Secretary
                            may administratively remove such person
                            from the biosimilar biological product
                            development program for the product. At
                            least 30 days prior to administratively
                            removing a person from the biosimilar
                            biological product development program
                            for a product under this clause, the
                            Secretary shall provide written notice
                            to such person of the intended
                            administrative removal.
                      (F) Limits regarding fees.--
                              (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).
                              (ii) No waivers, exemptions, or
                            reductions.--The Secretary shall not
                            grant a waiver, exemption, or reduction
                            of any initial or annual biosimilar
                            biological product development fee due
                            or payable under subparagraph (A) or
                            (B), or any reactivation fee due or
                            payable under subparagraph (D).
              (2) Biosimilar biological product application fee.--
                      (A) In general.--Each person that submits, on
                    or after October 1, 2017, a biosimilar
                    biological product application shall be subject
                    to the following fees:
                              (i) A fee established under
                            subsection (c)(5) for a biosimilar
                            biological product application for
                            which clinical data (other than
                            comparative bioavailability studies)
                            with respect to safety or effectiveness
                            are required for approval.
                              (ii) A fee established under
                            subsection (c)(5) for a biosimilar
                            biological product application for
                            which clinical data (other than
                            comparative bioavailability studies)
                            with respect to safety or effectiveness
                            are not required for approval. Such fee
                            shall be equal to half of the amount of
                            the fee described in clause (i).
                      (B) Rule of applicability; treatment of
                    certain previously paid fees.--Any person who
                    pays a fee under subparagraph (A), (B), or (D)
                    of paragraph (1) for a product before October
                    1, 2017, but submits a biosimilar biological
                    product application for that product after such
                    date, shall--
                              (i) be subject to any biosimilar
                            biological product application fees
                            that may be assessed at the time when
                            such biosimilar biological product
                            application is submitted; and
                              (ii) be entitled to no reduction of
                            such application fees based on the
                            amount of fees paid for that product
                            before October 1, 2017, under such
                            subparagraph (A), (B), or (D).
                      (C) Payment due date.--Any fee required by
                    subparagraph (A) shall be due upon submission
                    of the application for which such fee applies.
                      (D) Exception for previously filed
                    application.--If a biosimilar biological
                    product application was submitted by a person
                    that paid the fee for such application, was
                    accepted for filing, and was not approved or
                    was withdrawn prior to approval (without a
                    waiver), the submission of a biosimilar
                    biological product application for the same
                    product by the same person (or the person's
                    licensee, assignee, or successor) shall not be
                    subject to a fee under subparagraph (A).
                      (E) Refund of application fee if application
                    refused for filing or withdrawn before
                    filing.--The Secretary shall refund 75 percent
                    of the fee paid under this paragraph for any
                    application which is refused for filing or
                    withdrawn without a waiver before filing.
                      (F) Fees for applications previously refused
                    for filing or withdrawn before filing.--A
                    biosimilar biological product application that
                    was submitted but was refused for filing, or
                    was withdrawn before being accepted or refused
                    for filing, shall be subject to the full fee
                    under subparagraph (A) upon being resubmitted
                    or filed over protest, unless the fee is waived
                    under subsection (d).
              (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) may be dispensed only under
                            prescription pursuant to section
                            503(b); and
                              [(ii)] (iii) as of October 1 of such
                            fiscal year, does not appear on a list,
                            developed and maintained by the
                            Secretary, of discontinued biosimilar
                            biological products.
                      (B) Due date.--The biosimilar biological
                    product program fee for a fiscal year shall be
                    due on the later of--
                              (i) the first business day on or
                            after October 1 of each such year; or
                              (ii) the first business day after the
                            enactment of an appropriations Act
                            providing for the collection and
                            obligation of fees for such year under
                            this section.
                      (C) One fee per product per year.--The
                    biosimilar biological product program fee shall
                    be paid only once for each product for each
                    fiscal year.
                      (D) Limitation.--A person who is named as the
                    applicant in a biosimilar biological product
                    application shall not be assessed more than 5
                    biosimilar biological product program fees for
                    a fiscal year for biosimilar biological
                    products identified in such biosimilar
                    biological product application.
                      (E) Movement to discontinued list.--
                              (i) Date of inclusion.--If a written
                            request to place a product on the list
                            referenced in subparagraph (A) of
                            discontinued biosimilar biological
                            products is submitted to the Secretary
                            on behalf of an applicant, and the
                            request identifies the date the product
                            is withdrawn from sale, then for
                            purposes of assessing the biosimilar
                            biological product program fee, the
                            Secretary shall consider such product
                            to have been included on such list on
                            the later of--
                                      (I) the date such request was
                                    received; or
                                      (II) if the product will be
                                    withdrawn from sale on a future
                                    date, such future date when the
                                    product is withdrawn from sale.
                              (ii) Treatment as withdrawn from
                            sale.--For purposes of clause (i), a
                            product shall be considered withdrawn
                            from sale once the applicant has ceased
                            its own distribution of the product,
                            whether or not the applicant has
                            ordered recall of all previously
                            distributed lots of the product, except
                            that a routine, temporary interruption
                            in supply shall not render a product
                            withdrawn from sale.
                              (iii) Special rule.--If a biosimilar
                            biological product that is identified
                            in a biosimilar biological product
                            application approved as of October 1 of
                            a fiscal year appears, as of October 1
                            of such fiscal year, on the list
                            referenced in subparagraph (A) of
                            discontinued biosimilar biological
                            products, and on any subsequent day
                            during such fiscal year the biosimilar
                            biological product does not appear on
                            such list, then except as provided in
                            subparagraph (D), each person who is
                            named as the applicant in a biosimilar
                            biological product application with
                            respect to such product shall pay the
                            annual biosimilar biological product
                            program fee established for a fiscal
                            year under subsection (c)(5) for such
                            biosimilar biological product.
                            Notwithstanding subparagraph (B), such
                            fee shall be due on the last business
                            day of such fiscal year and shall be
                            paid only once for each such product
                            for each fiscal year.
              [(4) Biosimilar biological product fee.--
                      [(A) In general.--Each person who is named as
                    the applicant in a biosimilar biological
                    product application shall pay for each such
                    biosimilar biological product the annual fee
                    established under subsection (c)(5).
                      [(B) Due date.--The biosimilar biological
                    product 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 fee shall be paid
                    only once for each product for each fiscal
                    year.]
      (b) Fee Revenue Amounts.--
              [(1) Fiscal year 2018.--For fiscal year 2018, fees
            under subsection (a) shall be established to generate a
            total revenue amount equal to the sum of--
                      [(A) $45,000,000; and
                      [(B) the dollar amount equal to the fiscal
                    year 2018 adjustment (as determined under
                    subsection (c)(4)).
              [(2) Subsequent fiscal years.--For each of the fiscal
            years 2019 through 2022, fees under subsection (a)
            shall, except as provided in subsection (c), be
            established to generate a total revenue amount equal to
            the sum of--
                      [(A) the annual base revenue for the fiscal
                    year (as determined under paragraph (4));
                      [(B) the dollar amount equal to the inflation
                    adjustment for the fiscal year (as determined
                    under subsection (c)(1));
                      [(C) the dollar amount equal to the capacity
                    planning adjustment for the fiscal year (as
                    determined under subsection (c)(2)); and
                      [(D) the dollar amount equal to the operating
                    reserve adjustment for the fiscal year, if
                    applicable (as determined under subsection
                    (c)(3)).]
              (1) In general.--For each of the fiscal years 2023
            through 2027, 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 (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 strategic
                    hiring and retention adjustment (as determined
                    under subsection (c)(2));
                      (D) the dollar amount equal to the capacity
                    planning adjustment for the fiscal year (as
                    determined under subsection (c)(3));
                      (E) the dollar amount equal to the operating
                    reserve adjustment for the fiscal year, if
                    applicable (as determined under subsection
                    (c)(4));
                      (F) for fiscal year 2023 an additional amount
                    of $4,428,886; and
                      (G) for fiscal year 2024 an additional amount
                    of $320,569.
              [(3)] (2) Allocation of revenue amount among fees[;
            limitations on fee amounts].--
                      (A) Allocation.--The Secretary shall
                    determine the percentage of the total revenue
                    amount for a fiscal year to be derived from,
                    respectively--
                              (i) initial and annual biosimilar
                            biological product development fees and
                            reactivation fees under subsection
                            (a)(1);
                              (ii) biosimilar biological product
                            application fees under subsection
                            (a)(2); and
                              (iii) biosimilar biological product
                            program fees under subsection (a)(3).
                      [(B) Limitations on fee amounts.--Until the
                    first fiscal year for which the capacity
                    planning adjustment under subsection (c)(2) is
                    effective, the amount of any fee under
                    subsection (a) for a fiscal year after fiscal
                    year 2018 shall not exceed 125 percent of the
                    amount of such fee for fiscal year 2018.]
                      [(C)] (B) 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)] (C) 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).]
              (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 2023, $43,376,922; and
                      (B) for fiscal years 2024 through 2027, the
                    dollar amount of the total revenue amount
                    established under paragraph (1) for the
                    previous fiscal year, excluding any adjustments
                    to such revenue amount under subsection (c)(4).
      (c) Adjustments; Annual Fee Setting.--
              (1) Inflation adjustment.--
                      (A) In general.--For purposes of [subsection
                    (b)(2)(B)] 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)]
                            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 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]
                            Washington-Arlington-Alexandria, DC-VA-
                            MD-WV; Not Seasonally Adjusted; All
                            items; Annual Index) for the first 3
                            years of the preceding 4 years of
                            available data multiplied by the
                            proportion of all costs other than
                            personnel compensation and benefits
                            costs to total costs of the process for
                            the review of biosimilar biological
                            product applications (as defined in
                            section 744G(13)) for the first 3 years
                            of the preceding 4 fiscal years.
              [(2) Capacity planning adjustment.--
                      [(A) In general.--Beginning with the fiscal
                    year described in subparagraph (B)(ii)(II), the
                    Secretary shall, in addition to the adjustment
                    under paragraph (1), further increase the fee
                    revenue and fees under this section for a
                    fiscal year to reflect changes in the resource
                    capacity needs of the Secretary for the process
                    for the review of biosimilar biological product
                    applications.
                      [(B) Capacity planning methodology.--
                              [(i) Development; evaluation and
                            report.--The Secretary shall obtain,
                            through a contract with an independent
                            accounting or consulting firm, a report
                            evaluating options and recommendations
                            for a new methodology to accurately
                            assess changes in the resource and
                            capacity needs of the process for the
                            review of biosimilar biological product
                            applications. The capacity planning
                            methodological options and
                            recommendations presented in such
                            report shall utilize and be informed by
                            personnel time reporting data as an
                            input. The report shall be published
                            for public comment not later than
                            September 30, 2020.
                              [(ii) Establishment and
                            implementation.--After review of the
                            report described in clause (i) and
                            receipt and review of public comments
                            thereon, the Secretary shall establish
                            a capacity planning methodology for
                            purposes of this paragraph, which
                            shall--
                                      [(I) incorporate such
                                    approaches and attributes as
                                    the Secretary determines
                                    appropriate; and
                                      [(II) be effective beginning
                                    with the first fiscal year for
                                    which fees are set after such
                                    capacity planning methodology
                                    is established.
                      [(C) Limitation.--Under no circumstances
                    shall an adjustment under this paragraph result
                    in fee revenue for a fiscal year that is less
                    than the sum of the amounts under subsections
                    (b)(2)(A) (the annual base revenue for the
                    fiscal year) and (b)(2)(B) (the dollar amount
                    of the inflation adjustment for the fiscal
                    year).
                      [(D) Publication in federal register.--The
                    Secretary shall publish in the Federal Register
                    notice under paragraph (5) the fee revenue and
                    fees resulting from the adjustment and the
                    methodologies under this paragraph.
              [(3) Operating reserve adjustment.--
                      [(A) Interim application; fee reduction.--
                    Until the first fiscal year for which the
                    capacity planning adjustment under paragraph
                    (2) is effective, the Secretary may, in
                    addition to the adjustment under paragraph (1),
                    reduce the fee revenue and fees under this
                    section for a fiscal year as the Secretary
                    determines appropriate for long-term financial
                    planning purposes.
                      [(B) General application and methodology.--
                    Beginning with the first fiscal year for which
                    the capacity planning adjustment under
                    paragraph (2) is effective, the Secretary may,
                    in addition to the adjustments under paragraphs
                    (1) and (2)--
                              [(i) reduce the fee revenue and fees
                            under this section as the Secretary
                            determines appropriate for long-term
                            financial planning purposes; or
                              [(ii) increase the fee revenue and
                            fees under this section if such an
                            adjustment is necessary to provide for
                            not more than 21 weeks of operating
                            reserves of carryover user fees for the
                            process for the review of biosimilar
                            biological product applications.
                      [(C) Federal register notice.--If an
                    adjustment under subparagraph (A) or (B) is
                    made, the rationale for the amount of the
                    increase or decrease (as applicable) in fee
                    revenue and fees shall be contained in the
                    annual Federal Register notice under paragraph
                    (5)(B) establishing fee revenue and fees for
                    the fiscal year involved.
              [(4) Fiscal year 2018 adjustment.--
                      [(A) In general.--For fiscal year 2018, the
                    Secretary shall adjust the fee revenue and fees
                    under this section in such amount (if any) as
                    needed to reflect an updated assessment of the
                    workload for the process for the review of
                    biosimilar biological product applications.
                      [(B) Methodology.--The Secretary shall
                    publish under paragraph (5)(B) a description of
                    the methodology used to calculate the fiscal
                    year 2018 adjustment under this paragraph in
                    the Federal Register notice establishing fee
                    revenue and fees for fiscal year 2018.
                      [(C) Limitation.--No adjustment under this
                    paragraph shall result in an increase in fee
                    revenue and fees under this section in excess
                    of $9,000,000.]
              (2) Strategic hiring and retention adjustment.--For
            each fiscal year, after the annual base revenue under
            subsection (b)(1)(A) is adjusted for inflation in
            accordance with paragraph (1), the Secretary shall
            further increase the fee revenue and fees by $150,000.
              (3) Capacity planning adjustment.--
                      (A) In general.--For each fiscal year, the
                    Secretary shall, in addition to the adjustments
                    under paragraphs (1) and (2), further adjust
                    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) Methodology.--For purposes of this
                    paragraph, the Secretary shall employ the
                    capacity planning methodology utilized by the
                    Secretary in setting fees for fiscal year 2021,
                    as described in the notice titled ``Biosimilar
                    User Fee Rates for Fiscal Year 2021'' published
                    in the Federal Register on August 4, 2020 (85
                    Fed. Reg. 47220). The workload categories used
                    in applying such methodology in forecasting
                    shall include only the activities described in
                    that notice and, as feasible, additional
                    activities that are also directly related to
                    the direct review of biosimilar biological
                    product applications and supplements, including
                    additional formal meeting types, the direct
                    review of postmarketing commitments and
                    requirements, the direct review of risk
                    evaluation and mitigation strategies, and the
                    direct review of annual reports for approved
                    biosimilar biological products. Subject to the
                    exceptions in the preceding sentence, the
                    Secretary shall not include as workload
                    categories in applying such methodology in
                    forecasting any non-core review activities,
                    including those activities that the Secretary
                    referenced for potential future use in such
                    notice but did not utilize in setting fees for
                    fiscal year 2021.
                      (C) Limitations.--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), (b)(1)(B) (the dollar amount of
                    the inflation adjustment for the fiscal year),
                    and (b)(1)(C) (the dollar amount of the
                    strategic hiring and retention adjustment).
                      (D) Publication in federal register.--The
                    Secretary shall publish in the Federal Register
                    notice under paragraph (5) the fee revenue and
                    fees resulting from the adjustment and the
                    methodologies under this paragraph.
              (4) Operating reserve adjustment.--
                      (A) Increase.--For fiscal year 2023 and
                    subsequent fiscal years, the Secretary shall,
                    in addition to adjustments under paragraphs
                    (1), (2), and (3), further increase the fee
                    revenue and fees if such an adjustment is
                    necessary to provide for at least 10 weeks of
                    operating reserves of carryover user fees for
                    the process for the review of biosimilar
                    biological product applications.
                      (B) Decrease.--
                              (i) Fiscal year 2023.--For fiscal
                            year 2023, if the Secretary has
                            carryover balances for such process in
                            excess of 33 weeks of such operating
                            reserves, the Secretary shall decrease
                            such fee revenue and fees to provide
                            for not more than 33 weeks of such
                            operating reserves.
                              (ii) Fiscal year 2024.--For fiscal
                            year 2024, if the Secretary has
                            carryover balances for such process in
                            excess of 27 weeks of such operating
                            reserves, the Secretary shall decrease
                            such fee revenue and fees to provide
                            for not more than 27 weeks of such
                            operating reserves.
                              (iii) Fiscal year 2025 and subsequent
                            fiscal years.--For fiscal year 2025 and
                            subsequent fiscal years, if the
                            Secretary has carryover balances for
                            such process in excess of 21 weeks of
                            such operating reserves, the Secretary
                            shall decrease such fee revenue and
                            fees to provide for not more than 21
                            weeks of such operating reserves.
                      (C) Federal register notice.--If an
                    adjustment under subparagraph (A) or (B) is
                    made, the rationale for the amount of the
                    increase or decrease 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.
              (5) Annual fee setting.--For fiscal year [2018] 2023
            and each subsequent fiscal year, the Secretary shall,
            not later than 60 days before the start of each such
            fiscal year--
                      (A) establish, for the fiscal year, initial
                    and annual biosimilar biological product
                    development fees and reactivation fees under
                    subsection (a)(1), biosimilar biological
                    product application fees under subsection
                    (a)(2), and biosimilar biological product
                    program fees under subsection (a)(3), based on
                    the revenue amounts established under
                    subsection (b) and the adjustments provided
                    under this subsection; and
                      (B) publish such fee revenue and fees in the
                    Federal Register.
              (6) Limit.--The total amount of fees assessed for a
            fiscal year under this section may not exceed the total
            costs for such fiscal year for the resources allocated
            for the process for the review of biosimilar biological
            product applications.
      (d) Application Fee Waiver for Small Business.--
              (1) Waiver of application fee.--The Secretary shall
            grant to a person who is named in a biosimilar
            biological product application a waiver from the
            application fee assessed to that person under
            subsection (a)(2)(A) for the first biosimilar
            biological product application that a small business or
            its affiliate submits to the Secretary for review.
            After a small business or its affiliate is granted such
            a waiver, the small business or its affiliate shall pay
            application fees for all subsequent biosimilar
            biological product applications submitted to the
            Secretary for review in the same manner as an entity
            that is not a small business.
              (2) Considerations.--In determining whether to grant
            a waiver of a fee under paragraph (1), the Secretary
            shall consider only the circumstances and assets of the
            applicant involved and any affiliate of the applicant.
              (3) Small business defined.--In this subsection, the
            term ``small business'' means an entity that has fewer
            than 500 employees, including employees of affiliates,
            and does not have a drug product that has been approved
            under a human drug application (as defined in section
            735) or a biosimilar biological product application (as
            defined in section 744G(4)) and introduced or delivered
            for introduction into interstate commerce.
      (e) Effect of Failure To Pay Fees.--A biosimilar biological
    product application or supplement submitted by a person subject
    to fees under subsection (a) shall be considered incomplete and
    shall not be accepted for filing by the Secretary until all
    such fees owed by such person have been paid.
      (f) Crediting and Availability of Fees.--
              (1) In general.--Subject to paragraph (2), fees
            authorized under subsection (a) shall be collected and
            available for obligation only to the extent and in the
            amount provided in advance in appropriations Acts. Such
            fees are authorized to remain available until expended.
            Such sums as may be necessary may be transferred from
            the Food and Drug Administration salaries and expenses
            appropriation account without fiscal year limitation to
            such appropriation account for salaries and expenses
            with such fiscal year limitation. The sums transferred
            shall be available solely for the process for the
            review of biosimilar biological product applications.
              (2) Collections and appropriation acts.--
                      (A) In general.--Subject to subparagraphs (C)
                    and (D), the fees authorized by this section
                    shall be collected and available in each fiscal
                    year in an amount not to exceed the amount
                    specified in appropriation Acts, or otherwise
                    made available for obligation for such fiscal
                    year.
                      (B) Use of fees and limitations.--
                              (i) In general.--The fees authorized
                            by this section shall be available for
                            a fiscal year beginning after fiscal
                            year 2012 to defray the costs of the
                            process for the review of biosimilar
                            biological product applications
                            (including such costs for an additional
                            number of full-time equivalent
                            positions in the Department of Health
                            and Human Services to be engaged in
                            such process), only if the Secretary
                            allocates for such purpose an amount
                            for such fiscal year (excluding amounts
                            from fees collected under this section)
                            no less than $20,000,000, multiplied by
                            the adjustment factor applicable to the
                            fiscal year involved.
                              (ii) Leasing and necessary
                            equipment.--Beginning on October 1,
                            2023, the authorities under section
                            744G(9)(C) shall include only leasing
                            and necessary scientific equipment.
                      (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.
                      (D) Provision for early payments.--Payment of
                    fees authorized under this section for a fiscal
                    year, prior to the due date for such fees, may
                    be accepted by the Secretary in accordance with
                    authority provided in advance in a prior year
                    appropriations Act.
              (3) Authorization of appropriations.--For each of
            fiscal years [2018 through 2022] 2023 through 2027,
            there is authorized to be appropriated for fees under
            this section an amount equivalent to the total amount
            of fees assessed for such fiscal year under this
            section.
      (g) Collection of Unpaid Fees.--In any case where the
    Secretary does not receive payment of a fee assessed under
    subsection (a) within 30 days after it is due, such fee shall
    be treated as a claim of the United States Government subject
    to subchapter II of chapter 37 of title 31, United States Code.
      [(h) Written Requests for Waivers and Refunds.--To qualify
    for consideration for a waiver under subsection (d), or for a
    refund of any fee collected in accordance with subsection
    (a)(2)(A), a person shall submit to the Secretary a written
    request for such waiver or refund not later than 180 days after
    such fee is due.]
      (h) Written Requests for Waivers and Returns; Disputes
    Concerning Fees.--To qualify for consideration for a waiver
    under subsection (d), or for the return of any fee paid under
    this section, including if the fee is claimed to have been paid
    in error, a person shall submit to the Secretary a written
    request justifying such waiver or return and, except as
    otherwise specified in this section, such written request shall
    be submitted to the Secretary not later than 180 days after
    such fee is due. A request submitted under this paragraph shall
    include any legal authorities under which the request is made.
      (i) Construction.--This section may not be construed to
    require that the number of full-time equivalent positions in
    the Department of Health and Human Services, for officers,
    employers, and advisory committees not engaged in the process
    of the review of biosimilar biological product applications, be
    reduced to offset the number of officers, employees, and
    advisory committees so engaged.

    SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.

      (a) Performance Report.--
              (1) General requirements.--[Beginning with fiscal
            year 2018, not] Not later than 120 days after the end
            of each fiscal year for which fees are collected under
            this part, the Secretary shall prepare and 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 concerning
            the progress of the Food and Drug Administration in
            achieving the goals identified in the letters described
            in section 401(b) of the [Biosimilar User Fee
            Amendments of 2017] Biosimilar User Fee Amendments of
            2022 during such fiscal year and the future plans of
            the Food and Drug Administration for meeting such
            goals. The report for a fiscal year shall include
            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.
              (2) Additional information.--[Beginning with fiscal
            year 2018, the] 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] Not later than 30
                    calendar days after the end of each quarter of
                    each fiscal year for which fees are collected
                    under this part, 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] Biosimilar User Fee Amendments of
                            2022.
                              (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] Biosimilar User Fee
                            Amendments of 2022.
              (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] Biosimilar User Fee
                    Amendments of 2022 and the number of full time
                    equivalents funded by budget authority at the
                    Food and Drug Administration by each division
                    within the Center for Drug Evaluation and
                    Research, the Center for Biologics Evaluation
                    and Research, the Office of Regulatory Affairs,
                    and the Office of the Commissioner;
                      (B) data, analysis, and discussion of the
                    changes in the fee revenue amounts and costs
                    for the process for the review of biosimilar
                    biological product applications, including
                    identifying drivers of such changes; and
                      (C) for each of the Center for Drug
                    Evaluation and Research, the Center for
                    Biologics Evaluation and Research, the Office
                    of Regulatory Affairs, and the Office of the
                    Commissioner, the number of employees for whom
                    time reporting is required and the number of
                    employees for whom time reporting is not
                    required.
              (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] Biosimilar User Fee Amendments
                            of 2022 for the applicable fiscal year.
                      (B) Relevant data to determine whether the
                    Center for Drug Evaluation and Research and the
                    Center for Biologics Evaluation and Research
                    have met the performance enhancement goals
                    identified by the letters described in section
                    401(b) of the [Biosimilar User Fee Amendments
                    of 2017] Biosimilar User Fee Amendments of 2022
                    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.
      (b) Fiscal Report.--[Not later than 120 days after the end of
    fiscal year 2018 and each subsequent fiscal year for which fees
    are collected under this part] Not later than 120 days after
    the end of each fiscal year for which fees are collected under
    this part, the Secretary shall prepare and submit to the
    Committee on Energy and Commerce of the House of
    Representatives and the Committee on Health, Education, Labor,
    and Pensions of the Senate a report on the implementation of
    the authority for such fees during such fiscal year and the
    use, by the Food and Drug Administration, of the fees collected
    for such fiscal year.
      (c) Corrective Action Report.--[Beginning with fiscal year
    2018, and for] For each fiscal year for which fees are
    collected under this part, the Secretary shall prepare and
    submit a corrective action report to the Committee on Energy
    and Commerce and Committee on Appropriations of the House of
    Representatives and the Committee on Health, Education, Labor,
    and Pensions and Committee on Appropriations of the Senate. The
    report shall include the following information, as applicable:
              (1) Goals met.--For each fiscal year, if the
            Secretary determines, based on the analysis under
            subsection (a)(5), that each of the goals identified by
            the letters described in section 401(b) of the
            [Biosimilar User Fee Amendments of 2017] Biosimilar
            User Fee Amendments of 2022 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] Biosimilar
            User Fee Amendments of 2022 for the applicable fiscal
            year that the Secretary determines to not have been
            met, the corrective action report shall include--
                      (A) a justification for such determination
                    and a description of the types of circumstances
                    and trends, as applicable, under which
                    biosimilar biological product applications
                    missed the review goal times but were approved
                    during the first cycle review, or review goals
                    were missed; and
                      (B) with respect to performance enhancement
                    goals that were not achieved, a description of
                    efforts the Food and Drug Administration has
                    put in place for the fiscal year in which the
                    report is submitted to improve the ability of
                    such agency to meet each such goal for the such
                    fiscal year.
      (d) Enhanced Communication.--
              (1) Communications with congress.--Each fiscal year,
            as applicable and requested, representatives from the
            Centers with expertise in the review of human drugs
            shall meet with representatives from the Committee on
            Health, Education, Labor, and Pensions of the Senate
            and the Committee on Energy and Commerce of the House
            of Representatives to report on the contents described
            in the reports under this section.
              (2) Participation in congressional hearing.--Each
            fiscal year, as applicable and requested,
            representatives from the Food and Drug Administration
            shall participate in a public hearing before the
            Committee on Health, Education, Labor, and Pensions of
            the Senate and the Committee on Energy and Commerce of
            the House of Representatives, to report on the contents
            described in the reports under this section. Such
            hearing shall occur not later than 120 days after the
            end of each fiscal year for which fees are collected
            under this part.
      (e) Public Availability.--The Secretary shall make the
    reports required under subsections (a) and (b) available to the
    public on the Internet Web site of the Food and Drug
    Administration.
      (f) Reauthorization.--
              (1) Consultation.--In developing recommendations to
            present to the Congress with respect to the goals
            described in subsection (a), and plans for meeting the
            goals, for the process for the review of biosimilar
            biological product applications for the first 5 fiscal
            years after [fiscal year 2022] fiscal year 2027, and
            for the reauthorization of this part for such fiscal
            years, the Secretary shall consult with--
                      (A) the Committee on Energy and Commerce of
                    the House of Representatives;
                      (B) the Committee on Health, Education,
                    Labor, and Pensions of the Senate;
                      (C) scientific and academic experts;
                      (D) health care professionals;
                      (E) representatives of patient and consumer
                    advocacy groups; and
                      (F) the regulated industry.
              (2) Public review of recommendations.--After
            negotiations with the regulated industry, the Secretary
            shall--
                      (A) present the recommendations developed
                    under paragraph (1) to the congressional
                    committees specified in such paragraph;
                      (B) publish such recommendations in the
                    Federal Register;
                      (C) provide for a period of 30 days for the
                    public to provide written comments on such
                    recommendations;
                      (D) hold a meeting at which the public may
                    present its views on such recommendations; and
                      (E) after consideration of such public views
                    and comments, revise such recommendations as
                    necessary.
              (3) Transmittal of recommendations.--Not later than
            [January 15, 2022] January 15, 2027, the Secretary
            shall transmit to the Congress the revised
            recommendations under paragraph (2), a summary of the
            views and comments received under such paragraph, and
            any changes made to the recommendations in response to
            such views and comments.

               *       *       *       *       *       *       *

    CHAPTER VIII--IMPORTS AND EXPORTS

               *       *       *       *       *       *       *

    SEC. 809. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.

      (a) Inspection.--The Secretary--
              (1) may enter into arrangements and agreements with a
            foreign government or an agency of a foreign government
            to recognize the inspection of foreign establishments
            registered under section 510(i) in order to facilitate
            preapproval or risk-based inspections in accordance
            with the schedule established in paragraph (2) or (3)
            of section 510(h);
              (2) may enter into arrangements and agreements with a
            foreign government or an agency of a foreign government
            under this section only with a foreign government or an
            agency of a foreign government that the Secretary has
            determined as having the capability of conducting
            inspections that meet the applicable requirements of
            this Act; and
              (3) shall perform such reviews and audits of drug
            safety programs, systems, and standards of a foreign
            government or agency for the foreign government as the
            Secretary deems necessary to determine that the foreign
            government or agency of the foreign government is
            capable of conducting inspections that meet the
            applicable requirements of this Act.
      (b) Results of Inspection.--The results of inspections
    performed by a foreign government or an agency of a foreign
    government under this section may be used as--
              (1) evidence of compliance with section 501(a)(2)(B)
            or section 801(r); and
              (2) for any other purposes as determined appropriate
            by the Secretary.
      (c) Periodic Review.--
              (1) In general.--Beginning not later than 1 year
            after the date of the enactment of the Food and Drug
            Amendments of 2022, the Secretary shall periodically
            assess whether additional arrangements and agreements
            with a foreign government or an agency of a foreign
            government, as allowed under this section, are
            appropriate.
              (2) Reports to congress.--Beginning not later than 4
            years after the date of the enactment of the Food and
            Drug Amendments of 2022, and every 4 years 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 describing the findings and
            conclusions of each review conducted under paragraph
            (1).

               *       *       *       *       *       *       *

                                  ----------

                        FDA REAUTHORIZATION ACT OF 2017

               *       *       *       *       *       *       *
    TITLE I--FEES RELATING TO DRUGS

               *       *       *       *       *       *       *

    SEC. 104. SUNSET DATES.

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

               *       *       *       *       *       *       *

    TITLE II--FEES RELATING TO DEVICES

               *       *       *       *       *       *       *

    SEC. 210. SUNSET DATES.

      [(a) Authorization.--Sections 737 and 738 of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease
    to be effective October 1, 2022.
      [(b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-1)
    of the Federal Food, Drug, and Cosmetic Act (regarding
    reauthorization and reporting requirements) shall cease to be
    effective January 31, 2023.]
      (c) Previous Sunset Provision.--Effective October 1, 2017,
    section 207(a) of the Food and Drug Administration Safety and
    Innovation Act (Public Law 112-144) is repealed.

    TITLE III--FEES RELATING TO GENERIC DRUGS

               *       *       *       *       *       *       *

    SEC. 305. SUNSET DATES.

      [(a) Authorization.--Sections 744A and 744B of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall
    cease to be effective October 1, 2022.
      [(b) Reporting Requirements.--Section 744C of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43) shall cease to
    be effective January 31, 2023.]
      (c) Previous Sunset Provision.--
              (1) In general.--Effective October 1, 2017, section
            304 of the Food and Drug Administration Safety and
            Innovation Act (Public Law 112-144) is repealed.
              (2) Conforming amendment.--The Food and Drug
            Administration Safety and Innovation Act (Public Law
            112-144) is amended in the table of contents in section
            2 by striking the item relating to section 304.

               *       *       *       *       *       *       *

    TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

               *       *       *       *       *       *       *

    SEC. 405. SUNSET DATES.

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

               *       *       *       *       *       *       *

    TITLE VIII--IMPROVING GENERIC DRUG ACCESS

               *       *       *       *       *       *       *

    SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY
                        REVIEW APPLICATIONS.

      Not later than 180 calendar days after the date of enactment
    of this Act, and quarterly thereafter until October 1, [2022]
    2027, the Secretary of Health and Human Services shall post on
    the internet website of the Food and Drug Administration a
    report that provides, with respect to the months covered by the
    report--
              (1) with respect to applications filed under section
            505(j) of the Federal Food, Drug, and Cosmetic Act (21
            U.S.C. 355(j)) that, during the most recent calendar
            year, were subject to priority review under paragraph
            (11) of such section 505(j) (as added by section 801)
            or expedited development and review under section 506H
            of the Federal Food, Drug, and Cosmetic Act (as added
            by section 803), the numbers of such applications (with
            denotation of such applications that were filed prior
            to October 1, 2014) that are--
                      (A) awaiting action by the applicant;
                      (B) awaiting action by the Secretary; and
                      (C) approved by the Secretary;
              (2) the number of applications filed under section
            505(j) of the Federal Food, Drug, and Cosmetic Act (21
            U.S.C. 355(j)) and prior approval supplements withdrawn
            in each month;
              (3) the mean and median approval and tentative
            approval times and the number of review cycles for such
            applications;
              (4) the number and type of meetings requested and
            held under such section 506H (as added by section 803);
            and
              (5) the number of such applications on which the
            Secretary has taken action pursuant to subsection (c)
            of such section 506H (as added by section 803) and any
            effect such section 506H may have on the length of time
            for approval of applications under such section 505(j)
            and the number of review cycles for such approvals.

               *       *       *       *       *       *       *

    TITLE IX--ADDITIONAL PROVISIONS

               *       *       *       *       *       *       *

    [SEC. 902. ANNUAL REPORT ON INSPECTIONS.

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

    SEC. 902. ANNUAL REPORT ON INSPECTIONS.

      Not later than 120 days after the end of each fiscal year,
    the Secretary of Health and Human Services shall post on the
    public website of the Food and Drug Administration information
    related to inspections of facilities necessary for approval of
    a drug under subsection (c) or (j) of 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 fiscal
    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, including--
                      (A) the median time for drugs described in
                    section 505(j)(11)(A)(i) of the Federal Food,
                    Drug, and Cosmetic Act (21 U.S.C.
                    355(j)(11)(A)(i));
                      (B) the median time for drugs described in
                    section 506C(a) of such Act (21 U.S.C. 356c(a))
                    only; and
                      (C) the median time for drugs on the drug
                    shortage list in effect under section 506E of
                    such Act (21 U.S.C. 356e).
              (2) The median time from the issuance of a report
            pursuant to section 704(b) of such Act (21 U.S.C.
            374(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,
            including the median time for each category of drugs
            listed in subparagraphs (A) through (C) of paragraph
            (1).
              (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 actions
            indicated to address the conditions or practices
            observed during an inspection.
              (4) The number of facilities that failed to implement
            adequate corrective or preventive actions following a
            report pursuant to such section 704(b), resulting in a
            withhold recommendation, including the number of such
            times for each category of drugs listed in
            subparagraphs (A) through (C) of paragraph (1).

               *       *       *       *       *       *       *

                                  ----------

                           PUBLIC HEALTH SERVICE ACT

    TITLE IV--NATIONAL RESEARCH INSTITUTES

               *       *       *       *       *       *       *

    Part B--General Provisions Respecting National Research Institutes

               *       *       *       *       *       *       *

    SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

      (a) List of Priority Issues in Pediatric Therapeutics.--
              (1) In general.--Not later than one year after the
            date of the enactment of the Best Pharmaceuticals for
            Children Act of 2007, the Secretary, acting through the
            Director of the National Institutes of Health and in
            consultation with the Commissioner of Food and Drugs
            and experts in pediatric research, shall develop and
            publish a priority list of needs in pediatric
            therapeutics, including drugs, biological products, or
            indications that require study. The list shall be
            revised every three years.
              (2) Consideration of available information.--In
            developing and prioritizing the list under paragraph
            (1), the Secretary--
                      (A) shall consider--
                              (i) therapeutic gaps in pediatrics
                            that may include developmental
                            pharmacology, pharmacogenetic
                            determinants of drug response,
                            metabolism of drugs and biologics in
                            children, and pediatric clinical
                            trials;
                              (ii) particular pediatric diseases,
                            disorders or conditions where more
                            complete knowledge and testing of
                            therapeutics, including drugs and
                            biologics, and identification of
                            biomarkers for such diseases,
                            disorders, or conditions, may be
                            beneficial in pediatric populations;
                            and
                              (iii) the adequacy of necessary
                            infrastructure to conduct pediatric
                            pharmacological research, including
                            research networks and trained pediatric
                            investigators; and
                      (B) may consider the availability of
                    qualified countermeasures (as defined in
                    section 319F-1), security countermeasures (as
                    defined in section 319F-2), and qualified
                    pandemic or epidemic products (as defined in
                    section 319F-3) to address the needs of
                    pediatric populations, in consultation with the
                    Assistant Secretary for Preparedness and
                    Response, consistent with the purposes of this
                    section.
      (b) Pediatric Studies and Research.--The Secretary, acting
    through the National Institutes of Health, shall award funds to
    entities that have the expertise to conduct pediatric clinical
    trials or other research (including qualified universities,
    hospitals, laboratories, contract research organizations,
    practice groups, federally funded programs such as pediatric
    pharmacology research units, other public or private
    institutions, or individuals) to enable the entities to conduct
    the drug studies or other research on the issues described in
    paragraphs (1) and (2)(A) of subsection (a). The Secretary may
    use contracts, grants, or other appropriate funding mechanisms
    to award funds under this subsection.
      (c) Process for Proposed Pediatric Study Requests and
    Labeling Changes.--
              (1) Submission of proposed pediatric study request.--
            The Director of the National Institutes of Health
            shall, as appropriate, submit proposed pediatric study
            requests for consideration by the Commissioner of Food
            and Drugs for pediatric studies of a specific pediatric
            indication identified under subsection (a). Such a
            proposed pediatric study request shall be made in a
            manner equivalent to a written request made under
            subsection (b) or (c) of section 505A of the Federal
            Food, Drug, and Cosmetic Act, or section 351(m) of this
            Act, including with respect to the information provided
            on the pediatric studies to be conducted pursuant to
            the request. The Director of the National Institutes of
            Health may submit a proposed pediatric study request
            for a drug for which--
                      (A)(i) there is an approved application under
                    section 505(j) of the Federal Food, Drug, and
                    Cosmetic Act or section 351(k) of this Act; or
                      (ii) there is a submitted application that
                    could be approved under the criteria of such
                    section; and
                      (B) there remains no patent listed pursuant
                    to section 505(b)(1) of the Federal Food, Drug,
                    and Cosmetic Act, and every three-year and
                    five-year period referred to in subsection
                    (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv),
                    (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv)
                    of section 505 of the Federal Food, Drug, and
                    Cosmetic Act, or applicable twelve-year period
                    referred to in section 351(k)(7) of this Act,
                    and any seven-year period referred to in
                    section 527 of the Federal Food, Drug, and
                    Cosmetic Act has ended for at least one form of
                    the drug; and
                      (C) additional studies are needed to assess
                    the safety and effectiveness of the use of the
                    drug in the pediatric population.
              (2) Written request to holders of approved
            applications.--The Commissioner of Food and Drugs, in
            consultation with the Director of the National
            Institutes of Health, may issue a written request based
            on the proposed pediatric study request for the
            indication or indications submitted pursuant to
            paragraph (1) (which shall include a timeframe for
            negotiations for an agreement) for pediatric studies
            concerning a drug identified under subsection (a) to
            all holders of an approved application for the drug.
            Such a written request shall be made in a manner
            equivalent to the manner in which a written request is
            made under subsection (b) or (c) of section 505A of the
            Federal Food, Drug, and Cosmetic Act or section 351(m)
            of this Act, including with respect to information
            provided on the pediatric studies to be conducted
            pursuant to the request and using appropriate
            formulations for each age group for which the study is
            requested.
              (3) Requests for proposals.--If the Commissioner of
            Food and Drugs does not receive a response to a written
            request issued under paragraph (2) not later than 30
            days after the date on which a request was issued, the
            Secretary, acting through the Director of the National
            Institutes of Health and in consultation with the
            Commissioner of Food and Drugs, shall publish a request
            for proposals to conduct the pediatric studies
            described in the written request in accordance with
            subsection (b).
              (4) Disqualification.--A holder that receives a first
            right of refusal shall not be entitled to respond to a
            request for proposals under paragraph (3).
              (5) Contracts, grants, or other funding mechanisms.--
            A contract, grant, or other funding may be awarded
            under this section only if a proposal is submitted to
            the Secretary in such form and manner, and containing
            such agreements, assurances, and information as the
            Secretary determines to be necessary to carry out this
            section.
              (6) Reporting of studies.--
                      (A) In general.--On completion of a pediatric
                    study in accordance with an award under this
                    section, a report concerning the study shall be
                    submitted to the Director of the National
                    Institutes of Health and the Commissioner of
                    Food and Drugs. The report shall include all
                    data generated in connection with the study,
                    including a written request if issued.
                      (B) Availability of reports.--
                              (i) In general.--Each report
                            submitted under subparagraph (A) shall
                            be considered to be in the public
                            domain (subject to section 505A(d)(4)
                            of the Federal Food, Drug, and Cosmetic
                            Act) and not later than 90 days after
                            submission of such report, shall be--
                                      (I) posted on the internet
                                    website of the National
                                    Institutes of Health in a
                                    manner that is accessible and
                                    consistent with all applicable
                                    Federal laws and regulations,
                                    including such laws and
                                    regulations for the protection
                                    of--
                                              (aa) human research
                                            participants, including
                                            with respect to
                                            privacy, security,
                                            informed consent, and
                                            protected health
                                            information; and
                                              (bb) proprietary
                                            interests, confidential
                                            commercial information,
                                            and intellectual
                                            property rights; and
                                      (II) assigned a docket number
                                    by the Commissioner of Food and
                                    Drugs and made available for
                                    the submission of public
                                    comments.
                              (ii) Submission of comments.--An
                            interested person may submit written
                            comments concerning such pediatric
                            studies to the Commissioner of Food and
                            Drugs, and the submitted comments shall
                            become part of the docket file with
                            respect to each of the drugs.
                      (C) Action by commissioner.--The Commissioner
                    of Food and Drugs shall take 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).
              (7) Requests for labeling change.--Within the 180-day
            period after the date on which a report is submitted
            under paragraph (6)(A), the Commissioner of Food and
            Drugs shall--
                      (A) review the report and such other data as
                    are available concerning the safe and effective
                    use in the pediatric population of the drug
                    studied;
                      (B) negotiate with the holders of approved
                    applications for the drug studied for any
                    labeling changes that the Commissioner of Food
                    and Drugs determines to be appropriate and
                    requests the holders to make; and
                      (C)(i) 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 any requested labeling
                    changes; and
                      (ii) publish through a posting on the Web
                    site of the Food and Drug Administration a
                    summary of the report and a copy of any
                    requested labeling changes.
              (8) Dispute resolution.--
                      (A) Referral to pediatric advisory
                    committee.--If, not later than the end of the
                    180-day period specified in paragraph (7), the
                    holder of an approved application for the drug
                    involved does not agree to any labeling change
                    requested by the Commissioner of Food and Drugs
                    under that paragraph, the Commissioner of Food
                    and Drugs shall refer the request to the
                    Pediatric Advisory Committee.
                      (B) Action by the pediatric advisory
                    committee.--Not later than 90 days after
                    receiving a referral under subparagraph (A),
                    the Pediatric Advisory Committee shall--
                              (i) review the available information
                            on the safe and effective use of the
                            drug in the pediatric population,
                            including study reports submitted under
                            this section; and
                              (ii) make a recommendation to the
                            Commissioner of Food and Drugs as to
                            appropriate labeling changes, if any.
              (9) FDA determination.--Not later than 30 days after
            receiving a recommendation from the Pediatric Advisory
            Committee under paragraph (8)(B)(ii) with respect to a
            drug, the Commissioner of Food and Drugs shall consider
            the recommendation and, if appropriate, make a request
            to the holders of approved applications for the drug to
            make any labeling change that the Commissioner of Food
            and Drugs determines to be appropriate.
              (10) Failure to agree.--If a holder of an approved
            application for a drug, within 30 days after receiving
            a request to make a labeling change under paragraph
            (9), does not agree to make a requested labeling
            change, the Commissioner of Food and Drugs may deem the
            drug to be misbranded under the Federal Food, Drug, and
            Cosmetic Act.
              (11) No effect on authority.--Nothing in this
            subsection limits the authority of the United States to
            bring an enforcement action under the Federal Food,
            Drug, and Cosmetic Act when a drug lacks appropriate
            pediatric labeling. Neither course of action (the
            Pediatric Advisory Committee process or an enforcement
            action referred to in the preceding sentence) shall
            preclude, delay, or serve as the basis to stay the
            other course of action.
      (d) Authorization of Appropriations.--
              (1) In general.--There are authorized to be
            appropriated to carry out this section, $25,000,000 for
            each of fiscal years [2018 through 2022] 2023 through
            2027.
              (2) Availability.--Any amount appropriated under
            paragraph (1) shall remain available to carry out this
            section until expended.

               *       *       *       *       *       *       *

                                  ----------

          PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007

               *       *       *       *       *       *       *
    TITLE III--PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007

               *       *       *       *       *       *       *

    SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE
                        AVAILABILITY.

      (a) In general.--
              (1) Request for proposals.--Not later than 90 days
            after the date of the enactment of this Act, the
            Secretary of Health and Human Services shall issue a
            request for proposals for 1 or more grants or contracts
            to nonprofit consortia for demonstration projects to
            promote pediatric device development.
              (2) Determination on grants or contracts.--Not later
            than 180 days after the date the Secretary of Health
            and Human Services issues a request for proposals under
            paragraph (1), the Secretary shall make a determination
            on the grants or contracts under this section.
      (b) Application.--A nonprofit consortium that desires to
    receive a grant or contract under this section shall submit an
    application to the Secretary of Health and Human Services at
    such time, in such manner, and containing such information as
    the Secretary may require.
      (c) Use of Funds.--A nonprofit consortium that receives a
    grant or contract under this section shall facilitate the
    development, production, and distribution of pediatric medical
    devices by--
              (1) encouraging innovation and connecting qualified
            individuals with pediatric device ideas with potential
            manufacturers;
              (2) mentoring and managing pediatric device projects
            through the development process, including product
            identification, prototype design, device development,
            and marketing;
              (3) connecting innovators and physicians to existing
            Federal and non-Federal resources, including resources
            from the Food and Drug Administration, the National
            Institutes of Health, the Small Business
            Administration, the Department of Energy, the
            Department of Education, the National Science
            Foundation, the Department of Veterans Affairs, the
            Agency for Healthcare Research and Quality, and the
            National Institute of Standards and Technology;
              (4) assessing the scientific and medical merit of
            proposed pediatric device projects;
              (5) providing assistance and advice as needed on
            business development, personnel training, prototype
            development, postmarket needs, and other activities
            consistent with the purposes of this section; and
              (6) providing regulatory consultation to device
            sponsors in support of the submission of an application
            for a pediatric device, where appropriate.
      (d) Coordination.--
              (1) National institutes of health.--Each consortium
            that receives a grant or contract under this section
            shall--
                      (A) coordinate with the National Institutes
                    of Health's pediatric device contact point or
                    office, designated under section 402(b)(23) of
                    the Public Health Service Act, as added by
                    section 304(a) of this Act; and
                      (B) provide to the National Institutes of
                    Health any identified pediatric device needs
                    that the consortium lacks sufficient capacity
                    to address or those needs in which the
                    consortium has been unable to stimulate
                    manufacturer interest.
              (2) Food and drug administration.--Each consortium
            that receives a grant or contract under this section
            shall coordinate with the Commissioner of Food and
            Drugs and device companies to facilitate the
            application for approval or clearance of devices
            labeled for pediatric use.
              (3) Effectiveness and outcomes.--Each consortium that
            receives a grant or contract under this section shall
            annually report to the Secretary of Health and Human
            Services on the status of pediatric device development,
            production, and distribution that has been facilitated
            by the consortium.
      (e) Authorization of appropriations.--There are authorized to
    be appropriated to carry out this section $5,250,000 for each
    of fiscal years [2018 through 2022] 2023 through 2027.

               *       *       *       *       *       *       *

                                  ----------

                                ORPHAN DRUG ACT

      grants and contracts for development of drugs for rare diseases and
                                   conditions

      Sec. 5. (a) The Secretary may make grants to and enter into
    contracts with public and private entities and individuals to
    assist in (1) defraying the costs of developing drugs for rare
    diseases or conditions, including qualified testing expenses,
    (2) defraying the costs of developing medical devices for rare
    diseases or conditions, [and (3)] (3) defraying the costs of
    developing medical foods for rare diseases or conditions, and
    (4) developing regulatory science pertaining to the chemistry,
    manufacturing, and controls of individualized medical products
    to treat individuals with rare diseases or conditions.
      (b) For purposes of subsection (a):
              (1) The term ``qualified testing'' means--
                      (A) human clinical testing--
                              (i) which is carried out under an
                            exemption for a drug for a rare disease
                            or condition under section 505(i) of
                            the Federal Food, Drug, and Cosmetic
                            Act (or regulations issued under such
                            section); and
                              (ii) which occurs before the date on
                            which an application with respect to
                            such drug is submitted under section
                            505(b) of such Act or under section 351
                            of the Public Health Service Act;
                      (B) preclinical testing involving a drug for
                    a rare disease or condition which occurs after
                    the date such drug is designated under section
                    526 of such Act and before the date on which an
                    application with respect to such drug is
                    submitted under section 505(b) of such Act or
                    under section 351 of the Public Health Service
                    Act; and
                      (C) prospectively planned and designed
                    observational studies and other analyses
                    conducted to assist in the understanding of the
                    natural history of a rare disease or condition
                    and in the development of a therapy, including
                    studies and analyses to--
                              (i) develop or validate a drug
                            development tool related to a rare
                            disease or condition; or
                              (ii) understand the full spectrum of
                            the disease manifestations, including
                            describing genotypic and phenotypic
                            variability and identifying and
                            defining distinct subpopulations
                            affected by a rare disease or
                            condition.
              (2) The term ``rare disease or condition'' means (1)
            in the case of a drug, any disease or condition which
            (A) affects less than 200,000 persons in the United
            States, or (B) affects more than 200,000 in the United
            States and for which there is no reasonable expectation
            that the cost of developing and making available in the
            United States a drug for such disease or condition will
            be recovered from sales in the United States of such
            drugs, (2) in the case of a medical device, any disease
            or condition that occurs so infrequently in the United
            States that there is no reasonable expectation that a
            medical device for such disease or condition will be
            developed without assistance under subsection (a), and
            (3) in the case of a medical food, any disease or
            condition that occurs so infrequently in the United
            States that there is no reasonable expectation that a
            medical food for such disease or condition will be
            developed without assistance under subsection (a).
            Determinations under the preceding sentence with
            respect to any drug shall be made on the basis of the
            facts and circumstances as of the date the request for
            designation of the drug under section 526 of the
            Federal Food, Drug, and Cosmetic Act is made.
              (3) The term ``medical food'' means a food which is
            formulated to be consumed or administered enterally
            under the supervision of a physician and which is
            intended for the specific dietary management of a
            disease or condition for which distinctive nutritional
            requirements, based on recognized scientific
            principles, are established by medical evaluation.
      (c) Authorization of Appropriations.--For grants and
    contracts under subsection (a), there is authorized to be
    appropriated $30,000,000 for each of fiscal years [2018 through
    2022] 2023 through 2027.
                                  ----------

                             21ST CENTURY CURES ACT

    SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

      (a) Short Title.--This Act may be cited as the ``21st Century
    Cures Act''.
      (b) Table of Contents.--The table of contents for this Act is
    as follows:

    Sec. 1. Short title; table of contents.

                     section DIVISION A--21ST CENTURY CURES

         * * * * * * *

                             TITLE III--DEVELOPMENT

                  Subtitle A--Patient-Focused Drug Development

         * * * * * * *
    [Sec. 3003. Streamlining patient input.]
    Sec. 3003. Streamlining patient and blood donor input.

               *       *       *       *       *       *       *

    DIVISION A--21ST CENTURY CURES

               *       *       *       *       *       *       *

                             TITLE III--DEVELOPMENT

    Subtitle A--Patient-Focused Drug Development

               *       *       *       *       *       *       *

    [SEC. 3003. STREAMLINING PATIENT INPUT.

      [Chapter 35 of title 44, United States Code, shall not apply
    to the collection of information to which a response is
    voluntary, that is initiated by the Secretary under section
    569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    360bbb-8c) (as amended by section 3001) or section 3002.]

    SEC. 3003. STREAMLINING PATIENT AND BLOOD DONOR INPUT.

      Chapter 35 of title 44, United States Code, shall not apply
    to the collection of information to which a response is
    voluntary, to solicit--
              (1) the views and perspectives of patients under
            section 569C of the Federal Food, Drug, and Cosmetic
            Act (21 U.S.C. 360bbb-8c) (as amended by section 3001)
            or section 3002; or
              (2) information from blood donors or potential blood
            donors to support the development of recommendations by
            the Secretary of Health and Human Services acting
            through the Commissioner of Food and Drugs concerning
            blood donation.

               *       *       *       *       *       *       *

                                      [all]