Title: Food and Drug Amendments of 2022
Policy area: Health

Summary:
Food and Drug Amendments of 2022
This bill reauthorizes Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices.
Specifically, the bill reauthorizes through FY2027 the FDA user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.
The bill also requires the development of action plans and related reporting to increase the diversity of participants in clinical trials.
In addition, the bill requires the FDA to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why).
The bill also (1) establishes requirements and reauthorizes programs to support the development of specific categories of drugs and devices (e.g., pediatric drugs) and inspections of drug manufacturing facilities; and (2) establishes and revises requirements relating to the approval of drugs and devices, including requirements for postapproval studies and guidance about using real-world evidence to support drug and device applications.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7667 Introduced in House (IH)]

<DOC>






117th CONGRESS
  2d Session
                                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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 6, 2022

 Ms. Eshoo (for herself, Mr. Guthrie, Mr. Pallone, and Mrs. Rodgers of 
 Washington) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


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

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``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. Savings clause.
Sec. 208. Effective date.
Sec. 209. Sunset dates.
               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 TRIALS

Sec. 501. Premarket reporting of diversity action plans for clinical 
                            trials and 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 trial diversity.
Sec. 504. Annual report on progress to increase diversity in clinical 
                            trials and studies.
Sec. 505. Public meeting on clinical trial flexibilities initiated in 
                            response to COVID-19 pandemic.
Sec. 506. Decentralized clinical trials.
                   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 and gene 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.
                        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. Medical devices advisory committee meetings.
Sec. 807. Ensuring cybersecurity of medical devices.
Sec. 808. Public docket on proposed modifications to approved 
                            strategies.
Sec. 809. Facilitating exchange of product information prior to 
                            approval.
Sec. 810. Bans of devices for one or more intended uses.
Sec. 811. Clarifying application of exclusive approval, certification, 
                            or licensure for drugs designated for rare 
                            diseases or conditions.
Sec. 812. GAO report on third-party review.
Sec. 813. Reauthorization of device pilot projects.
Sec. 814. Reporting on pending generic drug applications and priority 
                            review applications.

                    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 in this title will be dedicated toward expediting the 
drug development process and the process for the review of human drug 
applications, including postmarket drug safety activities, as set forth 
in the goals identified for purposes of part 2 of subchapter C of 
chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters 
from the Secretary of Health and Human Services to the Chairman of the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Chairman of the Committee on Energy and Commerce of the House of 
Representatives, as set forth in the Congressional Record.

SEC. 102. 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'' and 
        inserting the following:
            ``(B) Such term does not include'';
            (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 reserve 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 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, 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
----------------------------------------------------------------------------------------------------------------

            (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''.
                    (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 
                                        is 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. 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 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.

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. 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, 2027.
    (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, 2028.
    (c) Previous Sunset Provisions.--Effective October 1, 2022, 
subsections (a) and (b) of section 210 of the Medical Device User Fee 
Amendments of 2017 (Public Law 115-52) are repealed.

               TITLE III--FEES RELATING TO GENERIC DRUGS

SEC. 301. SHORT TITLE; FINDING.

    (a) Short Title.--This title may be cited as the ``Generic Drug 
User Fee Amendments of 2022''.
    (b) Finding.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated to human generic drug 
activities, as set forth in the goals identified for purposes of part 7 
of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, in the letters from the Secretary of Health and Human Services to 
the Chairman of the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Congressional 
Record.

SEC. 302. 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''.

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 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, 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 in this title will be dedicated to expediting the 
process for the review of biosimilar biological product applications, 
including postmarket safety activities, as set forth in the goals 
identified for purposes of part 8 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary 
of Health and Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of 
Representatives, as set forth in the Congressional Record.

SEC. 402. DEFINITIONS.

    (a) Adjustment Factor.--Section 744G(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read as follows:
            ``(1) The term `adjustment factor' applicable to a fiscal 
        year is the Consumer Price Index for urban consumers 
        (Washington-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 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 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, 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 TRIALS

SEC. 501. PREMARKET REPORTING OF DIVERSITY ACTION PLANS FOR CLINICAL 
              TRIALS AND 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 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 
        investigation;
            ``(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, in such form and manner as specified in 
the guidance required by section 524B, submit such diversity action 
plan as soon as practicable during drug development, but not later 
than--
            ``(i) one month prior to an End-of-Phase 2 meeting, as 
        described in section 312.47(b) of title 21, Code of Federal 
        Regulations (or successor regulations); or
            ``(ii) if there is no End-of-Phase 2 meeting, one month 
        prior to commencing enrollment for a Phase 3 study.
    ``(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.''.
    (b) Biological Products.--Section 351(a)(3) of the Public Health 
Service Act (42 U.S.C. 262(a)(3)) is amended--
            (1) by striking ``(3) The Secretary'' and inserting 
        ``(3)(A) The Secretary''; and
            (2) by adding at the end the following:
    ``(B)(i) In order for a biological product to be exempt pursuant to 
this paragraph, the sponsor of a clinical investigation of such 
biological product shall submit to the Secretary a diversity action 
plan.
    ``(ii) Such diversity action plan shall include--
            ``(I) the sponsor's goals for enrollment in such clinical 
        investigation;
            ``(II) the sponsor's rationale for such goals; and
            ``(III) an explanation of how the sponsor intends to meet 
        such goals.
    ``(iii) The sponsor shall, in such form and manner as specified in 
the guidance required by section 524B, submit such diversity action 
plan as soon as practicable during biological product development, but 
not later than--
            ``(I) one month prior to an End-of-Phase 2 meeting, as 
        described in section 312.47(b) of title 21, Code of Federal 
        Regulations (or successor regulations); or
            ``(II) if there is no End-of-Phase 2 meeting, one month 
        prior to commencing enrollment for a Phase 3 study.
    ``(iv) 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 biological product.''.
    (c) 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) In order for a device to be exempt under this subsection, 
the sponsor of a clinical investigation of such device shall submit to 
the Secretary a diversity action plan the sponsor of a clinical 
investigation of such device 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 
        investigation;
            ``(ii) the sponsor's rationale for such goals; and
            ``(iii) an explanation of how the sponsor intends to meet 
        such goals.
    ``(C) Such diversity action plan shall be--
            ``(i) if submission of an application for an 
        investigational device exemption is required, submitted in such 
        application; and
            ``(ii) if submission of an application for investigational 
        device exemption is not required, submitted as soon as 
        practicable during device development, but no later than one 
        month prior to commencing enrollment for a study.
    ``(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 device.''.
    (d) 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 TRIALS AND 
              STUDIES.

    ``(a) In General.--The Secretary shall by guidance provide 
recommendations relating to--
            ``(1) the format and content of the diversity action plans 
        required by sections 505(i)(5) and 520(g)(9) of this Act, and 
        section 351(a)(3) of the Public Health Service Act, pertaining 
        to the sponsor's goals for clinical trial enrollment, 
        disaggregated by age group, sex, race, geographic location, and 
        ethnicity, including with respect to--
                    ``(A) the rationale for the sponsor's enrollment 
                goals, which may include--
                            ``(i) the estimated prevalence in the 
                        United States of the disease or condition for 
                        which the drug or device is being developed or 
                        investigated, if such estimated prevalence 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 and ethnicity;
                                    ``(II) co-morbidities frequently 
                                affecting the patient population; and
                                    ``(III) potential barriers to 
                                enrolling diverse participants, such as 
                                patient population size and geographic 
                                location; and
                            ``(v) any other data or information the 
                        sponsor deems 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 trial inclusion and exclusion 
                practices, and any diversity training for trial 
                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; 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 6 months after closing the comment 
        period on such draft guidance, finalize such guidance.''.
    (e) Applicability.--Sections 505(i)(5) and 520(g)(9) of the Federal 
Food, Drug, and Cosmetic Act, and section 351(a)(3)(B) of the Public 
Health Service Act, as added by subsections (a), (b), and (c) 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 (d).

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(d) 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 needed to assure that sponsors conduct postapproval 
studies or postmarket surveillance when they do not meet the enrollment 
goals submitted in their diversity action plan under section 505(i)(5) 
or 520(g)(9) of the Federal Food, Drug, and Cosmetic Act, or section 
351(a)(3)(B) of the Public Health Service Act, as added by subsection 
(a), (b), or (c) of section 501 of this Act.
    (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 the such evaluation, including any recommendations related 
to additional needed authorities.

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

    (a) In General.--Not later than September 30, 2023, 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 trials and encouraging clinical trial 
participation that reflects the prevalence of the disease or condition 
among demographic subgroups, and other topics, including--
            (1) how and when to collect and present demographic 
        subgroup and disease or condition prevalence data from clinical 
        trials, including with respect to--
                    (A) such data intended to support postapproval 
                study requirements; and
                    (B) the utilization of real world evidence (as 
                defined in section 505F(b) of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 355g(b)));
            (2) methodologies for assessing the diversity of a patient 
        population;
            (3) methodologies for the dissemination of information to 
        the public on clinical trial enrollment demographic data;
            (4) the establishment of goals for enrollment in clinical 
        trials with respect to the estimated prevalence in the United 
        States of the disease or condition for which the drug is being 
        developed or investigated, disaggregated by demographic 
        subgroup (including by age group, race, ethnicity, and sex); 
        and
            (5) approaches to support inclusion of underrepresented 
        populations and to encourage clinical trial participation that 
        reflects the prevalence of the disease or condition in certain 
        demographic subgroups, including with respect to--
                    (A) the establishment of inclusion and exclusion 
                criteria for certain demographic subgroups, such as 
                pregnant and lactating women and individuals with 
                disabilities, including intellectual or developmental 
                disabilities;
                    (B) considerations regarding informed consent with 
                respect to individuals with intellectual or 
                developmental disabilities;
                    (C) clinical trial designs, including utilization 
                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 date of 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 REPORT ON PROGRESS TO INCREASE DIVERSITY IN CLINICAL 
              TRIALS AND 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, or section 351(a)(3)(B) 
        of the Public Health Service Act, as added by subsection (a), 
        (b), or (c) of section 501 of this Act; and
            (2) contains information on--
                    (A) whether the clinical trials 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;
                    (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 trial diversity, including the 
                status and completion date of any such study; and
                    (D) additional authorities, if any, the Secretary 
                plans to use or considers necessary to ensure 
                compliance with the requirements of the amendments made 
                by section 501.
    (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 TRIAL 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 trials, including 
recommendations detailed in the March 2020 guidance entitled ``Conduct 
of Clinical Trials of Medical Products During the COVID-19 Public 
Health Emergency, Guidance for Industry, Investigators, and 
Institutional Review Boards'', and 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 trials 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, trials, and 
        patient populations impacted by such recommendations;
            (3) a consideration of how recommendations intended to 
        mitigate disruption of clinical trials during the COVID-19 
        emergency period, including any recommendations to consider 
        decentralized clinical trials when appropriate, may have 
        affected access to clinical trials for certain patient 
        populations, especially unrepresented racial and ethnic 
        minorities; and
            (4) recommendations for incorporating certain clinical 
        trial disruption mitigation recommendations into current or 
        additional guidance to improve clinical trial 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 TRIALS.

    (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 trials, including considerations 
        regarding the engagement, enrollment, and retention of a 
        meaningfully diverse clinical population, with respect to race, 
        ethnicity, age, gender, and geographic location, when 
        appropriate; and
            (2) not later than 6 months 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 trials, 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 trial participants through the use of 
        digital heath 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 trial setting.
    (c) Definition.--In this section, the term ``decentralized clinical 
trial'' means a clinical trial in which some or all of the trial-
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 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) 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 under section 1905 of title 18, United States 
Code.''.
    (b) Guidance.--
            (1) In general.--Not later than one year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall issue 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, 
                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 
(iv) 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; and
            ``(iii) the labeling revision described under clause (i) 
        does not include a change to the `Warnings' section of the 
        labeling.''.

    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) Sophisticated 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 meetings held or participated in by the 
        Food and Drug Administration, 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 licensing such drugs under 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), 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 enactment of this 
        Act--
                    (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(b)) 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) on specific 
                applications for diseases or conditions affecting 
                20,000 or fewer patients in the United States and 
                specific applications for diseases or conditions 
                affecting 200,000 or fewer patients in the United 
                States;
                    (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 diseases or conditions 
                affecting 20,000 or fewer patients in the United States 
                compared to applications for diseases or conditions 
                affecting 200,000 or fewer patients in the United 
                States 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, including any specific recommendations for 
                diseases or conditions affecting 20,000 or fewer 
                patients in the United States.
    (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 improve manufacturing processes 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 result in 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 AND GENE 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 
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 409I(d)(1) of the Public Health Service Act (42 U.S.C. 
284m) 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 
(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, regulatory 
                approval of, 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''.

                        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 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 clause (i)(I);
                            ``(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 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 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) 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 found in 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 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 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. 
        321 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 during 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 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 subsection:
            (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, including inspections that are 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. 356f).
            ``(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 were unable to 
        implement requested 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 of 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.

    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 concerning blood 
        donation.''.

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 a drug that is 
        intended for use in conjunction with an applicable 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 (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 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).''.

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 
                label 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.
            ``(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 any 
        agreed upon 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 each 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)); and
                    (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 submitted for clearance or 
        approval under sections 505, 510(k), 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.

SEC. 806. 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 in pandemic preparedness and response, including the 
issues 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. 807. 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) is intended 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. 808. PUBLIC DOCKET ON PROPOSED MODIFICATIONS TO APPROVED 
              STRATEGIES.

    (a) In General.--Not later than 90 days after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
open a public docket for the submission of public comments regarding 
factors related to patient access to a drug that is subject to a risk 
evaluation and mitigation strategy and the administration or 
prescribing of such drug by health care providers that should be taken 
into consideration when a proposed modification to such strategy is 
reviewed under section 505-1(h) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 255-1(h)). The Secretary may close such public docket 
not earlier than 90 days after such docket is opened.
    (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 proposed modifications to an approved 
        risk evaluation and mitigation strategy the Secretary has 
        granted under section 505-1(h) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 255-1(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. 809. 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), by striking ``drug'' each place it 
        appears and inserting ``drug or device'';
            (2) in paragraph (a)(2)(B), by striking ``under section 505 
        or under section 351 of the Public Health Service Act for such 
        drug'' and inserting ``under section 505, 510(k), 513, or 515 
        of this Act or section 351 of the Public Health Service Act''; 
        and
            (3) 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 considered 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 a premarket 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 
                Food and Drug Administration 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 approved 
                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 subsection, 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 520(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 a submission 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. 810. 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). Such 
devices are banned unless or until the Secretary promulgates a 
regulation to make such devices no longer banned based on a finding 
that such devices do not present an unreasonable and substantial risk 
of illness or injury, or that such risk can be corrected or eliminated 
by labeling.''.

SEC. 811. CLARIFYING 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 indication or use for which the Secretary has approved 
        or licensed such drug'';
            (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''.

SEC. 812. 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. 813. REAUTHORIZATION OF DEVICE PILOT PROJECTS.

    Section 519(i)(10) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360i(i)(10)) is amended by striking ``2022'' and inserting 
``2027''.

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''.
                                 <all>