[Congressional Record Volume 168, Number 97 (Tuesday, June 7, 2022)]
[House]
[Pages H5298-H5321]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                              {time}  1815
                    FOOD AND DRUG AMENDMENTS OF 2022

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 7667) to amend the Federal Food, Drug, and Cosmetic Act to 
revise and extend the user-fee programs for prescription drugs, medical 
devices, generic drugs, and biosimilar biological products, and for 
other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 7667

       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. Sunset dates.
Sec. 208. Effective date.
Sec. 209. Savings clause.

               TITLE III--FEES RELATING TO GENERIC DRUGS

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

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

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

            TITLE V--IMPROVING DIVERSITY IN CLINICAL STUDIES

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

                   TITLE VI--GENERIC DRUG COMPETITION

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

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

                         Subtitle A--In General

Sec. 701. Animal testing alternatives.
Sec. 702. Emerging technology program.
Sec. 703. Improving the treatment of rare diseases and conditions.
Sec. 704. Antifungal research and development.
Sec. 705. Advancing qualified infectious disease product innovation.
Sec. 706. National Centers of Excellence in Advanced and Continuous 
              Pharmaceutical Manufacturing.
Sec. 707. Advanced manufacturing technologies designation pilot 
              program.
Sec. 708. Public workshop on cell therapies.
Sec. 709. Reauthorization of best pharmaceuticals for children.
Sec. 710. Reauthorization for humanitarian device exemption and 
              demonstration grants for improving pediatric 
              availability.
Sec. 711. Reauthorization of provision related to exclusivity of 
              certain drugs containing single enantiomers.
Sec. 712. Reauthorization of the critical path public-private 
              partnership program.
Sec. 713. Reauthorization of orphan drug grants.
Sec. 714. Research into pediatric uses of drugs; additional authorities 
              of Food and Drug Administration regarding molecularly 
              targeted cancer drugs.

                        Subtitle B--Inspections

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

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

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

                        TITLE IX--MISCELLANEOUS

Sec. 901. Determination of budgetary effects.
Sec. 902. Medicaid Improvement Fund.

                    TITLE I--FEES RELATING TO DRUGS

     SEC. 101. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the 
     ``Prescription Drug User Fee Amendments of 2022''.
       (b) Finding.--The Congress finds that the fees authorized 
     by the amendments made by this title will be dedicated toward 
     expediting the drug development process and the process for 
     the review of human drug applications, including postmarket 
     drug safety activities, as set forth in the goals identified 
     for purposes of part 2 of subchapter C of chapter VII of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et 
     seq.), in the letters from the Secretary of Health and Human 
     Services to the Chairman of the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the Chairman 
     of the Committee on Energy and Commerce of the House of 
     Representatives, as set forth in the Congressional Record.

     SEC. 102. DEFINITIONS.

       (a) Human Drug Application.--Section 735(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended 
     by striking ``an allergenic extract product, or'' and 
     inserting ``does not include an application with respect to 
     an allergenic extract

[[Page H5299]]

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

       ``(I) an allergy to an antimicrobial agent;
       ``(II) an allergy that is not to an antimicrobial agent, if 
     the diagnostic product was authorized for marketing prior to 
     October 1, 2022; or
       ``(III) infection with fungal or mycobacterial pathogens; 
     and

       ``(B) includes positive and negative controls required to 
     interpret the results of a product described in subparagraph 
     (A).''.

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

       (a) Types of Fees.--
       (1) Human drug application fee.--Section 736(a) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is 
     amended--
       (A) in the matter preceding paragraph (1), by striking 
     ``fiscal year 2018'' and inserting ``fiscal year 2023'';
       (B) in paragraph (1)(A), by striking ``(c)(5)'' each place 
     it appears and inserting ``(c)(6)'';
       (C) in paragraph (1)(C), by inserting ``prior to approval'' 
     after ``or was withdrawn''; and
       (D) in paragraph (1), by adding at the end the following:
       ``(H) Exception for skin-test diagnostic products.--A human 
     drug application for a skin-test diagnostic product shall not 
     be subject to a fee under subparagraph (A).''.
       (2) Prescription drug program fee.--Section 736(a)(2) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379h(a)(2)) is amended--
       (A) in subparagraph (A)--
       (i) by striking ``Except as provided in subparagraphs (B) 
     and (C)'' and inserting the following:
       ``(i) Fee.--Except as provided in subparagraphs (B) and 
     (C)'';
       (ii) by striking ``subsection (c)(5)'' and inserting 
     ``subsection (c)(6)''; and
       (iii) by adding at the end the following:
       ``(ii) Special rule.--If a drug product that is identified 
     in a human drug application approved as of October 1 of a 
     fiscal year is not a prescription drug product as of that 
     date because the drug product is in the discontinued section 
     of a list referenced in section 735(3)(A)(iii), and on any 
     subsequent day during such fiscal year the drug product is a 
     prescription drug product, then except as provided in 
     subparagraphs (B) and (C), each person who is named as the 
     applicant in a human drug application with respect to such 
     product, and who, after September 1, 1992, had pending before 
     the Secretary a human drug application or supplement, shall 
     pay the annual prescription drug program fee established for 
     a fiscal year under subsection (c)(6) for such prescription 
     drug product. Such fee shall be due on the last business day 
     of such fiscal year and shall be paid only once for each such 
     product for a fiscal year in which the fee is payable.''; and
       (B) by amending subparagraph (B) to read as follows:
       ``(B) Exception for certain prescription drug products.--A 
     prescription drug program fee shall not be assessed for a 
     prescription drug product under subparagraph (A) if such 
     product is--
       ``(i) a large volume parenteral product (a sterile aqueous 
     drug product packaged in a single-dose container with a 
     volume greater than or equal to 100 mL, not including powders 
     for reconstitution or pharmacy bulk packages) identified on 
     the list compiled under section 505(j)(7);
       ``(ii) pharmaceutically equivalent (as defined in section 
     314.3 of title 21, Code of Federal Regulations (or any 
     successor regulation)) to another product on the list of 
     products compiled under section 505(j)(7) (not including the 
     discontinued section of such list); or
       ``(iii) a skin-test diagnostic product.''.
       (b) Fee Revenue Amounts.--
       (1) In general.--Paragraph (1) of section 736(b) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is 
     amended to read as follows:
       ``(1) In general.--For each of the fiscal years 2023 
     through 2027, fees under subsection (a) shall, except as 
     provided in subsections (c), (d), (f), and (g), be 
     established to generate a total revenue amount under such 
     subsection that is equal to the sum of--
       ``(A) the annual base revenue for the fiscal year (as 
     determined under paragraph (3));
       ``(B) the dollar amount equal to the inflation adjustment 
     for the fiscal year (as determined under subsection (c)(1));
       ``(C) the dollar amount equal to the strategic hiring and 
     retention adjustment for the fiscal year (as determined under 
     subsection (c)(2));
       ``(D) the dollar amount equal to the capacity planning 
     adjustment for the fiscal year (as determined under 
     subsection (c)(3));
       ``(E) the dollar amount equal to the operating reserve 
     adjustment for the fiscal year, if applicable (as determined 
     under subsection (c)(4));
       ``(F) the dollar amount equal to the additional direct cost 
     adjustment for the fiscal year (as determined under 
     subsection (c)(5)); and
       ``(G) additional dollar amounts for each fiscal year as 
     follows:
       ``(i) $65,773,693 for fiscal year 2023.
       ``(ii) $25,097,671 for fiscal year 2024.
       ``(iii) $14,154,169 for fiscal year 2025.
       ``(iv) $4,864,860 for fiscal year 2026.
       ``(v) $1,314,620 for fiscal year 2027.''.
       (2) Annual base revenue.--Paragraph (3) of section 736(b) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379h(b)) is amended to read as follows:
       ``(3) Annual base revenue.--For purposes of paragraph (1), 
     the dollar amount of the annual base revenue for a fiscal 
     year shall be--
       ``(A) for fiscal year 2023, $1,151,522,958; and
       ``(B) for fiscal years 2024 through 2027, the dollar amount 
     of the total revenue amount established under paragraph (1) 
     for the previous fiscal year, not including any adjustments 
     made under subsection (c)(4) or (c)(5).''.
       (c) Adjustments; Annual Fee Setting.--
       (1) Inflation adjustment.--Section 736(c)(1)(B)(ii) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379h(c)(1)(B)(ii)) is amended by striking ``Washington-
     Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
     Arlington-Alexandria, DC-VA-MD-WV''.
       (2) Strategic hiring and retention adjustment.--Section 
     736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379h(c)) is amended--
       (A) by redesignating paragraphs (2) through (6) as 
     paragraphs (3) through (7), respectively; and
       (B) by inserting after paragraph (1) the following:
       ``(2) Strategic hiring and retention adjustment.--For each 
     fiscal year, after the annual base revenue established in 
     subsection (b)(1)(A) is adjusted for inflation in accordance 
     with paragraph (1), the Secretary shall further increase the 
     fee revenue and fees by the following amounts:
       ``(A) For fiscal year 2023, $9,000,000.
       ``(B) For each of fiscal years 2024 through 2027, 
     $4,000,000.''.
       (3) Capacity planning adjustment.--Paragraph (3), as 
     redesignated, of section 736(c) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as 
     follows:
       ``(3) Capacity planning adjustment.--
       ``(A) In general.--For each fiscal year, after the annual 
     base revenue established in subsection (b)(1)(A) is adjusted 
     in accordance with paragraphs (1) and (2), such revenue shall 
     be adjusted further for such fiscal year, in accordance with 
     this paragraph, to reflect changes in the resource capacity 
     needs of the Secretary for the process for the review of 
     human drug applications.
       ``(B) Methodology.--For purposes of this paragraph, the 
     Secretary shall employ the capacity planning methodology 
     utilized by the Secretary in setting fees for fiscal year 
     2021, as described in the notice titled `Prescription Drug 
     User Fee Rates for Fiscal Year 2021' published in the Federal 
     Register

[[Page H5300]]

     on August 3, 2020 (85 Fed. Reg. 46651). The workload 
     categories used in applying such methodology in forecasting 
     shall include only the activities described in that notice 
     and, as feasible, additional activities that are also 
     directly related to the direct review of applications and 
     supplements, including additional formal meeting types, the 
     direct review of postmarketing commitments and requirements, 
     the direct review of risk evaluation and mitigation 
     strategies, and the direct review of annual reports for 
     approved prescription drug products. Subject to the 
     exceptions in the preceding sentence, the Secretary shall not 
     include as workload categories in applying such methodology 
     in forecasting any non-core review activities, including 
     those activities that the Secretary referenced for potential 
     future use in such notice but did not utilize in setting fees 
     for fiscal year 2021.
       ``(C) Limitation.--Under no circumstances shall an 
     adjustment under this paragraph result in fee revenue for a 
     fiscal year that is less than the sum of the amounts under 
     subsections (b)(1)(A) (the annual base revenue for the fiscal 
     year), (b)(1)(B) (the dollar amount of the inflation 
     adjustment for the fiscal year), and (b)(1)(C) (the dollar 
     amount of the strategic hiring and retention adjustment for 
     the fiscal year).
       ``(D) Publication in federal register.--The Secretary shall 
     publish in the Federal Register notice under paragraph (6) of 
     the fee revenue and fees resulting from the adjustment and 
     the methodologies under this paragraph.''.
       (4) Operating reserve adjustment.--Paragraph (4), as 
     redesignated, of section 736(c) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379h(c)) is amended--
       (A) by amending subparagraph (A) to read as follows:
       ``(A) Increase.--For fiscal year 2023 and subsequent fiscal 
     years, the Secretary shall, in addition to adjustments under 
     paragraphs (1), (2), and (3), further increase the fee 
     revenue and fees if such an adjustment is necessary to 
     provide for operating reserves of carryover user fees for the 
     process for the review of human drug applications for each 
     fiscal year in at least the following amounts:
       ``(i) For fiscal year 2023, at least 8 weeks of operating 
     reserves.
       ``(ii) For fiscal year 2024, at least 9 weeks of operating 
     reserves.
       ``(iii) For fiscal year 2025 and subsequent fiscal years, 
     at least 10 weeks of operating reserves.''; and
       (B) in subparagraph (C), by striking ``paragraph (5)'' and 
     inserting ``paragraph (6)''.
       (5) Additional direct cost adjustment.--Paragraph (5), as 
     redesignated, of section 736(c) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as 
     follows:
       ``(5) Additional direct cost adjustment.--
       ``(A) Increase.--The Secretary shall, in addition to 
     adjustments under paragraphs (1), (2), (3), and (4), further 
     increase the fee revenue and fees--
       ``(i) for fiscal year 2023, by $44,386,150; and
       ``(ii) for each of fiscal years 2024 through 2027, by the 
     amount set forth in clauses (i) through (iv) of subparagraph 
     (B), as applicable, multiplied by the Consumer Price Index 
     for urban consumers (Washington-Arlington-Alexandria, DC-VA-
     MD-WV; Not Seasonally Adjusted; All Items; Annual Index) for 
     the most recent year of available data, divided by such Index 
     for 2021.
       ``(B) Applicable amounts.--The amounts referred to in 
     subparagraph (A)(ii) are the following:
       ``(i) For fiscal year 2024, $60,967,993.
       ``(ii) For fiscal year 2025, $35,799,314.
       ``(iii) For fiscal year 2026, $35,799, 314.
       ``(iv) For fiscal year 2027, $35,799,314.''.
       (6) Annual fee setting.--Paragraph (6), as redesignated, of 
     section 736(c) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 379h(c)) is amended by striking ``September 30, 
     2017'' and inserting ``September 30, 2022''.
       (d) Crediting and Availability of Fees.--Section 736(g)(3) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379h(g)(3)) is amended by striking ``fiscal years 2018 
     through 2022'' and inserting ``fiscal years 2023 through 
     2027''.
       (e) Written Requests for Waivers, Reductions, Exemptions, 
     and Returns; Disputes Concerning Fees.--Section 736(i) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is 
     amended to read as follows:
       ``(i) Written Requests for Waivers, Reductions, Exemptions, 
     and Returns; Disputes Concerning Fees.--To qualify for 
     consideration for a waiver or reduction under subsection (d), 
     an exemption under subsection (k), or the return of any fee 
     paid under this section, including if the fee is claimed to 
     have been paid in error, a person shall--
       ``(1) not later than 180 days after such fee is due, submit 
     to the Secretary a written request justifying such waiver, 
     reduction, exemption, or return; and
       ``(2) include in the request any legal authorities under 
     which the request is made.''.
       (f) Orphan Drugs.--Section 736(k) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is amended--
       (1) in paragraph (1)(B), by striking ``during the previous 
     year'' and inserting ``as determined under paragraph (2)''; 
     and
       (2) by amending paragraph (2) to read as follows:
       ``(2) Evidence of qualification.--An exemption under 
     paragraph (1) applies with respect to a drug only if the 
     applicant involved submits a certification that the 
     applicant's gross annual revenues did not exceed $50,000,000 
     for the last calendar year ending prior to the fiscal year 
     for which the exemption is requested. Such certification 
     shall be supported by--
       ``(A) tax returns submitted to the United States Internal 
     Revenue Service; or
       ``(B) as necessary, other appropriate financial 
     information.''.

     SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Section 736B of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 379h-2) is amended--
       (1) in subsection (a)(1), by striking ``Beginning with 
     fiscal year 2018, not'' and inserting ``Not'';
       (2) by striking ``Prescription Drug User Fee Amendments of 
     2017'' each place it appears and inserting ``Prescription 
     Drug User Fee Amendments of 2022'';
       (3) in subsection (a)(3)(A), by striking ``Not later than 
     30 calendar days after the end of the second quarter of 
     fiscal year 2018, and not later than 30 calendar days after 
     the end of each quarter of each fiscal year thereafter'' and 
     inserting ``Not later than 30 calendar days after the end of 
     each quarter of each fiscal year for which fees are collected 
     under this part'';
       (4) in subsection (a)(3)(B), by adding at the end the 
     following:
       ``(v) For fiscal years 2023 and 2024, of the meeting 
     requests from sponsors for which the Secretary has determined 
     that a face-to-face meeting is appropriate, the number of 
     face-to-face meetings requested by sponsors to be conducted 
     in person (in such manner as the Secretary shall prescribe on 
     the internet website of the Food and Drug Administration), 
     and the number of such in-person meetings granted by the 
     Secretary.'';
       (5) in subsection (a)(4), by striking ``Beginning with 
     fiscal year 2020, the'' and inserting ``The'';
       (6) in subsection (b), by striking ``Beginning with fiscal 
     year 2018, not'' and inserting ``Not'';
       (7) in subsection (c), by striking ``Beginning with fiscal 
     year 2018, for'' and inserting ``For''; and
       (8) in subsection (f)--
       (A) in paragraph (1), in the matter preceding subparagraph 
     (A), by striking ``fiscal year 2022'' and inserting ``fiscal 
     year 2027''; and
       (B) in paragraph (5), by striking ``January 15, 2022'' and 
     inserting ``January 15, 2027''.

     SEC. 105. SUNSET DATES.

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

     SEC. 106. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2022, or the date of the enactment of this Act, 
     whichever is later, except that fees under part 2 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379g et seq.) shall be assessed for 
     all human drug applications received on or after October 1, 
     2022, regardless of the date of the enactment of this Act.

     SEC. 107. SAVINGS CLAUSE.

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

                   TITLE II--FEES RELATING TO DEVICES

     SEC. 201. SHORT TITLE; FINDING.

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

     SEC. 202. DEFINITIONS.

       Section 737 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 379i) is amended--
       (1) in paragraph (9)--
       (A) in the matter preceding subparagraph (A), by striking 
     ``and premarket notification submissions'' and inserting 
     ``premarket notification submissions, and de novo 
     classification requests'';
       (B) in subparagraph (D), by striking ``and submissions'' 
     and inserting ``submissions, and requests'';

[[Page H5301]]

       (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''; and
       (D) in subparagraph (D), in the matter preceding clause 
     (i), by striking ``fiscal years 2018 through 2022'' and 
     inserting ``fiscal years 2023 through 2027'';
       (3) in paragraph (3), by striking ``2018 through 2022'' and 
     inserting ``2023 through 2027'';
       (4) by redesignating paragraphs (4) and (5) as paragraphs 
     (7) and (8), respectively; and
       (5) by inserting after paragraph (3) the following:
       ``(4) Performance improvement adjustment.--
       ``(A) In general.--For each of fiscal years 2025 through 
     2027, after the adjustments under paragraphs (2) and (3), the 
     base establishment registration fee amounts for such fiscal 
     year shall be increased to reflect changes in the resource 
     needs of the Secretary due to improved review performance 
     goals for the process for the review of device applications 
     identified in the letters described in section 201(b) of the 
     Medical Device User Fee Amendments of 2022, as the Secretary 
     determines necessary to achieve an increase in total fee 
     collections for such fiscal year equal to the following 
     amounts:
       ``(i) For fiscal year 2025, the product of--

       ``(I) the amount determined under subparagraph (B)(i)(I); 
     and
       ``(II) the applicable inflation adjustment under paragraph 
     (2)(B) for such fiscal year.

       ``(ii) For fiscal year 2026, the product of--

       ``(I) the sum of the amounts determined under subparagraphs 
     (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); and
       ``(II) the applicable inflation adjustment under paragraph 
     (2)(B) for such fiscal year.

       ``(iii) For fiscal year 2027, the product of--

       ``(I) the sum of the amounts determined under subparagraphs 
     (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); and
       ``(II) the applicable inflation adjustment under paragraph 
     (2)(B) for such fiscal year.

       ``(B) Amounts.--
       ``(i) Pre-submission amount.--For purposes of subparagraph 
     (A), with respect to the pre-submission written feedback 
     goal, the amounts determined under this subparagraph are as 
     follows:

       ``(I) For fiscal year 2025, $15,396,600 if such goal for 
     fiscal year 2023 is met.
       ``(II) For fiscal year 2026:

       ``(aa) $15,396,600 if such goal for fiscal year 2023 is met 
     and such goal for fiscal year 2024 is not met.
       ``(bb) $36,792,200 if such goal for fiscal year 2024 is 
     met.

       ``(III) For fiscal year 2027:

       ``(aa) $15,396,600 if such goal for fiscal year 2023 is met 
     and such goal for each of fiscal years 2024 and 2025 is not 
     met.
       ``(bb) $36,792,200 if such goal for fiscal year 2024 is met 
     and such goal for fiscal year 2025 is not met.
       ``(cc) $40,572,600 if such goal for fiscal year 2025 is 
     met.
       ``(ii) De novo classification amount.--For purposes of 
     subparagraph (A), with respect to the de novo decision goal, 
     the amounts determined under this subparagraph are as 
     follows:

       ``(I) For fiscal year 2026, $6,323,500 if such goal for 
     fiscal year 2023 is met.
       ``(II) For fiscal year 2027:

       ``(aa) $6,323,500 if such goal for fiscal year 2023 is met 
     and such goal for fiscal year 2024 is not met.
       ``(bb) $11,765,400 if such goal for fiscal year 2024 is 
     met.
       ``(iii) Premarket notification and premarket approval 
     amount.--For purposes of subparagraph (A), with respect to 
     the 510(k) decision goal, 510(k) shared outcome total time to 
     decision goal, PMA decision goal, and PMA shared outcome 
     total time to decision goal, the amounts determined under 
     this subparagraph are as follows:

       ``(I) For fiscal year 2026, $1,020,000 if the four goals 
     for fiscal year 2023 are met.
       ``(II) For fiscal year 2027:

       ``(aa) $1,020,000 if the four goals for fiscal year 2023 
     are met and one or more of the four goals for fiscal year 
     2024 are not met.
       ``(bb) $3,906,000 if the four goals for fiscal year 2024 
     are met.
       ``(C) Performance calculation.--For purposes of this 
     paragraph, performance of the goals listed in subparagraph 
     (D) shall be determined as specified in the letters described 
     in section 201(b) of the Medical Device User Fee Amendments 
     of 2022 and based on data available as of the following 
     dates:
       ``(i) The performance of the pre-submission written 
     feedback goal shall be based on data available as of--

       ``(I) for fiscal year 2023, March 31, 2024;
       ``(II) for fiscal year 2024, March 31, 2025; and
       ``(III) for fiscal year 2025, March 31, 2026.

       ``(ii) The performance of the de novo decision goal, 510(k) 
     decision goal, 510(k) shared outcome total time to decision 
     goal, PMA decision goal, and PMA shared outcome total time to 
     decision goal shall be based on data available as of--

       ``(I) for fiscal year 2023, March 31, 2025; and
       ``(II) for fiscal year 2024, March 31, 2026.

       ``(D) Goals defined.--For purposes of this paragraph, the 
     terms `pre-submission written feedback goal', `de novo 
     decision goal', `510(k) decision goal', `510(k) shared 
     outcome total time to decision goal', `PMA decision goal', 
     and `PMA shared outcome total time to decision goal' refer to 
     the goals identified by the same names in the letters 
     described in section 201(b) of the Medical Device User Fee 
     Amendments of 2022.
       ``(5) Hiring adjustment.--
       ``(A) In general.--For each of fiscal years 2025 through 
     2027, after the adjustments under paragraphs (2), (3), and 
     (4), if applicable, if the number of hires to support the 
     process for the review of device applications falls below the 
     thresholds specified in subparagraph (B) for the applicable 
     fiscal years, the base establishment registration fee amounts 
     shall be decreased as the Secretary determines necessary to 
     achieve a reduction in total fee collections equal to the 
     hiring adjustment amount under subparagraph (C).
       ``(B) Thresholds.--The thresholds specified in this 
     subparagraph are as follows:
       ``(i) For fiscal year 2025, the threshold is 123 hires for 
     fiscal year 2023.

[[Page H5302]]

       ``(ii) For fiscal year 2026, the threshold is 38 hires for 
     fiscal year 2024.
       ``(iii) For fiscal year 2027, the threshold is--

       ``(I) 22 hires for fiscal year 2025 if the base 
     establishment registration fees are not increased by the 
     amount determined under paragraph (4)(A)(i); or
       ``(II) 75 hires for fiscal year 2025 if such fees are so 
     increased.

       ``(C) Hiring adjustment amount.--The hiring adjustment 
     amount for fiscal year 2025 and each subsequent fiscal year 
     is the product of--
       ``(i) the number of hires by which the hiring goal 
     specified in subparagraph (D) for the fiscal year before the 
     prior fiscal year was not met;
       ``(ii) $72,877; and
       ``(iii) the applicable inflation adjustment under paragraph 
     (2)(B) for the fiscal year for which the hiring goal was not 
     met.
       ``(D) Hiring goals.--The hiring goals for each of fiscal 
     years 2023 through 2025 are as follows:
       ``(i) For fiscal year 2023, 144 hires.
       ``(ii) For fiscal year 2024, 42 hires.
       ``(iii) For fiscal year 2025:

       ``(I) 24 hires if the base establishment registration fees 
     are not increased by the amount determined under paragraph 
     (4)(A)(i).
       ``(II) 83 hires if the base establishment registration fees 
     are increased by the amount determined under paragraph 
     (4)(A)(i).

       ``(E) Number of hires.--For purposes of this paragraph, the 
     number of hires shall be determined by the Secretary as set 
     forth in the letters described in section 201(b) of the 
     Medical Device User Fee Amendments of 2022.
       ``(6) Operating reserve adjustment.--
       ``(A) In general.--For each of fiscal years 2023 through 
     2027, after the adjustments under paragraphs (2), (3), (4), 
     and (5), if applicable, if the Secretary has operating 
     reserves of carryover user fees for the process for the 
     review of device applications in excess of the designated 
     amount in subparagraph (B), the Secretary shall decrease the 
     base establishment registration fee amounts to provide for 
     not more than such designated amount of operating reserves.
       ``(B) Designated amount.--Subject to subparagraph (C), for 
     each fiscal year, the designated amount in this subparagraph 
     is equal to the sum of--
       ``(i) 13 weeks of operating reserves of carryover user 
     fees; and
       ``(ii) 1 month of operating reserves maintained pursuant to 
     paragraph (8).
       ``(C) Excluded amount.--For the period of fiscal years 2023 
     through 2026, a total amount equal to $118,000,000 shall not 
     be considered part of the designated amount under 
     subparagraph (B) and shall not be subject to the decrease 
     under subparagraph (A).''.
       (d) Small Businesses.--Section 738 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379j) is amended in each of 
     subsections (d)(2)(B)(iii) and (e)(2)(B)(iii) by inserting 
     ``, if extant,'' after ``national taxing authority''.
       (e) Conditions.--Section 738(g) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379j(g)) is amended--
       (1) in paragraph (1)(A), by striking ``$320,825,000'' and 
     inserting ``$398,566,000''; and
       (2) in paragraph (2), by inserting ``de novo classification 
     requests,'' after ``class III device,''.
       (f) Crediting and Availability of Fees.--Section 738(h)(3) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379j(h)(3)) is amended to read as follows:
       ``(3) Authorization of appropriations.--
       ``(A) In general.--For each of fiscal years 2023 through 
     2027, there is authorized to be appropriated for fees under 
     this section an amount equal to the revenue amount determined 
     under subparagraph (B), less the amount of reductions 
     determined under subparagraph (C).
       ``(B) Revenue amount.--For purposes of this paragraph, the 
     revenue amount for each fiscal year is the sum of--
       ``(i) the total revenue amount under subsection (b)(3) for 
     the fiscal year, as adjusted under paragraphs (2) and (3) of 
     subsection (c); and
       ``(ii) the performance improvement adjustment amount for 
     the fiscal year under subsection (c)(4), if applicable.
       ``(C) Reductions.--For purposes of this paragraph, the 
     amount of reductions for each fiscal year is the sum of--
       ``(i) the hiring adjustment amount for the fiscal year 
     under subsection (c)(5), if applicable; and
       ``(ii) the operating reserve adjustment amount for the 
     fiscal year under subsection (c)(6), if applicable.''.

     SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.

       (a) Performance Reports.--Section 738A(a) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is 
     amended--
       (1) by striking ``fiscal year 2018'' each place it appears 
     and inserting ``fiscal year 2023'';
       (2) by striking ``Medical Device User Fee Amendments of 
     2017'' each place it appears and inserting ``Medical Device 
     User Fee Amendments of 2022'';
       (3) in paragraph (1)--
       (A) in subparagraph (A), by redesignating the second clause 
     (iv) (relating to analysis) as clause (v); and
       (B) in subparagraph (A)(iv), by striking ``fiscal year 
     2020'' and inserting ``fiscal year 2023''; and
       (4) in paragraph (4), by striking ``2018 through 2022'' and 
     inserting ``2023 through 2027''.
       (b) Reauthorization.--Section 738A(b) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
       (1) in paragraph (1), by striking ``2022'' and inserting 
     ``2027''; and
       (2) in paragraph (5), by striking ``2022'' and inserting 
     ``2027''.

     SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.

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

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

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

     SEC. 207. SUNSET DATES.

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

     SEC. 208. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2022, or the date of the enactment of this Act, 
     whichever is later, except that fees under part 3 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379i et seq.) shall be assessed for 
     all submissions listed in section 738(a)(2)(A) of such Act 
     received on or after October 1, 2022, regardless of the date 
     of the enactment of this Act.

     SEC. 209. SAVINGS CLAUSE.

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

[[Page H5303]]

  


               TITLE III--FEES RELATING TO GENERIC DRUGS

     SEC. 301. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the ``Generic 
     Drug User Fee Amendments of 2022''.
       (b) Finding.--The Congress finds that the fees authorized 
     by the amendments made by this title will be dedicated to 
     human generic drug activities, as set forth in the goals 
     identified for purposes of part 7 of subchapter C of chapter 
     VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379j-41 et seq.), in the letters from the Secretary of Health 
     and Human Services to the Chairman of the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Chairman of the Committee on Energy and Commerce of the House 
     of Representatives, as set forth in the Congressional Record.

     SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 
                   FEES.

       (a) Types of Fees.--Section 744B(a) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--
       (1) in the matter preceding paragraph (1), by striking 
     ``fiscal year 2018'' and inserting ``fiscal year 2023'';
       (2) in paragraph (2)(C), by striking ``2018 through 2022'' 
     and inserting ``2023 through 2027'';
       (3) in paragraph (3)(B), by striking ``2018 through 2022'' 
     and inserting ``2023 through 2027'';
       (4) in paragraph (4)(D), by striking ``2018 through 2022'' 
     and inserting ``2023 through 2027''; and
       (5) in paragraph (5)(D), by striking ``2018 through 2022'' 
     and inserting ``2023 through 2027''.
       (b) Fee Revenue Amounts.--Section 744B(b) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(b)) is 
     amended--
       (1) in paragraph (1)--
       (A) in subparagraph (A)--
       (i) in the heading, by striking ``2018'' and inserting 
     ``2023'';
       (ii) by striking ``2018'' and inserting ``2023''; and
       (iii) by striking ``$493,600,000'' and inserting 
     ``$582,500,000''; and
       (B) by amending subparagraph (B) to read as follows:
       ``(B) Fiscal years 2024 through 2027.--
       ``(i) In general.--For each of the fiscal years 2024 
     through 2027, fees under paragraphs (2) through (5) of 
     subsection (a) shall be established to generate a total 
     estimated revenue amount under such subsection that is equal 
     to the base revenue amount for the fiscal year under clause 
     (ii), as adjusted pursuant to subsection (c).
       ``(ii) Base revenue amount.--The base revenue amount for a 
     fiscal year referred to in clause (i) is equal to the total 
     revenue amount established under this paragraph for the 
     previous fiscal year, not including any adjustments made for 
     such previous fiscal year under subsection (c)(3).''; and
       (2) in paragraph (2)--
       (A) in subparagraph (C), by striking ``one-third the 
     amount'' and inserting ``twenty-four percent'';
       (B) in subparagraph (D), by striking ``Seven percent'' and 
     inserting ``Six percent''; and
       (C) in subparagraph (E)(i), by striking ``Thirty-five 
     percent'' and inserting ``Thirty-six percent''.
       (c) Adjustments.--Section 744B(c) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--
       (1) in paragraph (1)--
       (A) in the matter preceding subparagraph (A)--
       (i) by striking ``2019'' and inserting ``2024''; and
       (ii) by striking ``to equal the product of the total 
     revenues established in such notice for the prior fiscal year 
     multiplied'' and inserting ``to equal the base revenue amount 
     for the fiscal year (as specified in subsection (b)(1)(B)) 
     multiplied''; and
       (B) in subparagraph (C), by striking ``Washington-
     Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
     Arlington-Alexandria, DC-VA-MD-WV''; and
       (2) by striking paragraph (2) and inserting the following:
       ``(2) Capacity planning adjustment.--
       ``(A) In general.--Beginning with fiscal year 2024, the 
     Secretary shall, in addition to the adjustment under 
     paragraph (1), further increase the fee revenue and fees 
     under this section for a fiscal year, in accordance with this 
     paragraph, to reflect changes in the resource capacity needs 
     of the Secretary for human generic drug activities.
       ``(B) Capacity planning methodology.--The Secretary shall 
     establish a capacity planning methodology for purposes of 
     this paragraph, which shall--
       ``(i) be derived from the methodology and recommendations 
     made in the report titled `Independent Evaluation of the 
     GDUFA Resource Capacity Planning Adjustment Methodology: 
     Evaluation and Recommendations' announced in the Federal 
     Register on August 3, 2020;
       ``(ii) incorporate approaches and attributes determined 
     appropriate by the Secretary, including approaches and 
     attributes made in such report, except that in incorporating 
     such approaches and attributes the workload categories used 
     in forecasting resources shall only be the workload 
     categories specified in section VIII.B.2.e. of the letters 
     described in section 301(b) of the Generic Drug User Fee 
     Amendments of 2022; and
       ``(iii) be effective beginning with fiscal year 2024.
       ``(C) Limitations.--
       ``(i) In general.--Under no circumstances shall an 
     adjustment under this paragraph result in fee revenue for a 
     fiscal year that is less than the sum of the amounts under 
     subsection (b)(1)(B)(ii) (the base revenue amount for the 
     fiscal year) and paragraph (1) (the dollar amount of the 
     inflation adjustment for the fiscal year).
       ``(ii) Percentage limitation.--An adjustment under this 
     paragraph shall not exceed three percent of the sum described 
     in clause (i) for the fiscal year, except that such 
     limitation shall be four percent if--

       ``(I) for purposes of a fiscal year 2024 adjustment, the 
     Secretary determines that during the period from April 1, 
     2021, through March 31, 2023--

       ``(aa) the total number of abbreviated new drug 
     applications submitted was greater than or equal to 2,000; or
       ``(bb) thirty-five percent or more of abbreviated new drug 
     applications submitted related to complex products (as that 
     term is defined in section XI of the letters described in 
     section 301(b) of the Generic Drug User Fee Amendments of 
     2022);

       ``(II) for purposes of a fiscal year 2025 adjustment, the 
     Secretary determines that during the period from April 1, 
     2022, through March 31, 2024--

       ``(aa) the total number of abbreviated new drug 
     applications submitted was greater than or equal to 2,300; or
       ``(bb) thirty-five percent or more of abbreviated new drug 
     applications submitted related to complex products (as so 
     defined);

       ``(III) for purposes of a fiscal year 2026 adjustment, the 
     Secretary determines that during the period from April 1, 
     2023, through March 31, 2025--

       ``(aa) the total number of abbreviated new drug 
     applications submitted was greater than or equal to 2,300; or
       ``(bb) thirty-five percent or more of abbreviated new drug 
     applications submitted related to complex products (as so 
     defined); and

       ``(IV) for purposes of a fiscal year 2027 adjustment, the 
     Secretary determines that during the period from April 1, 
     2024, through March 31, 2026--

       ``(aa) the total number of abbreviated new drug 
     applications submitted was greater than or equal to 2,300; or
       ``(bb) thirty-five percent or more of abbreviated new drug 
     applications submitted related to complex products (as so 
     defined).
       ``(D) Publication in federal register.--The Secretary shall 
     publish in the Federal Register notice referred to in 
     subsection (a) the fee revenue and fees resulting from the 
     adjustment and the methodology under this paragraph.
       ``(3) Operating reserve adjustment.--
       ``(A) In general.--For fiscal year 2024 and each subsequent 
     fiscal year, the Secretary may, in addition to adjustments 
     under paragraphs (1) and (2), further increase the fee 
     revenue and fees under this section for such fiscal year if 
     such an adjustment is necessary to provide operating reserves 
     of carryover user fees for human generic drug activities for 
     not more than the number of weeks specified in subparagraph 
     (B) with respect to that fiscal year.
       ``(B) Number of weeks.--The number of weeks specified in 
     this subparagraph is--
       ``(i) 8 weeks for fiscal year 2024;
       ``(ii) 9 weeks for fiscal year 2025; and
       ``(iii) 10 weeks for each of fiscal year 2026 and 2027.
       ``(C) Decrease.--If the Secretary has carryover balances 
     for human generic drug activities in excess of 12 weeks of 
     the operating reserves referred to in subparagraph (A), the 
     Secretary shall decrease the fee revenue and fees referred to 
     in such subparagraph to provide for not more than 12 weeks of 
     such operating reserves.
       ``(D) Rationale for adjustment.--If an adjustment under 
     this paragraph is made, the rationale for the amount of the 
     increase or decrease (as applicable) in fee revenue and fees 
     shall be contained in the annual Federal Register notice 
     under subsection (a) publishing the fee revenue and fees for 
     the fiscal year involved.''.
       (d) Annual Fee Setting.--Section 744B(d)(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(d)(1)) is 
     amended--
       (1) in the paragraph heading, by striking ``2018 through 
     2022'' and inserting ``2023 through 2027''; and
       (2) by striking ``more than 60 days before the first day of 
     each of fiscal years 2018 through 2022'' and inserting 
     ``later than 60 days before the first day of each of fiscal 
     years 2023 through 2027''.
       (e) Crediting and Availability of Fees.--Section 744B(i)(3) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
     42(i)(3)) is amended by striking ``fiscal years 2018 through 
     2022'' and inserting ``fiscal years 2023 through 2027''.
       (f) Effect of Failure to Pay Fees.--The heading of 
     paragraph (3) of section 744B(g) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379j-42(g)) is amended by 
     striking ``and prior approval supplement fee''.

     SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Section 744C of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 379j-43) is amended--
       (1) in subsection (a)(1), by striking ``Beginning with 
     fiscal year 2018, not'' and inserting ``Not'';
       (2) by striking ``Generic Drug User Fee Amendments of 
     2017'' each place it appears

[[Page H5304]]

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

     SEC. 304. SUNSET DATES.

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

     SEC. 305. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2022, or the date of the enactment of this Act, 
     whichever is later, except that fees under part 7 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379j-41 et seq.) shall be assessed 
     for all abbreviated new drug applications received on or 
     after October 1, 2022, regardless of the date of the 
     enactment of this Act.

     SEC. 306. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, part 7 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379j-41 et seq.), as in effect on the 
     day before the date of the enactment of this title, shall 
     continue to be in effect with respect to abbreviated new drug 
     applications (as defined in such part as of such day) that 
     were received by the Food and Drug Administration within the 
     meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 
     355(j)(5)(A)), prior approval supplements that were 
     submitted, and drug master files for Type II active 
     pharmaceutical ingredients that were first referenced on or 
     after October 1, 2017, but before October 1, 2022, with 
     respect to assessing and collecting any fee required by such 
     part for a fiscal year prior to fiscal year 2023.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

     SEC. 401. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the 
     ``Biosimilar User Fee Amendments of 2022''.
       (b) Finding.--The Congress finds that the fees authorized 
     by the amendments made by this title will be dedicated to 
     expediting the process for the review of biosimilar 
     biological product applications, including postmarket safety 
     activities, as set forth in the goals identified for purposes 
     of part 8 of subchapter C of chapter VII of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379j-51 et seq.), in the 
     letters from the Secretary of Health and Human Services to 
     the Chairman of the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Chairman of the Committee 
     on Energy and Commerce of the House of Representatives, as 
     set forth in the Congressional Record.

     SEC. 402. DEFINITIONS.

       (a) Adjustment Factor.--Section 744G(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(1)) is 
     amended to read as follows:
       ``(1) The term `adjustment factor' applicable to a fiscal 
     year is the Consumer Price Index for urban consumers 
     (Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally 
     Adjusted; All items; Annual Index) for September of the 
     preceding fiscal year divided by such Index for September 
     2011.''.
       (b) Biosimilar Biological Product Application.--Section 
     744G(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 379j-51(4)(B)(iii)) is amended--
       (1) by striking subclause (II) (relating to an allergenic 
     extract product); and
       (2) by redesignating subclauses (III) and (IV) as 
     subclauses (II) and (III), respectively.

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

       (a) Types of Fees.--
       (1) In general.--The matter preceding paragraph (1) in 
     section 744H(a) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 379j-52(a)) is amended by striking ``fiscal year 
     2018'' and inserting ``fiscal year 2023''.
       (2) Initial biosimilar biological product development 
     fee.--Clauses (iv)(I) and (v)(II) of section 744H(a)(1)(A) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
     52(a)(1)(A)) are each amended by striking ``5 days'' and 
     inserting ``7 days''.
       (3) Annual biosimilar biological product development fee.--
     Section 744H(a)(1)(B) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 379j-52(a)(1)(B)) is amended--
       (A) in clause (i), by inserting before the period at the 
     end the following: ``, except where such product (including, 
     where applicable, ownership of the relevant investigational 
     new drug application) is transferred to a licensee, assignee, 
     or successor of such person, and written notice of such 
     transfer is provided to the Secretary, in which case such 
     licensee, assignee, or successor shall pay the annual 
     biosimilar biological product development fee'';
       (B) in clause (iii)--
       (i) in subclause (I), by striking ``or'' at the end;
       (ii) in subclause (II), by striking the period at the end 
     and inserting ``; or''; and
       (iii) by adding at the end the following:

       ``(III) been administratively removed from the biosimilar 
     biological product development program for the product under 
     subparagraph (E)(v).''; and

       (C) in clause (iv), by striking ``is accepted for filing on 
     or after October 1 of such fiscal year'' and inserting ``is 
     subsequently accepted for filing''.
       (4) Reactivation fee.--Section 744H(a)(1)(D) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a)(1)(D)) is 
     amended to read as follows:
       ``(D) Reactivation fee.--
       ``(i) In general.--A person that has discontinued 
     participation in the biosimilar biological product 
     development program for a product under subparagraph (C), or 
     who has been administratively removed from the biosimilar 
     biological product development program for a product under 
     subparagraph (E)(v), shall, if the person seeks to resume 
     participation in such program, pay all annual biosimilar 
     biological product development fees previously assessed for 
     such product and still owed and a fee (referred to in this 
     section as `reactivation fee') by the earlier of the 
     following:

       ``(I) Not later than 7 days after the Secretary grants a 
     request by such person for a biosimilar biological product 
     development meeting for the product (after the date on which 
     such participation was discontinued or the date of 
     administrative removal, as applicable).
       ``(II) Upon the date of submission (after the date on which 
     such participation was discontinued or the date of 
     administrative removal, as applicable) by such person of an 
     investigational new drug application describing an 
     investigation that the Secretary determines is intended to 
     support a biosimilar biological product application for that 
     product.

       ``(ii) Application of annual fee.--A person that pays a 
     reactivation fee for a product shall pay for such product, 
     beginning in the next fiscal year, the annual biosimilar 
     biological product development fee under subparagraph (B), 
     except where such product (including, where applicable, 
     ownership of the relevant investigational new drug 
     application) is transferred to a licensee, assignee, or 
     successor of such person, and written notice of such transfer 
     is provided to the Secretary, in which case such licensee, 
     assignee, or successor shall pay the annual biosimilar 
     biological product development fee.''.
       (5) Effect of failure to pay fees.--Section 744H(a)(1)(E) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
     52(a)(1)(E)) is amended by adding at the end the following:
       ``(v) Administrative removal from the biosimilar biological 
     product development program.--If a person has failed to pay 
     an annual biosimilar biological product development fee for a 
     product as required under subparagraph (B) for a period of 
     two consecutive fiscal years, the Secretary may 
     administratively remove such person from the biosimilar 
     biological product development program for the product. At 
     least 30 days prior to administratively removing a person 
     from the biosimilar biological product development program 
     for a product under this clause, the Secretary shall provide 
     written notice to such person of the intended administrative 
     removal.''.
       (6) Biosimilar biological product application fee.--Section 
     744H(a)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 379j-52(a)(2)(D)) is amended by inserting after ``or 
     was withdrawn'' the following: ``prior to approval''.
       (7) Biosimilar biological product program fee.--Section 
     744H(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 379j-52(a)(3)) is amended--
       (A) in subparagraph (A)--
       (i) in clause (i), by striking ``and'' at the end;
       (ii) by redesignating clause (ii) as clause (iii); and
       (iii) by inserting after clause (i) the following:
       ``(ii) may be dispensed only under prescription pursuant to 
     section 503(b); and''; and
       (B) by adding at the end the following:
       ``(E) Movement to discontinued list.--
       ``(i) Date of inclusion.--If a written request to place a 
     product on the list referenced in subparagraph (A) of 
     discontinued biosimilar biological products is submitted to 
     the Secretary on behalf of an applicant, and the request 
     identifies the date the product is withdrawn from sale, then 
     for purposes of assessing the biosimilar biological product 
     program fee, the Secretary shall consider such product to 
     have been included on such list on the later of--

       ``(I) the date such request was received; or

[[Page H5305]]

       ``(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

[[Page H5306]]

     fees are collected under this part'' and inserting ``Not 
     later than 120 days after the end of each fiscal year for 
     which fees are collected under this part'';
       (6) in subsection (c), by striking ``Beginning with fiscal 
     year 2018, and for'' and inserting ``For''; and
       (7) in subsection (f)--
       (A) in paragraph (1), in the matter preceding subparagraph 
     (A), by striking ``fiscal year 2022'' and inserting ``fiscal 
     year 2027''; and
       (B) in paragraph (3), by striking ``January 15, 2022'' and 
     inserting ``January 15, 2027''.

     SEC. 405. SUNSET DATES.

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

     SEC. 406. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2022, or the date of the enactment of this Act, 
     whichever is later, except that fees under part 8 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379j-51 et seq.) shall be assessed 
     for all biosimilar biological product applications received 
     on or after October 1, 2022, regardless of the date of the 
     enactment of this Act.

     SEC. 407. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, part 8 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379j-51 et seq.), as in effect on the 
     day before the date of the enactment of this title, shall 
     continue to be in effect with respect to biosimilar 
     biological product applications and supplements (as defined 
     in such part as of such day) that were accepted by the Food 
     and Drug Administration for filing on or after October 1, 
     2017, but before October 1, 2022, with respect to assessing 
     and collecting any fee required by such part for a fiscal 
     year prior to fiscal year 2023.

            TITLE V--IMPROVING DIVERSITY IN CLINICAL STUDIES

     SEC. 501. DIVERSITY ACTION PLANS FOR CLINICAL STUDIES.

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

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

       ``(a) In General.--The Secretary shall issue guidance 
     relating to--
       ``(1) the format and content of the diversity action plans 
     required by sections 505(i)(5) and 520(g)(9) pertaining to 
     the sponsor's goals for clinical study enrollment, 
     disaggregated by age group, sex, race, geographic location, 
     socioeconomic status, and ethnicity, including with respect 
     to--
       ``(A) the rationale for the sponsor's enrollment goals, 
     which may include--
       ``(i) the estimated prevalence or incidence in the United 
     States of the disease or condition for which the drug or 
     device is being developed or investigated, if such estimated 
     prevalence or incidence is known or can be determined based 
     on available data;
       ``(ii) what is known about the disease or condition for 
     which the drug or device is being developed or investigated;
       ``(iii) any relevant pharmacokinetic or pharmacogenomic 
     data;
       ``(iv) what is known about the patient population for such 
     disease or condition, including, to the extent data is 
     available--

       ``(I) demographic information, including age group, sex, 
     race, geographic location, socioeconomic status, and 
     ethnicity;
       ``(II) non-demographic factors, including co-morbidities 
     affecting the patient population; and
       ``(III) potential barriers to enrolling diverse 
     participants, such as patient population size, geographic 
     location, and socioeconomic status; and

       ``(v) any other data or information relevant to selecting 
     appropriate enrollment goals, disaggregated by demographic 
     subgroup, such as the inclusion of pregnant and lactating 
     women;
       ``(B) an explanation for how the sponsor intends to meet 
     such goals, including demographic-specific outreach and 
     enrollment strategies, study-site selection, clinical study 
     inclusion and exclusion practices, and any diversity training 
     for study personnel; and
       ``(C) procedures for the public posting of key information 
     from the diversity action plan that would be useful to 
     patients and providers on the sponsor's website, as 
     appropriate; and
       ``(2) how sponsors should include in regular reports to the 
     Secretary--
       ``(A) the sponsor's progress in meeting the goals referred 
     to in paragraph (1)(A); and
       ``(B) if the sponsor does not expect to meet such goals--
       ``(i) any updates needed to be made to a diversity action 
     plan referred to in paragraph (1) to help meet such goals; 
     and
       ``(ii) the sponsor's reasons for why the sponsor does not 
     expect to meet such goals.
       ``(b) Issuance.--The Secretary shall--
       ``(1) not later than 12 months after the date of enactment 
     of this section, issue new draft guidance or update existing 
     draft guidance described in subsection (a); and
       ``(2) not later than 9 months after closing the comment 
     period on such draft guidance, finalize such guidance.''.
       (d) Applicability.--Sections 505(i)(5) and 520(g)(9) of the 
     Federal Food, Drug, and Cosmetic Act, as added by subsections 
     (a) and (b) of this section, apply only with respect to 
     clinical investigations with respect to which enrollment 
     commences after the date that is 180 days after the 
     publication of final guidance under section 524B(b)(2) of the 
     Federal Food, Drug, and Cosmetic Act, as added by subsection 
     (c).

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

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

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

       (a) In General.--Not later than one year after the date of 
     enactment of this Act, the

[[Page H5307]]

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

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

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

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

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

     SEC. 506. DECENTRALIZED CLINICAL STUDIES.

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

                   TITLE VI--GENERIC DRUG COMPETITION

     SEC. 601. INCREASING TRANSPARENCY IN GENERIC DRUG 
                   APPLICATIONS.

       (a) In General.--Section 505(j)(3) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by 
     adding at the end the following:
       ``(H)(i) Upon request (in controlled correspondence or 
     otherwise) by a person that has submitted or intends to 
     submit an abbreviated application for a new drug under this 
     subsection for which the Secretary has specified in 
     regulation, including in section 314.94(a)(9) of title 21, 
     Code of Federal Regulations (or any successor regulations), 
     or recommended in applicable guidance, certain qualitative or 
     quantitative criteria with respect to an inactive ingredient, 
     or on the Secretary's own initiative during the review of 
     such abbreviated application, the Secretary shall inform the 
     person whether such new drug is qualitatively and 
     quantitatively the same as the listed drug.
       ``(ii) Notwithstanding section 301(j), if the Secretary 
     determines that such new drug is not qualitatively or 
     quantitatively the same as the listed drug, the Secretary 
     shall identify and disclose to the person--
       ``(I) the ingredient or ingredients that cause the new drug 
     not to be qualitatively or quantitatively the same as the 
     listed drug; and
       ``(II) for any ingredient for which there is an identified 
     quantitative deviation, the amount of such deviation.
       ``(iii) If the Secretary determines that such new drug is 
     qualitatively and quantitatively the same as the listed drug, 
     the Secretary shall not change or rescind such determination 
     after the submission of an abbreviated application for such 
     new drug under this subsection unless--
       ``(I) the formulation of the listed drug has been changed 
     and the Secretary has determined that the prior listed drug 
     formulation

[[Page H5308]]

     was withdrawn for reasons of safety or effectiveness; or
       ``(II) the Secretary makes a written determination that the 
     prior determination must be changed because an error has been 
     identified.
       ``(iv) If the Secretary makes a written determination 
     described in clause (iii)(II), the Secretary shall provide 
     notice and a copy of the written determination to the person 
     making the request under clause (i).
       ``(v) The disclosures required by this subparagraph are 
     disclosures authorized by law including for purposes of 
     section 1905 of title 18, United States Code.''.
       (b) Guidance.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall issue draft guidance, or update guidance, 
     describing how the Secretary will determine whether a new 
     drug is qualitatively and quantitatively the same as the 
     listed drug (as such terms are used in section 505(j)(3)(H) 
     of the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (a)), including with respect to assessing pH 
     adjusters.
       (2) Process.--In issuing guidance as required by paragraph 
     (1), the Secretary of Health and Human Services shall--
       (A) publish draft guidance;
       (B) provide a period of at least 60 days for comment on the 
     draft guidance; and
       (C) after considering any comments received, and not later 
     than one year after the close of the comment period on the 
     draft guidance, publish final guidance.
       (c) Applicability.--Section 505(j)(3)(H) of the Federal 
     Food, Drug, and Cosmetic Act, as added by subsection (a), 
     applies beginning on the date of enactment of this Act, 
     irrespective of the date on which the guidance required by 
     subsection (b) is finalized.

     SEC. 602. ENHANCING ACCESS TO AFFORDABLE MEDICINES.

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

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

                         Subtitle A--In General

     SEC. 701. ANIMAL TESTING ALTERNATIVES.

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

     SEC. 702. EMERGING TECHNOLOGY PROGRAM.

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

     ``SEC. 566A. EMERGING TECHNOLOGY PROGRAM.

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

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

       (a) Report on Orphan Drug Program.--
       (1) In general.--Not later than September 30, 2026, the 
     Secretary shall submit to the Committee on Energy and 
     Commerce of the House of Representatives and the Committee on 
     Health, Education, Labor, and Pensions of the Senate a report 
     summarizing the activities of the Food and Drug 
     Administration related to designating drugs under section 526 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) 
     for a rare disease or condition and approving such drugs 
     under section 505 of such Act (21 U.S.C. 355) or licensing 
     such drugs under section 351 of the Public Health Service Act 
     (42 U.S.C. 262), including--
       (A) the number of applications for such drugs under section 
     505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355) or section 351 of the Public Health Service Act (42 
     U.S.C. 262) received by the Food and Drug Administration, the 
     number of such applications accepted and rejected for filing, 
     and the number of such applications pending, approved, and 
     disapproved by the Food and Drug Administration;
       (B) a description of trends in drug approvals for rare 
     diseases and conditions across review divisions at the Food 
     and Drug Administration;
       (C) the extent to which the Food and Drug Administration is 
     consulting with external experts pursuant to section 
     569(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-8(a)(2)) on topics pertaining to drugs for a 
     rare disease or condition, including how and when any such 
     consultation is occurring; and
       (D) the Food and Drug Administration's efforts to promote 
     best practices in the development of novel treatments for 
     rare diseases, including--
       (i) reviewer training on rare disease-related policies, 
     methods, and tools; and
       (ii) new regulatory science and coordinated support for 
     patient and stakeholder engagement.
       (2) Public availability.--The Secretary shall make the 
     report under paragraph (1) available to the public, including 
     by posting the report on the website of the Food and Drug 
     Administration.
       (3) Information disclosure.--Nothing in this subsection 
     shall be construed to authorize the disclosure of information 
     that is prohibited from disclosure under section 1905 of 
     title 18, United States Code, or subject to withholding under 
     paragraph (4) of section 552(b) of title 5, United States 
     Code (commonly referred to as the ``Freedom of Information 
     Act'').

[[Page H5309]]

       (b) Study on European Union Safety and Efficacy Reviews of 
     Drugs for Rare Diseases and Conditions.--
       (1) In general.--The Secretary of Health and Human Services 
     shall enter into a contract with an appropriate entity to 
     conduct a study on processes for evaluating the safety and 
     efficacy of drugs for rare diseases or conditions in the 
     United States and the European Union, including--
       (A) flexibilities, authorities, or mechanisms available to 
     regulators in the United States and the European Union 
     specific to rare diseases or conditions;
       (B) the consideration and use of supplemental data 
     submitted during review processes in the United States and 
     the European Union, including data associated with open label 
     extension studies and expanded access programs specific to 
     rare diseases or conditions;
       (C) an assessment of collaborative efforts between United 
     States and European Union regulators related to--
       (i) product development programs under review;
       (ii) policies under development recently issued; and
       (iii) scientific information related to product development 
     or regulation; and
       (D) recommendations for how Congress can support 
     collaborative efforts described in subparagraph (C).
       (2) Consultation.--The contract under paragraph (1) shall 
     provide for consultation with relevant stakeholders, 
     including--
       (A) representatives from the Food and Drug Administration 
     and the European Medicines Agency;
       (B) rare disease or condition patients; and
       (C) patient groups that--
       (i) represent rare disease or condition patients; and
       (ii) have international patient outreach.
       (3) Report.--The contract under paragraph (1) shall provide 
     for, not later than 2 years after the date of entering into 
     such contract--
       (A) the completion of the study under paragraph (1); and
       (B) the submission of a report on the results of such study 
     to the Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate.
       (4) Public availability.--The contract under paragraph (1) 
     shall provide for the appropriate entity referred to in 
     paragraph (1) to make the report under paragraph (3) 
     available to the public, including by posting the report on 
     the website of the appropriate entity.
       (c) Public Meeting.--
       (1) In general.--Not later than December 31, 2023, the 
     Secretary of Health and Human Services, acting through the 
     Commissioner of Food and Drugs, shall convene one or more 
     public meetings to solicit input from stakeholders regarding 
     the approaches described in paragraph (2).
       (2) Approaches.--The public meeting or meetings under 
     paragraph (1) shall address approaches to increasing and 
     improving engagement with rare disease or condition patients, 
     groups representing such patients, rare disease or condition 
     experts, and experts on small population studies, in order to 
     improve the understanding with respect to rare diseases or 
     conditions of--
       (A) patient burden;
       (B) treatment options; and
       (C) side effects of treatments, including--
       (i) comparing the side effects of treatments; and
       (ii) understanding the risks of side effects relative to 
     the health status of the patient and the progression of the 
     disease or condition.
       (3) Public docket.--The Secretary of Health and Human 
     Services shall establish a public docket to receive written 
     comments related to the approaches addressed during each 
     public meeting under paragraph (1). Such public docket shall 
     remain open for 60 days following the date of each such 
     public meeting.
       (4) Reports.--Not later than 180 days after each public 
     meeting under paragraph (1), the Commissioner of Food and 
     Drugs shall develop and publish on the website of the Food 
     and Drug Administration a report on--
       (A) the approaches discussed at the public meeting; and
       (B) any related recommendations.
       (d) Consultation on the Science of Small Population 
     Studies.--Section 569(a)(2) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb-8(a)(2)) is amended by adding 
     at the end the following:
       ``(C) Small population studies.--The external experts on 
     the list maintained pursuant to subparagraph (A) may include 
     experts on the science of small population studies.''.
       (e) Study on Sufficiency and Use of FDA Mechanisms for 
     Incorporating the Patient and Clinician Perspective in FDA 
     Processes Related to Applications Concerning Drugs for Rare 
     Diseases or Conditions.--
       (1) In general.--The Comptroller General of the United 
     States shall conduct a study on the use of Food and Drug 
     Administration mechanisms and tools to ensure that patient 
     and physician perspectives are considered and incorporated 
     throughout the processes of the Food and Drug 
     Administration--
       (A) for approving or licensing under section 505 of the 
     Federal Food, Drug, or Cosmetic Act (21 U.S.C. 355) or 
     section 351 of the Public Health Service Act (42 U.S.C. 262) 
     a drug designated as a drug for a rare disease or condition 
     under section 526 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360bb); and
       (B) in making any determination related to such a drug's 
     approval, including assessment of the drug's--
       (i) safety or effectiveness; or
       (ii) postapproval safety monitoring.
       (2) Topics.--The study under paragraph (1) shall--
       (A) identify and compare the processes that the Food and 
     Drug Administration has formally put in place and utilized to 
     gather external expertise (including patients, patient 
     groups, and physicians) related to applications for rare 
     diseases or conditions;
       (B) examine tools or mechanisms to improve efforts and 
     initiatives of the Food and Drug Administration to collect 
     and consider such external expertise with respect to 
     applications for rare diseases or conditions throughout the 
     application review and approval or licensure processes, 
     including within internal benefit-risk assessments, advisory 
     committee processes, and postapproval safety monitoring; and
       (C) examine processes or alternatives to address or resolve 
     conflicts of interest that impede the Food and Drug 
     Administration in gaining external expert input on rare 
     diseases or conditions with a limited set of clinical and 
     research experts.
       (3) Report.--Not later than 2 years after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall--
       (A) complete the study under paragraph (1);
       (B) submit a report on the results of such study to the 
     Congress; and
       (C) include in such report recommendations, if appropriate, 
     for changes to the processes and authorities of the Food and 
     Drug Administration to improve the collection and 
     consideration of external expert opinions of patients, 
     patient groups, and physicians with expertise in rare 
     diseases or conditions.
       (f) Definition.--In this section, the term ``rare disease 
     or condition'' has the meaning given such term in section 
     526(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bb(a)(2)).

     SEC. 704. ANTIFUNGAL RESEARCH AND DEVELOPMENT.

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

     SEC. 705. ADVANCING QUALIFIED INFECTIOUS DISEASE PRODUCT 
                   INNOVATION.

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

     SEC. 706. NATIONAL CENTERS OF EXCELLENCE IN ADVANCED AND 
                   CONTINUOUS PHARMACEUTICAL MANUFACTURING.

       (a) In General.--Section 3016 of the 21st Century Cures Act 
     (21 U.S.C. 399h) is amended to read as follows:

[[Page H5310]]

  


     ``SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN ADVANCED AND 
                   CONTINUOUS PHARMACEUTICAL MANUFACTURING.

       ``(a) In General.--The Secretary of Health and Human 
     Services, acting through the Commissioner of Food and Drugs--
       ``(1) shall solicit and, beginning not later than one year 
     after the date of enactment of the Prescription Drug User Fee 
     Amendments of 2022, receive requests from institutions of 
     higher education, or consortia of institutions of higher 
     education, to be designated as a National Center of 
     Excellence in Advanced and Continuous Pharmaceutical 
     Manufacturing (in this section referred to as a `National 
     Center of Excellence') to support the advancement, 
     development, and implementation of advanced and continuous 
     pharmaceutical manufacturing; and
       ``(2) shall so designate not more than 5 institutions of 
     higher education or consortia of such institutions that--
       ``(A) request such designation; and
       ``(B) meet the criteria specified in subsection (c).
       ``(b) Request for Designation.--A request for designation 
     under subsection (a) shall be made to the Secretary at such 
     time, in such manner, and containing such information as the 
     Secretary may require. Any such request shall include a 
     description of how the institution of higher education, or 
     consortium of institutions of higher education, meets or 
     plans to meet each of the criteria specified in subsection 
     (c).
       ``(c) Criteria for Designation Described.--The criteria 
     specified in this subsection with respect to an institution 
     of higher education, or consortium of institutions of higher 
     education, are that the institution or consortium has, as of 
     the date of the submission of a request under subsection (a) 
     by such institution or consortium--
       ``(1) physical and technical capacity for research, 
     development, implementation, and demonstration of advanced 
     and continuous pharmaceutical manufacturing;
       ``(2) manufacturing knowledge-sharing networks with other 
     institutions of higher education, large and small 
     pharmaceutical manufacturers, generic and nonprescription 
     manufacturers, contract manufacturers, and other relevant 
     entities;
       ``(3) proven capacity to design, develop, implement, and 
     demonstrate new, highly effective technologies for use in 
     advanced and continuous pharmaceutical manufacturing;
       ``(4) a track record for creating, preserving, and 
     transferring knowledge with respect to advanced and 
     continuous pharmaceutical manufacturing;
       ``(5) the proven ability to facilitate training of an 
     adequate future workforce for research on, and implementation 
     of, advanced and continuous pharmaceutical manufacturing; and
       ``(6) experience in participating in and leading advanced 
     and continuous pharmaceutical manufacturing technology 
     partnerships with other institutions of higher education, 
     large and small pharmaceutical manufacturers, generic and 
     nonprescription manufacturers, contract manufacturers, and 
     other relevant entities--
       ``(A) to support companies seeking to implement advanced 
     and continuous pharmaceutical manufacturing in the United 
     States;
       ``(B) to support Federal agencies with technical assistance 
     and employee training, which may include regulatory and 
     quality metric guidance as applicable, and hands-on training, 
     for advanced and continuous pharmaceutical manufacturing;
       ``(C) with respect to advanced and continuous 
     pharmaceutical manufacturing, to organize and conduct 
     research and development activities needed to create new and 
     more effective technology, develop and share knowledge, 
     create intellectual property, and maintain technological 
     leadership;
       ``(D) to develop best practices for designing and 
     implementing advanced and continuous pharmaceutical 
     manufacturing processes; and
       ``(E) to assess and respond to the national workforce needs 
     for advanced and continuous pharmaceutical manufacturing, 
     including the development and implementing of training 
     programs.
       ``(d) Termination of Designation.--The Secretary may 
     terminate the designation of any National Center of 
     Excellence designated under this section if the Secretary 
     determines such National Center of Excellence no longer meets 
     the criteria specified in subsection (c). Not later than 90 
     days before the effective date of such a termination, the 
     Secretary shall provide written notice to the National Center 
     of Excellence, including the rationale for such termination.
       ``(e) Conditions for Designation.--As a condition of 
     designation as a National Center of Excellence under this 
     section, the Secretary shall require that an institution of 
     higher education or consortium of institutions of higher 
     education enter into an agreement with the Secretary under 
     which the institution or consortium agrees--
       ``(1) to collaborate directly with the Food and Drug 
     Administration to publish the reports required by subsection 
     (g);
       ``(2) to share data with the Food and Drug Administration 
     regarding best practices and research generated through the 
     funding under subsection (f);
       ``(3) to develop, along with industry partners (which may 
     include large and small biopharmaceutical manufacturers, 
     generic and nonprescription manufacturers, and contract 
     research organizations or contract manufacturers that carry 
     out drug development and manufacturing activities) and 
     another institution or consortium designated under this 
     section, if any, a roadmap for developing an advanced and 
     continuous pharmaceutical manufacturing workforce;
       ``(4) to develop, along with industry partners and other 
     institutions or consortia of such institutions designated 
     under this section, a roadmap for strengthening existing, and 
     developing new, relationships with other institutions of 
     higher education or consortia thereof; and
       ``(5) to provide an annual report to the Food and Drug 
     Administration regarding the institution's or consortium's 
     activities under this section, including a description of how 
     the institution or consortium continues to meet and make 
     progress on the criteria specified in subsection (c).
       ``(f) Funding.--
       ``(1) In general.--The Secretary shall award funding, 
     through grants, contracts, or cooperative agreements, to the 
     National Centers of Excellence designated under this section 
     for the purpose of studying and recommending improvements to 
     advanced and continuous pharmaceutical manufacturing, 
     including such improvements as may enable the Centers--
       ``(A) to continue to meet the conditions specified in 
     subsection (e);
       ``(B) to expand capacity for research on, and development 
     of, advanced and continuous pharmaceutical manufacturing; and
       ``(C) to implement research infrastructure in advanced and 
     continuous pharmaceutical manufacturing suitable for 
     accelerating the development of drug products needed to 
     respond to emerging medical threats, such as emerging drug 
     shortages, quality issues disrupting the supply chain, 
     epidemics and pandemics, and other such situations requiring 
     the rapid development of new products or new manufacturing 
     processes.
       ``(2) Consistency with fda mission.--As a condition on 
     receipt of funding under this subsection, a National Center 
     of Excellence shall agree to consider any input from the 
     Secretary regarding the use of funding that would--
       ``(A) help to further the advancement of advanced and 
     continuous pharmaceutical manufacturing through the National 
     Center of Excellence; and
       ``(B) be relevant to the mission of the Food and Drug 
     Administration.
       ``(3) Rule of construction.--Nothing in this section shall 
     be construed as precluding a National Center for Excellence 
     designated under this section from receiving funds under any 
     other provision of this Act or any other Federal law.
       ``(g) Annual Review and Reports.--
       ``(1) Annual report.--Beginning not later than one year 
     after the date on which the first designation is made under 
     subsection (a), and annually thereafter, the Secretary 
     shall--
       ``(A) submit to Congress a report describing the 
     activities, partnerships and collaborations, Federal policy 
     recommendations, previous and continuing funding, and 
     findings of, and any other applicable information from, the 
     National Centers of Excellence designated under this section;
       ``(B) include in such report an accounting of the Federal 
     administrative expenses described in subsection (i)(2) over 
     the reporting period; and
       ``(C) make such report available to the public in an easily 
     accessible electronic format on the website of the Food and 
     Drug Administration.
       ``(2) Review of national centers of excellence and 
     potential designees.--The Secretary shall periodically review 
     the National Centers of Excellence designated under this 
     section to ensure that such National Centers of Excellence 
     continue to meet the criteria for designation under this 
     section.
       ``(3) Report on long-term vision of fda role.--Not later 
     than 2 years after the date on which the first designation is 
     made under subsection (a), the Secretary, in consultation 
     with the National Centers of Excellence designated under this 
     section, shall submit a report to the Congress on the long-
     term vision of the Department of Health and Human Services on 
     the role of the Food and Drug Administration in supporting 
     advanced and continuous pharmaceutical manufacturing, 
     including--
       ``(A) a national framework of principles related to the 
     implementation and regulation of advanced and continuous 
     pharmaceutical manufacturing;
       ``(B) a plan for the development of Federal regulations and 
     guidance for how advanced and continuous pharmaceutical 
     manufacturing can be incorporated into the development of 
     pharmaceuticals and regulatory responsibilities of the Food 
     and Drug Administration;
       ``(C) a plan for development of Federal regulations or 
     guidance for how advanced and continuous pharmaceutical 
     manufacturing will be reviewed by the Food and Drug 
     Administration; and
       ``(D) appropriate feedback solicited from the public, which 
     may include other institutions of higher education, large and 
     small biopharmaceutical manufacturers, generic and 
     nonprescription manufacturers, and contract manufacturers.
       ``(h) Definitions.--In this section:
       ``(1) Advanced.--The term `advanced', with respect to 
     pharmaceutical manufacturing, refers to an approach that 
     incorporates novel technology, or uses an established 
     technique or technology in a new or innovative way,

[[Page H5311]]

     that enhances drug quality or improves the performance of a 
     manufacturing process.
       ``(2) Continuous.--The term `continuous', with respect to 
     pharmaceutical manufacturing, refers to a process--
       ``(A) where the input materials are continuously fed into 
     and transformed within the process, and the processed output 
     materials are continuously removed from the system; and
       ``(B) that consists of an integrated process that consists 
     of a series of two or more simultaneous unit operations.
       ``(3) Institution of higher education.--The term 
     `institution of higher education' has the meaning given such 
     term in section 101(a) of the Higher Education Act of 1965 
     (20 U.S.C. 1001(a)).
       ``(4) Secretary.--The term `Secretary' means the Secretary 
     of Health and Human Services, acting through the Commissioner 
     of Food and Drugs.
       ``(i) Authorization of Appropriations.--
       ``(1) In general.--There is authorized to be appropriated 
     to carry out this section $100,000,000 for the period of 
     fiscal years 2023 through 2027.
       ``(2) Federal administrative expenses.--Of the amounts made 
     available to carry out this section for a fiscal year, the 
     Secretary shall not use more than eight percent for Federal 
     administrative expenses, including training, technical 
     assistance, reporting, and evaluation.''.
       (b) Transition Rule.--Section 3016 of the 21st Century 
     Cures Act (21 U.S.C. 399h), as in effect on the day before 
     the date of the enactment of this section, shall apply with 
     respect to grants awarded under such section before such date 
     of enactment.
       (c) Clerical Amendment.--The item relating to section 3016 
     in the table of contents in section 1(b) of the 21st Century 
     Cures Act (Public Law 114-255) is amended to read as follows:

``Sec. 3016. National Centers of Excellence in Advanced and Continuous 
              Pharmaceutical Manufacturing.''.

     SEC. 707. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION 
                   PILOT PROGRAM.

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

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

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

     SEC. 708. PUBLIC WORKSHOP ON CELL THERAPIES.

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

     SEC. 709. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR 
                   CHILDREN.

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

[[Page H5312]]

  


     SEC. 710. REAUTHORIZATION FOR HUMANITARIAN DEVICE EXEMPTION 
                   AND DEMONSTRATION GRANTS FOR IMPROVING 
                   PEDIATRIC AVAILABILITY.

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

     SEC. 711. 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. 712. 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. 713. REAUTHORIZATION OF ORPHAN DRUG GRANTS.

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

     SEC. 714. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDITIONAL 
                   AUTHORITIES OF FOOD AND DRUG ADMINISTRATION 
                   REGARDING MOLECULARLY TARGETED CANCER DRUGS.

       (a) In General.--
       (1) Additional active ingredient for application drug; 
     limitation regarding novel-combination application drug.--
     Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355c(a)(3)) is amended--
       (A) by redesignating subparagraphs (B) and (C) as 
     subparagraphs (C) and (D), respectively; and
       (B) by striking subparagraph (A) and inserting the 
     following:
       ``(A) In general.--For purposes of paragraph (1)(B), the 
     investigation described in this paragraph is (as determined 
     by the Secretary) a molecularly targeted pediatric cancer 
     investigation of--
       ``(i) the drug or biological product for which the 
     application referred to in such paragraph is submitted; or
       ``(ii) such drug or biological product in combination 
     with--

       ``(I) an active ingredient of a drug or biological 
     product--

       ``(aa) for which an approved application under section 
     505(j) under this Act or under section 351(k) of the Public 
     Health Service Act is in effect; and
       ``(bb) that is determined by the Secretary to be the 
     standard of care for treating a pediatric cancer; or

       ``(II) an active ingredient of a drug or biological 
     product--

       ``(aa) for which an approved application under section 
     505(b) of this Act or section 351(a) of the Public Health 
     Service Act to treat an adult cancer is in effect and is held 
     by the same person submitting the application under paragraph 
     (1)(B); and
       ``(bb) that is directed at a molecular target that the 
     Secretary determines to be substantially relevant to the 
     growth or progression of a pediatric cancer.
       ``(B) Additional requirements.--
       ``(i) Design of investigation.--A molecularly targeted 
     pediatric cancer investigation referred to in subparagraph 
     (A) shall be designed to yield clinically meaningful 
     pediatric study data that is gathered using appropriate 
     formulations for each age group for which the study is 
     required, regarding dosing, safety, and preliminary efficacy 
     to inform potential pediatric labeling.
       ``(ii) Limitation.--An investigation described in 
     subparagraph (A)(ii) may be required only if the drug or 
     biological product for which the application referred to in 
     paragraph (1)(B) contains either--

       ``(I) a single new active ingredient; or
       ``(II) more than one active ingredient, if an application 
     for the combination of active ingredients has not previously 
     been approved but each active ingredient has been previously 
     approved to treat an adult cancer.

       ``(iii) Results of already-completed preclinical studies of 
     application drug.--The Secretary may require that reports on 
     an investigation required pursuant to paragraph (1)(B) 
     include the results of all preclinical studies on which the 
     decision to conduct such investigation was based.
       ``(iv) Rule of construction regarding inactive 
     ingredients.--With respect to a combination of active 
     ingredients referred to in subparagraph (A)(ii), such 
     subparagraph shall not be construed as addressing the use of 
     inactive ingredients with such combination.''.
       (2) Determination of applicable requirements.--Section 
     505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355c(e)(1)) is amended by adding at the end the 
     following: ``The Secretary shall determine whether 
     subparagraph (A) or (B) of subsection (a)(1) shall apply with 
     respect to an application before the date on which the 
     applicant is required to submit the initial pediatric study 
     plan under paragraph (2)(A).''.
       (3) Clarifying applicability.--Section 505B(a)(1) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) 
     is amended by adding at the end the following:
       ``(C) Rule of construction.--No application that is subject 
     to the requirements of subparagraph (B) shall be subject to 
     the requirements of subparagraph (A), and no application (or 
     supplement to an application) that is subject to the 
     requirements of subparagraph (A) shall be subject to the 
     requirements of subparagraph (B).''.
       (4) Conforming amendments.--Section 505B(a) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended--
       (A) in paragraph (3)(C), as redesignated by paragraph 
     (1)(A) of this subsection, by striking ``investigations 
     described in this paragraph'' and inserting ``investigations 
     referred to in subparagraph (A)''; and
       (B) in paragraph (3)(D), as redesignated by paragraph 
     (1)(A) of this subsection, by striking ``the assessments 
     under paragraph (2)(B)'' and inserting ``the assessments 
     required under paragraph (1)(A)''.
       (b) Guidance.--The Secretary shall--
       (1) not later than 12 months after the date of enactment of 
     this Act, issue draft guidance on the implementation of the 
     requirements in subsection (a); and
       (2) not later than 12 months after closing the comment 
     period on such draft guidance, finalize such guidance.
       (c) Applicability.--The amendments made by this section 
     apply with respect to any application under section 505(b) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 
     and any application under section 351(a) of the Public Health 
     Service Act (42 U.S.C. 262), that is submitted on or after 
     the date that is 3 years after the date of enactment of this 
     Act.
       (d) Reports to Congress.--
       (1) Secretary of health and human services.--Not later than 
     2 years after the date of enactment of this Act, the 
     Secretary of Health and Human Services shall submit to the 
     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a report on the Secretary's 
     efforts, in coordination with industry, to ensure 
     implementation of the amendments made by subsection (a).
       (2) GAO study and report.--
       (A) Study.--Not later than 3 years after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall conduct a study of the effectiveness of 
     requiring assessments and investigations described in section 
     505B of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C.355c), as amended by subsection (a), in the development 
     of drugs and biological products for pediatric cancer 
     indications.
       (B) Findings.--Not later than 7 years after the date of 
     enactment of this Act, the Comptroller General shall submit 
     to the Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a report containing the 
     findings of the study conducted under subparagraph (A).

                        Subtitle B--Inspections

     SEC. 721. FACTORY INSPECTION.

       (a) In General.--Section 704(a)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by 
     striking ``restricted devices'' each place it appears and 
     inserting ``devices''.
       (b) Records or Other Information.--
       (1) Establishments.--Section 704(a)(4)(A) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is 
     amended--
       (A) by striking ``an establishment that is engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a drug'' and inserting ``an establishment that 
     is engaged in the manufacture, preparation, propagation, 
     compounding, or processing of a drug or device, or that is 
     subject to inspection under paragraph (5)(C),''; and
       (B) by inserting after ``a sufficient description of the 
     records requested'' the following: ``and a rationale for 
     requesting such records or other information in advance of, 
     or in lieu of, an inspection''.
       (2) Guidance.--
       (A) In general.--The Secretary of Health and Human Services 
     shall issue or update guidance describing--
       (i) circumstances in which the Secretary intends to issue 
     requests for records or other information in advance of, or 
     in lieu of, an inspection under section 704(a)(4) of the 
     Federal Food, Drug, and Cosmetic Act, as amended by paragraph 
     (1);
       (ii) processes for responding to such requests 
     electronically or in physical form; and
       (iii) factors the Secretary intends to consider in 
     evaluating whether such records and other information are 
     provided within a reasonable timeframe, within reasonable 
     limits, and in a reasonable manner, accounting for resource 
     and other limitations that may exist, including for small 
     businesses.
       (B) Timing.--The Secretary of Health and Human Services 
     shall--
       (i) not later than 1 year after the date of enactment of 
     this Act, issue draft guidance under subparagraph (A); and

[[Page H5313]]

       (ii) not later than 1 year after the close of the comment 
     period for such draft guidance, issue final guidance under 
     subparagraph (A).
       (c) Bioresearch Monitoring Inspections.--
       (1) In general.--Section 704(a) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 374(a)) is amended by adding at 
     the end the following:
       ``(5) Bioresearch monitoring inspections.--
       ``(A) In general.--The Secretary may, to ensure the 
     accuracy and reliability of studies and records or other 
     information described in subparagraph (B) and to assess 
     compliance with applicable requirements under this Act or the 
     Public Health Service Act, enter sites and facilities 
     specified in subparagraph (C) in order to inspect such 
     records or other information.
       ``(B) Information subject to inspection.--An inspection 
     under this paragraph shall extend to all records and other 
     information related to the studies and submissions described 
     in subparagraph (E), including records and information 
     related to the conduct, results, and analyses of, and the 
     protection of human and animal trial participants 
     participating in, such studies.
       ``(C) Sites and facilities subject to inspection.--
       ``(i) Sites and facilities described.--The sites and 
     facilities subject to inspection by the Secretary under this 
     paragraph are those owned or operated by a person described 
     in clause (ii) and which are (or were) utilized by such 
     person in connection with--

       ``(I) developing an application or other submission to the 
     Secretary under this Act or the Public Health Service Act 
     related to marketing authorization for a product described in 
     paragraph (1);
       ``(II) preparing, conducting, or analyzing the results of a 
     study described in subparagraph (E); or
       ``(III) holding any records or other information described 
     in subparagraph (B).

       ``(ii) Persons described.--A person described in this 
     clause is--

       ``(I) the sponsor of an application or submission specified 
     in subparagraph (E);
       ``(II) a person engaged in any activity described in clause 
     (i) on behalf of such a sponsor, through a contract, grant, 
     or other business arrangement with such sponsor;
       ``(III) an institutional review board, or other individual 
     or entity, engaged by contract, grant, or other business 
     arrangement with a nonsponsor in preparing, collecting, or 
     analyzing records or other information described in 
     subparagraph (B); or
       ``(IV) any person not otherwise described in this clause 
     that conducts, or has conducted, a study described in 
     subparagraph (E) yielding records or other information 
     described in subparagraph (B).

       ``(D) Conditions of inspection.--
       ``(i) Access to information subject to inspection.--Subject 
     to clause (ii), an entity that owns or operates any site or 
     facility subject to inspection under this paragraph shall 
     provide the Secretary with access to records and other 
     information described in subparagraph (B) that is held by or 
     under the control of such entity, including--

       ``(I) permitting the Secretary to record or copy such 
     information for purposes of this paragraph;
       ``(II) providing the Secretary with access to any 
     electronic information system utilized by such entity to 
     hold, process, analyze, or transfer any records or other 
     information described in subparagraph (B); and
       ``(III) permitting the Secretary to inspect the facilities, 
     equipment, written procedures, processes, and conditions 
     through which records or other information described in 
     subparagraph (B) is or was generated, held, processed, 
     analyzed, or transferred.

       ``(ii) No effect on applicability of provisions for 
     protection of proprietary information or trade secrets.--
     Nothing in clause (i) shall negate, supersede, or otherwise 
     affect the applicability of provisions, under this or any 
     other Act, preventing or limiting the disclosure of 
     confidential commercial information or other information 
     considered proprietary or trade secret.
       ``(iii) Reasonableness of inspections.--An inspection under 
     this paragraph shall be conducted at reasonable times and 
     within reasonable limits and in a reasonable manner.
       ``(E) Studies and submissions described.--The studies and 
     submissions described in this subparagraph are each of the 
     following:
       ``(i) Clinical and nonclinical studies submitted to the 
     Secretary in support of, or otherwise related to, 
     applications and other submissions to the Secretary under 
     this Act or the Public Health Service Act for marketing 
     authorization of a product described in paragraph (1).
       ``(ii) Postmarket safety activities conducted under this 
     Act or the Public Health Service Act.
       ``(iii) Any other clinical investigation of--

       ``(I) a drug subject to section 505 or 512 of this Act or 
     section 351 of the Public Health Service Act; or
       ``(II) a device subject to section 520(g).

       ``(iv) Any other submissions made under this Act or the 
     Public Health Service Act with respect to which the Secretary 
     determines an inspection under this paragraph is warranted in 
     the interest of public health.
       ``(F) Clarification.--This paragraph clarifies the 
     authority of the Secretary to conduct inspections of the type 
     described in this paragraph and shall not be construed as a 
     basis for inferring that, prior to the date of enactment of 
     this paragraph, the Secretary lacked the authority to conduct 
     such inspections, including under this Act or the Public 
     Health Service Act.''.
       (2) Review of processes and practices; guidance for 
     industry.--
       (A) In general.--The Secretary of Health and Human Services 
     shall--
       (i) review processes and practices in effect as of the date 
     of enactment of this Act applicable to inspections of foreign 
     and domestic sites and facilities described in subparagraph 
     (C)(i) of section 704(a)(5) of the Federal Food, Drug, and 
     Cosmetic Act, as added by paragraph (1); and
       (ii) evaluate whether any updates are needed to facilitate 
     the consistency of such processes and practices.
       (B) Guidance.--
       (i) In general.--The Secretary of Health and Human Services 
     shall issue guidance describing the processes and practices 
     applicable to inspections of sites and facilities described 
     in subparagraph (C)(i) of section 704(a)(5) of the Federal 
     Food, Drug, and Cosmetic Act, as added by paragraph (1), 
     including with respect to the types of records and 
     information required to be provided, best practices for 
     communication between the Food and Drug Administration and 
     industry in advance of or during an inspection or request for 
     records or other information, and other inspections-related 
     conduct, to the extent not specified in existing publicly 
     available Food and Drug Administration guides and manuals for 
     such inspections.
       (ii) Timing.--The Secretary of Health and Human Services 
     shall--

       (I) not later than 18 months after the date of enactment of 
     this Act, issue draft guidance under clause (i); and
       (II) not later than 1 year after the close of the public 
     comment period for such draft guidance, issue final guidance 
     under clause (i).

     SEC. 722. USES OF CERTAIN EVIDENCE.

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

     SEC. 723. IMPROVING FDA INSPECTIONS.

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

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

       (a) In General.--Not later than 18 months after the date of 
     the enactment of this Act, the Comptroller General of the 
     United States shall submit to the Committee on Energy and 
     Commerce of the House of Representatives and the Committee on 
     Health, Education, Labor, and Pensions of the Senate a report 
     on inspections conducted by--

[[Page H5314]]

       (1) the Secretary of Health and Human Services (in this 
     section referred to as the ``Secretary'') of foreign 
     establishments pursuant to subsections (h) and (i) of section 
     510 and section 704 of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 360; 374); or
       (2) a foreign government or an agency of a foreign 
     government pursuant to section 809 of such Act (21 U.S.C. 
     384e).
       (b) Contents.--The report conducted under subsection (a) 
     shall include--
       (1) what alternative tools, including remote inspections or 
     remote evaluations, other countries are utilizing to 
     facilitate inspections of foreign establishments;
       (2) how frequently trusted foreign regulators conduct 
     inspections of foreign facilities that could be useful to the 
     Food and Drug Administration to review in lieu of its own 
     inspections;
       (3) how frequently and under what circumstances, including 
     for what types of inspections, the Secretary utilizes 
     existing agreements or arrangements under section 809 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e) and 
     whether the use of such agreements could be appropriately 
     expanded;
       (4) whether the Secretary has accepted reports of 
     inspections of facilities in China and India conducted by 
     entities with which they have entered into such an agreement 
     or arrangement;
       (5) what additional foreign governments or agencies of 
     foreign governments the Secretary has considered entering 
     into a mutual recognition agreement with and, if applicable, 
     reasons why the Secretary declined to enter into a mutual 
     recognition agreement with such foreign governments or 
     agencies;
       (6) what tools, if any, the Secretary used to facilitate 
     inspections of domestic facilities that could also be 
     effectively utilized to appropriately inspect foreign 
     facilities;
       (7) what steps the Secretary has taken to identify and 
     evaluate tools and strategies the Secretary may use to 
     continue oversight with respect to inspections when in-person 
     inspections are disrupted;
       (8) how the Secretary is considering incorporating 
     alternative tools into the inspection activities conducted 
     pursuant to the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 301 et seq.); and
       (9) what steps the Secretary has taken to identify and 
     evaluate how the Secretary may use alternative tools to 
     address workforce shortages to carry out such inspection 
     activities.

     SEC. 725. UNANNOUNCED FOREIGN FACILITY INSPECTIONS PILOT 
                   PROGRAM.

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

     SEC. 726. REAUTHORIZATION OF INSPECTION PROGRAM.

       Section 704(g)(11) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 374(g)(11)) is amended by striking ``2022'' 
     and inserting ``2027''.

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

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

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

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

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

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

     ``SEC. 902. ANNUAL REPORT ON INSPECTIONS.

       ``Not later than 120 days after the end of each fiscal 
     year, the Secretary of Health and Human Services shall post 
     on the public website of the Food and Drug Administration 
     information related to inspections of facilities necessary 
     for approval of a drug under subsection (c) or (j) of section 
     505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355), approval of a device under section 515 of such Act (21 
     U.S.C. 360e), or clearance of a device under section 510(k) 
     of

[[Page H5315]]

     such Act (21 U.S.C. 360(k)) that were conducted during the 
     previous fiscal year. Such information shall include the 
     following:
       ``(1) The median time following a request from staff of the 
     Food and Drug Administration reviewing an application or 
     report to the beginning of the inspection, including--
       ``(A) the median time for drugs described in section 
     505(j)(11)(A)(i) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(j)(11)(A)(i));
       ``(B) the median time for drugs described in section 
     506C(a) of such Act (21 U.S.C. 356c(a)) only; and
       ``(C) the median time for drugs on the drug shortage list 
     in effect under section 506E of such Act (21 U.S.C. 356e).
       ``(2) The median time from the issuance of a report 
     pursuant to section 704(b) of such Act (21 U.S.C. 374(b)) to 
     the sending of a warning letter, issuance of an import alert, 
     or holding of a regulatory meeting for inspections for which 
     the Secretary concluded that regulatory or enforcement action 
     was indicated, including the median time for each category of 
     drugs listed in subparagraphs (A) through (C) of paragraph 
     (1).
       ``(3) The median time from the sending of a warning letter, 
     issuance of an import alert, or holding of a regulatory 
     meeting to resolution of the actions indicated to address the 
     conditions or practices observed during an inspection.
       ``(4) The number of facilities that failed to implement 
     adequate corrective or preventive actions following a report 
     pursuant to such section 704(b), resulting in a withhold 
     recommendation, including the number of such times for each 
     category of drugs listed in subparagraphs (A) through (C) of 
     paragraph (1).''.

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

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

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

     SEC. 802. ENCOURAGING BLOOD DONATION.

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

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

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

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

     SEC. 803. REGULATION OF CERTAIN PRODUCTS AS DRUGS.

       Section 503 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 353) is amended by adding at the end the following:
       ``(h)(1) Any contrast agent, radioactive drug, or OTC 
     monograph drug shall be deemed to be a drug under section 
     201(g) and not a device under section 201(h).
       ``(2) For purposes of this subsection:
       ``(A) The term `contrast agent' means an article that is 
     intended for use in conjunction with a medical imaging 
     device, and--
       ``(i) is a diagnostic radiopharmaceutical, as defined in 
     sections 315.2 and 601.31 of title 21, Code of Federal 
     Regulations (or any successor regulations); or
       ``(ii) is a diagnostic agent that improves the 
     visualization of structure or function within the body by 
     increasing the relative difference in signal intensity within 
     the target tissue, structure, or fluid.
       ``(B) The term `radioactive drug' has the meaning given 
     such term in section 310.3(n) of title 21, Code of Federal 
     Regulations (or any successor regulations), except that such 
     term does not include--
       ``(i) an implant or article similar to an implant;
       ``(ii) an article that applies radiation from outside of 
     the body; or
       ``(iii) the radiation source of an article described in 
     clause (i) or (ii).
       ``(C) The term `OTC monograph drug' has the meaning given 
     such term in section 744L.
       ``(3) Nothing in this subsection shall be construed as 
     allowing for the classification of a product as a drug (as 
     defined in section 201(g)) if such product--
       ``(A) is not described in paragraph (1); and
       ``(B) meets the definition of a device under section 
     201(h),
     unless another provision of this Act otherwise indicates a 
     different classification.''.

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

       (a) In General.--Section 506(c) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 356(c)) is amended--
       (1) by striking paragraph (2) and inserting the following:
       ``(2) Limitation.--
       ``(A) In general.--Approval of a product under this 
     subsection may be subject to 1 or both of the following 
     requirements:
       ``(i) That the sponsor conduct an appropriate postapproval 
     study or studies (which may be augmented or supported by real 
     world evidence) to verify and describe the predicted effect 
     on irreversible morbidity or mortality or other clinical 
     benefit.
       ``(ii) That the sponsor submit copies of all promotional 
     materials related to the product during the preapproval 
     review period and, following approval and for such period 
     thereafter as the Secretary determines to be appropriate, at 
     least 30 days prior to dissemination of the materials.

[[Page H5316]]

       ``(B) Studies not required.--If the Secretary does not 
     require that the sponsor of a product approved under 
     accelerated approval conduct a postapproval study under this 
     paragraph, the Secretary shall publish on the website of the 
     Food and Drug Administration the rationale for why such study 
     is not appropriate or necessary.
       ``(C) Postapproval study conditions.--Not later than the 
     time of approval of a product under accelerated approval, the 
     Secretary shall specify the conditions for a postapproval 
     study or studies required to be conducted under this 
     paragraph with respect to such product, which may include 
     enrollment targets, the study protocol, and milestones, 
     including the target date of study completion.
       ``(D) Studies begun before approval.--The Secretary may 
     require such study or studies to be underway prior to 
     approval.''; and
       (2) by striking paragraph (3) and inserting the following:
       ``(3) Expedited withdrawal of approval.--
       ``(A) In general.--The Secretary may withdraw approval of a 
     product approved under accelerated approval using expedited 
     procedures described in subparagraph (B), if--
       ``(i) the sponsor fails to conduct any required 
     postapproval study of the product with due diligence, 
     including with respect to conditions specified by the 
     Secretary under paragraph (2)(C);
       ``(ii) a study required to verify and describe the 
     predicted effect on irreversible morbidity or mortality or 
     other clinical benefit of the product fails to verify and 
     describe such effect or benefit;
       ``(iii) other evidence demonstrates that the product is not 
     shown to be safe or effective under the conditions of use; or
       ``(iv) the sponsor disseminates false or misleading 
     promotional materials with respect to the product.
       ``(B) Expedited procedures described.--Expedited procedures 
     described in this subparagraph shall consist of, prior to the 
     withdrawal of accelerated approval--
       ``(i) providing the sponsor with--

       ``(I) due notice;
       ``(II) an explanation for the proposed withdrawal;
       ``(III) an opportunity for a meeting with the Commissioner 
     of Food and Drugs or the Commissioner's designee; and
       ``(IV) an opportunity for written appeal to--

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

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

       (a) Guidance.--Not later than 1 year after the date of the 
     enactment of this Act, the Secretary of Health and Human 
     Services shall issue, or revise existing, guidance on 
     considerations for the use of real world data and real world 
     evidence to support regulatory decisionmaking, as follows:
       (1) With respect to drugs, such guidance shall address--
       (A) the use of such data and evidence to support the 
     approval of a drug application under section 505 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or a 
     biological product application under section 351 of the 
     Public Health Service Act (42 U.S.C. 262), or to support an 
     investigational use exemption under section 505(i) of the 
     Federal Food, Drug, and Cosmetic Act or section 351(a)(3) of 
     the Public Health Service Act; and
       (B) the use of such data and evidence obtained as a result 
     of the use of drugs authorized for emergency use under 
     section 564 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-3) in such applications, submissions, or 
     requests; and
       (C) standards and methodologies which may be used for 
     collection and analysis of real world evidence included in 
     such applications, submissions, or requests, as appropriate.
       (2) With respect to devices, such guidance shall address--

[[Page H5317]]

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

     SEC. 806. DUAL SUBMISSION FOR CERTAIN DEVICES.

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

     SEC. 807. MEDICAL DEVICES ADVISORY COMMITTEE MEETINGS.

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

     SEC. 808. ENSURING CYBERSECURITY OF MEDICAL DEVICES.

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

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

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

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

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

[[Page H5318]]

     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-
     1(h));
       (2) any issues affecting patient access to the drug that is 
     subject to the strategy or considerations with respect to the 
     administration or prescribing of such drug by health care 
     providers that arose as a result of such modifications; and
       (3) how such issues were resolved, as applicable.

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

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

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

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

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

       (a) Application of Exclusive Approval, Certification, or 
     Licensure for Drugs Designated for Rare Diseases or 
     Conditions.--Section 527 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360cc) is amended--
       (1) in subsection (a), in the matter following paragraph 
     (2), by striking ``same disease or condition'' and inserting 
     ``same approved indication or use within such rare disease or 
     condition'';
       (2) in subsection (b)--
       (A) in the matter preceding paragraph (1), by striking 
     ``same rare disease or condition'' and inserting ``same 
     indication or use for which the Secretary has approved or 
     licensed such drug''; and
       (B) in paragraph (1), by striking ``with the disease or 
     condition for which the drug was designated'' and inserting 
     ``for whom the drug is indicated''; and
       (3) in subsection (c), by striking ``same rare disease or 
     condition'' and inserting ``same indication or use''.
       (b) Application of Amendments.--The amendments made by 
     subsection (a) shall apply with respect to any drug 
     designated under section 526 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bb), regardless of the date on 
     which the drug was so designated, and regardless of the date 
     on which the drug was approved under section 505 of such Act 
     (21 U.S.C. 355) or licensed under section 351 of the Public 
     Health Service Act (42 U.S.C. 262).

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

       Not later than September 30, 2026, the Comptroller General 
     of the United States

[[Page H5319]]

     shall submit to the Committee on Energy and Commerce of the 
     House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report on the 
     third-party review program described in section 523 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m). Such 
     report shall include--
       (1) a description of the financial and staffing resources 
     used to carry out such program;
       (2) a description of actions taken by the Secretary 
     pursuant section 523(b)(2)(C) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360m(b)(2)(C)); and
       (3) the results of an audit of the performance of select 
     persons accredited under such program.

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

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

     SEC. 815. FDA WORKFORCE IMPROVEMENTS.

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

                        TITLE IX--MISCELLANEOUS

     SEC. 901. DETERMINATION OF BUDGETARY EFFECTS.

       The budgetary effects of this Act, for the purpose of 
     complying with the Statutory Pay-As-You-Go Act of 2010, shall 
     be determined by reference to the latest statement titled 
     ``Budgetary Effects of PAYGO Legislation'' for this Act, 
     submitted for printing in the Congressional Record by the 
     Chairman of the House Budget Committee, provided that such 
     statement has been submitted prior to the vote on passage.

     SEC. 902. MEDICAID IMPROVEMENT FUND.

       Section 1941(b)(3)(A) of the Social Security Act (42 U.S.C. 
     1396w-1(b)(3)(A)) is amended by striking ``$0'' and inserting 
     ``$450,000,000''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Kentucky (Mr. Guthrie) each 
will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material on H.R. 7667.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise today in strong support of the Food and Drug 
Amendments of 2022, a bill that recently passed out of the Energy and 
Commerce Committee with unanimous support. This bill will provide the 
FDA the funding it needs to ensure drugs and devices are safe and 
effective. It also promotes development of new medical products to 
treat every American, reduces the cost of prescription drugs, and 
strengthens program integrity at the agency.
  Primarily, the user fee reauthorization's main purpose is to give the 
agency funding to conduct product reviews, facilitate the development 
of new products to treat rare diseases, inspect facilities to ensure 
they are compliant, and monitor medical products on the market for 
continued safety and effectiveness.
  It is essential that the House pass this legislation today because 
funding that comes from these user fees expires in September. At 
hearings earlier this year, senior FDA officials told us that failure 
to pass this legislation well before the September deadline could be 
catastrophic to the agency's operations and, more importantly, could 
limit our ability to get patients the medical products that they and 
their doctors rely on.
  Mr. Speaker, I am very pleased that in addition to coming together to 
reauthorize this funding, we have worked across the aisle to come to 
agreement on a wide-ranging package of programs to improve biomedical 
research and development, give FDA more tools to conduct quality 
inspections, improve the medical product supply chain, improve generic 
drug competition and access, and bring greater transparency and program 
integrity to FDA's operations.
  While I do not have time to discuss all the provisions in the Food 
and Drug Amendments of 2022, I want to highlight a few.
  First, the bill includes reforms to the accelerated approval program, 
which I first introduced in Congress earlier this year. Under the 
accelerated approval pathway, drugs may be approved based on a 
surrogate endpoint, such as an improved lab measurement or 
visualization on an MRI, even though additional evidence is still 
needed to show a clear clinical benefit for the patient. If a drug is 
approved under this pathway, the sponsor must conduct studies after the 
product is on the market to show that the drug actually provides a 
benefit to patients. This approval pathway has led to patients having 
access to groundbreaking treatments for cancer, HIV, and other 
illnesses faster than they otherwise would have.
  However, in recent years, it has become clear that some drug sponsors 
have failed to conduct their post-approval studies in a timely manner, 
while others have conducted studies that indicate that the drug is not 
effective but are able to keep the product on the market for years 
afterwards.
  Patients deserve to know the drugs they are taking are safe and 
effective. Food and Drug Amendments of 2022 ensures that the products 
patients are taking are providing a benefit by allowing FDA to require 
that sponsors begin adequate and well-controlled post-approval studies 
before the drug goes on the market. The legislation will provide 
greater transparency in drug labeling, and it streamlines the process 
for FDA to remove products from the market when the sponsors have 
failed to act with due diligence to conduct studies or where studies 
have failed to show a benefit to patients.
  The second thing is, this legislation ensures that clinical trials 
for drugs and medical devices are representative of the people who will 
use the products. The lack of diversity in clinical trials is an urgent 
problem. It compromises our ability to understand how drugs and 
diseases affect populations differently, compounds health disparities, 
and can hinder innovation and add cost burdens into the health system.
  Food and Drug Amendments of 2022 for the first time will require drug 
and device sponsors to develop a clinical trial diversity action plan 
early in the development process and submit the plan to FDA. This will 
help improve our understanding of these products and lead to better 
outcomes for all Americans.
  Food and Drug Amendments of 2022 will also help lower drug costs by 
making it easier for generic products to come to market. Under current 
law, generic drug sponsors sometimes need to play a guessing game of 
the ingredients in brand drugs, and this can add months on to the 
generic drug development process. Under Food and Drug Amendments of 
2022, we are making it easier for FDA to communicate this information 
to drug sponsors, thereby speeding up development times for generics. 
The bill will also make it easier for generics to come to market when a 
brand drug changes its label at the last second in an attempt to limit 
competition. Together, these provisions will produce millions of 
dollars in savings for American families and the overall healthcare 
system.
  This legislation also takes concrete action to address the infant 
formula crisis American families are currently facing, and which we are 
so concerned about, and will prevent future problems related to food 
safety and supply, so it's not just about infant formula, but about 
food safety in general.
  Currently, FDA is operating its food safety and other divisions with 
one

[[Page H5320]]

hand tied behind its back when it comes to hiring and retaining highly 
qualified scientific and regulatory staff. Today, FDA can hire 
technical staff in its drug and medical device centers under 
streamlined processes and compete with the private sector in terms of 
salary, but those same flexibilities do not extend to other centers, 
including those overseeing food at the FDA. Our bill would extend these 
to the oversight of food, tobacco, and other products regulated by the 
agency. While we must do more in this area, I am pleased that we are 
able to move forward on a bipartisan basis here today. I think it is 
going to make a difference, Mr. Speaker, not only with infant formula 
but with so many other food products.

  Lastly, Mr. Speaker, I thank my colleagues on the Energy and Commerce 
Committee for their cooperation and bipartisan work on this package. As 
I said, it passed unanimously out of the committee last month, thanks 
to the leadership of Health Subcommittee Chairwoman Eshoo, Ranking 
Member Guthrie, and the full committee Ranking Member Rodgers.
  When you bring a bill to the floor on suspension and it is 
bipartisan, and it was voted out of committee unanimously, it might 
kind of belie the amount of work that the staff who are here with me 
today and others put into this. This was a lot of work. It wasn't easy 
to get it done in a timely fashion, even though it has unanimous 
support. I hope today everyone will vote for it; I do not want anyone 
to get the impression that this was not an easy thing to accomplish 
because it certainly was.
  Mr. Speaker, I encourage all Members to support this bill, and I 
reserve the balance of my time.
  Mr. GUTHRIE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise today in support of the Food and Drug Amendments 
of 2022, introduced by Chair Eshoo and myself. This legislation 
recently passed the full Energy and Commerce Committee unanimously.
  The bill will protect access to lifesaving cures, promote innovation, 
secure our medical supply chains, and lower costs for patients. It 
would also reauthorize the Food and Drug Administration's medical 
product user fee programs through 2027.
  User fees allow the FDA to collect fees from industry in exchange for 
timely review of their drug or device applications. Importantly, these 
fees not only permit the FDA to carry out drug or device application 
reviews, but they also represent significant percentages of FDA's total 
operating budget without costing the taxpayer.
  Additionally, according to the Congressional Budget Office, sections 
of the bill will save close to $600 million by promoting increased 
access to generic drugs. Some of these savings will be used for deficit 
reduction and other amounts can be put toward preserving access to 
critical services in the Medicaid program, such as telehealth.
  Not only do these agreements help save taxpayer dollars, but they 
also yield significant returns on investment since they were originally 
authorized by Congress decades ago. For example, in 2021 alone, 38 of 
50 of the world's novel drugs were first approved in the United States. 
This was made possible by the Food and Drug Administration Amendments 
of 2017.
  I am proud to say that the legislation includes two of my bills, the 
Pre-approval Information Exchange Act, which will help reduce the time 
in which patients wait for a drug or a device to be covered by the 
insurer after it is approved by the FDA.
  The bill before us today also includes legislation that Chair Pallone 
and I have been championing for several years to help facilitate the 
transformation of drug manufacturing processes, so they are more 
efficient, less costly, and result in improved drug quality. The use of 
continuous manufacturing technology will not only serve as an incentive 
for U.S. drug manufacturers to bring their production back to American 
soil but will also help reduce drug shortages.
  Other important components of the Food and Drug Amendments of 2022 
require guidance on the collection of real-world evidence for companies 
with products authorized under emergency use authorization during the 
COVID-19 public health emergency. This can serve as a strong foundation 
for the regulatory community in addition to drug or device companies to 
best understand how products can get approved more quickly and safely 
in the future.
  Finally, the Food and Drug Amendments of 2022 preserves access to 
lifesaving therapies approved under the accelerated approval pathway. 
By preserving the pathway, we are giving patients hope to one day find 
cures to currently incurable diseases, such as Alzheimer's disease or 
terminal cancers.
  As the Chair said, usually when you come to the floor on suspension 
bills, they are ones that have great unanimous consent with Congress. 
This has gone through the regular process, and it has gone through a 
lot of hard work by Members, but I have to say a lot of hard work, 
significant hard work, by the men and women who work with us here on 
the committee. We really appreciate the staff's hard work.

  Although we are here in a suspension moment on the floor, I emphasize 
to my colleagues, there has been a lot of work, a lot of committee 
work, a lot of subcommittee work, a lot of Member work, and a whole lot 
of staff work to make this move forward. I really appreciate that.
  Mr. Speaker, I urge my colleagues to support this legislation today, 
and I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I have no additional speakers at this time. 
I continue to reserve the balance of my time.
  Mr. GUTHRIE. Mr. Speaker, I yield 3 minutes to the gentleman from 
Indiana (Mr. Bucshon).
  Mr. BUCSHON. Mr. Speaker, I rise today in support of the bipartisan 
Food and Drug Amendments of 2022.
  This is an important reauthorization that is necessary to help drive 
innovation and make sure patients have continued access to critical 
treatments and cures.
  I am pleased to see the continued focus on innovation this agreement 
brings, as well as its included policies like the DIVERSE Trials Act, 
which I helped author, which will help increase diverse participation 
in clinical trials.
  More can be done to protect patients. One example being diagnostic 
testing, specifically lab-developed tests.
  For well over 5 years, I have been working on the bipartisan VALID 
Act, H.R. 4128, with my colleague Diana DeGette, which establishes a 
risk-based regulatory framework for diagnostic and laboratory-developed 
tests.
  This legislation allows for leading-edge development and innovation 
to thrive while assuring doctors and patients have the certainty that 
their test results are analytically and clinically valid. The draft 
version of the user fee agreements introduced in the Senate addresses 
the issue by including a version of the VALID Act.

  Mr. Speaker, I again express my strong support for the Food and Drug 
Amendments Act of 2022, and I urge my colleagues to vote ``yes'' on 
this legislation.

                              {time}  1830

  Mr. PALLONE. Mr. Speaker, I reserve the balance of my time.
  Mr. GUTHRIE. Mr. Speaker, I was incorrect. I said Mr. Bucshon. Dr. 
Bucshon; his words on healthcare are certainly very important to all of 
us.
  Mr. Speaker, I yield 4 minutes to the gentlewoman from Washington 
(Mrs. Rodgers), my good friend, the Republican leader of the full 
Committee on Energy and Commerce.
  Mrs. RODGERS of Washington. Mr. Speaker, I rise today in support of 
H.R. 7667, the Food and Drug Amendments Act.
  The Committee on Energy and Commerce plowed the hard ground necessary 
to legislate in a strong bipartisan way on this bill. We held three 
hearings in the Subcommittee on Health in February and March. In April, 
we introduced legislation, and then over the next week, the 
subcommittee voted.
  H.R. 7667 passed out of Committee on Energy and Commerce by a vote of 
55-0, and at each step, members' ideas were included to improve the 
legislation.
  Today, we consider a suspension print with further improvements. It 
adds another provision for more drug manufacturing in America by 
providing the regulatory clarity needed

[[Page H5321]]

and the training necessary to utilize novel manufacturing technologies.
  Overall, the FDA Act will reauthorize four user fee programs created 
to expedite the review of critical medical products that people depend 
on to live healthier and longer lives.
  In addition to delivering drugs and medical devices to people faster, 
the FDA Act includes policies to lower healthcare costs, spur more 
lifesaving innovation, secure our supply chains, and provide hope to 
patients in need of breakthrough drugs and therapies. Those treatments 
won't make it to patients if FDA doesn't have the right tools to keep 
up with science, such as accelerated approval pathway.
  Chairman Pallone and I initially had quite different versions for how 
the accelerated approval process should be updated, but we focused on 
where we could agree. We streamlined the process to remove drugs that 
no longer show effectiveness in post-market studies and made sure that 
real-world evidence can be used. We also made sure rare diseases aren't 
left out of accelerated approval because of a lack of knowledge and 
interest in developing the biomarkers necessary.
  Lastly, not only is this legislation necessary to preserve patient 
access to new medical breakthroughs, it is fiscally responsible. It 
ensures FDA's timely review of medical products at a reduced cost to 
the taxpayer, and it reduces the deficit.
  Many other members have priorities included in this legislation.
  Mr. Buchanan has a bipartisan bill to make sure that we are moving 
away from preclinical testing on animal models where alternatives can 
work just as well.
  Messrs. Griffith, Carter, and Hudson all have legislation to hold FDA 
accountable regarding inspections of foreign manufacturing facilities 
and pilots for FDA to give companies with novel manufacturing 
technologies more certainty.
  Mr. Guthrie has a solution included to help insurers plan for 
breakthrough future treatments. This will help patients avoid sticker 
shock and protect earlier access to those treatments.
  These are just some of more than a dozen examples of member 
priorities in the FDA Act. I strongly urge support of this legislation, 
and I encourage all of my colleagues to vote ``yes.''
  Mr. Speaker, this is for patients and families in every district and 
every corner of America who are relying on a generic drug, a medical 
device, like a pacemaker, or a novel cancer treatment. Those patients 
are relying on Congress to do its job so their drug approval isn't 
stalled.
  I think about all the advocates, the hundreds of disease and rare 
disease groups who come to the people's House to share their stories 
with us. They have an extraordinary amount of hope in the promise of 
American innovation for new cures and access to treatments.
  For them, I am supporting this legislation, and I am committed to 
work to get this signed into law on time.
  Mr. PALLONE. Madam Speaker, I am prepared to close, and I reserve the 
balance of my time.
  Mr. GUTHRIE. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, through the years, since this medical device fee has 
been put into place, has Congress taken action to make sure an agency 
is efficient; that it does its job to make sure that our drugs and 
medical devices have efficacy, but also are safe? So we make them more 
efficient and we have drug companies, device companies, other 
companies, generic companies, trying to get their devices or their 
pharmaceuticals approved so they can bring them on the marketplace that 
are safe and efficient. So this is really an example of Congress 
working together to move this process forward.
  And the innovations that have come out in the last few years, if we 
look at what has gone on in the diabetes world with the artificial 
pancreas, all the pumps and insulin devices, to hepatitis C, 
pharmaceuticals and other ways, and just so much more, what is going to 
happen in the next 5 years as we continue to move this process forward?
  We had a hearing in the Subcommittee on Health on ALS, and we had an 
ALS patient before us who just wants hope. So all of that is accounted 
for in this process.
  We, as Members of Congress, we, as members of the Committee on Energy 
and Commerce have worked together to make the process streamlined, to 
make sure we have efficient, efficacy, and safe products. Our hope and 
our prayers from this is the science will come into place so those who 
testified before our committee with rare diseases will have the 
opportunity and hope to be healed.

  I urge my colleagues to support this piece of legislation. A lot of 
hard work went into it. A lot of lives can be affected by it. I 
encourage everyone to vote for it.
  Madam Speaker, I yield back the balance of my time.
  Mr. PALLONE. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, I couldn't agree more with what Ranking Member Guthrie 
said, and also our full committee ranking member, Mrs. Rodgers. This is 
a product of a lot of hard work on behalf of members, as well as the 
staff that are here, and others. It is really great that we are able to 
do it in a timely fashion because we want the FDA to be able to 
operate, not to have to put out pink slips because the authorization 
expires in September.
  This is really a reauthorization that does a lot more than just 
reauthorize the current programs. It really is going to make a 
difference in terms of our ability to innovate and also affect access 
to generic drugs.
  Madam Speaker, I encourage all Members to support the bill. We are 
going to work hard to get this passed in the Senate in a timely 
fashion.
  Madam Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore (Ms. Pingree). The question is on the motion 
offered by the gentleman from New Jersey (Mr. Pallone) that the House 
suspend the rules and pass the bill, H.R. 7667, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. HARRIS. Madam Speaker, on that I demand the yeas and nays.
  The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution 
8, the yeas and nays are ordered.
  Pursuant to clause 8 of rule XX, further proceedings on this motion 
are postponed.

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