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[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4348 Introduced in Senate (IS)]

<DOC>

117th CONGRESS
  2d Session
                                S. 4348

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

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              May 26, 2022

 Mrs. Murray (for herself and Mr. Burr) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

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

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Food and Drug 
Administration Safety and Landmark Advancements Act of 2022'' or the 
``FDASLA Act of 2022''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; 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 requirement.
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. Accreditation programs.
Sec. 205. Sunset dates.
Sec. 206. Effective date.
Sec. 207. 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 biological product 
                            fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.
     TITLE V--IMPROVING REGULATION OF DRUGS AND BIOLOGICAL PRODUCTS

Sec. 501. Alternatives to animal testing.
Sec. 502. Safer disposal of opioids.
Sec. 503. Clarifications to exclusivity provisions for first 
                            interchangeable biosimilar biological 
                            products.
Sec. 504. Improvements to the Purple Book.
Sec. 505. Therapeutic equivalence evaluations.
Sec. 506. Modernizing accelerated approval.
                    TITLE VI--OTHER REAUTHORIZATIONS

Sec. 601. Reauthorization of the critical path public-private 
                            partnership.
Sec. 602. Reauthorization of the best pharmaceuticals for children 
                            program.
Sec. 603. Reauthorization of the humanitarian device exemption 
                            incentive.
Sec. 604. Reauthorization of the pediatric device consortia program.
Sec. 605. Reauthorization of provision pertaining to drugs containing 
                            single enantiomers.
Sec. 606. Reauthorization of orphan drug grants.
Sec. 607. Reauthorization of certain device inspections.
              TITLE VII--ENHANCING FDA HIRING AUTHORITIES

Sec. 701. Enhancing FDA hiring authority for scientific, technical, and 
                            professional personnel.
Sec. 702. Strategic workforce plan and report.
TITLE VIII--ADVANCING REGULATION OF COSMETICS, DIETARY SUPPLEMENTS, AND 
                       LABORATORY DEVELOPED TESTS

                         Subtitle A--Cosmetics

Sec. 801. Short title.
Sec. 802. Amendments to cosmetic requirements.
Sec. 803. Enforcement and conforming amendments.
Sec. 804. Records inspection.
Sec. 805. Talc-containing cosmetics.
Sec. 806. PFAS in cosmetics.
Sec. 807. Funding.
                    Subtitle B--Dietary Supplements

Sec. 811. Regulation of dietary supplements.
                  Subtitle C--In Vitro Clinical Tests

Sec. 821. Short title; table of contents.
Sec. 822. Definitions.
Sec. 823. Regulation of in vitro clinical tests.
Sec. 824. Enforcement and other provisions.
Sec. 825. Transition.
Sec. 826. Emergency use authorization.
Sec. 827. Antimicrobial susceptibility tests.
Sec. 828. Combination products.
Sec. 829. Resources.
Sec. 830. Authorization of appropriations.
                       TITLE IX--OTHER PROVISIONS

Sec. 901. Facilities management.
Sec. 902. Annual report on inspections.
Sec. 903. User fee program transparency and accountability.
Sec. 904. OTC hearing aids final rule.
Sec. 905. Enhance intra-agency coordination and public health 
                            assessment with regard to compliance 
                            activities.

                    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.--Congress finds that the fees authorized by the 
amendments made in this title will be dedicated toward expediting the 
drug development process and the process for the review of human drug 
applications, including postmarket drug safety activities, as set forth 
in the goals identified for purposes of part 2 of subchapter C of 
chapter VII of the Federal Food, Drug, and Cosmetic Act (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.

    Section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379g) is amended--
            (1) in paragraph (1), in the matter following subparagraph 
        (B), by striking ``an allergenic extract product, or'' and 
        inserting ``does not include an application with respect to an 
        allergenic extract product licensed before October 1, 2022, 
        does not include an application with respect to a standardized 
        allergenic extract product submitted pursuant to a notification 
        to the applicant from the Secretary regarding the existence of 
        a potency test that measures the allergenic activity of an 
        allergenic extract product licensed by the applicant before 
        October 1, 2022, does not include an application with respect 
        to'';
            (2) in paragraph (3), in the matter following subparagraph 
        (C)--
                    (A) by inserting ``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,'' after ``an allergenic extract 
                product'';
                    (B) by adding at the end the following: ``If a 
                written request to place a product in the discontinued 
                section of either of the lists described in 
                subparagraph (C) is submitted to the Secretary on 
                behalf of an applicant, and the request identifies the 
                date the product is, or will be, 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. For 
                purposes of subparagraph (C), 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.''; and
                    (C) 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.--Section 736(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``2018'' and inserting ``2023'';
            (2) in paragraph (1)--
                    (A) in subparagraph (A), by striking ``subsection 
                (c)(5)'' each place it appears and inserting 
                ``subsection (c)(6)'';
                    (B) in subparagraph (C), by inserting ``prior to 
                approval'' after ``or was withdrawn''; and
                    (C) 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).''; and
            (3) in paragraph (2)--
                    (A) in subparagraph (A)--
                            (i) by striking ``subsection (c)(5)'' and 
                        inserting ``subsection (c)(6)'';
                            (ii) by striking ``Except as provided'' and 
                        inserting the following:
                            ``(i) Payment of fees.--Except as 
                        provided''; and
                            (iii) by adding at the end the following:
                            ``(ii) Previously discontinued drug 
                        products.--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 identified in section 735(3), 
                        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 
                        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 
                        regulations)), 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.--Section 736(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h(b)) is amended--
            (1) in paragraph (1)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``2018 through 2022'' and inserting ``2023 
                through 2027'';
                    (B) by redesignating subparagraphs (C) through (F) 
                as subparagraphs (D) through (G), respectively;
                    (C) by inserting after subparagraph (B) the 
                following:
                    ``(C) The dollar amount equal to the strategic 
                hiring and retention adjustment for the fiscal year (as 
                determined under subsection (c)(2));'';
                    (D) in subparagraph (D), as so redesignated, by 
                striking ``(c)(2)'' and inserting ``(c)(3)'';
                    (E) in subparagraph (E), as so redesignated, by 
                striking ``(c)(3)'' and inserting ``(c)(4)'';
                    (F) in subparagraph (F), as so redesignated, by 
                striking ``(c)(4)'' and inserting ``(c)(5)''; and
                    (G) in subparagraph (G), as so redesignated, by 
                striking clauses (i) through (v) and inserting the 
                following:
                            ``(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.''; 
                        and
            (2) in paragraph (3)--
                    (A) in subparagraph (A), by striking ``2018, 
                $878,590,000'' and inserting ``2023, $1,151,522,958''; 
                and
                    (B) in subparagraph (B)--
                            (i) by striking ``2019 through 2022'' and 
                        inserting ``2024 through 2027''; and
                            (ii) by striking ``subsection (c)(3) or 
                        (c)(4)'' and inserting ``subsection (c)(4) or 
                        (c)(5)''.
    (c) Adjustments; Annual Fee Setting.--Section 736(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended--
            (1) in paragraph (1)(B)(ii), by striking ``Washington-
        Baltimore, DC-MD-VA-WV'' and inserting ``Washington-Arlington-
        Alexandria, DC-VA-MD-WV'';
            (2) by redesignating paragraphs (2) through (6) as 
        paragraphs (3) through (7), respectively;
            (3) 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--
                    ``(A) for fiscal year 2023, by $9,000,000; and
                    ``(B) for fiscal year 2024 and each subsequent 
                fiscal year, by $4,000,000.'';
            (4) in paragraph (3), as so redesignated--
                    (A) in subparagraph (A)--
                            (i) by striking ``for inflation''; and
                            (ii) by striking ``paragraph (1)'' and 
                        inserting ``paragraphs (1) and (2)'';
                    (B) by amending subparagraph (B) to read as 
                follows:
                    ``(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' 
                (85 Fed. Reg. 46651; August 3, 2020). The workload 
                categories used in forecasting shall include only the 
                activities described in such notice and, as feasible, 
                additional activities that are 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 forecasting 
                any non-core review activities, including any 
                activities that the Secretary referenced for potential 
                future use in such notice but did not utilize in the 
                setting fees for fiscal year 2021.'';
                    (C) by striking subparagraph (C);
                    (D) by redesignating subparagraphs (D) and (E) as 
                subparagraphs (C) and (D), respectively;
                    (E) in subparagraph (C), as so redesignated--
                            (i) by striking ``year) and'' and inserting 
                        ``year),''; and
                            (ii) by inserting ``, and subsection 
                        (b)(1)(C) (the dollar amount of the strategic 
                        hiring and retention adjustment).''; and
                    (F) in subparagraph (D), as so redesignated, by 
                striking ``paragraph (5)'' and inserting ``paragraph 
                (6)'';
            (5) in paragraph (4), as so redesignated--
                    (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 at least the 
                following amounts of operating reserves of carryover 
                user fees for the process for the review of human drug 
                applications for each fiscal year, as follows:
                            ``(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)'';
            (6) by amending paragraph (5), as so redesignated, to read 
        as follows:
            ``(5) Additional direct cost adjustment.--The Secretary 
        shall, in addition to adjustments under paragraphs (1), (2), 
        (3), and (4), further increase the fee revenue and fees--
                    ``(A) for fiscal year 2023, by $44,386,150; and
                    ``(B) for fiscal years 2024 through 2027, by the 
                amount set forth in clauses (i) through (iv), 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--
                            ``(i) for fiscal year 2024, $60,967,993;
                            ``(ii) for fiscal year 2025, $35,799,314;
                            ``(iii) for fiscal year 2026, $35,799,314; 
                        and
                            ``(iv) for fiscal year 2027, 
                        $35,799,314.''; and
            (7) in paragraph (6), as so redesignated, by striking 
        ``2017'' and inserting ``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 ``2018 through 2022'' and inserting ``2023 through 2027''.
    (e) Written Requests for Waivers, Reductions, and Refunds.--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 submit to the 
Secretary a written request justifying such waiver, reduction, 
exemption, or return 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.''.
    (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) in paragraph (2), by striking ``that its gross annual 
        revenues'' and all that follows through the period at the end 
        and inserting ``supported by tax returns submitted to the 
        Internal Revenue Service, or, as necessary, by other 
        appropriate financial information, that its 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.''.

SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENT.

    Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h-2) is amended--
            (1) by striking ``2018'' each place it appears and 
        inserting ``2023'';
            (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)(4), by striking ``2020'' and 
        inserting ``2023''; and
            (4) in subsection (f), by striking ``2022'' each place it 
        appears and inserting ``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 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 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.--Congress finds that the fees authorized under the 
amendments made by this title will be dedicated toward expediting the 
process for the review of device applications and for assuring the 
safety and effectiveness of devices, as set forth in the goals 
identified for purposes of part 3 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act in the letters from the Secretary 
of Health and Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of 
Representatives, as set forth in the Congressional Record.

SEC. 202. DEFINITIONS.

    Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379i) is amended--
            (1) 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 de novo 
                classification requests'';
                    (C) in subparagraph (F), by striking ``and 
                premarket notification submissions'' and inserting 
                ``premarket notification submissions, and de novo 
                classification requests'';
                    (D) in subparagraphs (G) and (H), by striking ``or 
                submissions'' each place it appears 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 ``2018'' and inserting 
        ``2023''; and
            (2) in paragraph (2)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i), by 
                        striking ``2017'' and inserting ``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 the table in paragraph (2) to read 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) in paragraph (3), by amending subparagraphs (A) through 
        (E) to read 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) by striking ``2018'' each place it appears and 
                inserting ``2023'';
                    (B) in subparagraph (B)(ii), by striking ``2016'' 
                and inserting ``2022'';
                    (C) in subparagraph (C)(i)(II), by striking 
                ``Washington-Baltimore, DC-MD-VA-WV'' and inserting 
                ``Washington-Arlington-Alexandria, DC-VA-MD-WV''; and
                    (D) in subparagraph (D), by striking ``2022'' and 
                inserting ``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 adjustment under paragraph (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, as applicable:
                            ``(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) Presubmission amount.--For purposes 
                        of subparagraph (A), with respect to the 
                        presubmission written feedback goal, the 
                        amounts determined under this subparagraph are 
                        as follows:
                                    ``(I) For fiscal year 2025, 
                                $15,396,600 if the goal for fiscal year 
                                2023 is met.
                                    ``(II) For fiscal year 2026--
                                            ``(aa) $15,396,600 if the 
                                        goal for fiscal year 2023 is 
                                        met and the goal for fiscal 
                                        year 2024 is missed; or
                                            ``(bb) $36,792,200 if the 
                                        goal for fiscal year 2024 is 
                                        met.
                                    ``(III) For fiscal year 2027--
                                            ``(aa) $15,396,600 if the 
                                        goal for fiscal year 2023 is 
                                        met and the goal for each of 
                                        fiscal years 2024 and 2025 is 
                                        missed;
                                            ``(bb) $36,792,200 if the 
                                        goal for fiscal year 2024 is 
                                        met and the goal for fiscal 
                                        year 2025 is missed; or
                                            ``(cc) $40,572,600 if the 
                                        goal for fiscal year 2025 is 
                                        met.
                            ``(ii) De novo classification request 
                        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 the goal for fiscal year 
                                2023 is met.
                                    ``(II) For fiscal year 2027--
                                            ``(aa) $6,323,500 if the 
                                        goal for fiscal year 2023 is 
                                        met and the goal for fiscal 
                                        year 2024 is missed; or
                                            ``(bb) $11,765,400 if the 
                                        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 4 goals for fiscal 
                                year 2023 are met.
                                    ``(II) For fiscal year 2027--
                                            ``(aa) $1,020,000 if the 4 
                                        goals for fiscal year 2023 are 
                                        met and one or more of the 4 
                                        goals for fiscal year 2024 is 
                                        missed; or
                                            ``(bb) $3,906,000 if the 4 
                                        goals for fiscal year 2024 are 
                                        met.
                    ``(C) Performance calculation.--For purposes of 
                this paragraph, performance of the following goals 
                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 applicable dates as follows:
                            ``(i) The performance of the presubmission 
                        written feedback goal--
                                    ``(I) for fiscal year 2023, shall 
                                be based on data available as of March 
                                31, 2024;
                                    ``(II) for fiscal year 2024, shall 
                                be based on data available as of March 
                                31, 2025; and
                                    ``(III) for fiscal year 2025, shall 
                                be based on data available as of 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--
                                    ``(I) for fiscal year 2023, shall 
                                be based on data available as of March 
                                31, 2025; and
                                    ``(II) for fiscal year 2024, shall 
                                be based on data available as of March 
                                31, 2026.
                    ``(D) Definitions.--For purposes of this paragraph, 
                the terms `presubmission 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' have the meanings given such terms in 
                the goals identified 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 
                (3) and (4), if applicable, 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 (B), if the number of hires 
                to support the process for the review of device 
                applications falls below the following thresholds for 
                the applicable fiscal years:
                            ``(i) For fiscal year 2025, 85 percent of 
                        the hiring goal specified in subparagraph (C) 
                        for fiscal year 2023.
                            ``(ii) For fiscal year 2026, 90 percent of 
                        the hiring goal specified in subparagraph (C) 
                        for fiscal year 2024.
                            ``(iii) For fiscal year 2027, 90 percent of 
                        the hiring goal specified in subparagraph (C) 
                        for fiscal year 2025.
                    ``(B) 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 (C) for 
                        the fiscal year before the prior fiscal year 
                        was missed;
                            ``(ii) $72,877; and
                            ``(iii) the applicable inflation adjustment 
                        under paragraph (2)(B) for the fiscal year for 
                        which the hiring goal was missed.
                    ``(C) Hiring goals.--
                            ``(i) In general.--For purposes of 
                        subparagraph (B), 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--
                                            ``(aa) 24 hires if the base 
                                        establishment registration fees 
                                        are not increased by the amount 
                                        determined under paragraph 
                                        (4)(A)(i); or
                                            ``(bb) 83 hires if the base 
                                        establishment registration fees 
                                        are increased by the amount 
                                        determined under paragraph 
                                        (4)(A)(i).
                            ``(ii) Number of hires.--For purposes of 
                        this paragraph, the number of hires for a 
                        fiscal year 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 
                (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) the 1 month of operating reserves 
                        described in 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--
            (1) in subsection (d)(2)(B)(iii), by inserting ``, if 
        extant,'' after ``national taxing authority''; and
            (2) in subsection (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) Authorization of Appropriations.--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 the fiscal years 
                2023 through 2027, there is authorized to be 
                appropriated for fees under this section an amount 
                equal to the revenue amount determined in subparagraph 
                (B), less the amount of reductions determined in 
                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 subsection (c)(2); and
                            ``(ii) the performance improvement 
                        adjustment amount for the fiscal year under 
                        subsection (c)(4)(A), if applicable.
                    ``(C) Amount of 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. ACCREDITATION PROGRAMS.

    (a) Accreditation Scheme for Conformity Assessment.--Section 514(d) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(d)) is 
amended--
            (1) in the subsection heading, by striking ``Pilot'';
            (2) in paragraph (1)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``pilot'';
                    (B) in subparagraph (A)--
                            (i) by inserting ``meeting criteria 
                        specified by the Secretary in guidance'' after 
                        ``testing laboratories'';
                            (ii) by inserting ``in guidance'' after 
                        ``by the Secretary''; and
                            (iii) by striking ``assess the conformance 
                        of a device with'' and inserting ``conduct 
                        testing to support the assessment of the 
                        conformance of a device to''; and
                    (C) in subparagraph (B)--
                            (i) by striking ``determinations'' and 
                        inserting ``results'';
                            (ii) by inserting ``to support'' after ``so 
                        accredited''; and
                            (iii) by striking ``a particular such 
                        determination'' and inserting ``particular such 
                        results'';
            (3) in paragraph (2)--
                    (A) in the paragraph heading, by striking 
                ``determinations'' and inserting ``results'';
                    (B) in subparagraph (A)--
                            (i) by striking ``determinations by testing 
                        laboratories'' and all that follows through 
                        ``such determinations or'' and inserting 
                        ``results by testing laboratories accredited 
                        pursuant to this subsection, including by 
                        conducting periodic audits of such results or 
                        of the'';
                            (ii) by inserting a comma after ``or 
                        testing laboratories'';
                            (iii) by inserting ``or recognition of an 
                        accreditation body'' after ``accreditation of 
                        such testing laboratory''; and
                            (iv) by striking ``such device'' and 
                        inserting ``a device''; and
                    (C) in subparagraph (B)--
                            (i) by striking ``by a testing laboratory 
                        so accredited'' and inserting ``under this 
                        subsection''; and
                            (ii) by inserting ``or recognition of an 
                        accreditation body'' before ``under paragraph 
                        (1)(A)'';
            (4) in paragraph (3)(C)--
                    (A) in the subparagraph heading, by inserting ``and 
                transition'' after ``initiation''; and
                    (B) by adding at the end the following: ``After 
                September 30, 2023, such pilot program will be 
                considered to be completed, and the Secretary shall 
                have the authority to continue operating a program 
                consistent with this subsection.''; and
            (5) by striking paragraph (4).
    (b) Accredited Persons.--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. 205. SUNSET DATES.

    (a) Authorization.--Sections 737 and 738 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379i; 379fj) shall cease to be effective 
October 1, 2027.
    (b) Reporting Requirements.--Section 738A of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-1) shall cease to be effective 
January 31, 2028.
    (c) Previous Sunset Provision.--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. 206. 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. 207. SAVINGS CLAUSE.

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

               TITLE III--FEES RELATING TO GENERIC DRUGS

SEC. 301. SHORT TITLE; FINDING.

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

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

    (a) Types of Fees.--Section 744B(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``2018'' and inserting ``2023'';
            (2) in paragraph (2)(C), by striking ``fiscal years 2018 
        through 2022'' and inserting ``fiscal years 2023 through 
        2027'';
            (3) in paragraph (3)(B), by striking ``fiscal years 2018 
        through 2022'' and inserting ``fiscal years 2023 through 
        2027'';
            (4) in paragraph (4)(D), by striking ``fiscal years 2018 
        through 2022'' and inserting ``fiscal years 2023 through 
        2027''; and
            (5) in paragraph (5)(D), by striking ``fiscal years 2018 
        through 2022'' and inserting ``fiscal years 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) in subparagraph (B)--
                            (i) in the heading, by striking ``2019 
                        through 2022'' and inserting ``2024 through 
                        2027'';
                            (ii) by striking ``For each'' and inserting 
                        the following:
                            ``(i) In general.--For each'';
                            (iii) by striking ``2019 through 2022'' and 
                        inserting ``2024 through 2027'';
                            (iv) by striking ``$493,600,000'' and 
                        inserting ``the base revenue amount under 
                        clause (ii)''; and
                            (v) by adding at the end the following:
                            ``(ii) Base revenue amount.--The base 
                        revenue amount for a fiscal year is 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 ``24 percent'';
                    (B) in subparagraph (D), by striking ``Seven'' and 
                inserting ``Six''; and
                    (C) in subparagraph (E)(i), by striking ``Thirty-
                five'' and inserting ``Thirty-six''.
    (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 ``the product of the total 
                        revenues established in such notice for the 
                        prior fiscal year'' and inserting ``the base 
                        revenue amount for the fiscal year determined 
                        under subsection (b)(1)(B)(ii)''; 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' as announced in 
                        the Federal Register on August 3, 2020 (85 Fed. 
                        Reg. 46658); and
                            ``(ii) incorporate approaches and 
                        attributes determined appropriate by the 
                        Secretary, including those made in such report 
                        recommendations, except the workload categories 
                        used in forecasting resources shall only be 
                        those specified in section VIII.B.2.e. of the 
                        letters described in section 301(b) of the 
                        Generic Drug User Fee Amendments of 2022.
                    ``(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) Additional limitation.--An 
                        adjustment under this paragraph shall not 
                        exceed 3 percent of the sum described in clause 
                        (i) for the fiscal year, except that such 
                        limitation shall be 4 percent if--
                                    ``(I) for purposes of an adjustment 
                                for fiscal year 2024, 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 an 
                                adjustment for fiscal year 2025, 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 an 
                                adjustment for fiscal year 2026, 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 an 
                                adjustment for fiscal year 2027, 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 
                under 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 
                subsequent fiscal years, the Secretary may, in addition 
                to adjustments under paragraphs (1) and (2), further 
                increase the fee revenue and fees under this section 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).
                    ``(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 heading, by striking ``2018 through 2022'' and 
        inserting ``2023 through 2027'';
            (2) by striking ``more'' and inserting ``later''; and
            (3) by striking ``2018 through 2022'' and inserting ``2023 
        through 2027''.
    (e) 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''.
    (f) 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 ``2018 through 2022'' and inserting ``2023 through 
2027''.

SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-43) is amended--
            (1) in subsection (a)--
                    (A) by striking ``2018'' each place it appears and 
                inserting ``2023''; and
                    (B) by striking ``Generic Drug User Fee Amendments 
                of 2017'' each place it appears and inserting ``Generic 
                Drug User Fee Amendments of 2022'';
            (2) in subsection (b), by striking ``2018'' and inserting 
        ``2023'';
            (3) in subsection (c)--
                    (A) by striking ``2018'' and inserting ``2023''; 
                and
                    (B) by striking ``Generic Drug User Fee Amendments 
                of 2017'' each place it appears and inserting ``Generic 
                Drug User Fee Amendments of 2022''; and
            (4) in subsection (f)--
                    (A) in paragraph (1), by striking ``2022'' and 
                inserting ``2027''; and
                    (B) in paragraph (5), by striking ``January 15, 
                2022'' and inserting ``January 15, 2027''.

SEC. 304. SUNSET DATES.

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

SEC. 305. EFFECTIVE DATE.

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

SEC. 306. SAVINGS CLAUSE.

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

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

SEC. 401. SHORT TITLE; FINDING.

    (a) Short Title.--This title may be cited as the ``Biosimilar User 
Fee Amendments of 2022''.
    (b) Finding.--Congress finds that the fees authorized by the 
amendments made in this title will be dedicated to expediting the 
process for the review of biosimilar biological product applications, 
including postmarket safety activities, as set forth in the goals 
identified for purposes of part 8 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act (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.

    Section 744G of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-51) is amended--
            (1) in paragraph (1)--
                    (A) by striking ``Washington-Baltimore, DC-MD-VA-
                WV'' and inserting ``Washington-Arlington-Alexandria, 
                DC-VA-MD-WV'';
                    (B) by striking ``October of'' and inserting 
                ``September of''; and
                    (C) by striking ``October 2011'' and inserting 
                ``September 2011''; and
            (2) in paragraph (4)(B)(iii)--
                    (A) by striking subclause (II); and
                    (B) by redesignating subclauses (III) and (IV) as 
                subclauses (II) and (III), respectively.

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

    (a) Types of Fees.--Section 744H(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-52(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``2018'' and inserting ``2023'';
            (2) in paragraph (1)--
                    (A) in subparagraph (A)--
                            (i) in clause (iv)(I), by striking ``5 
                        days'' and inserting ``7 days''; and
                            (ii) in clause (v)(II), by striking ``5 
                        days'' and inserting ``7 days'';
                    (B) in subparagraph (B)--
                            (i) in clause (i), by inserting ``except 
                        that, in the case that 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, 
                        such licensee, assignee or successor shall pay 
                        the annual biosimilar biological product 
                        development fee'' before the period;
                            (ii) in clause (iii)--
                                    (I) in subclause (I), by striking 
                                ``; or'' and inserting a semicolon;
                                    (II) in subclause (II), by striking 
                                the period 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
                            (iii) in clause (iv), by striking 
                        ``accepted for filing on or after October 1 of 
                        such fiscal year'' and inserting ``subsequently 
                        accepted for filing'';
                    (C) in subparagraph (D)--
                            (i) in clause (i)--
                                    (I) in the matter preceding 
                                subclause (I), by striking ``shall, if 
                                the person seeks to resume 
                                participation in such program, pay'' 
                                and inserting ``or who has been 
                                administratively removed from such 
                                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'';
                                    (II) in subclause (I)--
                                            (aa) by striking ``5 days'' 
                                        and inserting ``7 days''; and
                                            (bb) by inserting ``or the 
                                        date of administrative removal, 
                                        as applicable'' after 
                                        ``discontinued''; and
                                    (III) in subclause (II), by 
                                inserting ``or the date of 
                                administrative removal, as applicable'' 
                                after ``discontinued''; and
                            (ii) in clause (ii), by inserting ``except 
                        that, in the case that 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, 
                        such licensee, assignee or successor shall pay 
                        the annual biosimilar biological product 
                        development fee'' before the period at the end; 
                        and
                    (D) in subparagraph (E), 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 2 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.'';
            (3) in paragraph (2)(D), by inserting ``prior to approval'' 
        after ``withdrawn'';
            (4) in paragraph (3)--
                    (A) in subparagraph (A)--
                            (i) in clause (i), by striking ``; and'' 
                        and inserting a semicolon;
                            (ii) by redesignating clause (ii) as clause 
                        (iii); and
                            (iii) by inserting the following after 
                        clause (i):
                            ``(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) Written request to place on 
                        discontinued list.--
                                    ``(I) In general.--If a written 
                                request to place a product on the list 
                                of discontinued biosimilar biological 
                                products referred to in subparagraph 
                                (A)(iii) is submitted to the Secretary 
                                on behalf of an applicant, and the 
                                request identifies the date the product 
                                is, or will be, 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--
                                            ``(aa) the date such 
                                        request was received; or
                                            ``(bb) if the product will 
                                        be withdrawn from sale on a 
                                        future date, such future date 
                                        when the product is withdrawn 
                                        from sale.
                                    ``(II) Withdrawn from sale 
                                defined.--For purposes of this clause, 
                                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.
                            ``(ii) Products removed from discontinued 
                        list.--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 of discontinued 
                        biosimilar biological products referred to in 
                        subparagraph (A)(iii), and on any subsequent 
                        day during such fiscal year the biosimilar 
                        biological product does not appear on such 
                        list, except as provided in subparagraph (D), 
                        each person who is named as the applicant in 
                        the biosimilar biological product application 
                        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 product for each 
                        fiscal year.''; and
            (5) by striking paragraph (4).
    (b) Fee Revenue Amounts.--Section 744H(b) of the Federal Food, 
Drug, and Cosmetic Act ((21 U.S.C. 379j-52(b)) is amended--
            (1) by striking paragraph (1);
            (2) by redesignating paragraphs (2) through (4) as 
        paragraphs (1) through (3), respectively;
            (3) in paragraph (1), as so redesignated--
                    (A) in the paragraph heading, by striking 
                ``Subsequent fiscal years'' and inserting ``In 
                general'';
                    (B) in the matter preceding subparagraph (A), by 
                striking ``2019 through 2022'' and inserting ``2023 
                through 2027'';
                    (C) in subparagraph (A), by striking ``paragraph 
                (4)'' and inserting ``paragraph (3)'';
                    (D) by redesignating subparagraphs (C) and (D) as 
                subparagraphs (D) and (E), respectively;
                    (E) by inserting after subparagraph (B) the 
                following:
                    ``(C) the dollar amount equal to the strategic 
                hiring and retention adjustment (as determined under 
                subsection (c)(2));'';
                    (F) in subparagraph (D), as so redesignated, by 
                striking ``subsection (c)(2)); and'' and inserting 
                ``subsection (c)(3));'';
                    (G) in subparagraph (E), as so redesignated, by 
                striking ``subsection (c)(3)).'' and inserting 
                ``subsection (c)(4)); and''; and
                    (H) by adding at the end the following:
                    ``(F) for fiscal years 2023 and 2024, additional 
                dollar amounts equal to--
                            ``(i) $4,428, 886 for fiscal year 2023; and
                            ``(ii) $320,569 for fiscal year 2024.'';
            (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 subaparagraphs (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).''.
    (c) 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 paragraph (4);
            (3) by redesignating paragraphs (2) and (3) as paragraphs 
        (3) and (4), respectively;
            (4) by inserting after paragraph (1) the following:
            ``(2) Strategic hiring and retention adjustment.--For each 
        fiscal year beginning in fiscal year 2023, 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.'';
            (5) in paragraph (3), as so redesignated--
                    (A) in subparagraph (A)--
                            (i) by striking ``Beginning with the fiscal 
                        year described in subparagraph (B)(ii)(II)'' 
                        and inserting ``For each fiscal year''; and
                            (ii) by striking ``adjustment under 
                        paragraph (1), further increase'' and inserting 
                        ``adjustments under paragraphs (1) and (2), 
                        further adjust''; and
                    (B) by amending subparagraph (B) to read as 
                follows:
                    ``(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' (85 
                Fed. Reg. 47220; August 4, 2020). The workload 
                categories used in forecasting shall include only the 
                activities described in such 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 and 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 forecasting 
                any non-core review activities, including any 
                activities that the Secretary referenced for potential 
                future use in such notice but did not utilize in 
                setting fees for fiscal year 2021.''; and
                    (C) in subparagraph (C)--
                            (i) by striking ``subsections (b)(2)(A)'' 
                        and inserting ``subsections (b)(1)(A)'';
                            (ii) by striking ``and (b)(2)(B)'' and 
                        inserting ``, (b)(1)(B)''; and
                            (iii) by inserting ``, and (b)(1)(C) (the 
                        dollar amount of the strategic hiring and 
                        retention adjustment)'' before the period at 
                        the end;
            (6) by amending paragraph (4), as so redesignated, to read 
        as follows:
            ``(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 the process for the review of biosimilar 
                        biological product applications 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 the process for the review of biosimilar 
                        biological product applications 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 the process for the 
                        review of biosimilar biological product 
                        applications 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 (as 
                applicable) in fee revenue and fees shall be contained 
                in the annual Federal Register notice under paragraph 
                (5)(B) establishing fee revenue and fees for the fiscal 
                year involved.''; and
            (7) in paragraph (5), in the matter preceding subparagraph 
        (A), by striking ``2018'' and inserting ``2023''.
    (d) Crediting and Availability of Fees.--Section 744H(f)(3) 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''.
    (e) Written Requests for Waivers and Refunds.--Subsection (h) of 
section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-52) 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 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) by striking ``2018'' each place it appears and 
        inserting ``2023'';
            (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)(4), by striking ``2020'' and 
        inserting ``2023''; and
            (4) in subsection (f), by striking ``2022'' each place it 
        appears and inserting ``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 (21 U.S.C. 379j-53) 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 REGULATION OF DRUGS AND BIOLOGICAL PRODUCTS

SEC. 501. ALTERNATIVES TO ANIMAL TESTING.

    (a) In General.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended--
            (1) 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
            (2) 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 non-human in vivo test that occurs before or during 
the clinical trial phase of the investigation of the safety and 
effectiveness of a drug, and may include animal tests, or non-animal or 
human biology-based test methods, such as cell-based assays, 
microphysiological systems, or computer models.''.
    (b) Biosimilar Biological Product Applications.--Item (bb) of 
section 351(k)(2)(A)(i)(I) of the Public Health Service Act (42 U.S.C. 
262(k)(2)(A)(i)(I)) is amended to read as follows:
                                            ``(bb) an assessment of 
                                        toxicity (which may rely on, or 
                                        consist of, a study or studies 
                                        described in item (aa) or 
                                        (cc)); and''.

SEC. 502. SAFER DISPOSAL OF OPIOIDS.

    Section 505-1(e)(4)(B) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355-1(e)(4)(B)) is amended by striking ``for purposes of 
rendering drugs nonretrievable (as defined in section 1300.05 of title 
21, Code of Federal Regulations (or any successor regulation))''.

SEC. 503. CLARIFICATIONS TO EXCLUSIVITY PROVISIONS FOR FIRST 
              INTERCHANGEABLE BIOSIMILAR BIOLOGICAL PRODUCTS.

    Section 351(k)(6) of the Public Health Service Act (42 U.S.C. 
262(k)(6)) is amended--
            (1) in the matter preceding subparagraph (A)--
                    (A) by striking ``Upon review of'' and inserting 
                ``The Secretary shall not make licensure as an 
                interchangeable biological product effective with 
                respect to'';
                    (B) by striking ``relying on'' and inserting ``that 
                relies on''; and
                    (C) by striking ``the Secretary shall not make a 
                determination under paragraph (4) that the second or 
                subsequent biological product is interchangeable for 
                any condition of use''; and
            (2) in the flush text that follows subparagraph (C), by 
        striking the period and inserting ``, and the term `first 
        interchangeable biosimilar biological product' means any 
        interchangeable biosimilar biological product that is approved 
        on the first day on which such a product is approved as 
        interchangeable with the reference product.''.

SEC. 504. IMPROVEMENTS TO THE PURPLE BOOK.

    (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) 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 inserting ``(in the case 
                of a biological product, the proper name)'' after 
                ``established 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 inserting ``(in the case 
                of a biological product, the proper name)'' after 
                ``established 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 Administration Safety and Landmark 
Advancements Act 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) in subsection (d)--
                    (A) by striking ``or (c), the Secretary'' and 
                inserting ``or (c)--
            ``(1) the Secretary'';
                    (B) by striking the period at the end, and 
                inserting ``; and''; and
                    (C) by adding at the end the following:
            ``(2) the Secretary may 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 any biological product 
        for which a 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 any biological product for which 
                the license has been revoked or suspended for reasons 
                of safety, purity, or potency shall be removed from the 
                list in accordance with section 351(k)(9)(B) of the 
                Public Health Service Act.''; and
                    (B) in the last sentence--
                            (i) by striking ``updates to the list'' and 
                        inserting ``updates to the lists published 
                        under section 505(j)(7)(A) of this Act and 
                        section 351(k)(9)(A) of the Public Health 
                        Service Act''; and
                            (ii) by striking ``update the list'' and 
                        inserting ``update such lists''.

SEC. 505. THERAPEUTIC EQUIVALENCE EVALUATIONS.

    Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)(7)(A)) is amended by adding at the end the following:
    ``(v)(I) With respect to an application submitted pursuant to 
subsection (b)(2) for a drug that is subject to section 503(b) for 
which the sole difference from a listed drug relied upon in the 
application is a difference in inactive ingredients not permitted under 
clause (iii) or (iv) of section 314.94(a)(9) of title 21, Code of 
Federal Regulations (or successor regulations), the Secretary shall 
make an evaluation with respect to whether such drug is a therapeutic 
equivalent (as defined in section 314.3 of title 21, Code of Federal 
Regulations (or any successor regulations)) to another approved drug 
product in the prescription drug product section of the list under this 
paragraph as follows:
            ``(aa) With respect to such an application submitted after 
        the date of enactment of the Food and Drug Administration 
        Safety and Landmark Advancements Act of 2022, the evaluation 
        shall be made with respect to a listed drug relied upon in the 
        application under subsection (b)(2) that is a pharmaceutical 
        equivalent (as defined in section 314.3 of title 21, Code of 
        Federal Regulations (or any successor regulations)) to the drug 
        in the application under subsection (b)(2) at the time of 
        approval of such application or not later than 180 days after 
        the date of such approval, provided that the request for such a 
        determination is made in the original application (or in a 
        resubmission to a complete response letter), and all necessary 
        data and information are submitted in the original application 
        (or in a resubmission in response to a complete response 
        letter) for the therapeutic equivalence evaluation, including 
        information to demonstrate bioequivalence, in a form and manner 
        prescribed by the Secretary.
            ``(bb) With respect to such an application submitted prior 
        to the date of enactment of the Food and Drug Administration 
        Safety and Landmark Advancements Act of 2022, with respect to 
        an application approved on or after the date of enactment of 
        such Act, the evaluation shall be made not later than 180 days 
        after receipt of a request for a therapeutic equivalence 
        evaluation submitted as part of a supplement to such 
        application; or with respect to an application that was not 
        approved as of the date of enactment of such Act, the 
        evaluation shall be made not later than 180 days after the date 
        of approval of such application if a request for such 
        evaluation is submitted to the application, provided that--
                    ``(AA) such request for a therapeutic equivalent 
                evaluation is being sought with respect to a listed 
                drug relied upon in the application, and the relied 
                upon listed drug is in the prescription drug product 
                section of the list under this paragraph and is a 
                pharmaceutical equivalent (as defined in section 314.3 
                of title 21, Code of Federal Regulations (or any 
                successor regulations)) to the drug for which a 
                therapeutic equivalence evaluation is sought; and
                    ``(BB) the initial submission containing such 
                request, or the relevant application, includes all 
                necessary data and information for the therapeutic 
                equivalence evaluation, including information to 
                demonstrate bioequivalence, in a form and manner 
                prescribed by the Secretary.
    ``(II) When the Secretary makes an evaluation under subclause (I), 
the Secretary shall, in revisions made to the list pursuant to clause 
(ii), include such information for such drug.''.

SEC. 506. MODERNIZING ACCELERATED APPROVAL.

    (a) In General.--Section 506(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356(c)) is amended--
            (1) in paragraph (2)--
                    (A) by redesignating subparagraphs (A) and (B) as 
                clauses (i) and (ii), respectively, and adjusting the 
                margins accordingly;
                    (B) by striking ``Approval of a product'' and 
                inserting the following:
                    ``(A) In general.--Approval of a product'';
                    (C) in clause (i) of such subparagraph (A), as so 
                redesignated, by striking ``appropriate postapproval 
                studies'' and inserting ``an appropriate postapproval 
                study or studies (which may be augmented or supported 
                by real world evidence)''; and
                    (D) by adding at the end the following:
                    ``(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) in paragraph (3)--
                    (A) by redesignating subparagraphs (A) through (D) 
                as clauses (i) through (iv), respectively and adjusting 
                the margins accordingly;
                    (B) by striking ``The Secretary may'' and inserting 
                the following:
                    ``(A) In general.--The Secretary may'';
                    (C) in clause (i) of such subparagraph (A), as so 
                redesignated, by striking ``drug with due diligence'' 
                and inserting ``product with due diligence, including 
                with respect to conditions specified by the Secretary 
                under paragraph (2)(C)'';
                    (D) in clause (iii) of such subparagraph (A), as so 
                redesignated, by inserting ``shown to be'' after 
                ``product is not''; and
                    (E) by adding at the end the following:
                    ``(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 or the 
                                Commissioner's designee; and
                                    ``(IV) an opportunity for written 
                                appeal to--
                                            ``(aa) the Commissioner; or
                                            ``(bb) a designee of the 
                                        Commissioner who has not 
                                        participated in the proposal 
                                        withdrawal of approval (other 
                                        than a meeting pursuant to 
                                        subclause (III)) and is not 
                                        subordinate of an individual 
                                        (other than the Commissioner) 
                                        who participated in such 
                                        proposed withdrawal;
                            ``(ii) providing an opportunity for public 
                        comment on the proposing to withdrawal 
                        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.''.
    (b) Reports of Postmarketing Studies.--Section 506B 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) Enforcement.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), as amended by section 824, is further 
amended by adding at the end the following:
    ``(ll) The failure of a sponsor of a product approved under 
accelerated approval pursuant to section 506(c)--
            ``(1) to conduct with due diligence any postapproval study 
        required under section 506(c) with respect to such product; or
            ``(2) to submit timely reports with respect to such product 
        in accordance with section 506B(a)(2).''.
    (d) 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 post-approval 
                studies as may be required under section 506(c)(2)(A) 
                of the Federal Food, Drug, and Cosmetic Act, as amended 
                by subsection (a);
                    (C) the expedited procedures described in section 
                506(c)(3)(B) of the Federal Food, Drug, and Cosmetic 
                Act; and
                    (D) considerations related to the use of surrogate 
                or intermediate clinical endpoints that may support the 
                accelerated approval of an application under 
                506(c)(1)(A), including considerations in evaluating 
                the evidence related to any such endpoints.
            (2) Final guidance.--The Secretary shall issue--
                    (A) 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.
    (e) 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 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 work 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.
    (f) Accelerated Approval Council.--
            (1) General.--Not later than 180 days after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall establish an intra-agency coordinating council 
        within the Food and Drug Administration to ensure the 
        consistent and appropriate use of accelerated approval across 
        the Food and Drug Administration, pursuant to section 506(c) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)).
            (2) Membership.--The members of the Council shall consist 
        of the following senior officials, or a designee of such 
        official, from the Food and Drug Administration and relevant 
        Centers:
                    (A) The Director of the Center for Drug Evaluation 
                and Research.
                    (B) The Director of the Center for Biologics 
                Evaluation and Research.
                    (C) The Director of the Oncology Center of 
                Excellence.
                    (D) The Director of the Office of New Drugs.
                    (E) The Director of the Office of Orphan Products 
                Development.
                    (F) The Director of the Office of Tissues and 
                Advanced Therapies.
                    (G) The Director of the Office of Medical Policy.
                    (H) At least 3 directors of review division 
                overseeing products approved under accelerated 
                approval, including at least one director of a review 
                division within the Office of Neuroscience.
            (3) Duties of the council.--
                    (A) Meetings.--The Council shall convene not fewer 
                than 3 times per calendar year to discuss issues 
                related to accelerated approval, including any relevant 
                cross-disciplinary approaches related to product review 
                with respect to accelerated approval.
                    (B) Policy development.--The Council shall directly 
                engage with product review teams to support the 
                consistent and appropriate use of accelerated approval 
                across the Food and Drug Administration. Such 
                activities may include--
                            (i) developing guidance for Food and Drug 
                        Administration staff and best practices for, 
                        and across, product review teams, including 
                        with respect to communication between sponsors 
                        and the Food and Drug Administration and the 
                        review of products under accelerated approval;
                            (ii) providing training for product review 
                        teams; and
                            (iii) advising review divisions on product-
                        specific development, review, and withdrawal of 
                        products under accelerated approval.
            (4) Publication of a report.--Not later than 1 year after 
        the date of enactment of this Act, and annually thereafter, the 
        council shall publish on the public website of the Food and 
        Drug Administration a report on the activities of the council.
    (g) Rule of Construction.--Nothing in this section (including the 
amendments made by this section) shall be construed to affect products 
approved under 506(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 356(c)) prior to the date of enactment of this Act.

                    TITLE VI--OTHER REAUTHORIZATIONS

SEC. 601. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 
              PARTNERSHIP.

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

SEC. 602. REAUTHORIZATION OF THE BEST PHARMACEUTICALS FOR CHILDREN 
              PROGRAM.

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

SEC. 603. REAUTHORIZATION OF THE HUMANITARIAN DEVICE EXEMPTION 
              INCENTIVE.

    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''.

SEC. 604. REAUTHORIZATION OF THE PEDIATRIC DEVICE CONSORTIA PROGRAM.

    Section 305(e) of the Food and Drug Administration Amendments Act 
of 2007 (Public Law 110-85; 42 U.S.C. 282 note) is amended by striking 
``$5,250,000 for each of fiscal years 2018 through 2022'' and inserting 
``$7,000,000 for each of fiscal years 2023 through 2027''.

SEC. 605. REAUTHORIZATION OF PROVISION PERTAINING TO DRUGS CONTAINING 
              SINGLE ENANTIOMERS.

    Section 505(u) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(u)) is amended by--
            (1) in paragraph (1)(A)(ii)(II), by adding ``(other than 
        bioavailability studies)'' after ``any clinical 
        investigations''; and
            (2) in paragraph (4), by striking ``October 1, 2022'' and 
        inserting ``October 1, 2027''.

SEC. 606. REAUTHORIZATION OF ORPHAN DRUG GRANTS.

    Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended 
by striking ``2018 through 2022'' and inserting ``2023 through 2027''.

SEC. 607. REAUTHORIZATION OF CERTAIN DEVICE INSPECTIONS.

    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''.

              TITLE VII--ENHANCING FDA HIRING AUTHORITIES

SEC. 701. ENHANCING FDA HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND 
              PROFESSIONAL PERSONNEL.

    Section 714A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379d-3a) is amended--
            (1) in subsection (a)--
                    (A) by inserting ``, including cross-cutting 
                operational positions,'' after ``professional 
                positions''; and
                    (B) by inserting ``and the regulation of food'' 
                after ``medical products''; and
            (2) in subsection (d)(1)--
                    (A) in the matter preceding subparagraph (A)--
                            (i) by striking ``the 21st Century Cures 
                        Act'' and inserting ``the Food and Drug 
                        Administration Safety and Landmark Advancements 
                        Act of 2022''; and
                            (ii) by striking ``that examines the 
                        extent'' and all that follows through ``, 
                        including'' and inserting ``that addresses'';
                    (B) in subparagraph (A)--
                            (i) by inserting ``updated'' before 
                        ``analysis''; and
                            (ii) by striking ``; and'' and inserting a 
                        semicolon;
                    (C) by redesignating subparagraph (B) as 
                subparagraph (C);
                    (D) by inserting after subparagraph (A) the 
                following:
                    ``(B) an analysis of how the Secretary has used the 
                authorities provided under this section, and a plan for 
                how the Secretary will use the authority under this 
                section, and other applicable hiring authorities, for 
                employees of the Food and Drug Administration; and''; 
                and
                    (E) in subparagraph (C), as so redesignated, by 
                striking ``a recruitment'' and inserting ``an updated 
                recruitment''.

SEC. 702. STRATEGIC WORKFORCE PLAN AND REPORT.

    Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
371 et seq.) is amended by inserting after section 714A the following:

``SEC. 714B. STRATEGIC WORKFORCE PLAN AND REPORT.

    ``(a) In General.--Not later than September 30, 2023, and at least 
every 4 years thereafter, the Secretary shall develop and submit to the 
appropriate committees of Congress and post on the website of the Food 
and Drug Administration, a coordinated strategy and report to provide 
direction for the activities and programs of the Secretary to recruit, 
hire, train, develop, and retain the workforce needed to fulfill the 
public health mission of the Food and Drug Administration, including to 
facilitate collaboration across centers, to keep pace with new 
biomedical, technological, and scientific advancements, and support the 
development, review, and regulation of medical products. Each such 
report shall be known as the `Food and Drug Administration Strategic 
Workforce Plan'.
    ``(b) Use of the Food and Drug Administration Strategic Workforce 
Plan.--Each center within the Food and Drug Administration shall 
develop and update, as appropriate, a strategic plan that will be 
informed by the Food and Drug Administration Strategic Workforce Plan 
developed and updated under this subsection.
    ``(c) Contents of the Food and Drug Administration Strategic 
Workforce Plan.--Each Food and Drug Administration Strategic Workforce 
Plan under subsection (a) shall--
            ``(1) include agency-wide strategic goals and priorities 
        for recruiting, hiring, training, developing, and retaining a 
        qualified workforce for the Food and Drug Administration;
            ``(2) establish specific activities the Secretary will take 
        to achieve its strategic goals and priorities and address the 
        workforce needs of the Food and Drug Administration in the 
        forthcoming fiscal years;
            ``(3) identify challenges and risks the Secretary will face 
        in meeting its strategic goals and priorities, and the 
        activities the Secretary will undertake to overcome those 
        challenges and mitigate those risks;
            ``(4) establish metrics and milestones that the Secretary 
        will use to measure progress in achieving its strategic goals 
        and priorities; and
            ``(5) define functions, capabilities, and gaps in such 
        workforce and identify strategies to recruit, hire, train, 
        develop, and retain such workforce.
    ``(d) Considerations.--In developing each Food and Drug 
Administration Strategic Workforce Plan under subsection (a), the 
Secretary shall consider--
            ``(1) the number of employees, employee expertise, and 
        employing center of employees, including senior leadership and 
        non-senior leadership employees, eligible for retirement;
            ``(2) the vacancy and turnover rates for employees with 
        different types of expertise and from different centers, 
        including any changes or trends related to such rates;
            ``(3) the results of the Federal Employee Viewpoint Survey 
        for employees of the Food and Drug Administration, including 
        any changes or trends related to such results;
            ``(4) rates of pay for different types of positions, 
        including rates for different types of expertise within the 
        same field (such as differences in pay between different 
        medical specialists), and how such rates of pay impact the 
        ability of the Secretary to achieve strategic goals and 
        priorities; and
            ``(5) the statutory hiring authorities used to hire Food 
        and Drug Administration employees, and the time to hire across 
        different hiring authorities.
    ``(e) Evaluation of Progress.--Each Food and Drug Administration 
Strategic Workforce Plan issued pursuant to subsection (a), with the 
exception of the first such Food and Drug Administration Strategic 
Workforce Plan, shall include an evaluation of the progress the 
Secretary has made, based on the metrics, benchmarks, and other 
milestones that measure successful recruitment, hiring, training, 
development, and retention activities; and whether such actions 
improved the capacity of the Food and Drug Administration to achieve 
the strategic goals and priorities set forth in the previous Food and 
Drug Administration Strategic Workforce Plan.
    ``(f) Additional Considerations.--The Food and Drug Administration 
Strategic Workforce Plan issued in fiscal year 2023 shall address the 
effect of the COVID-19 pandemic on hiring, retention, and other 
workforce challenges for the Food and Drug Administration, including 
protecting such workforce during public health emergencies.''.

TITLE VIII--ADVANCING REGULATION OF COSMETICS, DIETARY SUPPLEMENTS, AND 
                       LABORATORY DEVELOPED TESTS

                         Subtitle A--Cosmetics

SEC. 801. SHORT TITLE.

    This subtitle may be cited as the ``Modernization of Cosmetics 
Regulation Act of 2022''.

SEC. 802. AMENDMENTS TO COSMETIC REQUIREMENTS.

    Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
361 et seq.) is amended by adding at the end the following:

``SEC. 604. DEFINITIONS.

    ``In this chapter:
            ``(1) Adverse event.--The term `adverse event' means any 
        health-related event associated with the use of a cosmetic 
        product that is adverse.
            ``(2) Cosmetic product.--The term `cosmetic product' means 
        a preparation of cosmetic ingredients with a qualitatively and 
        quantitatively set composition for use in a finished product.
            ``(3) Facility.--
                    ``(A) In general.--The term `facility' includes any 
                establishment (including an establishment of an 
                importer) that manufactures or processes cosmetic 
                products distributed in the United States.
                    ``(B) Such term does not include any of the 
                following:
                            ``(i) Beauty shops and salons, unless such 
                        establishment manufactures or processes 
                        cosmetic products at that location.
                            ``(ii) Cosmetic product retailers, 
                        including individual sales representatives, 
                        direct sellers, retail distribution facilities, 
                        and pharmacies, unless such establishment 
                        manufactures or processes cosmetic products 
                        that are not sold directly to consumers at that 
                        location.
                            ``(iii) Hospitals, physicians' offices, and 
                        health care clinics.
                            ``(iv) Public health agencies and other 
                        nonprofit entities that provide cosmetic 
                        products directly to the consumer.
                            ``(v) Entities (such as hotels and 
                        airlines) that provide complimentary cosmetic 
                        products to customers incidental to other 
                        services.
                            ``(vi) Trade shows and other venues where 
                        cosmetic product samples are provided free of 
                        charge.
                            ``(vii) An establishment that manufactures 
                        or processes cosmetic products that are solely 
                        for use in research or evaluation, including 
                        for production testing and not offered for 
                        retail sale.
                            ``(viii) An establishment that solely 
                        performs one or more of the following with 
                        respect to cosmetic products:
                                    ``(I) Labeling.
                                    ``(II) Relabeling.
                                    ``(III) Packaging.
                                    ``(IV) Repackaging.
                                    ``(V) Holding.
                                    ``(VI) Distributing.
                    ``(C) Clarification.--For the purposes of 
                subparagraph (B)(viii), the terms `packaging' and 
                `repackaging' do not include filling a product 
                container with a cosmetic product.
            ``(4) Responsible person.--The term `responsible person' 
        means the manufacturer, packer, or distributor of a cosmetic 
        product whose name appears on the label of such cosmetic 
        product in accordance with section 609(a) of this Act or 
        section 4(a) of the Fair Packaging and Labeling Act.
            ``(5) Serious adverse event.--The term `serious adverse 
        event' means an adverse event that--
                    ``(A) results in--
                            ``(i) death;
                            ``(ii) a life-threatening experience;
                            ``(iii) inpatient hospitalization;
                            ``(iv) a persistent or significant 
                        disability or incapacity;
                            ``(v) a congenital anomaly or birth defect; 
                        or
                            ``(vi) significant disfigurement (including 
                        serious and persistent rashes or infections, 
                        second- or third-degree burns, significant hair 
                        loss, or permanent or significant alteration of 
                        appearance), other than as intended, under 
                        conditions of use that are customary or usual; 
                        or
                    ``(B) requires, based on reasonable medical 
                judgment, a medical or surgical intervention to prevent 
                an outcome described in subparagraph (A).

``SEC. 605. ADVERSE EVENTS.

    ``(a) Serious Adverse Event Reporting Requirements.--The 
responsible person shall submit to the Secretary any report received of 
a serious adverse event associated with the use, in the United States, 
of a cosmetic product manufactured, packed, or distributed by such 
person.
    ``(b) Submission of Reports.--
            ``(1) Serious adverse event report.--The responsible person 
        shall submit to the Secretary a serious adverse event report 
        accompanied by a copy of the label on or within the retail 
        packaging of such cosmetic product no later than 15 business 
        days after the report is received by the responsible person.
            ``(2) New medical information.--The responsible person 
        shall submit to the Secretary any new and material medical 
        information, related to a serious adverse event report 
        submitted to the Secretary in accordance with paragraph (1), 
        that is received by the responsible person within 1 year of the 
        initial report to the Secretary, no later than 15 business days 
        after such information is received by such responsible person.
            ``(3) Consolidation of reports.--The Secretary shall 
        develop systems to enable responsible persons to submit a 
        single report that includes duplicate reports of, or new 
        medical information related to, a serious adverse event.
    ``(c) Exemptions.--The Secretary may establish by regulation an 
exemption to any of the requirements of this section if the Secretary 
determines that such exemption would have no significant adverse effect 
on public health.
    ``(d) Contact Information.--The responsible person shall receive 
reports of adverse events through the domestic address, domestic 
telephone number, or electronic contact information included on the 
label in accordance with section 609(a).
    ``(e) Maintenance and Inspection of Adverse Event Records.--
            ``(1) Maintenance.--The responsible person shall maintain 
        records related to each report of an adverse event associated 
        with the use, in the United States, of a cosmetic product 
        manufactured or distributed by such person received by such 
        person, for a period of 6 years.
            ``(2) Inspection.--
                    ``(A) In general.-- The responsible person shall 
                permit an authorized person to have access to records 
                required to be maintained under this section during an 
                inspection pursuant to section 704.
                    ``(B) Authorized person.--For purposes of this 
                paragraph, the term `authorized person' means an 
                officer or employee of the Department of Health and 
                Human Services who has--
                            ``(i) appropriate credentials, as 
                        determined by the Secretary; and
                            ``(ii) been duly designated by the 
                        Secretary to have access to the records 
                        required under this section.
    ``(f) Fragrance and Flavor Ingredients.--If the Secretary has 
reasonable grounds to believe that an ingredient or combination of 
ingredients in a fragrance or flavor has caused or contributed to a 
serious adverse event required to be reported under this section, the 
Secretary may request in writing a complete list of ingredients in the 
specific fragrances or flavors in the cosmetic product, from the 
responsible person. The responsible person shall ensure that the 
requested information is submitted to the Secretary within 30 days of 
such request. Information submitted to the Secretary under this 
subsection that is confidential commercial or trade secret information 
shall be exempt from disclosure under section 552 of title 5, United 
States Code.
    ``(g) Protected Information.--A serious adverse event report 
submitted to the Secretary under this section, including any new 
medical information submitted under subsection (a)(2), or an adverse 
event report, or any new information, voluntarily submitted to the 
Secretary shall be considered to be--
            ``(1) a safety report under section 756 and may be 
        accompanied by a statement, which shall be a part of any report 
        that is released for public disclosure, that denies that the 
        report or the records constitute an admission that the product 
        involved caused or contributed to the adverse event; and
            ``(2) a record about an individual under section 552a of 
        title 5, United States Code (commonly referred to as the 
        `Privacy Act of 1974') and a medical or similar file the 
        disclosure of which would constitute a violation of section 552 
        of such title 5 (commonly referred to as the `Freedom of 
        Information Act'), and shall not be publicly disclosed unless 
        all personally identifiable information is redacted.
    ``(h) Effect of Section.--
            ``(1) In general.--Nothing in this section shall affect the 
        authority of the Secretary to provide adverse event reports and 
        information to any health, food, or drug officer or employee of 
        any State, territory, or political subdivision of a State or 
        territory, under a memorandum of understanding between the 
        Secretary and such State, territory, or political subdivision.
            ``(2) Personally identifiable information.--Notwithstanding 
        any other provision of law, personally identifiable information 
        in adverse event reports provided by the Secretary to any 
        health, food, or drug officer or employee of any State, 
        territory, or political subdivision of a State or territory, 
        shall not--
                    ``(A) be made publicly available pursuant to any 
                State or other law requiring disclosure of information 
                or records; or
                    ``(B) otherwise be disclosed or distributed to any 
                party without the written consent of the Secretary and 
                the person submitting such information to the 
                Secretary.
            ``(3) Use of reports.--Nothing in this section shall permit 
        a State, territory, or political subdivision of a State or 
        territory, to use any safety report received from the Secretary 
        in a manner inconsistent with this section.
            ``(4) Rule of construction.--The submission of any report 
        in compliance with this section shall not be construed as an 
        admission that the cosmetic product involved caused or 
        contributed to the relevant adverse event.

``SEC. 606. GOOD MANUFACTURING PRACTICE.

    ``(a) In General.--The Secretary shall by regulation establish good 
manufacturing practices for facilities that are consistent, to the 
extent practicable, and appropriate, with national and international 
standards, in accordance with section 601. Any such regulations shall 
be intended to protect the public health and ensure that cosmetic 
products are not adulterated. Such regulations may allow for the 
Secretary to inspect records necessary to demonstrate compliance with 
good manufacturing practices prescribed by the Secretary under this 
paragraph during an inspection conducted under section 704.
    ``(b) Considerations.--In establishing regulations for good 
manufacturing practices under this section, the Secretary shall take 
into account the size and scope of the businesses engaged in the 
manufacture of cosmetics, and the risks to public health posed by such 
cosmetics, and provide sufficient flexibility to be practicable for all 
sizes and types of facilities to which such regulations will apply. 
Such regulations shall include simplified good manufacturing practice 
requirements for smaller businesses, as appropriate, to ensure that 
such regulations do not impose undue economic hardship for smaller 
businesses, and may include longer compliance times for smaller 
businesses. Before issuing regulations to implement subsection (a), the 
Secretary shall consult with cosmetics manufacturers, including smaller 
businesses, consumer organizations, and other experts selected by the 
Secretary.
    ``(c) Timeframe.--The Secretary shall publish a notice of proposed 
rulemaking not later than 2 years after the date of enactment of the 
Modernization of Cosmetics Regulation Act of 2022 and shall publish a 
final such rule not later than 3 years after such date of enactment.

``SEC. 607. REGISTRATION AND PRODUCT LISTING.

    ``(a) Submission of Registration.--
            ``(1) Initial registration.--
                    ``(A) Existing facilities.--Every person that, on 
                the date of enactment of the Modernization of Cosmetics 
                Regulation Act of 2022, owns or operates a facility 
                that engages in the manufacturing or processing of a 
                cosmetic product for distribution in the United States 
                shall register each facility with the Secretary not 
                later than 1 year after date of enactment of such Act.
                    ``(B) New facilities.--Every person that owns or 
                operates a facility that first engages, after the date 
                of enactment of the Modernization of Cosmetics 
                Regulation Act of 2022, in manufacturing or processing 
                of a cosmetic product for distribution in the United 
                States, shall register with the Secretary such facility 
                within 60 days of first engaging in such activity or 60 
                days after the deadline for registration under 
                subparagraph (A), whichever is later.
            ``(2) Biennial renewal of registration.--A person required 
        to register a facility under paragraph (1) shall renew such 
        registrations with the Secretary biennially.
            ``(3) Contract manufacturers.--If a facility manufactures 
        or processes cosmetic products on behalf of a responsible 
        person, the Secretary shall require only a single registration 
        for such facility even if such facility is manufacturing or 
        processing its own cosmetic products or cosmetic products on 
        behalf of more than one responsible person. Such single 
        registration may be submitted to the Secretary by such facility 
        or any responsible person whose products are manufactured or 
        processed at such facility.
            ``(4) Updates to content.--A person that is required to 
        register under subsection (a)(1) shall notify the Secretary 
        within 60 days of any changes to information required under 
        subsection (b)(2).
            ``(5) Abbreviated renewal registrations.--The Secretary 
        shall provide for an abbreviated registration renewal process 
        for any person that owns or operates a facility that has not 
        been required to submit updates under paragraph (4) for a 
        registered facility since submission of the most recent 
        registration of such facility under paragraph (1) or (2).
    ``(b) Format; Contents of Registration.--
            ``(1) In general.--Registration information under this 
        section may be submitted at such time and in such manner as the 
        Secretary may prescribe.
            ``(2) Contents.--The registration under subsection (a) 
        shall contain--
                    ``(A) the facility's name, physical address, email 
                address, and telephone number;
                    ``(B) with respect to any foreign facility, the 
                contact for the United States agent of the facility, 
                and, if available, the electronic contact information;
                    ``(C) the facility registration number, if any, 
                previously assigned by the Secretary under subsection 
                (d);
                    ``(D) all brand names under which cosmetic products 
                manufactured or processed in the facility are sold; and
                    ``(E) the product category or categories and 
                responsible person for each cosmetic product 
                manufactured or processed at the facility.
    ``(c) Cosmetic Product Listing.--
            ``(1) In general.--For each cosmetic product, the 
        responsible person shall submit, or ensure is submitted, to the 
        Secretary a cosmetic product listing, at such time and in such 
        manner as the Secretary may prescribe.
            ``(2) Cosmetic product listing.--The responsible person of 
        a cosmetic product that is marketed on the date of enactment of 
        the Modernization of Cosmetics Regulation Act of 2022 shall 
        submit to the Secretary a cosmetic product listing not later 
        than 1 year after the date of enactment of the Modernization of 
        Cosmetics Regulation Act of 2022, or for a cosmetic product 
        that is first marketed after the date of enactment of such Act, 
        within 120 days of marketing such product in interstate 
        commerce. Thereafter, any updates to such listing shall be made 
        annually, consistent with paragraphs (4) and (5).
            ``(3) Abbreviated renewal.--The Secretary shall provide for 
        an abbreviated process for the renewal of any cosmetic product 
        listing under this subsection with respect to which there has 
        been no change since the responsible person submitted the 
        previous listing.
            ``(4) Contents of listing.--
                    ``(A) In general.--Each such cosmetic product 
                listing shall include--
                            ``(i) the facility registration number of 
                        each facility where the cosmetic product is 
                        manufactured or processed;
                            ``(ii) the name and contact number of the 
                        responsible person and the name for the 
                        cosmetic product, as such name appears on the 
                        label;
                            ``(iii) the applicable cosmetic category or 
                        categories for the cosmetic product;
                            ``(iv) a list of ingredients in the 
                        cosmetic product, including any fragrances, 
                        flavors, or colors, with each ingredient 
                        identified by the name adopted in regulations 
                        promulgated by the Secretary, if any, or by the 
                        common or usual name of the ingredient; and
                            ``(v) the product listing number, if any 
                        previously assigned by the Secretary under 
                        subsection (d).
                    ``(B) Flexible listings.--A single listing 
                submission for a cosmetic product may include multiple 
                cosmetic products with identical formulations, or 
                formulations that differ only with respect to colors, 
                fragrances or flavors, or quantity of contents.
            ``(5) Updates to content.--A responsible person that is 
        required to submit a cosmetic product listing shall submit any 
        updates to such cosmetic product listing annually.
            ``(6) Submission.--A responsible person may submit product 
        listing information as part of a facility registration or 
        separately.
    ``(d) Facility Registration and Product Listing Numbers.--At the 
time of the initial registration of any facility under subsection 
(a)(1) or initial listing of any cosmetic product under (c)(1), the 
Secretary shall assign a facility registration number to the facility 
and a product listing number to each cosmetic product. The Secretary 
shall not make such product listing number publicly available.
    ``(e) Confidentiality.--Information submitted to the Secretary 
under this section that is confidential commercial or trade secret 
information shall be exempt from disclosure under section 552 of title 
5, United States Code, including all information submitted under 
subsection (b)(2)(D) or (c)(4)(A)(i).
    ``(f) Suspensions.--
            ``(1) Suspension of registration of a facility.--The 
        Secretary may suspend the registration of a facility if the 
        Secretary determines that a cosmetic product manufactured or 
        processed by a registered facility and distributed in the 
        United States has a reasonable probability of causing serious 
        adverse health consequences or death to humans and the 
        Secretary has a reasonable belief that other products 
        manufactured or processed by the facility may be similarly 
        affected because of a failure that cannot be isolated to a 
        product or products, or is sufficiently pervasive to raise 
        concerns about other products manufactured in the facility.
            ``(2) Notice of suspension.--Before suspending a facility 
        registration under this section, the Secretary shall provide--
                    ``(A) notice to the facility registrant of the 
                cosmetic product or other responsible person, as 
                appropriate, of the intent to suspend the facility 
                registration, which shall specify the basis of the 
                determination by the Secretary that the facility should 
                be suspended; and
                    ``(B) an opportunity, within 5 business days of the 
                notice provided under subparagraph (A), for the 
                responsible person to provide a plan for addressing the 
                reasons for possible suspension of the facility 
                registration.
            ``(3) Hearing on suspension.--The Secretary shall provide 
        the registrant subject to an order under paragraph (1) or (2) 
        with an opportunity for an informal hearing, to be held as soon 
        as possible but not later than 5 business days after the 
        issuance of the order, or such other time period agreed upon by 
        the Secretary and the registrant, on the actions required for 
        reinstatement of registration and why the registration that is 
        subject to the suspension should be reinstated. The Secretary 
        shall reinstate a registration if the Secretary determines, 
        based on evidence presented, that adequate grounds do not exist 
        to continue the suspension of the registration.
            ``(4) Post-hearing corrective action plan.--If, after 
        providing opportunity for an informal hearing under paragraph 
        (3), the Secretary determines that the suspension of 
        registration remains necessary, the Secretary shall require the 
        registrant to submit a corrective action plan to demonstrate 
        how the registrant plans to correct the conditions found by the 
        Secretary. The Secretary shall review such plan not later than 
        14 business days after the submission of the corrective action 
        plan or such other time period as determined by the Secretary, 
        in consultation with the registrant.
            ``(5) Vacating of order; reinstatement.--Upon a 
        determination by the Secretary that adequate grounds do not 
        exist to continue the suspension actions, the Secretary shall 
        promptly vacate the suspension and reinstate the registration 
        of the facility.
            ``(6) Effect of suspension.--If the registration of the 
        facility is suspended under this section, no person shall 
        introduce or deliver for introduction into commerce in the 
        United States cosmetic products from such facility.
            ``(7) No delegation.--The authority conferred by this 
        section to issue an order to suspend a registration or vacate 
        an order of suspension shall not be delegated to any officer or 
        employee other than the Commissioner.

``SEC. 608. SAFETY SUBSTANTIATION.

    ``(a) Substantiation of Safety.--A responsible person for a 
cosmetic product shall ensure, and maintain records supporting, that 
there is adequate substantiation of safety of such cosmetic product.
    ``(b) Coal-Tar Hair Dye.--Subsection (a) shall not apply to coal-
tar hair dye that otherwise complies with the requirements of section 
601(a). A responsible person for a coal-tar hair dye shall maintain 
records related to the safety of such product.
    ``(c) Definitions.--For purposes of this section:
            ``(1) Adequate substantiation of safety.--The term 
        `adequate substantiation of safety' means tests or studies, 
        research, analyses, or other evidence or information that is 
        considered, among experts qualified by scientific training and 
        experience to evaluate the safety of cosmetic products and 
        their ingredients, sufficient to support a reasonable certainty 
        that a cosmetic product is safe.
            ``(2) Safe.--The term `safe' means that the cosmetic 
        product, including any ingredient thereof, is not injurious to 
        users under the conditions of use prescribed in the labeling 
        thereof, or under such conditions of use as are customary or 
        usual. The Secretary shall not consider a cosmetic ingredient 
        or cosmetic product injurious to users solely because it can 
        cause minor and transient reactions or minor and transient skin 
        irritations in some users. In determining for purposes of this 
        section whether a cosmetic product is safe, the Secretary may 
        consider, as appropriate and available, the cumulative or other 
        relevant exposure to the cosmetic product, including any 
        ingredient thereof.

``SEC. 609. LABELING.

    ``(a) General Requirement.--Each cosmetic product shall bear a 
label that includes a domestic address, domestic phone number, or 
electronic contact information, which may include a website, through 
which the responsible person can receive adverse event reports with 
respect to such cosmetic product.
    ``(b) Fragrance Allergens.--The responsible person shall identify 
on the label of a cosmetic product each fragrance allergen included in 
such cosmetic product. Substances that are fragrance allergens for 
purposes of this subsection shall be determined by the Secretary by 
regulation. The Secretary shall issue a notice of proposed rulemaking 
promulgating the regulation implementing this requirement not later 
than 18 months after the date of enactment of the Modernization of 
Cosmetics Regulation Act of 2022, and not later than 180 days after the 
date on which the public comment period on the proposed rulemaking 
closes, shall issue a final rulemaking. In promulgating regulations 
implementing this subsection, the Secretary shall consider 
international, State, and local requirements for allergen disclosure, 
including the substance and format of requirements in the European 
Union, and may establish threshold levels of amounts of substances 
subject to disclosure pursuant to such regulations.
    ``(c) Cosmetic Products for Professional Use.--
            ``(1) Definition of professional.--For purposes of this 
        subsection, the term `professional' means an individual who is 
        licensed by an official State authority to practice in the 
        field of cosmetology, nail care, barbering, or esthetics.
            ``(2) Professional use labeling.--A cosmetic product 
        introduced into interstate commerce and intended to be used 
        only by a professional shall bear a label that--
                    ``(A) contains a clear and prominent statement that 
                the product shall be administered or used only by 
                licensed professionals; and
                    ``(B) is in conformity with the requirements of the 
                Secretary for cosmetics labeling under this Act and 
                section 4(a) of the Fair Packaging and Labeling Act.

``SEC. 610. RECORDS.

    ``(a) In General.--If the Secretary has a reasonable belief that a 
cosmetic product, including an ingredient in such cosmetic product, and 
any other cosmetic product that the Secretary reasonably believes is 
likely to be affected in a similar manner, is likely to be adulterated 
such that the use or exposure to such product presents a threat of 
serious adverse health consequences or death to humans, each 
responsible person and facility shall, at the request of an officer or 
employee duly designated by the Secretary, permit such officer or 
employee, upon presentation of appropriate credentials and a written 
notice to such person, at reasonable times and within reasonable limits 
and in a reasonable manner, to have access to and copy all records 
relating to such cosmetic product, and to any other cosmetic product 
that the Secretary reasonably believes is likely to be affected in a 
similar manner, that are needed to assist the Secretary in determining 
whether the cosmetic product is adulterated and presents a threat of 
serious adverse health consequences or death to humans. This subsection 
shall not be construed to extend to recipes or formulas for cosmetics, 
financial data, pricing data, personnel data (other than data as to 
qualification of technical and professional personnel performing 
functions subject to this Act), research data (other than safety 
substantiation data for cosmetic products and their ingredients), or 
sales data (other than shipment data regarding sales).
    ``(b) Protection of Sensitive Information.--The Secretary shall 
take appropriate measures to ensure that there are in effect effective 
procedures to prevent the unauthorized disclosure of any trade secret 
or confidential information that is obtained by the Secretary pursuant 
to this section.
    ``(c) Rule of Construction.--Nothing in this section shall be 
construed to limit the authority of the Secretary to inspect records or 
require establishment and maintenance of records under any other 
provision of this Act, including section 605 or 606.

``SEC. 611. MANDATORY RECALL AUTHORITY.

    ``(a) In General.--If the Secretary determines that there is a 
reasonable probability that a cosmetic is adulterated under section 601 
or misbranded under section 602 and the use of or exposure to such 
cosmetic will cause serious adverse health consequences or death, the 
Secretary shall provide the responsible person with an opportunity to 
voluntarily cease distribution and recall such article. If the 
responsible person refuses to or does not voluntarily cease 
distribution or recall such cosmetic within the time and manner 
prescribed by the Secretary (if so prescribed), the Secretary may, by 
order, require, as the Secretary deems necessary, such person to 
immediately cease distribution of such article.
    ``(b) Hearing.--The Secretary shall provide the responsible person 
who is subject to an order under subsection (a) with an opportunity for 
an informal hearing, to be held not later than 10 days after the date 
of issuance of the order, on whether adequate evidence exists to 
justify the order.
    ``(c) Order Resolution.--After an order is issued according to the 
process under subsections (a) and (b), the Secretary shall, except as 
provided in subsection (d)--
            ``(1) vacate the order, if the Secretary determines that 
        inadequate grounds exist to support the actions required by the 
        order;
            ``(2) continue the order ceasing distribution of the 
        cosmetic until a date specified in such order; or
            ``(3) amend the order to require a recall of the cosmetic, 
        including any requirements to notify appropriate persons, a 
        timetable for the recall to occur, and a schedule for updates 
        to be provided to the Secretary regarding such recall.
    ``(d) Action Following Order.--Any person who is subject to an 
order pursuant to paragraph (2) or (3) of subsection (c) shall 
immediately cease distribution of or recall, as applicable, the 
cosmetic and provide notification as required by such order.
    ``(e) Notice to Persons Affected.--If the Secretary determines 
necessary, the Secretary may require the person subject to an order 
pursuant to subsection (a) or an amended order pursuant to paragraph 
(2) or (3) of subsection (c) to provide either a notice of a recall 
order for, or an order to cease distribution of, such cosmetic, as 
applicable, under this section to appropriate persons, including 
persons who manufacture, distribute, import, or offer for sale such 
product that is the subject of an order and to the public.
    ``(f) Public Notification.--In conducting a recall under this 
section, the Secretary shall--
            ``(1) ensure that a press release is published regarding 
        the recall, and that alerts and public notices are issued, as 
        appropriate, in order to provide notification--
                    ``(A) of the recall to consumers and retailers to 
                whom such cosmetic was, or may have been, distributed; 
                and
                    ``(B) that includes, at a minimum--
                            ``(i) the name of the cosmetic subject to 
                        the recall;
                            ``(ii) a description of the risk associated 
                        with such article; and
                            ``(iii) to the extent practicable, 
                        information for consumers about similar 
                        cosmetics that are not affected by the recall; 
                        and
            ``(2) ensure publication, as appropriate, on the website of 
        the Food and Drug Administration of an image of the cosmetic 
        that is the subject of the press release described in paragraph 
        (1), if available.
    ``(g) No Delegation.--The authority conferred by this section to 
order a recall or vacate a recall order shall not be delegated to any 
officer or employee other than the Commissioner.
    ``(h) Effect.--Nothing in this section shall affect the authority 
of the Secretary to request or participate in a voluntary recall, or to 
issue an order to cease distribution or to recall under any other 
provision of this chapter.

``SEC. 612. SMALL BUSINESSES.

    ``(a) In General.--Responsible persons, and owners and operators of 
facilities, whose average gross annual sales in the United States of 
cosmetic products for the previous 3-year period is less than 
$1,000,000, adjusted for inflation, and who do not engage in the 
manufacturing or processing of the cosmetic products described in 
subsection (b), shall be considered small businesses and not subject to 
the requirements of section 606 or 607.
    ``(b) Requirements Applicable to All Manufacturers and Processors 
of Cosmetics.--The exemptions under subsection (a) shall not apply to 
any responsible person or facility engaged in the manufacturing or 
processing of any of the following products:
            ``(1) Cosmetic products that regularly come into contact 
        with mucus membrane of the eye under conditions of use that are 
        customary or usual.
            ``(2) Cosmetic products that are injected.
            ``(3) Cosmetic products that are intended for internal use.
            ``(4) Cosmetic products that are intended to alter 
        appearance for more than 24 hours under conditions of use that 
        are customary or usual and removal by the consumer is not part 
        of such conditions of use that are customary or usual.

``SEC. 613. EXEMPTION FOR CERTAIN PRODUCTS AND FACILITIES.

    ``(a) In General.--Notwithstanding any other provision of law, 
except as provided in subsection (b), a cosmetic product or facility 
that is also subject to the requirements of chapter V shall be exempt 
from the requirements of sections 605, 606, 607, 608, 609(a), 610, and 
611.
    ``(b) Exception.--A facility described in subsection (a) that also 
manufactures or processes cosmetic products that are not subject to the 
requirements of chapter V shall not be exempt from the requirements of 
sections 605, 606, 607, 608, 609(a), 610, and 611, with respect to such 
cosmetic products.

``SEC. 614. PREEMPTION.

    ``(a) In General.--No State or political subdivision of a State may 
establish or continue in effect any law, regulation, order, or other 
requirement for cosmetics that is different from or in addition to, or 
otherwise not identical with, any requirement applicable under this 
chapter with respect to registration and product listing, good 
manufacturing practice, recordkeeping, recalls, adverse event 
reporting, or safety substantiation.
    ``(b) Limitation.--Nothing in the amendments to this Act made by 
the Modernization of Cosmetics Regulation Act of 2022 shall be 
construed to preempt any State statute, public initiative, referendum, 
regulation, or other State action, except as expressly provided in 
subsection (a). Notwithstanding subsection (a), nothing in this section 
shall be construed to prevent any State from prohibiting the use or 
limiting the amount of an ingredient in a cosmetic product, or from 
continuing in effect a requirement of any State that is in effect at 
the time of enactment of the Modernization of Cosmetics Regulation Act 
of 2022 for the reporting to the State of an ingredient in an cosmetic 
product.
    ``(c) Savings.--Nothing in the amendments to this Act made by the 
Modernization of Cosmetics Regulation Act of 2022, nor any standard, 
rule, requirement, regulation, or adverse event report shall be 
construed to modify, preempt, or displace any action for damages or the 
liability of any person under the law of any State, whether statutory 
or based in common law.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed to amend, expand, or limit the provisions under section 
752.''.

SEC. 803. ENFORCEMENT AND CONFORMING AMENDMENTS.

    (a) In General.--
            (1) Prohibited acts.--Section 301 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331) is amended--
                    (A) by adding at the end the following:
    ``(fff) The failure to register or submit listing information in 
accordance with section 607.
    ``(ggg) The refusal or failure to follow an order under section 
611.''; and
                    (B) in paragraph (d), by striking ``or 564'' and 
                inserting ``, 564, or 607''.
            (2) Adulterated products.--Section 601 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 361) is amended by adding at 
        the end the following:
    ``(f) If it has been manufactured or processed under conditions 
that do not meet good manufacturing practice regulations, as prescribed 
by the Food and Drug Administration in accordance with section 606.
    ``(g) If it is a cosmetic product, and the cosmetic product, 
including each ingredient in the cosmetic product, does not have 
adequate substantiation for safety, as defined in section 608(c).''.
            (3) Misbranded cosmetics.--Section 602(b) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 362(b)) is amended--
                    (A) by striking ``and (2)'' and inserting ``(2)''; 
                and
                    (B) by inserting after ``numerical count'' the 
                following: ``; and (3) the information required under 
                section 609''.
            (4) Adverse event reporting.--The Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
                    (A) in section 301(e) (21 U.S.C. 331(e))--
                            (i) by striking ``564, 703'' and inserting 
                        ``564, 605, 703''; and
                            (ii) by striking ``564, 760'' and inserting 
                        ``564, 605, 611, 760'';
                    (B) in section 301(ii) (21 U.S.C. 331(ii))--
                            (i) by striking ``760 or 761) or'' and 
                        inserting ``604, 760, or 761) or''; and
                            (ii) by inserting ``or required under 
                        section 605(a)'' after ``report (as defined 
                        under section 760 or 761'';
                    (C) in section 801(a) (21 U.S.C. 381(a))--
                            (i) by striking ``under section 760 or 
                        761'' and inserting ``under section 605, 760, 
                        or 761'';
                            (ii) by striking ``defined in such section 
                        760 or 761'' and inserting ``defined in section 
                        604, 760, or 761'';
                            (iii) by striking ``of such section 760 or 
                        761'' and inserting ``of such section 605, 760, 
                        or 761''; and
                            (iv) by striking ``described in such 
                        section 760 or 761'' and inserting ``described 
                        in such section 605, 760, or 761''; and
                    (D) in section 801(b) (21 U.S.C. 381(b))--
                            (i) by striking ``requirements of sections 
                        760 or 761,'' and inserting ``requirements of 
                        section 605, 760, or 761'';
                            (ii) by striking ``as defined in section 
                        760 or 761'' and inserting ``as defined in 
                        section 604, 760, or 761''; and
                            (iii) by striking ``with section 760 or 
                        761'' and inserting ``with section 605, 760, or 
                        761''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
take effect on the date that is 1 year after the date of enactment of 
this Act.

SEC. 804. RECORDS INSPECTION.

    Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 374(a)(1)) is amended by inserting after the second sentence the 
following: ``In the case of a facility (as defined in section 604) that 
manufactures or processes cosmetic products, the inspection shall 
extend to all records and other information described in sections 605, 
606, and 610, when the standard for records inspection under such 
section applies.''.

SEC. 805. TALC-CONTAINING COSMETICS.

    The Secretary of Health and Human Services--
            (1) not later than one year after the date of enactment of 
        this Act, shall promulgate proposed regulations to establish 
        and require standardized testing methods for detecting and 
        identifying asbestos in talc-containing cosmetic products; and
            (2) not later than 180 days after the date on which the 
        public comment period on the proposed regulations closes, shall 
        issue such final regulations.

SEC. 806. PFAS IN COSMETICS.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall assess the use 
of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products 
and the scientific evidence regarding the safety of such use in 
cosmetic products, including any risks associated with such use. In 
conducting such assessment, the Secretary may, as appropriate, consult 
with the National Center for Toxicological Research.
    (b) Report.--Not later than 2 years after enactment of this Act, 
the Secretary shall publish on the website of the Food and Drug 
Administration a report summarizing the results of the assessment 
conducted under subsection (a).

SEC. 807. FUNDING.

    There is authorized to be appropriated $14,200,000 for fiscal year 
2023, $25,960,000 for fiscal year 2024, and $41,890,000 for each of the 
fiscal years 2025 through 2027, for purposes of conducting the 
activities under this subtitle (including the amendments made by this 
subtitle) and hiring personnel required to carry out this subtitle 
(including the amendments made by this subtitle).

                    Subtitle B--Dietary Supplements

SEC. 811. REGULATION OF DIETARY SUPPLEMENTS.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding after section 403C of 
such Act (21 U.S.C. 343-3) the following:

``SEC. 403D. DIETARY SUPPLEMENT LISTING REQUIREMENT.

    ``(a) In General.--Beginning on the date specified in subsection 
(b)(4), each dietary supplement shall be listed with the Secretary in 
accordance with this section. Each such listing shall include, with 
respect to the dietary supplement, the information specified in 
subsection (b)(1).
    ``(b) Requirements.--
            ``(1) In general.--The manufacturer, packer, or distributor 
        of a dietary supplement whose name (pursuant to section 
        403(e)(1)) appears on the label of a dietary supplement 
        marketed in the United States (referred to in this section as 
        the `responsible person'), or if the responsible person is a 
        foreign entity, the United States agent of such person, shall 
        submit to the Secretary in accordance with this section the 
        following information for a dietary supplement that is 
        marketed:
                    ``(A) Any name of the dietary supplement and the 
                statement of identity, including brand name and 
                specified flavors, if applicable.
                    ``(B) The name and address of the responsible 
                person and the name and email address of the owner, 
                operator, or agent in charge of the responsible person.
                    ``(C) The name, domestic address, and email address 
                for the United States agent, if the responsible person 
                is a foreign entity.
                    ``(D) The business name and mailing address of all 
                locations at which the responsible person manufactures, 
                packages, labels, or holds the dietary supplement.
                    ``(E) A list of all ingredients in each such 
                dietary supplement required under sections 101.4 and 
                101.36, title 21, Code of Federal Regulations (or any 
                successor regulations) to appear on the label of a 
                dietary supplement, including--
                            ``(i) where applicable, ingredients in a 
                        proprietary blend as described in section 
                        101.36(c) of title 21, Code of Federal 
                        Regulations (or any successor regulations);
                            ``(ii) the amount per serving of each 
                        listed dietary ingredient;
                            ``(iii) if required by section 101.36 of 
                        title 21, Code of Federal Regulations (or any 
                        successor regulations), the percent of the 
                        daily value of each listed dietary ingredient; 
                        and
                            ``(iv) the amount per serving of dietary 
                        ingredients within a proprietary blend.
                    ``(F) The number of servings per container for each 
                container size of the identical formulation.
                    ``(G) The directions for use.
                    ``(H) Warnings, notice, and safe handling 
                statements, as required by section 101.17 of title 21, 
                Code of Federal Regulations (or any successor 
                regulations).
                    ``(I) Allergen statements for major food allergens 
                (pursuant to sections 403(w) and 403(x)).
                    ``(J) The form of the dietary supplement (such as 
                tablets, capsules).
                    ``(K) Any health claims or structure or function 
                claims.
                    ``(L) The dietary supplement product listing number 
                for the product provided by the Secretary in accordance 
                with subsection (c) for that product.
            ``(2) Format.--The Secretary may require that a listing 
        submitted under paragraph (1) be submitted in an electronic 
        format. Upon receipt of a complete listing under paragraph (1), 
        the Secretary shall promptly notify the responsible person of 
        the receipt of such listing.
            ``(3) Listing content.--A single listing submission for a 
        dietary supplement under paragraph (1) may include multiple 
        dietary supplements with identical formulations, or 
        formulations that differ only with respect to color, additives, 
        or flavorings, whether offered in a single package size or in 
        multiple package sizes.
            ``(4) Timing.--
                    ``(A) In general.--
                            ``(i) Dietary supplements on the market.--
                        In the case of a dietary supplement that is 
                        being offered in interstate commerce on or 
                        before January 1, 2024, a listing for each such 
                        dietary supplement introduced or delivered for 
                        introduction into interstate commerce shall be 
                        submitted by the responsible person to the 
                        Secretary under this subsection not later than 
                        18 months after the date of enactment of the 
                        Food and Drug Administration Safety and 
                        Landmark Advancements Act of 2022.
                            ``(ii) New dietary supplements.--In the 
                        case of a dietary supplement that is not being 
                        offered in interstate commerce on or before 
                        January 1, 2024, a listing for each such 
                        dietary supplement introduced or delivered for 
                        introduction into interstate commerce that has 
                        not been included in any listing previously 
                        submitted by the responsible person to the 
                        Secretary under this subsection shall be 
                        submitted to the Secretary at the time of 
                        introduction into interstate commerce.
                    ``(B) Discontinued dietary supplements.--The 
                responsible person shall notify the Secretary within 
                one year of the date of discontinuance of a dietary 
                supplement required to be listed with the Secretary 
                under paragraph (1) for which the responsible person 
                has discontinued commercial marketing.
                    ``(C) Changes to existing listings.--The 
                responsible person shall submit to the Secretary a 
                change or modification to listing information submitted 
                under paragraph (1) included on the label for a dietary 
                supplement at the time the dietary supplement with the 
                change or modification is introduced into interstate 
                commerce.
            ``(5) Additional information.--The responsible person shall 
        provide upon request from the Secretary, within 10 calendar 
        days of such request, the full business name and physical and 
        mailing address from which the responsible person receives a 
        dietary ingredient or combination of dietary ingredients that 
        the responsible person uses in the manufacture of the dietary 
        supplement or, if applicable, from which the responsible person 
        receives the dietary supplement.
    ``(c) Product Listing Number and Dietary Supplement Electronic 
Database.--
            ``(1) Dietary supplement product listing number.--The 
        Secretary shall provide each dietary supplement listed in 
        accordance with subsection (b)(1) a dietary supplement product 
        listing number, which may apply to multiple dietary supplements 
        with identical formulations, or formulations that differ only 
        with respect to color, additives, or flavorings, including 
        dietary supplements offered in a single package size or in 
        multiple package sizes. The Secretary shall provide a process 
        for a responsible person to reserve dietary supplement listing 
        numbers in advance of listing under subsection (b)(1).
            ``(2) Electronic database.--Not later than 2 years after 
        the date of enactment of the Food and Drug Administration 
        Safety and Landmark Advancements Act of 2022, the Secretary 
        shall establish and maintain an electronic database that is 
        publicly available and contains information submitted under 
        subsection (b)(1) (except for the information submitted under 
        subparagraphs (D) and (E)(iv) of such subsection). The 
        Secretary shall make such information maintained in the 
        electronic database publicly searchable, including by dietary 
        supplement product listing number, and by any field of 
        information or combination of fields of information provided 
        under subsection (b)(1).
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed--
            ``(1) to limit the authority of the Secretary to inspect or 
        copy records or to require the establishment and maintenance of 
        records under any other provision of this Act; or
            ``(2) to authorize the disclosure of trade secret or 
        confidential commercial information subject to section 
        552(b)(4) of title 5, United States Code, as prohibited under 
        section 301(j) of this Act or section 1905 of title 18, United 
        States Code, including information provided to the Secretary 
        under subsection (b)(1)(D) or (b)(1)(E)(iv).
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated $7,498,080 for fiscal year 2023, and $6,300,000 for each 
of fiscal years 2024 through 2027, for purposes of conducting the 
activities under this section and hiring personnel required to carry 
out this section.''.
    (b) Guidance.--Not later than 18 months after the date of enactment 
of this Act, the Secretary of Health and Human Services shall publish 
final guidance related to the draft guidance titled, ``Dietary 
Supplements: New Dietary Ingredient Notifications and Related Issues; 
Revised Draft Guidance for Industry; Availability'' (81 Fed. Reg. 
53486; August 12, 2016), consistent with section 403D of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection (a).
    (c) Inspections for Certain Dietary Supplements.--The Secretary of 
Health and Human Services shall direct resources to inspections of 
facilities, suppliers, and dietary supplement types that present a high 
risk to public health (as identified by the Secretary).
    (d) Misbranding.--Section 403 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following:
    ``(z) If it is a dietary supplement for which a responsible person 
is required under section 403D to file a listing, file a change to an 
existing listing, or provide additional information to the Secretary, 
and such person has failed to comply with any such requirements under 
section 403D with respect to such dietary supplement.''.
    (e) New Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), as amended by section 803(a), is further 
amended by adding at the end the following:
    ``(hhh) The introduction or delivery for introduction into 
interstate commerce of any product marketed as a dietary supplement 
that does not meet the definition of a dietary supplement under section 
201(ff).
    ``(iii) The introduction or delivery for introduction into 
interstate commerce of a dietary supplement that has been prepared, 
packed, or held using the assistance of, or at the direction of, a 
person debarred under section 306.''.

                  Subtitle C--In Vitro Clinical Tests

SEC. 821. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This subtitle may be cited as the ``Food and Drug 
Administration Safety and Landmark Advancements Act of 2022'' or the 
``VALID Act of 2022''.
    (b) Table of Contents.--The table of contents of this subtitle is 
as follows:

                 subchapter c--in vitro clinical tests

Sec. 821. Short title; table of contents.
Sec. 822. Definitions.
Sec. 823. Regulation of in vitro clinical tests.
                ``subchapter j--in vitro clinical tests

        ``SUBCHAPTER J. In Vitro Clinical Tests
        ``Sec. 587. Definitions.
        ``Sec. 587A. Regulation of in vitro clinical tests.
        ``Sec. 587B. Premarket review.
        ``Sec. 587C. Exemptions.
        ``Sec. 587D. Technology certification.
        ``Sec. 587E. Mitigating measures.
        ``Sec. 587F. Regulatory pathway designation.
        ``Sec. 587G. Grandfathered in vitro clinical tests.
        ``Sec. 587H. Advisory committees.
        ``Sec. 587I. Breakthrough in vitro clinical tests.
        ``Sec. 587J. Registration and listing.
        ``Sec. 587K. Test design and quality requirements.
        ``Sec. 587L. Labeling requirements.
        ``Sec. 587M. Adverse event reporting.
        ``Sec. 587N. Corrections and removals.
        ``Sec. 587O. Restricted in vitro clinical tests.
        ``Sec. 587P. Appeals.
        ``Sec. 587Q. Accredited persons.
        ``Sec. 587R. Recognized standards.
        ``Sec. 587S. Investigational use.
        ``Sec. 587T. Collaborative communities for in vitro clinical 
                            tests.
        ``Sec. 587U. Comprehensive test information system.
        ``Sec. 587V. Preemption.
        ``Sec. 587W. Adulteration.
        ``Sec. 587X. Misbranding.
        ``Sec. 587Y. Postmarket surveillance.
        ``Sec. 587Z. Electronic format for submissions.
        ``Sec. 587AA. Postmarket remedies.
        ``Sec. 587BB. Applicability.
        ``Sec. 587CC. Judicial review.
Sec. 824. Enforcement and other provisions.
Sec. 825. Transition.
Sec. 826. Emergency use authorization.
Sec. 827. Antimicrobial susceptibility tests.
Sec. 828. Combination products.
Sec. 829. Resources.

SEC. 822. DEFINITIONS.

    (a) In General.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended--
            (1) by adding at the end the following:
    ``(ss)(1) The term `in vitro clinical test' means an article 
specified in subparagraph (2) that is intended by its developer (as 
defined in section 587) to be used in the collection, preparation, 
analysis, or in vitro clinical examination of specimens taken or 
derived from the human body for the purpose of--
            ``(A) identifying or diagnosing a disease or condition;
            ``(B) providing information for diagnosing, screening, 
        measuring, detecting, predicting, prognosing, analyzing, or 
        monitoring a disease or condition, including by making a 
        determination of an individual's state of health; or
            ``(C) selecting, monitoring, or informing therapy or 
        treatment for a disease or condition.
    ``(2) An article specified in this subparagraph is--
            ``(A) a test kit;
            ``(B) a test system;
            ``(C) a test protocol or laboratory test protocol;
            ``(D) an instrument (as defined in section 587(11));
            ``(E) a specimen receptacle (as defined in section 
        587(17));
            ``(F) software, excluding software that is excluded by 
        section 520(o) from the definition of a device under section 
        201(h), that--
                    ``(i) is a component or part of another in vitro 
                clinical test or analyzes, processes, or interprets a 
                signal or pattern from another in vitro clinical test; 
                and
                    ``(ii) does not analyze, process, or interpret a 
                signal, pattern, or medical image from a device; and
            ``(G) subject to subparagraph (3), a component or part of a 
        test, a test protocol, an instrument, an article, or software 
        described in any of clauses (A) through (D) of such 
        subparagraph, whether alone or in combination, including 
        reagents, calibrators, and controls.
    ``(3) Notwithstanding subparagraph (2)(G), an article intended to 
be used as a component or part of an in vitro clinical test described 
in subparagraph (1) is excluded from the definition in subparagraph (1) 
if the article consists of any of the following:
            ``(A) Blood, blood components, or human cells or tissues, 
        from the time of acquisition, donation, or recovery of such 
        article, including determination of donor eligibility, as 
        applicable, until such time as the article is released as a 
        component or part of an in vitro clinical test by the 
        establishment that collected such article.
            ``(B) An article used for invasive sampling, a needle, or a 
        lancet, except to the extent such article, needle, or lancet is 
        an integral component of an article for holding, storing, or 
        transporting a specimen.
            ``(C) General purpose laboratory equipment, including 
        certain pre-analytical equipment, as determined by the 
        Secretary.
            ``(D) An article used solely for personal protection during 
        the administering, conducting, or otherwise performing of test 
        activities.'';
            (2) by adding at the end of section 201(g) the following:
    ``(3) The term `drug' does not include an in vitro clinical 
test.''; and
            (3) in section 201(h)(1), in the matter following clause 
        (C), by striking ``section 520(o)'' and inserting ``section 
        520(o) or an in vitro clinical test''.
    (b) Exclusion From Definition of Biological Product.--Section 
351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)) is 
amended--
            (1) by striking ``(1) The term `biological product' means'' 
        and inserting ``(1)(A) The term `biological product' means''; 
        and
            (2) by adding at the end the following:
            ``(B) The term `biological product' does not include an in 
        vitro clinical test as defined in section 201(ss) of the 
        Federal Food, Drug, and Cosmetic Act.''.
    (c) In Vitro Clinical Test Definition.--In this Act, the term ``in 
vitro clinical test'' has the meaning given such term in section 
201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a).

SEC. 823. REGULATION OF IN VITRO CLINICAL TESTS.

    The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is 
amended--
            (1) by amending the heading of chapter V to read as 
        follows: ``DRUGS, DEVICES, AND IN VITRO CLINICAL TESTS''; and
            (2) by adding at the end of chapter V the following:

                ``Subchapter J--In Vitro Clinical Tests

``SEC. 587. DEFINITIONS.

    ``In this subchapter:
            ``(1) Analytical validity.--The term `analytical validity' 
        means, with respect to an in vitro clinical test, the ability 
        of the in vitro clinical test, to identify, measure, detect, 
        calculate, or analyze (or assist in such identification, 
        measurement, detection, calculation, or analysis of) one or 
        more analytes, biomarkers, substances, or other targets 
        intended to be identified, measured, detected, calculated, or 
        analyzed by the test.
            ``(2) Applicable standard.--The term `applicable standard', 
        with respect to an in vitro clinical test, means a reasonable 
        assurance of analytical and clinical validity for its 
        indications for use, and a reasonable assurance of safety for 
        individuals who come into contact with such in vitro clinical 
        test, except that such term, with respect to specimen 
        receptacles and test instruments, means a reasonable assurance 
        of analytical validity for its indications for use and safety 
        for individuals who come into contact with such specimen 
        receptacle or test instrument.
            ``(3) Clinical use.--The term `clinical use' means the 
        operation, application, or functioning of an in vitro clinical 
        test for the purpose for which it is intended as described in 
        section 201(ss)(1).
            ``(4) Clinical validity.--The term `clinical validity' 
        means the ability of an in vitro clinical test to achieve the 
        purpose for which it is intended as described in section 
        201(ss)(1).
            ``(5) Component or part.--The term `component or part' 
        means a substance, piece, part, raw material, software, 
        firmware, labeling, or assembly, including reagents, that is 
        intended by the developer to be included as an aspect of an in 
        vitro clinical test described in section 201(ss)(1).
            ``(6) Develop.--The term `develop', with respect to an in 
        vitro clinical test, means--
                    ``(A) designing, validating, producing, 
                manufacturing, remanufacturing, labeling, advertising, 
                propagating, or assembling an in vitro clinical test;
                    ``(B) modifying an in vitro clinical test, 
                including modifying the indications for use of the in 
                vitro clinical test, or modifying an article to be in 
                an in vitro clinical test; or
                    ``(C) establishing a test system as described or 
                included in a test protocol developed by another entity 
                unless such test protocol is listed as an in vitro 
                clinical test in the comprehensive test information 
                system established under section 587T by that other 
                entity.
            ``(7) Developer.--The term `developer' means a person who 
        engages in development as described in paragraph (6), except 
        the term does not include a laboratory that--
                    ``(A) is certified by the Secretary under section 
                353 of the Public Health Service Act; and
                    ``(B) assembles for use solely within that 
                laboratory, without otherwise developing, an in vitro 
                clinical test appropriately listed in the comprehensive 
                test information system established under section 587T 
                by a different person.
            ``(8) First-of-a-kind.--The term `first-of-a-kind', with 
        respect to an in vitro clinical test, means that such test has 
        any novel combination of the elements specified in paragraph 
        (10) that differs from in vitro clinical tests that already are 
        legally available in the United States, except for such tests 
        offered under section 587C(a)(3), 587C(a)(4), or 587G.
            ``(9) High-risk.--The term `high-risk', with respect to an 
        in vitro clinical test or category of in vitro clinical tests, 
        means that an undetected inaccurate result from such test, or 
        such category of tests, when used as intended--
                    ``(A)(i) has the substantial likelihood to result 
                in serious or irreversible harm or death to a patient 
                or patients, or would otherwise cause serious harm to 
                the public health; or
                    ``(ii) is reasonably likely to result in the 
                absence, significant delay, or discontinuation of life-
                supporting or life-sustaining medical treatment; and
                    ``(B) sufficient mitigating measures are not able 
                to be established and applied to prevent, mitigate, or 
                detect the inaccurate result, or otherwise mitigate the 
                risk resulting from an undetected inaccurate result 
                described in subparagraph (A), such that the test would 
                be moderate-risk or low-risk.
            ``(10) Indications for use.--The term `indications for 
        use', with respect to an in vitro clinical test, means the 
        following elements:
                    ``(A) Substance or substances measured by the in 
                vitro clinical test, such as an analyte, protein, or 
                pathogen.
                    ``(B) Test method.
                    ``(C) Test purpose or purposes, as described in 
                section 201(ss)(1).
                    ``(D) Diseases or conditions for which the in vitro 
                clinical test is intended for use, including intended 
                patient populations.
                    ``(E) Context of use, such as in a clinical 
                laboratory, in a health care facility, prescription 
                home use, over-the-counter use, or direct-to-consumer 
                testing.
            ``(11) Instrument.--
                    ``(A) In general.--The term `instrument' means an 
                analytical or pre-analytical instrument.
                    ``(B) Analytic instrument.--The term `analytic 
                instrument' means an in vitro clinical test that is 
                hardware intended by the hardware developer to be used 
                with one or more other in vitro clinical tests to 
                generate a clinical test result, including software 
                used to effectuate the functionality of the hardware.
                    ``(C) Pre-analytical instrument.--The term `pre-
                analytical instrument' means an in vitro clinical test 
                that is hardware intended by the hardware's developer 
                solely to generate an output for use exclusively with 
                one or more analytical instruments as defined in 
                subparagraph (B) and which does not itself generate a 
                clinical test result. Such term may include software 
                used to effectuate the hardware's functionality.
            ``(12) Instrument family.--The term `instrument family' 
        means more than one instrument developed by the same developer 
        for which the developer demonstrates and documents, with 
        respect to all such instruments, that all--
                    ``(A) have the same basic architecture, design, and 
                performance characteristics;
                    ``(B) have the same indications for use and 
                capabilities;
                    ``(C) share the same measurement principles, 
                detection methods, and reaction conditions, as 
                applicable; and
                    ``(D) produce the same or similar analytical 
                results from samples of the same specimen type or 
                types.
            ``(13) Low-risk.--The term `low-risk', with respect to an 
        in vitro clinical test or category of in vitro clinical tests, 
        means that an undetected inaccurate result from such in vitro 
        clinical test, or such category of in vitro clinical tests, 
        when used as intended--
                    ``(A) would cause only minimal or immediately 
                reversible harm, and would lead to only a remote risk 
                of adverse patient impact or adverse public health 
                impact; or
                    ``(B) sufficient mitigating measures are able to be 
                established and applied such that the in vitro clinical 
                test meets the standard described in subparagraph (A).
            ``(14) Mitigating measures.--The term `mitigating 
        measures'--
                    ``(A) means controls, standards, and other 
                requirements that the Secretary determines, based on 
                evidence, are necessary--
                            ``(i) for an in vitro clinical test, or a 
                        category of in vitro clinical tests, to meet 
                        the applicable standard; or
                            ``(ii) to mitigate the risk of harm ensuing 
                        from an undetected inaccurate result or 
                        misinterpretation of a result; and
                    ``(B) may include, as required by the Secretary, as 
                appropriate, applicable requirements regarding 
                labeling, conformance to performance standards and 
                consensus standards, performance testing, submission of 
                clinical data, advertising, website posting of 
                information, clinical studies, postmarket surveillance, 
                user comprehension studies, training, and confirmatory 
                laboratory, clinical findings, or testing.
            ``(15) Moderate-risk.--The term `moderate-risk', with 
        respect to an in vitro clinical test or category of in vitro 
        clinical tests, means that, when used as intended, such test or 
        category of tests--
                    ``(A) meets the criteria specified in paragraph (9) 
                for classification as high-risk, but one or more 
                mitigating measures are able to be established and 
                applied to prevent or detect an inaccurate result or 
                otherwise sufficiently mitigate such risk, but are not 
                sufficient such that the test is low-risk; or
                    ``(B)(i) an undetected inaccurate result for the 
                intended use of the test would cause only non-life-
                threatening harm, harm that is medically reversible, or 
                the absence, significant delay, or discontinuation of 
                necessary treatment that is not life-supporting or 
                life-sustaining; and
                    ``(ii) mitigating measures are not able to be 
                established and applied to prevent or detect such 
                inaccurate result or otherwise sufficiently mitigate 
                the risk of such inaccurate result such that the test 
                would be low-risk.
            ``(16) Specimen receptacle.--The term `specimen receptacle' 
        means an in vitro clinical test intended for taking, 
        collecting, holding, storing, or transporting of specimens 
        derived from the human body or for in vitro examination for 
        purposes described in subparagraph (A) or (B) of section 
        201(ss)(1).
            ``(17) Technology.--The term `technology'--
                    ``(A) means a set of control mechanisms, energy 
                sources, or operating principles--
                            ``(i) that do not differ significantly 
                        among multiple in vitro clinical tests; and
                            ``(ii) for which design and development 
                        (including analytical and clinical validation, 
                        as applicable) of the tests would be addressed 
                        in a similar manner or through similar 
                        procedures; and
                    ``(B) may include clot detection, colorimetric 
                (non-immunoassay), electrochemical (non-immunoassay), 
                enzymatic (non-immunoassay), flow cytometry, 
                fluorometry (non-immunoassay), immunoassay, mass 
                spectrometry or chromatography, microbial culture, next 
                generation sequencing, nephlometric or turbidimetric 
                (non-immunoassay), singleplex or multiplex non-NGS 
                nucleic acid analysis, slide-based technology, 
                spectroscopy, and any other technology, as the 
                Secretary determines appropriate.
            ``(18) Test.--The term `test', unless otherwise provided, 
        means an in vitro clinical test.
            ``(19) Valid scientific evidence.--The term `valid 
        scientific evidence'--
                    ``(A) means, with respect to an in vitro clinical 
                test, evidence that--
                            ``(i) has been generated and evaluated by 
                        persons qualified by training or experience to 
                        do so, using procedures generally accepted by 
                        other persons so qualified; and
                            ``(ii) forms an appropriate basis for 
                        concluding by qualified experts whether the 
                        applicable standard has been met by the in 
                        vitro clinical test; and
                    ``(B) may include evidence described in 
                subparagraph (A) consisting of--
                            ``(i) peer-reviewed literature;
                            ``(ii) clinical guidelines;
                            ``(iii) reports of significant human 
                        experience with an in vitro clinical test;
                            ``(iv) bench studies;
                            ``(v) case studies or histories;
                            ``(vi) clinical data;
                            ``(vii) consensus standards;
                            ``(viii) reference standards;
                            ``(ix) data registries;
                            ``(x) postmarket data;
                            ``(xi) real world data;
                            ``(xii) clinical trials; and
                            ``(xiii) data collected in countries other 
                        than the United States if such data are 
                        demonstrated to be appropriate for the purpose 
                        of making a regulatory determination under this 
                        subchapter.

``SEC. 587A. REGULATION OF IN VITRO CLINICAL TESTS.

    ``(a) In General.--No person shall introduce or deliver for 
introduction into interstate commerce any in vitro clinical test, 
unless--
            ``(1) an approval of an application filed pursuant to 
        subsection (a) or (b) of section 587B is effective with respect 
        to such in vitro clinical test;
            ``(2) a technology certification order is in effect under 
        section 587D; or
            ``(3) the test is exempt under sections 587C or 587G from 
        the requirements of section 587B.
    ``(b) Transfer or Sale of In Vitro Clinical Tests.--
            ``(1) Transfer and assumption of regulatory obligations.--
        If ownership of an in vitro clinical test is sold or 
        transferred in such manner that the developer transfers the 
        regulatory submissions and obligations applicable under this 
        subchapter with respect to the test, the transferee or 
        purchaser becomes the developer of the test and shall have all 
        regulatory obligations applicable to such a test under this 
        subchapter. The transferee or purchaser shall update the 
        registration and listing information under section 587J for the 
        in vitro clinical test.
            ``(2) Transfer or sale of premarket approval.--
                    ``(A) Notice required.--If a developer of an in 
                vitro clinical test transfers or sells the approval of 
                the in vitro clinical test, the transferor or seller 
                shall--
                            ``(i) submit a notice of the transfer or 
                        sale to the Secretary and update the 
                        registration and listing information under 
                        section 587J for the in vitro clinical test; 
                        and
                            ``(ii) submit a supplement to an 
                        application if required under section 587B(h).
                    ``(B) Effective date of approval transfer.--A 
                transfer or sale described in subparagraph (A) shall 
                become effective upon completion of a transfer or sale 
                described in paragraph (1) or the approval of a 
                supplement to an application under section 587B(h) if 
                required, whichever is later. The transferee or 
                purchaser shall update the registration and listing 
                information under section 587J for the in vitro 
                clinical test within 15 calendar days of the effective 
                date of the transfer or sale.
            ``(3) Transfer or sale of technology certification.--
                    ``(A) Requirements for transfer or sale of 
                technology certification.--An unexpired technology 
                certification can be transferred or sold if the 
                transferee or purchaser--
                            ``(i) is an eligible person under section 
                        587D(a)(2); and
                            ``(ii) maintains, upon such transfer or 
                        sale, test design and quality requirements, 
                        processes and procedures under the scope of 
                        technology certification, and scope of the 
                        technology certification identified in the 
                        applicable technology certification order.
                    ``(B) Notice required.--If a developer of an in 
                vitro clinical test transfers or sells a technology 
                certification order that has not expired, the 
                transferor or seller shall submit a notice of the 
                transfer or sale to the Secretary and shall update the 
                registration and listing information under section 587J 
                for all in vitro clinical tests covered by the 
                technology certification.
                    ``(C) Effective date of technology certification 
                transfer.--The transfer of a technology certification 
                shall become effective upon completion of a transfer or 
                sale described in subparagraph (A). The transferee or 
                purchaser shall update the registration and listing 
                information under section 587J for the in vitro 
                clinical test within 30 calendar days of the effective 
                date of the technology certification transfer.
                    ``(D) New technology certification required.--If 
                the requirements of subparagraph (A)(ii) are not met, 
                the technology certification order may not be 
                transferred and the transferee or purchaser of an in 
                vitro clinical test is required to submit an 
                application for technology certification and obtain a 
                technology certification order prior to offering the 
                test for clinical use.
    ``(c) Regulations.--The Secretary may issue regulations to 
implement this subchapter.

``SEC. 587B. PREMARKET REVIEW.

    ``(a) Application.--
            ``(1) Filing.--Any developer may file with the Secretary an 
        application for premarket approval of an in vitro clinical test 
        under this subsection.
            ``(2) Transparency and predictability.--If a developer 
        files a premarket application under this section and provides 
        any additional documentation required under section 587D, the 
        in vitro clinical test that is the subject of the premarket 
        application may be utilized as the representative in vitro 
        clinical test reviewed by the Secretary to support a technology 
        certification order under section 587D.
            ``(3) Application content.--An application submitted under 
        paragraph (1) shall include the following, in such format as 
        the Secretary specifies:
                    ``(A) General information regarding the in vitro 
                clinical test, including--
                            ``(i) the name and address of the 
                        applicant;
                            ``(ii) the table of contents for the 
                        application and the identification of the 
                        information the applicant claims as trade 
                        secret or confidential commercial or financial 
                        information;
                            ``(iii) a description of the test's design 
                        and intended use, including the indications for 
                        use; and
                            ``(iv) a description regarding test 
                        function and performance characteristics.
                    ``(B) A summary of the data and information in the 
                application for the in vitro clinical test, including--
                            ``(i) a brief description of the foreign 
                        and domestic marketing history of the test, if 
                        any, including a list of all countries in which 
                        the test has been marketed and a list of all 
                        countries in which the test has been withdrawn 
                        from marketing for any reason related to the 
                        ability of the in vitro clinical test to meet 
                        the applicable standard, if known by the 
                        applicant;
                            ``(ii) a description of benefit and risk 
                        considerations related to the in vitro clinical 
                        test, including a description of any applicable 
                        adverse effects of the test on health and how 
                        such adverse effects have been, or will be, 
                        mitigated;
                            ``(iii) a risk assessment of the test; and
                            ``(iv) a description of how the data and 
                        information in the application constitute valid 
                        scientific evidence and support a showing that 
                        the test meets the applicable standard under 
                        section 587(2).
                    ``(C) The signature of the developer filing the 
                premarket application or an authorized representative.
                    ``(D) A bibliography of applicable published 
                reports relied upon by the applicant and a description 
                of any studies conducted, including any unpublished 
                studies related to such test, that are known or that 
                should reasonably be known to the applicant, and a 
                description of data and information relevant to the 
                evaluation of whether the test meets the applicable 
                standard.
                    ``(E) Applicable information regarding the methods 
                used in, and the facilities or controls used for, the 
                development of the test to demonstrate compliance with 
                the applicable quality requirements under section 587K.
                    ``(F) Information demonstrating compliance with any 
                relevant and applicable--
                            ``(i) mitigating measures under section 
                        587E; and
                            ``(ii) standards established or recognized 
                        under section 514 prior to the date of 
                        enactment of the VALID Act of 2022, or, after 
                        applicable standards are established or 
                        recognized under section 587Q, with such 
                        standards.
                    ``(G) Valid scientific evidence to support that the 
                test meets the applicable standard, which shall 
                include--
                            ``(i) summary information for all 
                        supporting validation studies performed, 
                        including a description of the objective of the 
                        study, a description of the experimental design 
                        of the study, a description of any limitations 
                        of the study, a brief description of how the 
                        data were collected and analyzed, a brief 
                        description of the results of each study, and 
                        conclusions drawn from each study;
                            ``(ii) new raw data for each study, which 
                        may include, as applicable, tabulations of data 
                        and results as required under section 
                        814.20(b)(6)(ii) of title 21, Code of Federal 
                        Regulations (or any successor regulations); and
                            ``(iii) for nonclinical laboratory studies 
                        involving the test, if applicable, a statement 
                        that studies were conducted in compliance with 
                        applicable good laboratory practices.
                    ``(H) To the extent the application seeks 
                authorization to make modifications to the test within 
                the scope of the approval that are not otherwise 
                permitted without premarket review under this 
                subchapter, a proposed change protocol that includes 
                validation procedures and acceptance criteria for 
                anticipated modifications that could be made to the 
                test within the scope of the approval.
                    ``(I) Proposed labeling, in accordance with the 
                requirements of section 587L.
                    ``(J) Such other data or information as the 
                Secretary may require in accordance with the least 
                burdensome requirements under section 587AA(c).
            ``(4) Guidance for premarket and abbreviated premarket 
        applications.--In accordance with section 825 of the VALID Act 
        of 2022, the Secretary shall issue draft guidance detailing the 
        information to be provided in a premarket application and 
        abbreviated premarket application under this section. The 
        Secretary shall issue final guidance detailing the information 
        to be provided in a premarket application and abbreviated 
        premarket application under this section not later than 1 year 
        prior to the effective date of such Act.
            ``(5) Refuse to file a premarket or abbreviated premarket 
        application.--The Secretary may refuse to file an application 
        under this section only for lack of completeness or legibility 
        of the application. If, after receipt of an application under 
        this section, the Secretary refuses to file such an 
        application, the Secretary shall provide to the developer, 
        within 60 calendar days of receipt of such application, a 
        description of the reason for such refusal, and identify the 
        information required, if any, to allow for the filing of the 
        application.
            ``(6) Substantive review for deficient application.--If, 
        after receipt of an application under this section, the 
        Secretary determines that any portion of such application is 
        materially deficient, the Secretary shall provide to the 
        applicant a description of such material deficiencies and the 
        information required to resolve such deficiencies.
            ``(7) Inspections.--With respect to an application under 
        paragraph (1), preapproval inspections authorized by an 
        employee of the Food and Drug Administration or a person 
        accredited under section 587Q need not occur unless requested 
        by the Secretary.
    ``(b) Abbreviated Premarket Review.--
            ``(1) In general.--Any developer may file with the 
        Secretary an application for abbreviated premarket approval 
        for--
                    ``(A) an instrument;
                    ``(B) a specimen receptacle;
                    ``(C) an in vitro clinical test that is moderate-
                risk; or
                    ``(D) an in vitro clinical test that is determined 
                by the Secretary to be eligible for abbreviated 
                premarket review under section 587F(a)(1)(B).
            ``(2) Application content.--An application under paragraph 
        (1) shall include--
                    ``(A) the information required for applications 
                submitted under subsection (a)(2), except that 
                applications under paragraph (1) need not include--
                            ``(i) quality requirement information; or
                            ``(ii) raw data, unless explicitly 
                        requested by the Secretary; and
                    ``(B) data, as applicable, to support software 
                validation, electromagnetic compatibility, and 
                electrical safety, and information demonstrating 
                compliance with maintaining quality systems 
                documentation.
            ``(3) Safety information.--The developer of an in vitro 
        clinical test specimen receptacle reviewed under this 
        subsection shall maintain safety information for such specimen 
        receptacle.
            ``(4) Inspections.--With respect to an application under 
        paragraph (1), preapproval inspections authorized by an 
        employee of the Food and Drug Administration or a person 
        accredited under section 587Q need not occur unless requested 
        by the Secretary.
    ``(c) Instruments and Instrument Families.--
            ``(1) In general.--A developer of an instrument family 
        shall file with the Secretary an application for premarket 
        approval of one version of an instrument under this subsection. 
        Any modified versions of the instrument that generate a new 
        instrument within the same instrument family shall be exempt 
        from premarket review requirements of this section, provided 
        that the developer of such instrument or instrument family--
                    ``(A) maintains documentation that the new 
                instrument is part of the instrument family, as defined 
                in section 587;
                    ``(B) performs, documents, and maintains a risk 
                assessment (as described in subsection (a)(2)(B)(iv)) 
                of the new instrument compared to the instrument 
                approved under subsection (b) and no new risks are 
                identified;
                    ``(C) performs, documents, and maintains validation 
                and verification activities for the new instrument;
                    ``(D) makes such documentation available to the 
                Secretary upon request; and
                    ``(E) registers and lists the new instrument in 
                accordance with section 587J.
            ``(2) Test kits and test protocols.--A test kit or test 
        protocol that is approved under this section for use on an 
        approved instrument or an instrument exempt from premarket 
        review, including an instrument within an instrument family 
        under this section, a submission under this section shall not 
        be required for such test kit or test protocol in order for it 
        to be used on a new instrument within its instrument family, 
        provided that--
                    ``(A) use of the test kit or test protocol with the 
                new instrument does not--
                            ``(i) change the claims for the test kit or 
                        test protocol, except as applicable, claims 
                        regarding an instrument or instruments that can 
                        be used with such test kit or test protocol;
                            ``(ii) adversely affect performance of the 
                        test kit or test protocol; or
                            ``(iii) cause the test kit or test protocol 
                        to no longer conform with performance standards 
                        required under section 587R or comply with any 
                        applicable mitigating measures under section 
                        587E, conditions of approval under subsection 
                        (e)(2)(B), or restrictions under section 587O;
                    ``(B) the test developer does not identify any new 
                risks for the test kit or test protocol when using the 
                new instrument;
                    ``(C) the test developer validates the use of the 
                new instrument with the test kit or test protocol and 
                maintains validation documentation;
                    ``(D) the test kit or test protocol is not intended 
                for use--
                            ``(i) at the point of care setting or in 
                        settings for which a certificate of waiver is 
                        in effect under section 353 of the Public 
                        Health Service Act;
                            ``(ii) without a prescription;
                            ``(iii) at home; or
                            ``(iv) in testing donors, donations, and 
                        recipients of blood, blood components, human 
                        cells, tissues, cellular-based products, or 
                        tissue-based products;
                    ``(E) the test developer makes the documentation 
                described under subparagraph (C) available to the 
                Secretary upon request; and
                    ``(F) the test developer updates the listing 
                information for the test kit or test protocol, as 
                applicable.
    ``(d) Amendments to an Application.--An applicant shall amend an 
application submitted under subsection (a), (b), or (f) if the 
applicant becomes aware of information that could reasonably affect an 
evaluation under subsection (e) of whether the approval standard has 
been met.
    ``(e) Action on an Application for Premarket Approval.--
            ``(1) Review.--
                    ``(A) Disposition.--As promptly as possible, but 
                not later than 90 calendar days after an application 
                under subsection (a) is accepted for submission (unless 
                the Secretary determines that an extension is necessary 
                to review one or more major amendments to the 
                application), or not later than 60 calendar days after 
                an application under subsection (b) is accepted for 
                submission or a supplemental application under 
                subsection (f) is accepted for submission, the 
                Secretary, after considering any applicable report and 
                recommendations pursuant to advisory committees under 
                section 587H, shall issue an order approving the 
                application, unless the Secretary finds that the 
                grounds for approval in paragraph (2) are not met.
                    ``(B) Reliance on proposed labeling.--In 
                determining whether to approve or deny an application 
                under paragraph (1), the Secretary shall rely on the 
                indications for use included in the proposed labeling, 
                provided that such labeling is not false or misleading 
                based on a fair evaluation of all material facts.
            ``(2) Approval of an application.--
                    ``(A) In general.--The Secretary shall approve an 
                application submitted under subsection (a) or (b) with 
                respect to an in vitro clinical test if the Secretary 
                finds that the applicable standard is met, and--
                            ``(i) the applicant is in compliance with 
                        applicable quality requirements in section 
                        587K;
                            ``(ii) the application does not contain a 
                        false statement or misrepresentation of 
                        material fact;
                            ``(iii) based on a fair evaluation of all 
                        material facts, the proposed labeling is 
                        truthful and non-misleading and complies with 
                        the requirements of section 587L;
                            ``(iv) the applicant permits, if requested, 
                        authorized employees of the Food and Drug 
                        Administration and persons accredited under 
                        section 587Q an opportunity to inspect pursuant 
                        to section 704;
                            ``(v) the test conforms with any applicable 
                        performance standards required under section 
                        587R and any applicable mitigating measures 
                        under section 587E;
                            ``(vi) all nonclinical laboratory studies 
                        and clinical investigations involving human 
                        subjects that are described in the application 
                        were conducted in a manner that meets the 
                        applicable requirements of this subchapter; and
                            ``(vii) other data and information the 
                        Secretary may require under subsection 
                        (a)(2)(K) support approval.
                    ``(B) Conditions of approval.--An order approving 
                an application pursuant to this section may require 
                reasonable conditions of approval for the in vitro 
                clinical test, which may include conformance with 
                applicable mitigating measures under section 587E, 
                restrictions under section 587O, and performance 
                standards under section 587R.
                    ``(C) Publication.--The Secretary shall publish an 
                order for each application approved pursuant to this 
                paragraph on the public website of the Food and Drug 
                Administration and make publicly available a summary of 
                the data used to approve such application, except to 
                the extent the Secretary determines that such order--
                            ``(i) contains commercially confidential or 
                        trade secret information; or
                            ``(ii) if published, would present a risk 
                        to national security.
            ``(3) Review of denials.--An applicant whose application 
        submitted under this section has been denied approval under 
        this subsection may, by petition filed not more than 60 
        calendar days after the date on which the applicant receives 
        notice of such denial, obtain review of the denial in 
        accordance with section 587P.
    ``(f) Supplements to an Approved Application.--
            ``(1) Risk analysis.--Prior to implementing any 
        modification to an in vitro clinical test, the holder of the 
        application approved under subsection (a) or (b) for such test 
        shall perform risk analyses in accordance with this subsection, 
        unless such modification is included in the change protocol 
        submitted by the applicant and approved under this section or 
        exempt under section 587C.
            ``(2) Supplement requirement.--
                    ``(A) In general.--If the holder of an application 
                of an approved in vitro clinical test makes a 
                modification to such in vitro clinical test, except as 
                provided in subparagraph (C), or otherwise specified by 
                the Secretary, the holder of the application approved 
                under subsection (e) for an in vitro clinical test 
                shall submit a supplemental application to the 
                Secretary. The holder of the application may not 
                implement such modification to the in vitro clinical 
                test until such supplemental application is approved. 
                The information required in a supplemental application 
                is limited to what is needed to support the change.
                    ``(B) Adjustments to change protocol.--The holder 
                of an approved application may submit under this 
                paragraph a supplemental application to modify the 
                change protocol of the test at any time after the 
                application is submitted under subsection (a) or (b).
                    ``(C) Exceptions.--Notwithstanding subparagraphs 
                (A) and (B), and so long as the holder of an approved 
                application submitted under subsection (a) or (b) for 
                an in vitro clinical test does not add a manufacturing 
                site, or change activities at an existing manufacturing 
                site, with respect to the test, the holder of an 
                approved application may, without submission of a 
                supplemental application, implement the following 
                modifications to the test:
                            ``(i) Modifications in accordance with an 
                        approved change protocol under subsection 
                        (a)(3)(H).
                            ``(ii) Modifications that are exempt under 
                        section 587C(b).
                            ``(iii) Labeling changes that are 
                        appropriate to address a safety concern, except 
                        such labeling changes that include any of the 
                        following, remain subject to subparagraph (A):
                                    ``(I) A change to the indications 
                                for use of the test.
                                    ``(II) A change to the performance 
                                claims made with respect to the test.
                                    ``(III) A change that adversely 
                                affects performance of the test.
                    ``(D) Reporting for certain modifications made 
                pursuant to a change protocol.--The holder of an 
                application approved under subsection (e), with an 
                approved change protocol under subsection (a)(2)(H) for 
                such in vitro clinical test shall--
                            ``(i) report any modification to such test 
                        made pursuant to such change protocol approved 
                        under subsection (a)(2)(H) in a submission 
                        under section 587J(c)(2)(B); and
                            ``(ii) include in such report--
                                    ``(I) a description of the 
                                modification;
                                    ``(II) the rationale for 
                                implementing such modification; and
                                    ``(III) as applicable, a summary of 
                                the evidence supporting that the test, 
                                as modified, meets the applicable 
                                standard, complies with performance 
                                standards required under section 587Q, 
                                and complies with any mitigating 
                                measures established under section 587E 
                                and any restrictions under section 
                                587O.
                    ``(E) Reporting for certain safety related labeling 
                changes.--The holder of the application for an in vitro 
                clinical test approved under subsection (a) or (b) 
                pursuant to subsection (e) shall--
                            ``(i) report to the Secretary any 
                        modification to the test described in 
                        subparagraph (C)(iii) not more than 30 days 
                        after the date on which the test, with the 
                        modifications, is introduced into interstate 
                        commerce; and
                            ``(ii) include in the report--
                                    ``(I) a description of the change 
                                or changes;
                                    ``(II) the rationale for 
                                implementing such change or changes; 
                                and
                                    ``(III) a description of how the 
                                change or changes were evaluated.
            ``(3) Contents of supplement.--Unless otherwise specified 
        by the Secretary, a supplement under this subsection shall 
        include--
                    ``(A) for modifications other than manufacturing 
                site changes requiring a supplement--
                            ``(i) a description of the modification;
                            ``(ii) data relevant to the modification to 
                        demonstrate that the applicable standard is 
                        met, not to exceed data requirements for the 
                        original submission;
                            ``(iii) acceptance criteria; and
                            ``(iv) any revised labeling; and
                    ``(B) for manufacturing site changes--
                            ``(i) the information listed in 
                        subparagraph (A); and
                            ``(ii) information regarding the methods 
                        used in, or the facilities or controls used 
                        for, the development of the test to demonstrate 
                        compliance with the applicable quality 
                        requirements under section 587K.
            ``(4) Additional data.--The Secretary may require, when 
        necessary, data to evaluate a modification to an in vitro 
        clinical test that is in addition to the data otherwise 
        required under the preceding paragraphs if the data request is 
        in accordance with the least burdensome requirements under 
        section 587AA(c).
            ``(5) Conditions of approval.--In an order approving a 
        supplement under this subsection, the Secretary may require 
        conditions of approval for the in vitro clinical test, 
        including compliance with restrictions under section 587O and 
        conformance to performance standards under section 587R.
            ``(6) Approval.--The Secretary shall approve a supplement 
        under this subsection if--
                    ``(A) the data demonstrate that the modified in 
                vitro clinical test meets the applicable standard; and
                    ``(B) the holder of the application approved under 
                subsection (e) for the test has demonstrated compliance 
                with applicable quality and inspection requirements, as 
                applicable and appropriate.
            ``(7) Publication.--The Secretary shall publish on the 
        public website of the Food and Drug Administration notice of 
        any order approving a supplement under this subsection, except 
        that such publication shall exclude--
                    ``(A) commercial confidential or trade secret 
                information; and
                    ``(B) any other information that the Secretary 
                determines to relate to national security or 
                countermeasures or to be restricted from disclosure 
                pursuant to another provision of law.
            ``(8) Review of denial.--An applicant whose supplement 
        under this subsection has been denied approval may, by petition 
        filed on or before the 60th calendar day after the date upon 
        which the applicant receives notice of such denial, obtain 
        review of the denial in accordance with section 587P.
    ``(g) Withdrawal and Temporary Suspension of Approval.--
            ``(1) Order withdrawing approval.--
                    ``(A) In general.--The Secretary may, after 
                providing due notice and an opportunity for an informal 
                hearing to the holder of an approved application for an 
                in vitro clinical test under this section, issue an 
                order withdrawing approval of the application if the 
                Secretary finds that--
                            ``(i) the grounds for approval under 
                        subsection (e) are no longer met;
                            ``(ii) there is a reasonable likelihood 
                        that the test would cause death or serious 
                        adverse health consequences, including by 
                        causing the absence, significant delay, or 
                        discontinuation of life-saving or life 
                        sustaining medical treatment;
                            ``(iii) the holder of the approved 
                        application--
                                    ``(I) has failed to, or repeatedly 
                                or deliberately failed to, maintain 
                                records to make reports, as required 
                                under section 587M;
                                    ``(II) has refused to permit access 
                                to, or copying or verification of such 
                                records, as required under section 704;
                                    ``(III) has not complied with the 
                                requirements of section 587K; or
                                    ``(IV) has not complied with any 
                                mitigating measure required under 
                                section 587E or restriction under 
                                section 587O; or
                            ``(iv) the labeling of such in vitro 
                        clinical test, based on a fair evaluation of 
                        all material facts, is false or misleading in 
                        any particular and was not corrected within a 
                        reasonable time after receipt of written notice 
                        from the Secretary of such fact.
                    ``(B) Content.--An order under subparagraph (A) 
                withdrawing approval of an application shall state each 
                ground for withdrawal and shall notify the holder of 
                such application 60 calendar days prior to issuing such 
                order.
                    ``(C) Publication.--The Secretary shall publish any 
                order under subparagraph (A) on the public website of 
                the Food and Drug Administration, except that such 
                publication shall exclude--
                            ``(i) commercial confidential or trade 
                        secret information; and
                            ``(ii) any other information that the 
                        Secretary determines, if published, would 
                        present a risk to national security.
            ``(2) Order of temporary suspension.--If, after providing 
        due notice and an opportunity for an informal hearing to the 
        holder of an approved application for an in vitro clinical test 
        under this section, the Secretary determines, based on 
        scientific evidence, that there is a reasonable likelihood that 
        the in vitro clinical test would cause death or serious adverse 
        health consequences, such as by causing the absence, 
        significant delay, or discontinuation of life-saving or life-
        sustaining medical treatment, the Secretary shall, by order, 
        temporarily suspend the approval of the application. If the 
        Secretary issues such an order, the Secretary shall proceed 
        expeditiously under paragraph (1) to withdraw approval of such 
        application.
            ``(3) Appeal withdrawing approval and orders of temporary 
        suspensions.--An order of withdrawal or an order of temporary 
        suspension may be appealed under 587P.

``SEC. 587C. EXEMPTIONS.

    ``(a) In General.--The following in vitro clinical tests are exempt 
from premarket review under section 587B, and may be lawfully marketed 
subject to other applicable requirements of this Act:
            ``(1) Tests exempt from section 510(k).--
                    ``(A) Exemption.--An in vitro clinical test is 
                exempt from premarket review under section 587B and may 
                be lawfully marketed subject to the other applicable 
                requirements of this Act, if the developer of the in 
                vitro clinical test--
                            ``(i) maintains documentation demonstrating 
                        that the test meets and continues to meet the 
                        criteria set forth in subparagraph (B); and
                            ``(ii) makes such documentation available 
                        to the Secretary upon request.
                    ``(B) Criteria for exemption.--An in vitro clinical 
                test is exempt as specified in subparagraph (A) if such 
                test--
                            ``(i)(I) was offered for clinical use prior 
                        to the date of enactment of the VALID Act of 
                        2022;
                            ``(II) immediately prior to such date of 
                        enactment was exempt pursuant to subsection (l) 
                        or (m)(2) of section 510 from the requirements 
                        for submission of a report under section 
                        510(k); or
                            ``(III)(aa) was not offered for clinical 
                        use prior to such date of enactment;
                            ``(bb) is not an instrument; and
                            ``(cc) falls within a category of tests 
                        that was exempt from the requirements for 
                        submission of a report under section 510(k) as 
                        of such date of enactment (including class II 
                        devices and excluding class I devices described 
                        in section 510(l));
                            ``(ii) meets the applicable standard as 
                        described in section 587(2);
                            ``(iii) is not offered with labeling and 
                        advertising that is false or misleading; and
                            ``(iv) is not likely to cause or contribute 
                        to serious adverse health consequences.
                    ``(C) Effect on special controls.--For any in vitro 
                clinical test, or category of in vitro clinical tests, 
                that is exempt from premarket review based on the 
                criteria in subparagraph (B), any special control that 
                applied to a device within a predecessor category 
                immediately prior to the date of enactment of the VALID 
                Act of 2022 shall be deemed a mitigating measure 
                applicable under section 587E to an in vitro clinical 
                test within the successor category, except to the 
                extent such mitigating measure is withdrawn or changed 
                in accordance with section 587E.
                    ``(D) Near-patient testing.--Not later than 1 year 
                after the date of enactment of the VALID Act of 2022, 
                the Secretary shall issue draft guidance indicating 
                categories of tests that shall be exempt from premarket 
                review under section 587B when offered for near-patient 
                testing (point of care), which were not exempt from 
                submission of a report under section 510(k) pursuant to 
                subsection (l) or (m)(2) of section 510 and regulations 
                imposing limitations on exemption for in vitro devices 
                intended for near-patient testing (point of care).
            ``(2) Low-risk tests.--
                    ``(A) Exemption.--An in vitro clinical test is 
                exempt from premarket review under section 587B and may 
                be lawfully marketed subject to the other applicable 
                requirements of this Act, including section 587J(b)(6), 
                if such test meets the definition of low-risk under 
                section 587 and if the developer of the test--
                            ``(i) maintains documentation demonstrating 
                        that the in vitro clinical test meets and 
                        continues to meet the criteria set forth in 
                        paragraph (2); and
                            ``(ii) makes such documentation available 
                        to the Secretary upon request.
                    ``(B) Criteria for exemption.--An in vitro clinical 
                test is exempt as specified in subparagraph (A) if--
                            ``(i) the in vitro clinical test meets the 
                        applicable standard as described in 587(2);
                            ``(ii) the labeling and advertising are not 
                        false or misleading;
                            ``(iii) the in vitro clinical test is not 
                        likely to cause or contribute to serious 
                        adverse health consequences; and
                            ``(iv) the in vitro clinical test is listed 
                        pursuant to section 587J or falls within a 
                        category of tests listed as described in 
                        subparagraph (C).
                    ``(C) List of low-risk tests.--
                            ``(i) In general.--The Secretary shall 
                        maintain, and make publicly available on the 
                        website of the Food and Drug Administration, a 
                        list of in vitro clinical tests, and categories 
                        of in vitro clinical tests, that are low-risk 
                        in vitro clinical tests for purposes of the 
                        exemption under this paragraph.
                            ``(ii) Inclusion.--The list under clause 
                        (i) shall consist of--
                                    ``(I) all in vitro clinical tests 
                                and categories of in vitro clinical 
                                tests that are exempt from premarket 
                                review pursuant to subsection (d)(1) or 
                                (d)(3); and
                                    ``(II) all in vitro clinical tests 
                                and categories of in vitro clinical 
                                tests that are designated by the 
                                Secretary pursuant to subparagraph (C) 
                                as low-risk for purposes of this 
                                paragraph.
                    ``(D) Designation of tests and categories.--Without 
                regard to subchapter II of chapter 5 of title 5, United 
                States Code, the Secretary may designate, in addition 
                to the tests and categories described in subparagraph 
                (C)(i), additional in vitro clinical tests, and 
                categories of in vitro clinical tests, as low-risk in 
                vitro clinical tests for purposes of the exemption 
                under this paragraph. The Secretary may make such a 
                designation on the Secretary's own initiative or in 
                response to a request by a developer pursuant to 
                subsection (a) or (b) of section 587F. In making such a 
                designation for a test or category of tests, the 
                Secretary shall consider--
                            ``(i) whether the test, or category of 
                        tests, is low-risk;
                            ``(ii) the existence of and ability to 
                        develop mitigating measures sufficient for such 
                        test category to meet the low-risk standard; 
                        and
                            ``(iii) such other factors as the Secretary 
                        determines to be appropriate for the protection 
                        of the public health.
            ``(3) Humanitarian test exemption.--
                    ``(A) In general.--An in vitro clinical test that 
                meets the criteria under subparagraph (B) is exempt 
                from premarket review under section 587B and may be 
                lawfully offered subject to the other applicable 
                requirements of this subchapter, if the developer of 
                the test--
                            ``(i) maintains documentation (which may 
                        include literature citations in specialized 
                        medical journals, textbooks, specialized 
                        medical society proceedings, and governmental 
                        statistics publications, or, if no such studies 
                        or literature citations exist, credible 
                        conclusions from appropriate research or 
                        surveys) demonstrating that such test meets and 
                        continues to meet the criteria described in 
                        this subsection; and
                            ``(ii) makes such documentation available 
                        to the Secretary upon request.
                    ``(B) Criteria for exemption.--An in vitro clinical 
                test is exempt as described in subparagraph (A) if--
                            ``(i) the in vitro clinical test is 
                        intended by the developer for use for a 
                        diagnostic purpose for a disease or condition 
                        that affects not more than 10,000 (or such 
                        other higher number determined by the 
                        Secretary) individuals in the United States per 
                        year; and
                            ``(ii) the in vitro clinical test meets the 
                        applicable standard described in section 
                        587(2);
                            ``(iii) the labeling and advertising for 
                        the in vitro clinical test are not false or 
                        misleading;
                            ``(iv) the in vitro clinical test is not 
                        likely to cause or contribute to serious health 
                        consequences; and
                            ``(v) the in vitro clinical test is not 
                        intended for screening.
                    ``(C) Exception for certain tests.--An in vitro 
                clinical test intended to inform the use of a specific 
                individual or specific type of biological product, 
                drug, or device shall be eligible for an exemption from 
                premarket review under this subsection only if, the 
                developer submits a request under subsection (m) for 
                informal feedback and the Secretary determines that 
                such in vitro clinical test is eligible for an 
                exemption from premarket review under this subsection.
            ``(4) Custom tests and low-volume tests.--An in vitro 
        clinical test is exempt from premarket review under section 
        587B, quality requirements under section 587K, and listing 
        requirements under section 587J, and may be lawfully marketed 
        subject to the other applicable requirements of this Act, if--
                    ``(A) such in vitro clinical test--
                            ``(i) is a test protocol performed for not 
                        more than 5 patients per year (or such other 
                        higher number determined by the Secretary), in 
                        a laboratory certified by the Secretary under 
                        section 353 of the Public Health Service Act 
                        that--
                                    ``(I) meets the requirements to 
                                perform tests of high-complexity in 
                                which the test protocol was developed; 
                                or
                                    ``(II) meets the requirements to 
                                perform tests of high-complexity within 
                                the same corporate organization and 
                                having common ownership by the same 
                                parent corporation as the laboratory in 
                                which such test protocol was developed; 
                                or
                            ``(ii) is an in vitro clinical test 
                        developed or modified to diagnose a unique 
                        pathology or physical condition of a specific 
                        patient or patients, upon order of a health 
                        professional or other specially qualified 
                        person designated under regulations, for which 
                        no other in vitro clinical test is commercially 
                        available in the United States, and is--
                                    ``(I) not intended for use with 
                                respect to more than 5 (or such other 
                                higher number determined by the 
                                Secretary) other patients; and
                                    ``(II) after the development of 
                                such test, not included in any test 
                                menu or template test report or other 
                                promotional materials, and is not 
                                otherwise advertised; and
                    ``(B) the developer of the in vitro clinical test--
                            ``(i) maintains documentation demonstrating 
                        that such test meets the applicable criteria 
                        described in subparagraph (A);
                            ``(ii) makes such documentation, such as a 
                        prescription order requesting the custom test 
                        for an individual patient, available to the 
                        Secretary upon request; and
                            ``(iii) informs the Secretary, on an annual 
                        basis, in a manner prescribed by the Secretary 
                        by guidance, that such test was offered.
            ``(5) In vitro clinical tests under a technology 
        certification order.--An in vitro clinical test that is within 
        the scope of a technology certification order, as described in 
        section 587D(a), is exempt from premarket review under section 
        587B.''.
            ``(6) Modified tests.--
                    ``(A) In general.--An in vitro clinical test that 
                is modified is exempt from premarket review under 
                section 587B if--
                            ``(i)(I) the modification is made by--
                                    ``(aa) the developer that obtained 
                                premarket approval for the unmodified 
                                version of the test under section 587B; 
                                or
                                    ``(bb) a clinical laboratory 
                                certified by the Secretary under 
                                section 353 of the Public Health 
                                Service Act that meets the requirements 
                                for performing high complexity testing, 
                                to a lawfully offered in vitro clinical 
                                test, including another developer's 
                                lawfully offered in vitro clinical 
                                test, excluding investigational in 
                                vitro clinical tests offered under 
                                section 587S, and the modified test is 
                                performed--
                                            ``(AA) in the same clinical 
                                        laboratory in which it was 
                                        developed for which a 
                                        certification is still in 
                                        effect under section 353 that 
                                        meets the requirements to 
                                        perform tests of high 
                                        complexity;
                                            ``(BB) by another clinical 
                                        laboratory for which a 
                                        certificate is in effect under 
                                        section 353 that meets the 
                                        requirements to perform tests 
                                        of high complexity, is within 
                                        the same corporate 
                                        organization, and has common 
                                        ownership by the same parent 
                                        corporation as the laboratory 
                                        in which the test was 
                                        developed; or
                                            ``(CC) by a clinical 
                                        laboratory for which a 
                                        certificate is in effect under 
                                        section 353 that meets the 
                                        requirements to perform tests 
                                        of high complexity and is 
                                        within a public health 
                                        laboratory network coordinated 
                                        [or managed] by the Centers for 
                                        Disease Control and Prevention, 
                                        if the test was developed by 
                                        the Centers for Disease Control 
                                        and Prevention or another 
                                        laboratory within such public 
                                        health laboratory network; or
                            ``(II) the modification does not--
                                    ``(aa) constitute a significant 
                                change to the indications for use;
                                    ``(bb) cause the test to no longer 
                                comply with applicable mitigating 
                                measures under section 587E or 
                                restrictions under section 587O;
                                    ``(cc) significantly change 
                                performance claims or significantly and 
                                adversely change performance, unless 
                                provided for under an approved change 
                                protocol under section 587(a)(2)(H); or
                                    ``(dd) constitute an adverse change 
                                in the safety of the in vitro clinical 
                                test for individuals who come in 
                                contact with the in vitro clinical 
                                test;
                            ``(ii) the test meets the applicable 
                        standard as described in section 587(2);
                            ``(iii) the labeling and advertising are 
                        not false or misleading; and
                            ``(iv) the test is not likely to cause or 
                        contribute to serious adverse health 
                        consequences.
                    ``(B) Certain modifications.--A modification to 
                extend specimen stability is exempt from premarket 
                review under section 587B if the modified test meets 
                the requirements in clauses (iii) through (v) of 
                subparagraph (A).
                    ``(C) Modifications under a change protocol.--
                Notwithstanding subparagraph (A), a modification made 
                under a change protocol pursuant to subsection 
                (a)(2)(H) of section 587B is exempt from review under 
                such section.
                    ``(D) Documentation.--A person who modifies an in 
                vitro clinical test in a manner that is a modification 
                described in subparagraph (A) shall--
                            ``(i) document the modification that was 
                        made and the basis for determining that the 
                        modification, considering the changes 
                        individually and collectively, is a type of 
                        modification described in subparagraph (A), 
                        (B), or (C); and
                            ``(ii) provide such documentation to the 
                        Secretary upon request or inspection.
                    ``(E) Guidance.--Not later than 30 months after the 
                date of enactment of the VALID Act of 2022, the 
                Secretary shall issue guidance regarding the in vitro 
                clinical tests that are modified and exempt from 
                premarket review under section 587B pursuant to this 
                paragraph.
    ``(b) Manual Tests.--
            ``(1) Exemption.--An in vitro clinical test is exempt from 
        all requirements of this subchapter if the output of such in 
        vitro clinical test is the result of direct, manual 
        observation, without the use of automated instrumentation or 
        software for intermediate or final interpretation, by a 
        qualified laboratory professional, and such in vitro clinical 
        test--
                    ``(A) is designed, developed, and used within a 
                single clinical laboratory for which a certificate is 
                in effect under section 353 of the Public Health 
                Service Act that meets the requirements under section 
                353 for performing high-complexity testing;
                    ``(B) is not a specimen receptacle, instrument, or 
                an in vitro clinical test that includes an instrument 
                or specimen receptacle that is not approved under or 
                exempt from section 587B;
                    ``(C) is not a high-risk test, or is a high-risk 
                test that the Secretary has determined meets at least 
                one condition in paragraph (2) and is otherwise 
                appropriate for this exemption; and
                    ``(D) is not intended for testing donors, 
                donations, or recipients of blood, blood components, 
                human cells, tissues, cellular-based products, or 
                tissue-based products.
            ``(2) High-risk test limitation or condition.--A high-risk 
        test may be exempt under paragraph (1) from the requirements of 
        this subchapter only if--
                    ``(A) no component or part of such test, including 
                any reagent, is introduced into interstate commerce 
                under the exemption under paragraph (5), and any 
                article for taking or deriving specimens from the human 
                body used in conjunction with the test remains subject 
                to the requirements of this subchapter; or
                    ``(B) the test has been developed in accordance 
                with the applicable test design and quality 
                requirements under section 587J.
    ``(c) Public Health Surveillance Activities.--
            ``(1) In general.--The provisions of this subchapter shall 
        not apply to a test intended by the developer to be used solely 
        for public health surveillance activities.
            ``(2) Exclusion.--An in vitro clinical test used for public 
        health surveillance activities is not excluded from the 
        provisions of this subchapter pursuant to this subsection if 
        such test is intended for use in making clinical decisions for 
        individual patients. 
    ``(d) General Laboratory Equipment.--Any instrument that does not 
produce an analytical result, and that functions as a component of pre-
analytical procedures related to in vitro clinical tests, is not 
subject to the requirements of this subchapter, provided that the 
instrument is operating in a clinical laboratory that is certified 
under section 353 of the Public Health Service Act.
    ``(e) Components and Parts.--
            ``(1) In general.--Subject to paragraph (2), a component or 
        part described in section 201(ss)(2)(E) is--
                    ``(A) exempt from the requirements of this 
                subchapter if it is intended for further development as 
                described in paragraph (3); or
                    ``(B) subject to the requirements of this 
                subchapter and regulated based on its risk when used as 
                intended by the developer, notwithstanding its 
                subsequent use by a developer as a component, part, or 
                raw material of another in vitro clinical test.
            ``(2) Inapplicability to other tests.--Notwithstanding 
        paragraph (1), an in vitro clinical test that is described in 
        section 201(ss)(1)(B) and that uses a component or part 
        described in such subparagraph shall be subject to the 
        requirements of this subchapter, unless the test is otherwise 
        exempt under this section.
            ``(3) Further development.--A component, part, or raw 
        material (as described in paragraph (1)) is intended for 
        further development (for purposes of such paragraph) if--
                    ``(A) it is intended solely for use in the 
                development of another in vitro clinical test; and
                    ``(B) in the case of such a test that is introduced 
                or delivered for introduction into interstate commerce 
                after the date of enactment of the VALID Act of 2022, 
                the labeling of such test bears the following 
                statement: `This product is intended solely for further 
                development of an in vitro clinical test and is exempt 
                from FDA regulation. This product must be evaluated by 
                the in vitro clinical test developer if it is used with 
                or in the development of an in vitro clinical test.'.
    ``(f) General Exemption Authority.--The Secretary may, by order 
published in the Federal Register following notice and an opportunity 
for comment, exempt a class of persons from any section under this 
subchapter upon a finding that such exemption is appropriate for the 
protection of the public health and other relevant considerations.
    ``(g) Exemption.--An in vitro clinical test that is intended solely 
for use in forensic analysis or law enforcement activity is exempt from 
the requirements of this subchapter. An in vitro clinical test that is 
intended for use in making clinical decisions for individual patients, 
or whose individually identifiable results may be reported back to an 
individual patient or the patient's health care provider, even if also 
intended for forensic analysis or law enforcement purposes, is not 
intended solely for forensic analysis or law enforcement for purposes 
of this subsection.
    ``(h) Revocation.--
            ``(1) In general.--The Secretary may revoke any exemption 
        with respect to in vitro clinical tests with the same 
        indications for use if new clinical information indicates that 
        the exemption of an in vitro clinical test or tests from 
        premarket review under section 587B has a reasonable 
        probability of severe adverse health consequences, including 
        the absence, delay, or discontinuation of appropriate medical 
        treatment.
            ``(2) Process.--Any action under paragraph (1) shall be 
        made by publication of a notice of such proposed action on the 
        website of the Food and Drug Administration, the consideration 
        of comments to a public docket on such proposal, and 
        publication of a final action on such website within 60 
        calendar days of the close of the comment period posted to such 
        public docket, notwithstanding subchapter II of chapter 5 of 
        title 5, United States Code.
    ``(i) Pre-Analytical Instrument.--A pre-analytical instrument is 
exempt from premarket review under section 587B and may be lawfully 
offered subject to the other applicable requirements of this Act, if 
either of the following applies:
            ``(1) Such instrument provides additional information 
        regarding the sample or performs an action on the sample but is 
        not preparing or processing the sample and does not perform any 
        function of an analytical instrument. Such types of pre-
        analytical instruments include barcode readers, sample movers, 
        and sample identifiers.
            ``(2) Such instrument processes or prepares the sample 
        prior to use on an analytical instrument, does not perform any 
        function of an analytical instrument, and does not select, 
        isolate, or prepare a part of a sample based on specific 
        properties. Such types of pre-analytical instruments may 
        include sample mixers, DNA extractors and those used to dilute 
        samples.

``SEC. 587D. TECHNOLOGY CERTIFICATION.

    ``(a) Definitions.--In this section:
            ``(1) Eligible in vitro clinical test.--The term `eligible 
        in vitro clinical test' means an in vitro clinical test that is 
        not--
                    ``(A) a component or part of an in vitro clinical 
                test as described in section 201(ss)(2)(E);
                    ``(B) an instrument under section 201(ss)(2)(B) or 
                an in vitro clinical test that includes an instrument 
                that is not approved under, or exempt from, section 
                587B;
                    ``(C) a specimen receptacle under section 
                201(ss)(2)(C) or an in vitro clinical test that 
                includes a specimen receptacle that is not approved 
                under, or exempt from, section 587B;
                    ``(D) an in vitro clinical test, including reagents 
                used in such tests, intended for use for testing 
                donors, donations, and recipients of blood, blood 
                components, human cells, tissues, cellular-based 
                products, or tissue-based products;
                    ``(E) high-risk;
                    ``(F) a combination product unless such test has 
                been determined to be eligible to be introduced into 
                interstate commerce under a technology certification 
                order pursuant to the regulatory pathway designation 
                process described in section 587F, or as described in 
                subsection (k); or
                    ``(G) a first-of-a-kind in vitro clinical test, 
                unless such test has been determined to be eligible to 
                be introduced into interstate commerce under a 
                technology certification order pursuant to the 
                regulatory pathway designation process described in 
                section 587F, or as described in subsection (k).
            ``(2) Eligible person.--The term `eligible person' means an 
        in vitro clinical test developer unless such developer--
                    ``(A) is a laboratory subject to section 353 of the 
                Public Health Service Act and does not have in effect a 
                certificate applicable to the category of laboratory 
                examination or other procedure;
                    ``(B) was a laboratory, or an owner or operator or 
                any employee of a laboratory, found to have committed a 
                significant violation of section 353 of the Public 
                Health Service Act that resulted in a suspended, 
                revoked, or limited certificate within the 2-year 
                period preceding the date of the submission of the 
                application for a technology certificate under 
                subsection (c) and such violation has not been 
                resolved; or
                    ``(C) has been found to have submitted information 
                to the Secretary, or otherwise disseminated 
                information, that--
                            ``(i) made false or misleading statements 
                        relevant to the requirements of this 
                        subchapter; or
                            ``(ii) violated any requirement of this 
                        Act, where such violation exposed individuals 
                        to serious risk of illness, injury, or death, 
                        unless--
                                    ``(I) such violation has been 
                                resolved; or
                                    ``(II) such violation is not 
                                pertinent to any in vitro clinical test 
                                within the scope of the technology 
                                certification that such developer 
                                seeks.
    ``(b) Applicability.--
            ``(1) In general.--An in vitro clinical test is not subject 
        to section 587B and may be introduced into interstate commerce 
        if the in vitro clinical test--
                    ``(A) is an eligible in vitro clinical test;
                    ``(B) is developed by an eligible person;
                    ``(C) falls within the scope of a technology 
                certification order issued under this section and that 
                is in effect;
                    ``(D) complies with the conditions of the 
                technology certification order, including with 
                applicable mitigating measures under section 587E, 
                restrictions under section 587O, and performance 
                standards under section 587R; and
                    ``(E) meets the applicable standard described in 
                section 587(2).
            ``(2) Scope.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                scope of a technology certification order issued under 
                this section shall apply to multiple in vitro clinical 
                tests utilizing the technology do not significantly 
                differ in control mechanisms, energy sources, or 
                operating principles and for which development, 
                including design, and analytical and clinical 
                validation, of the in vitro clinical tests would be 
                addressed through similar procedures, and be no broader 
                than--
                            ``(i) a single technology type; or
                            ``(ii) a fixed combination of technologies.
                    ``(B) Technology type.--A technology type described 
                in this paragraph may include clot detection, 
                colorimetric (non-immunoassay), electrochemical (non-
                immunoassay), enzymatic (non-immunoassay), flow 
                cytometry, fluorometry (non-immunoassay), immunoassay, 
                mass spectrometry or chromatography, microbial culture, 
                next generation sequencing, nephlometric or 
                turbidimetric (non-immunoassay), singleplex or 
                multiplex non-NGS nucleic acid analysis, slide-based 
                technology, spectroscopy, and any other technology, as 
                the Secretary determines appropriate.
    ``(c) Application for Technology Certification.--
            ``(1) In general.--A developer seeking a technology 
        certification order shall submit an application under this 
        subsection, which shall contain the information specified under 
        paragraph (2).
            ``(2) Content of application.--A developer that submits an 
        application for a technology certification shall include all 
        necessary information to make a showing that all eligible in 
        vitro clinical tests developed within the scope of the 
        technology certification order will meet the applicable 
        standard, including--
                    ``(A) the name and address of the developer;
                    ``(B) a table of contents for the application and 
                the identification of the information the developer 
                claims as trade secret or confidential commercial or 
                financial information;
                    ``(C) the signature of the individual filing the 
                application or an authorized representative;
                    ``(D) a statement identifying the scope of the 
                proposed technology certification intended to be 
                introduced into interstate commerce under the 
                application;
                    ``(E) information establishing that the developer 
                submitting the application is an eligible person;
                    ``(F) quality procedures showing that eligible in 
                vitro clinical tests covered under the technology 
                certification will conform to the applicable quality 
                requirements of section 587K with respect to--
                            ``(i) design controls, including related 
                        purchasing controls and acceptance activities;
                            ``(ii) complaint investigation, adverse 
                        event reporting, and corrections and removals; 
                        and
                            ``(iii) process validation, as applicable;
                    ``(G) procedures for analytical and clinical 
                validation, including all procedures for validation, 
                verification, and acceptance criteria, and an 
                explanation as to how such procedures, when used, 
                provide a showing of analytical validity of eligible in 
                vitro clinical tests within the proposed scope of the 
                technology certification order that is analytically and 
                clinically valid;
                    ``(H) procedures that provide a showing that in 
                vitro clinical tests covered by the proposed scope of 
                the technology certification order will be safe for 
                individuals who come into contact with in vitro 
                clinical tests covered by such order;
                    ``(I) a proposed listing submission under section 
                587J(b) for in vitro clinical tests that the developer 
                intends to introduce into interstate commerce upon 
                receiving a technology certification order, which shall 
                not be construed to limit the developer from 
                introducing additional tests not included in such 
                submission under the same technology certification 
                order;
                    ``(J) information concerning one or more 
                representative in vitro clinical tests, including--
                            ``(i) a test within the scope of the 
                        technology certification application with the 
                        appropriate analytical complexity at the time 
                        of the submission of the application under this 
                        section to serve as the representative test and 
                        validate and run within the developer's stated 
                        scope;
                            ``(ii) the information specified in 
                        subsection (a) or (b) of section 587B, as 
                        applicable, for the representative in vitro 
                        clinical test or tests, including information 
                        and data required pursuant to subsection 
                        (a)(2)(G) of section 587B, unless the Secretary 
                        determines that such information is not 
                        necessary;
                            ``(iii) a summary of a risk assessment of 
                        the in vitro clinical test;
                            ``(iv) an explanation of the choice of the 
                        representative in vitro clinical test or tests 
                        for the technology certification application 
                        and how such test adequately demonstrates the 
                        range of procedures that the developer includes 
                        in the application under subparagraphs (F), 
                        (G), (H), and (I); and
                            ``(v) a brief explanation of the ways in 
                        which the procedures included in the 
                        application under subparagraphs (F), (G), (H), 
                        and (I) have been applied to the representative 
                        in vitro clinical test or tests; and
                    ``(K) such other information necessary to make a 
                determination on a technology certification application 
                as the Secretary may determine necessary.
            ``(3) Reference to existing applications.--With respect to 
        the content requirements in the technology certification 
        application described in paragraph (2), a developer may 
        incorporate by reference any content of an application 
        previously submitted by the developer.
    ``(d) Action on an Application for Technology Certification.--
            ``(1) Secretary response.--
                    ``(A) In general.--As promptly as practicable, and 
                not later than 90 days after receipt of an application 
                under subsection (c), the Secretary shall--
                            ``(i) issue a technology certification 
                        order granting the application, which shall 
                        specify the scope of the technology 
                        certification, if the Secretary finds that all 
                        of the grounds in paragraph (3) are met; or
                            ``(ii) deny the application if the 
                        Secretary finds (and sets forth the basis of 
                        such finding as part of or accompanying such 
                        denial) that one or more grounds for granting 
                        the application specified in paragraph (3) are 
                        not met.
                    ``(B) Extension.--The timeline described in 
                subparagraph (A) may be extended by mutual agreement 
                between the Secretary and the applicant.
            ``(2) Deficient applications.--
                    ``(A) In general.--If, after receipt of an 
                application under this section, the Secretary 
                determines that any portion of such application is 
                deficient, the Secretary, not later than 60 days after 
                receipt of such application, shall provide to the 
                applicant a description of such deficiencies and 
                identify the information required to resolve such 
                deficiencies.
                    ``(B) Converting to premarket applications.--When 
                responding to the deficiency letter, the developer may 
                convert the application for technology certification 
                under subsection (c) into a premarket application under 
                section 587B.
            ``(3) Technology certification order.--The Secretary shall 
        issue an order granting a technology certification under this 
        section if, on the basis of the information submitted to the 
        Secretary as part of the application and any other information 
        with respect to such applicant, the Secretary finds that--
                    ``(A) there is a showing that in vitro clinical 
                tests within the scope of the technology certification 
                order will meet the applicable standard;
                    ``(B) the methods used in, and the facilities or 
                controls used for, the development of eligible in vitro 
                clinical tests covered by the proposed scope of the 
                technology certification conform to the applicable 
                requirements of section 587K with respect to--
                            ``(i) design controls, including related 
                        purchasing controls and acceptance activities;
                            ``(ii) complaint investigation, adverse 
                        event reporting, and corrections and removals; 
                        and
                            ``(iii) process validation, as applicable;
                    ``(C) based on a fair evaluation of all material 
                facts, the applicant's proposed labeling and 
                advertising are not false or misleading in any 
                particular;
                    ``(D) the application does not contain a false 
                statement of material fact;
                    ``(E) there is a showing that the representative in 
                vitro clinical test or tests--
                            ``(i) meet the applicable standard; and
                            ``(ii) reasonably represent the range of 
                        procedures required to be submitted in the 
                        application;
                    ``(F) the applicant has agreed to permit, upon 
                request, authorized employees of the Food and Drug 
                Administration or persons accredited, or recognized 
                under this Act, an opportunity to inspect at a 
                reasonable time and in a reasonable manner the 
                facilities and all pertinent equipment, finished and 
                unfinished materials, containers, and labeling therein, 
                including all things (including records, files, papers, 
                and controls) bearing on whether an in vitro clinical 
                test is adulterated, misbranded, or otherwise in 
                violation of this Act, and permits such authorized 
                employees or persons accredited under this Act to view 
                and to copy and verify all records pertinent to the 
                application and the in vitro clinical test; and
                    ``(G) based on other data and information the 
                Secretary may require under subsection (c)(2)(K), the 
                Secretary finds that such data and information support 
                granting a technology certification order.
            ``(4) Review of denials.--An applicant whose application 
        has been denied under this subsection may obtain review of such 
        denial under section 587P.
    ``(e) Supplements.--
            ``(1) Supplemental applications.--
                    ``(A) In general.--With respect to any of the 
                following changes related to an in vitro clinical test 
                under a technology certification order, a supplemental 
                application to a technology certification order shall 
                be submitted by the holder of the technology 
                certification order describing such proposed changes, 
                prior to introducing the in vitro clinical test that is 
                the subject of the technology certification order into 
                interstate commerce--
                            ``(i) any significant change to the 
                        procedures provided in support of the 
                        application for technology certification 
                        submitted under subparagraph (G) or (H) of 
                        subsection (c)(2); or
                            ``(ii) any significant change to the 
                        procedures provided in support of the 
                        application for technology certification 
                        submitted under subparagraph (F) of subsection 
                        (c)(2).
                    ``(B) Secretary action on supplemental 
                applications.--Any action by the Secretary on a 
                supplemental application shall be in accordance with 
                subsection (d), and any order resulting from such 
                supplement shall be treated as an amendment to a 
                technology certification order.
            ``(2) Content of application.--
                    ``(A) In general.--A supplemental application for a 
                change to an in vitro clinical test under a technology 
                certification order shall--
                            ``(i) contain all necessary information to 
                        make a showing that any in vitro clinical test 
                        affected by such change that is within the 
                        scope of the technology certification order 
                        will meet the applicable standard; and
                            ``(ii) be limited to such information that 
                        is needed to support the change.
                    ``(B) Content.--Unless otherwise specified by the 
                Secretary, a supplemental application under this 
                subsection shall include--
                            ``(i) a description of the change, 
                        including a rationale for implementing such 
                        change;
                            ``(ii) a description of how the change was 
                        evaluated;
                            ``(iii) data from a representative in vitro 
                        clinical test or tests that supports a showing 
                        that, in using the modified procedure or 
                        procedures, all eligible in vitro clinical 
                        tests within the scope of the technology 
                        certification will meet the applicable 
                        standard;
                            ``(iv) as applicable, information to 
                        demonstrate that the modified procedure or 
                        procedures submitted under subsection (c)(2)(F) 
                        continue to conform to applicable requirements 
                        under section 587K; and
                            ``(v) any other information requested by 
                        the Secretary.
            ``(3) Changes in response to a public health risk.--
                    ``(A) In general.--If the holder of a technology 
                certification makes a change to an in vitro clinical 
                test or tests to address a potential risk to public 
                health by adding a new specification or test method, 
                such holder may immediately implement such change and 
                shall submit a notification for such change to the 
                Secretary within 30 days.
                    ``(B) Content.--Any notification to the Secretary 
                under this paragraph shall include--
                            ``(i) a summary of the relevant change;
                            ``(ii) the rationale for implementing such 
                        change;
                            ``(iii)(I) if such a change necessitates a 
                        change to the procedures reviewed as part of 
                        the granted technology certification order, the 
                        modified procedures; or
                            ``(II) if the procedures were not changed, 
                        an explanation as to why they were not changed; 
                        and
                            ``(iv) if such a change necessitates a 
                        change to the procedures reviewed as part of 
                        the granted technology certification order, 
                        data from a representative in vitro clinical 
                        test or tests that support a showing that, in 
                        using the modified procedures, all eligible in 
                        vitro clinical tests within the scope of the 
                        technology certification will meet the 
                        applicable standard.
    ``(f) Temporary Hold.--
            ``(1) In general.--Subject to the process specified in 
        paragraph (2), and based on one or more findings under 
        paragraph (4), the Secretary may issue a temporary hold 
        prohibiting any holder of a technology certification order 
        issued under this section from introducing into interstate 
        commerce an in vitro clinical test that was not previously the 
        subject of a listing under section 587J. The temporary hold 
        shall identify the grounds for the temporary hold under 
        paragraph (4) and the rationale for such finding.
            ``(2) Process for issuing a temporary hold.--If the 
        Secretary makes a finding that a temporary hold may be 
        warranted based on one or more grounds specified in paragraph 
        (4), the Secretary shall promptly notify the holder of the 
        technology certification order of such finding and provide 30 
        calendar days for the developer to come into compliance with or 
        otherwise resolve the finding.
            ``(3) Written requests.--Any written request to the 
        Secretary from the holder of a technology certification order 
        that a temporary hold under paragraph (1) be removed shall 
        receive a decision, in writing and specifying the reasons 
        therefore, within 90 days after receipt of such request. Any 
        such request shall include information to support the removal 
        of the temporary hold.
            ``(4) Grounds for temporary hold.--The Secretary may 
        initiate a temporary hold under this subsection upon a finding 
        that the holder of a technology certification order--
                    ``(A) is not in compliance with the conditions of 
                the technology certification order pursuant to 
                subsection (b)(1)(D);
                    ``(B) offers one or more in vitro clinical tests 
                with advertising or labeling that is false or 
                misleading;
                    ``(C) has reported a correction or removal of an in 
                vitro clinical test that is offered under a technology 
                certification order under this section and has failed 
                to demonstrate that the issue or issues causing the 
                correction or removal does not adversely impact the 
                ability of other in vitro clinical tests offered under 
                the same technology certification order to meet the 
                applicable standard; or
                    ``(D) has introduced into interstate commerce an in 
                vitro clinical test under a technology certification 
                order and such test is adulterated or misbranded, based 
                on a determination by the Secretary, and has failed to 
                demonstrate that the issue or issues causing the 
                adulteration or misbranding does not adversely impact 
                the ability of other in vitro clinical tests offered 
                under the same technology certification granted under 
                this section to meet the applicable standard.
    ``(g) Withdrawal.--The Secretary may, after due notice and 
opportunity for an informal hearing, issue an order withdrawing a 
technology certification order including all tests introduced into 
interstate commerce under the technology certification order if the 
Secretary finds that--
            ``(1) the application, supplement, or report under 
        subsection (h) contains false or misleading information or 
        fails to reveal a material fact;
            ``(2) such holder fails to correct false or misleading 
        labeling or advertising upon the request of the Secretary;
            ``(3) in connection with a technology certification, the 
        holder provides false or misleading information to the 
        Secretary; or
            ``(4) the holder of such technology certification order 
        fails to correct the grounds for a temporary hold within a 
        timeframe specified in the temporary hold order.
    ``(h) Reports to Congress.--
            ``(1) In general.--Not later than 1 year after the 
        effective date of the VALID Act of 2022, and annually 
        thereafter for the next 4 years, the Secretary shall submit to 
        the Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives, and make publicly available, including through 
        posting on the website of the Food and Drug Administration, a 
        report containing the information described in paragraph (2).
            ``(2) Content.--
                    ``(A) In general.--Each report under paragraph (1) 
                shall address, at a minimum--
                            ``(i) the total number of applications for 
                        technology certifications filed, granted, 
                        withdrawn and denied;
                            ``(ii) the total number of technology 
                        certification orders the Secretary put on 
                        temporary hold under subsection (h) and the 
                        number of technology certification orders 
                        withdrawn under subsection (i);
                            ``(iii) the types of technologies for which 
                        the Secretary granted technology certification 
                        orders;
                            ``(iv) the total number of holders of 
                        technology certification orders that are in 
                        effect; and
                            ``(v) the total number of in vitro clinical 
                        test categories that required premarket review 
                        under section 587B that were redesignated as 
                        eligible in vitro clinical tests under this 
                        section.
                    ``(B) Final report.--The fifth report submitted 
                under paragraph (1) shall include a summary of, and 
                responses to, comments raised in the docket.
                    ``(C) Performance reports.--The reports required 
                under this section may be issued with performance 
                reports as required under section 829 of the VALID Act 
                of 2022.
    ``(i) Public Meeting and Input.--
            ``(1) Public docket.--Not later than 30 days after the date 
        of enactment of the VALID Act of 2022, the Secretary shall 
        establish a public docket to receive comments concerning 
        recommendations for implementation of this section, including 
        criteria and procedures for subsections (c) through (h). The 
        public docket shall remain open for at least 1 year after the 
        establishment of the public docket.
            ``(2) Public meeting.--Not later than 180 days after the 
        date of enactment of the VALID Act of 2022, the Secretary shall 
        convene a public meeting to which stakeholders from 
        organizations representing patients and consumers, academia, 
        and the in vitro clinical test industry are invited to discuss 
        the technology certification process including application 
        requirements, inspections, alignment with third-party 
        accreditors, and the definition of the term `technology' under 
        section 587.
    ``(j) Regulations.--The Secretary shall issue regulations regarding 
the technology certification process, including describing criteria or 
procedures relating to technology certification under this section, 
which shall be subject to public comment for a minimum of 60 days from 
issuance prior to finalizing such regulations after considering the 
comments received. The regulation shall include an outline of the 
application process, opportunities to meet with officials of the Food 
and Drug Administration, and plans to streamline inspections.
    ``(k) Notification.--
            ``(1) In general.--Notwithstanding subsection (a)(1), a 
        first-of-a-kind in vitro clinical test or a combination product 
        that meets the definition of a moderate-risk test under section 
        587A may be introduced into interstate commerce under a 
        technology certification order that has been issued by the 
        Secretary, subject to other applicable requirements if--
                    ``(A) the developer provides notification to the 
                Secretary 60 days prior to introducing such tests into 
                interstate commerce that includes information 
                demonstrating that the test is moderate-risk and within 
                the scope of the applicable technology certification 
                order; and
                    ``(B) the Secretary has not issued a notification 
                to the developer under paragraph (2) before such time 
                has elapsed.
            ``(2) Notification from secretary.--The Secretary shall 
        issue a notification to the developer that such test may not be 
        introduced into interstate commerce under such order if the 
        Secretary determines that--
                    ``(A) such test--
                            ``(i) does not meet the definition of a 
                        moderate-risk test under section 587A;
                            ``(ii) is not eligible to be introduced 
                        into interstate commerce under the referenced 
                        technology certification order issued by the 
                        Secretary; or
                            ``(iii) is not eligible for technology 
                        certification under subsection (b)(2); or
                    ``(B) based on the information included in the 
                notification submitted by the developer pursuant to 
                this subsection, there is insufficient information for 
                the Secretary to make the determinations described in 
                clauses (i), (ii), and (iii) of subparagraph (A).

``SEC. 587E. MITIGATING MEASURES.

    ``(a) Establishment of Mitigating Measures.--
            ``(1) Establishing, changing, or withdrawing.--
                    ``(A) Establishment.--The Secretary may establish 
                and require, on the basis of evidence, mitigating 
                measures for any in vitro clinical test or category of 
                in vitro clinical tests with the same indications for 
                use that is introduced or delivered for introduction 
                into interstate commerce after the establishment of 
                such mitigating measures.
                    ``(B) Methods of establishment.--The Secretary may 
                establish mitigating measures--
                            ``(i) under the process set forth in 
                        subparagraph (D);
                            ``(ii) as provided under section 587F; or
                            ``(iii) through a premarket approval or 
                        technology certification order, which may 
                        establish mitigating measures for an individual 
                        in vitro clinical test or a category of in 
                        vitro clinical tests.
                    ``(C) Methods of change or withdrawal.--The 
                Secretary may change or withdraw mitigating measures--
                            ``(i) under the process set forth in 
                        subparagraph (D); or
                            ``(ii) as provided under section 587F.
                    ``(D) Process for establishment, change, or 
                withdrawal.--Notwithstanding subchapter II of chapter 5 
                of title 5, United States Code, the Secretary may, upon 
                the initiative of the Secretary or upon petition of an 
                interested person--
                            ``(i) establish, change, or withdraw 
                        mitigating measures for an in vitro clinical 
                        test or category of in vitro clinical tests 
                        by--
                                    ``(I) publishing a proposed order 
                                in the Federal Register;
                                    ``(II) providing an opportunity for 
                                public comment for a period of not less 
                                than 30 60 calendar days; and
                                    ``(III) after consideration of any 
                                comments submitted, publishing a final 
                                order in the Federal Register that 
                                responds to the comments submitted, and 
                                which shall include a reasonable 
                                transition period.
                    ``(E) Effect of mitigating measures on 
                grandfathered tests.--A mitigating measure shall not be 
                required by the Secretary for an in vitro clinical test 
                subject to section 587G(a), unless otherwise provided 
                under section 587F.
            ``(2) In vitro clinical tests previously cleared or exempt 
        as devices with special controls.--
                    ``(A) In general.--Any special controls applicable 
                to an in vitro clinical test previously cleared or 
                exempt under section 510(k), or classified under 
                section 513(f)(2) prior to date of enactment of the 
                VALID Act of 2022, including any such special controls 
                established during the period beginning on the date of 
                enactment of the VALID Act of 2022 and ending on the 
                effective date of such Act (as described in section 
                5(b) of such Act)--
                            ``(i) shall continue to apply to such in 
                        vitro clinical test after such effective date; 
                        and
                            ``(ii) are deemed to be mitigating measures 
                        as of the effective date specified in section 
                        825(a)(1)(A) of the VALID Act of 2022.
                    ``(B) Changes.--Notwithstanding subparagraph (A), 
                the Secretary may establish, change, or withdraw 
                mitigating measures for such tests or category of tests 
                using the procedures under paragraph (1).
    ``(b) Documentation.--
            ``(1) In vitro clinical tests subject to premarket 
        review.--The developer of an in vitro clinical test subject to 
        premarket review under section 587B and to which mitigating 
        measures apply shall--
                    ``(A) in accordance with section 587B(c)(2)(G)(i), 
                submit documentation to the Secretary as part of the 
                application for the test under subsection (c) or (d) of 
                section 587B demonstrating that such mitigating 
                measures have been met;
                    ``(B) if such application is approved, maintain 
                documentation demonstrating that such mitigating 
                measures continue to be met following a test 
                modification by the developer; and
                    ``(C) make such documentation available to the 
                Secretary upon request or inspection.
            ``(2) Other tests.--The developer of an in vitro clinical 
        test that is offered under a technology certification order or 
        other exemption from premarket review under section 587B and to 
        which mitigating measures apply shall--
                    ``(A) maintain documentation in accordance with the 
                applicable quality requirements under section 587J 
                demonstrating that such mitigating measures continue to 
                be met following a test modification by the developer;
                    ``(B) make such documentation available to the 
                Secretary upon request or inspection; and
                    ``(C) include in the performance summary for such 
                test a brief description of how such mitigating 
                measures are met, if applicable.

``SEC. 587F. REGULATORY PATHWAY DESIGNATION.

    ``(a) Pathway Determinations.--
            ``(1) In general.--After considering available evidence 
        with respect to an in vitro clinical test or category of in 
        vitro clinical tests with the same intended use, including the 
        identification, establishment, and implementation of mitigating 
        measures under section 587E, as appropriate, the Secretary may, 
        upon the initiative of the Secretary or upon request of a 
        developer, determine that--
                    ``(A) such in vitro clinical test is high-risk and 
                subject to premarket review under section 587B;
                    ``(B) such in vitro clinical tests, including a 
                first of a kind test, is moderate-risk and subject to 
                abbreviated premarket review under section 587B(d) or 
                technology certification under section 587D(b)(2); or
                    ``(C) such in vitro clinical test, including a 
                first of a kind test is low-risk or otherwise exempt 
                from premarket review under section 587B.
            ``(2) Requests.--
                    ``(A) Submissions by developers.--
                            ``(i) Special premarket review; technology 
                        certification.--A developer submitting a 
                        request that the Secretary make a determination 
                        as described in paragraph (1)(B) shall submit 
                        information to support that the in vitro 
                        clinical test is moderate-risk or propose 
                        mitigating measures, if applicable, that would 
                        support such a determination.
                            ``(ii) Low-risk; exempt from premarket 
                        review.--A developer submitting a request that 
                        the Secretary make a determination as described 
                        in paragraph (1)(C) shall submit information 
                        that the in vitro clinical test is low-risk, or 
                        otherwise appropriate for exemption from 
                        premarket review under section 587B and propose 
                        mitigating measures, if applicable, that would 
                        support such a determination.
                    ``(B) Response by the secretary.--After receiving a 
                request under clause (i) or (ii) of subparagraph (A), 
                the Secretary shall provide a timely response 
                describing whether or not the Secretary will initiate 
                the process for making a determination under paragraph 
                (1)(B) or (1)(C) as described in paragraph (4).
            ``(3) Sufficiency of mitigating measures.--When determining 
        whether mitigating measures for an in vitro clinical test, or 
        category of in vitro clinical tests, are sufficient to make 
        such test moderate-risk or low-risk, the Secretary shall take 
        into account the following:
                    ``(A) The degree to which the technology for the 
                intended use of the in vitro clinical test is well-
                characterized, taking into consideration factors that 
                include one or more of the following:
                            ``(i) Peer-reviewed literature.
                            ``(ii) Practice guidelines.
                            ``(iii) Consensus standards.
                            ``(iv) Recognized standards of care.
                            ``(v) Use of such technology, including 
                        historical use.
                            ``(vi) Multiple scientific publications by 
                        different authors.
                            ``(vii) Adoption by the scientific or 
                        clinical community.
                            ``(viii) Real world evidence.
                    ``(B) Whether the criteria for performance of the 
                test are well-established to be sufficient for the 
                intended use.
                    ``(C) The clinical circumstances under which the in 
                vitro clinical test is used, including whether the in 
                vitro clinical test is the sole determinate for the 
                diagnosis or treatment of the targeted disease, and the 
                availability of other tests (such as confirmatory or 
                adjunctive tests) or relevant material standards.
                    ``(D) Whether such mitigating measures sufficiently 
                mitigate the risk of harm such that the test or 
                category of tests is moderate-risk or low-risk.
            ``(4) Process.--
                    ``(A) In general.--For a test that is not first-of-
                a-kind, any action under paragraph (1) shall be made by 
                publication of a notice of such proposed action on the 
                website of the Food and Drug Administration, the 
                consideration of comments to a public docket on such 
                proposal, and publication of a final action on such 
                website within 60 calendar days of the close of the 
                comment period posted to such public docket, 
                notwithstanding subchapter II of chapter 5 of title 5, 
                United States Code.
                    ``(B) Process for first-of-a-kind test.--In the 
                case of an in vitro clinical test that is first-of-a-
                kind, the process is as follows:
                            ``(i) Any determination that the test is 
                        subject to premarket approval or abbreviated 
                        premarket review under subparagraph (A) or (B) 
                        of paragraph (1) shall be published on the 
                        website of the Food and Drug Administration, 
                        notwithstanding subclause II of chapter 5 of 
                        title 5, United States Code, only after the in 
                        vitro clinical test is approved under section 
                        587B. Until that time, the determination shall 
                        not be binding on other in vitro clinical 
                        tests.
                            ``(ii) Any determination other than those 
                        made under clause (i) shall be made by 
                        publication of a notice of final action on the 
                        website of the Food and Drug Administration, 
                        notwithstanding subchapter II of chapter 5 of 
                        title 5, United States Code.
    ``(b) Transition Period.--Upon a decision by the Secretary to 
change a regulatory pathway designation, or reclassifies an in vitro 
clinical test, or category of in vitro clinical tests, the Secretary 
shall provide an appropriate transition period with respect to any new 
requirements.
    ``(c) Appeals.--A decision by the Secretary under this section 
shall be deemed a significant decision subject to appeal under section 
587P.
    ``(d) Advisory Committee.--The Secretary may request 
recommendations from an advisory committee under section 587H pursuant 
to carrying out this section.
    ``(e) Request for Informal Feedback.--Before submitting a premarket 
application or technology certification application for an in vitro 
clinical test--
            ``(1) the developer of the test may submit to the Secretary 
        a written request for a meeting, conference, or written 
        feedback to discuss and provide information relating to the 
        regulation of such in vitro clinical test which may include--
                    ``(A) the submission process and the type and 
                amount of evidence expected to demonstrate the 
                applicable standard;
                    ``(B) which regulatory pathway is appropriate for 
                an in vitro clinical test; and
                    ``(C) an investigation plan for an in vitro 
                clinical test, including a clinical protocol; and
            ``(2) upon receipt of such a request, the Secretary shall--
                    ``(A) if a meeting is requested--
                            ``(i) within 60 calendar days after such 
                        receipt, or within such time period as may be 
                        agreed to by the developer, meet or confer with 
                        the developer submitting the request; and
                            ``(ii) within 15 calendar days after such 
                        meeting or conference, provide to the developer 
                        a written record or response describing the 
                        issues discussed and conclusions reached in the 
                        meeting or conference; and
                    ``(B) if written feedback is requested, provide 
                feedback to the requestor within 75 days after such 
                receipt.

``SEC. 587G. GRANDFATHERED IN VITRO CLINICAL TESTS.

    ``(a) In General.--Subject to subsection (d), an in vitro clinical 
test is exempt from the requirements of this subchapter specified in 
subsection (b) if--
            ``(1) the test was first offered for clinical use before 
        the date of enactment of the VALID Act of 2022;
            ``(2) the was developed by a clinical laboratory for which 
        a certificate was in effect under section 353 of the Public 
        Health Service Act that meets the requirements for performing 
        tests of high complexity;
            ``(3) the test is performed--
                    ``(A) in the same clinical laboratory in which the 
                test was developed for which a certification is still 
                in effect under section 353 of the Public Health 
                Service Act that meets the requirements to perform 
                tests of high complexity;
                    ``(B) by another clinical laboratory for which a 
                certificate is in effect under section 353 of such Act 
                that meets the requirements to perform tests of high 
                complexity, and that is within the same corporate 
                organization and having common ownership by the same 
                parent corporation as the laboratory in which the test 
                was developed; or
                    ``(C) in the case of a test that was developed by 
                the Centers for Disease Control and Prevention or 
                another laboratory a public health laboratory network 
                coordinated or managed by the Centers for Disease 
                Control and Prevention, by a clinical laboratory for 
                which a certificate is in effect under section 353 of 
                such Act that meets the requirements to perform tests 
                of high complexity, and that is within a public health 
                laboratory network coordinated or managed by the 
                Centers for Disease Control and Prevention;
            ``(4) the test does not have in effect an approval under 
        section 515, a clearance under section 510(k), an authorization 
        under section 513(f)(2), or an exemption under section 520(m), 
        or licensure under section 351 of the Public Health Service 
        Act;
            ``(5) any modification to the test on or after the date of 
        enactment of the VALID Act of 2022 made by the initial 
        developer and conform with section 587C(a)(6)(A)(ii) and does 
        not meet the criterial in subsection (d)(1);
            ``(6) the test is not for investigational use;
            ``(7) the test is offered with an order from an authorized 
        person as required under section 353 of the Public Health 
        Service Act, and was offered with a prescription required under 
        section 809.30(f) of title 21, Code of Federal Regulations 
        prior to the effective date of this subchapter;
            ``(8) the test is not for use with home specimen 
        collection, unless the specimen is collected with a collection 
        container, receptacle, or kit that--
                    ``(A) has been approved, cleared, or authorized by 
                the Secretary for home specimen collection and the 
                collection is performed pursuant to the approved, 
                cleared, or authorized labeling, including any 
                indication for use as prescription use or over-the-
                counter use, or
                    ``(B) is exempt from premarket review and its use 
                is consistent with applicable limitations on the 
                exemption;
            ``(9) is not a specimen receptacle or instrument
            ``(10) each test report template for the test bears a 
        statement that reads as follows: `This in vitro clinical test 
        has not been reviewed by the Food and Drug Administration.'; 
        and
            ``(11) the developer of the test--
                    ``(A) maintains documentation demonstrating that 
                the test meets and continues to meet the criteria set 
                forth in this subsection; and
                    ``(B) makes such documentation available to the 
                Secretary upon request.
    ``(b) Exemptions Applicable to Grandfathered Tests.--An in vitro 
clinical test that meets the criteria specified in subsection (a) is 
exempt from premarket review under 587B, labeling requirements under 
587L, and test design requirements and quality requirements under 587K, 
and may be lawfully offered subject to the other applicable 
requirements of this Act.
    ``(c) Modifications.--In the case of an in vitro clinical test that 
meets the criteria specified in subsection (a), such test continues to 
qualify for the exemptions described in subsection (b) if the test is 
modified and the modification is not of a type described in subsection 
(a)(5), and the person modifying such in vitro clinical test--
            ``(1) documents each such modification and maintains 
        documentation of the basis for such determination;
            ``(2) provides such documentation relating to the change to 
        the Secretary upon request or inspection; and
            ``(3) does not modify the in vitro clinical test such that 
        it no longer meets the criteria under subsection (a).
    ``(d) Request for Information.--
            ``(1) Criteria.--The criteria described in this paragraph 
        are any of the following:
                    ``(A) There is insufficient valid scientific 
                evidence to support that the test is analytically valid 
                or clinically valid.
                    ``(B) Such in vitro clinical test is being offered 
                by its developer with any false or misleading 
                analytical or clinical claims.
                    ``(C) It is probable that such in vitro clinical 
                test will cause serious adverse health consequences.
            ``(2) Process.--
                    ``(A) Written request for information.--The 
                Secretary may issue a written request to a developer 
                identifying specific scientific concerns, based on 
                credible information, with an in vitro clinical test, 
                which indicate that one or more of the criteria 
                described in paragraph (1) apply to such in vitro 
                clinical tests. Such written request shall include 
                specific information requests pertaining to such 
                criteria.
                    ``(B) Deadline for submitting information.--Not 
                later than 45 days after receiving a request for 
                information under subparagraph (A)--
                            ``(i) the developer of an in vitro clinical 
                        test--
                                    ``(I) may seek a teleconference 
                                prior to the submission of information 
                                under clause (ii) to discuss the 
                                Secretary's request; and
                                    ``(II) shall submit the information 
                                requested pursuant to subparagraph (A) 
                                within 30 days of receipt of such 
                                request; and
                            ``(ii) the Secretary shall--
                                    ``(I) schedule a teleconference 
                                requested under clause (i)(I); and
                                    ``(II) hold a teleconference so 
                                requested within 10 days of the 
                                Secretary's receipt of the information 
                                requested under clause (i)(II).
                    ``(C) Review deadline.--Upon receiving a submission 
                under subparagraph (B), the Secretary shall--
                            ``(i) review the submitted information 
                        within 45 calendar days of such receipt, which 
                        may include communication with the developer; 
                        and
                            ``(ii) determine whether the criteria 
                        listed in paragraph (1) apply to the in vitro 
                        clinical test and communicate such 
                        determination to the developer as described in 
                        subparagraph (D).
                    ``(D) Communication and results of determination.--
                The Secretary shall notify the developer, in writing, 
                of the Secretary's determination under subparagraph 
                (C), as follows:
                            ``(i) If the Secretary determines that none 
                        of the criteria listed in paragraph (1) apply 
                        to the in vitro clinical test, such test shall 
                        be exempt from relevant requirements of this 
                        subchapter, as set forth in subsection (b), 
                        subject to applicable limitation.
                            ``(ii) If the Secretary determines that one 
                        or more of the criteria listed in subparagraph 
                        (1) apply to the test but such a determination 
                        may be resolved within a reasonable time, and 
                        the test has not been previously subject to 
                        this subsection on the basis of the same or 
                        substantially similar scientific concerns 
                        identified in the written request issued under 
                        paragraph (d)(2)(A)--
                                    ``(I) the Secretary shall notify 
                                the developer of such a determination 
                                and allow the developer to seek a 
                                teleconference to discuss the finding;
                                    ``(II) the developer shall submit 
                                information demonstrating resolution of 
                                the determination within 15 days of 
                                receiving the notification; and
                                    ``(III) the Secretary shall make a 
                                determination within 30 days of the 
                                submission of information as to whether 
                                the criteria under paragraph (1) apply 
                                to the test.
                            ``(iii) If the Secretary determines that 
                        none of the criteria listed in paragraph (1) 
                        apply to the test, such test shall be exempt 
                        from relevant requirements of the subchapter as 
                        set forth in subsection (b), subject to 
                        applicable limitations.
                            ``(iv) If the Secretary determines that one 
                        or more of the criteria listed in paragraph (1) 
                        apply to the in vitro clinical test, such test 
                        is not exempt as set forth in this section and 
                        shall not be offered unless approved under 
                        section 587B, offered under a technology 
                        certification order under section 587D, or 
                        offered as a low-risk test. upon a 
                        determination by the Secretary pursuant to 
                        section 587F.
                            ``(v) If the Secretary determines that one 
                        or more of the criteria listed in paragraph (1) 
                        apply to the in vitro clinical test and clause 
                        (ii) does not apply, the in vitro clinical test 
                        is not exempt as set forth in section and shall 
                        not be offered unless approved under section 
                        587B, offered under a technology certification 
                        order under section 587D, or offered as a low-
                        risk test upon a determination by the Secretary 
                        pursuant to section 587F.

``SEC. 587H. ADVISORY COMMITTEES.

    ``(a) In General.--The Secretary may establish advisory committees 
or use advisory committee panels of experts established before the date 
of enactment of the VALID Act of 2022 (including a device 
classification panel under section 513) for the purposes of providing 
expert scientific advice and making recommendations related to--
            ``(1) the approval of an application for an in vitro 
        clinical test submitted under this subchapter, including for 
        evaluating, as applicable, the analytical validity, clinical 
        validity, and safety of in vitro clinical tests;
            ``(2) the potential effectiveness of mitigating measures 
        for a determination of the applicable regulatory pathway under 
        section 587F(b) or risk evaluation for an in vitro clinical 
        test or tests;
            ``(3) quality requirements under section 587K or applying 
        such requirements to in vitro clinical tests developed or 
        imported by developers;
            ``(4) appeals under section 587P; or
            ``(5) such other purposes as the Secretary determines 
        appropriate.
    ``(b) Appointments.--
            ``(1) Voting members.--The Secretary shall appoint to each 
        committee established under subsection (a), as voting members, 
        individuals who are qualified by training and experience to 
        evaluate in vitro clinical tests referred to the committee for 
        the purposes specified in subsection (a), including individuals 
        with, to the extent feasible, scientific expertise in the 
        development of such in vitro clinical tests, laboratory 
        operations, and the use of in vitro clinical tests. The 
        Secretary shall designate one member of each committee to serve 
        as chair.
            ``(2) Nonvoting members.--In addition to the individuals 
        appointed pursuant to paragraph (1), the Secretary shall 
        appoint to each committee established under subsection (a), as 
        nonvoting members--
                    ``(A) a representative of consumer interests; and
                    ``(B) a representative of interests of in vitro 
                clinical test developers not directly affected by the 
                matter to be brought before the committee.
            ``(3) Limitation.--No individual who is a regular full-time 
        employee of the United States and engaged in the administration 
        of this Act may be a member of any advisory committee 
        established under subsection (a).
            ``(4) Education and training.--The Secretary shall, as 
        appropriate, provide education and training to each new 
        committee member before such member participates in a 
        committee's activities, including education regarding 
        requirements under this Act and related regulations of the 
        Secretary, and the administrative processes and procedures 
        related to committee meetings.
            ``(5) Meetings.--The Secretary shall ensure that scientific 
        advisory committees meet regularly and at appropriate intervals 
        so that any matter to be reviewed by such a committee can be 
        presented to the committee not more than 60 calendar days after 
        the matter is ready for such review. Meetings of the committee 
        may be held using electronic or telephonic communication to 
        convene the meetings.
            ``(6) Compensation.--Members of an advisory committee 
        established under subsection (a), while attending meetings or 
        conferences or otherwise engaged in the business of the 
        advisory committee--
                    ``(A) shall be entitled to receive compensation at 
                rates to be fixed by the Secretary, but not to exceed 
                the daily equivalent of the rate in effect for 
                positions classified above level GS-15 of the General 
                Schedule; and
                    ``(B) may be allowed travel expenses as authorized 
                by section 5703 of title 5, United States Code, for 
                employees serving intermittently in the Government 
                service.
    ``(c) Guidance.--The Secretary may issue guidance on the policies 
and procedures governing advisory committees established under 
subsection (a).

``SEC. 587I. BREAKTHROUGH IN VITRO CLINICAL TESTS.

    ``(a) In General.--The purpose of this section is to encourage the 
Secretary, and provide the Secretary with sufficient authority, to 
apply efficient and flexible approaches to expedite the development of, 
and prioritize the review of, in vitro clinical tests that represent 
breakthrough technologies.
    ``(b) Establishment of Program.--The Secretary shall establish a 
program to expedite the development of, and provide for the priority 
review of, in vitro clinical tests.
    ``(c) Eligibility.--The program developed under subsection (b) 
shall be available for any in vitro clinical test that--
            ``(1) provides or enables more effective treatment or 
        diagnosis of life-threatening or irreversibly debilitating 
        human disease or conditions compared to existing approved or 
        cleared alternatives, including an in vitro clinical test 
        offered under a technology certification order; and
            ``(2) is a test--
                    ``(A) that represents a breakthrough technology;
                    ``(B) for which no approved or cleared alternative 
                in vitro clinical test exists, including no in vitro 
                clinical test offered under a technology certification 
                order;
                    ``(C) that offers a clinically meaningful advantage 
                over any existing alternative in vitro clinical test 
                that is approved or cleared (including any in vitro 
                clinical test offered under a technology certification 
                order), including the potential to reduce or eliminate 
                the need for hospitalization, improve patient quality 
                of life, facilitate patients' ability to manage their 
                own care (such as through self-directed personal 
                assistance), or establish long-term clinical 
                efficiencies; or
                    ``(D) the availability of which is in the best 
                interest of patients or public health.
    ``(d) Designation.--
            ``(1) Request.--To receive breakthrough designation under 
        this section, an applicant may request that the Secretary 
        designate the in vitro clinical test for expedited development 
        and priority review. Any such request for designation may be 
        made at any time prior to, or at the time of, the submission of 
        an application under section 587B or 587D, and shall include 
        information demonstrating that the test meets the criteria 
        described in subsection (c).
            ``(2) Determination.--Not later than 60 calendar days after 
        the receipt of a request under paragraph (1), the Secretary 
        shall determine whether the in vitro clinical test that is the 
        subject of the request meets the criteria described in 
        subsection (c). If the Secretary determines that the test meets 
        the criteria, the Secretary shall designate the test for 
        expedited development and priority review.
            ``(3) Review.--Review of a request under paragraph (1) 
        shall be undertaken by a team that is composed of experienced 
        staff and senior managers of the Food and Drug Administration.
            ``(4) Withdrawal.--
                    ``(A) In general.--The designation of an in vitro 
                clinical test under this subsection is deemed to be 
                withdrawn, and such in vitro clinical test shall no 
                longer be eligible for designation under this section, 
                if an application for approval for such test under 
                section 587B or 587D is denied. Such test shall be 
                eligible for breakthrough designation upon a new 
                request for such designation.
                    ``(B) Exception.--The Secretary may not withdraw a 
                designation granted under this subsection based on the 
                subsequent approval or technology certification of 
                another in vitro clinical test that--
                            ``(i) is designated under this section; or
                            ``(ii) was given priority review under 
                        section 515B.
    ``(e) Actions.--For purposes of expediting the development and 
review of in vitro clinical tests under this section, the Secretary may 
take the actions and additional actions set forth in paragraphs (1) and 
(2), respectively, of section 515B(e) when reviewing such tests. Any 
reference or authorization in section 515B(e) with respect to a device 
shall be deemed a reference or authorization with respect to an in 
vitro clinical test for purposes of this section.
    ``(f) Guidance.--Not later than the date specified for final 
guidance under section 825 of the VALID Act of 2022, the Secretary 
shall issue final guidance on the implementation of this section. Such 
guidance shall--
            ``(1) set forth the process by which a person may seek a 
        designation under subsection (d);
            ``(2) provide a template for request under subsection (d);
            ``(3) identify the criteria the Secretary will use in 
        evaluating a request for designation; and
            ``(4) identify the criteria and processes the Secretary 
        will use to assign a team of staff, including team leaders, to 
        review in vitro clinical tests designated for expedited 
        development and priority review, including any training 
        required for such personnel to ensure effective and efficient 
        review.
    ``(g) Rules of Construction.--Nothing in this section shall be 
construed to affect--
            ``(1) the criteria and standards for evaluating an 
        application pursuant to section 587B or 587D, including the 
        recognition of valid scientific evidence as described in 
        section 587(17) and consideration and application of the least 
        burdensome means described under section 587AA(c);
            ``(2) the authority of the Secretary with respect to 
        clinical holds under section 587R;
            ``(3) the authority of the Secretary to act on an 
        application pursuant to section 587B before completion of an 
        establishment inspection, as the Secretary determines 
        appropriate; or
            ``(4) the authority of the Secretary with respect to 
        postmarket surveillance under sections 587L(d) and 587Y.

``SEC. 587J. REGISTRATION AND LISTING.

    ``(a) Registration Requirement.--
            ``(1) In general.--Each person described in subsection 
        (b)(1) shall--
                    ``(A) during the period beginning on October 1 and 
                ending on December 31 of each year, register with the 
                Secretary the name of such person, places of business 
                of such person, all establishments engaged in the 
                activities specified under this paragraph, the 
                establishment registration number of each such 
                establishment, and a point of contact for each such 
                establishment, including an electronic point of 
                contact; and
                    ``(B) submit an initial registration containing the 
                information required under subparagraph (A) not later 
                than--
                            ``(i) the effective date of this section if 
                        such establishment is engaged in any activity 
                        described in subsection (b)(1) on such 
                        effective date, unless the Secretary 
                        establishes by guidance a date later than such 
                        implementation date for all or a category of 
                        such establishments; or
                            ``(ii) 30 days prior to engaging in any 
                        activity described in subsection (b)(1), if 
                        such establishment is not engaged in any 
                        activity described in this paragraph on such 
                        effective date.
            ``(2) Registration numbers.--The Secretary may assign a 
        registration number to any person or an establishment 
        registration number to any establishment registered in 
        accordance with this section. Registration information shall be 
        made publicly available by publication on the website 
        maintained by the Food and Drug Administration, in accordance 
        with subsection (d).
            ``(3) Inspection.--Each person or establishment that is 
        required to be registered with the Secretary under this section 
        shall be subject to inspection pursuant to section 704.
    ``(b) Listing Information for In Vitro Clinical Tests.--
            ``(1) In general.--Each person who--
                    ``(A) is a developer; and
                    ``(B) introduces or proposes to begin the 
                introduction or delivery for introduction into 
                interstate commerce through an exemption under 
                subsection (a)(1), (a)(2), (a)(3), or (g) of section 
                587C or section 587G or through the filing of an 
                application under section 587B or section 587D,
        shall submit a listing to the Secretary containing the 
        information described in paragraph (2), (4), or (5), as 
        applicable, in accordance with the applicable schedule 
        described under subsection (c). Such listing shall be prepared 
        in such form and manner as the Secretary may specify in 
        guidance. Listing information shall be submitted through the 
        comprehensive test information system in accordance with 
        section 587T, as appropriate.
            ``(2) Submissions.--Each developer submitting a listing 
        under paragraph (1) shall electronically submit to the 
        comprehensive test information system described in section 587T 
        the following information, as applicable, for each in vitro 
        clinical test for which such person is a developer in the form 
        and manner prescribed by the Secretary, taking into account 
        least burdensome principles:
                    ``(A) Name of the establishment and its 
                establishment registration number.
                    ``(B) Contact information for the official 
                correspondent for the listing.
                    ``(C) Name (common name and trade name, if 
                applicable) of the in vitro clinical test and its test 
                listing number (when available).
                    ``(D) The certificate number for any laboratory 
                certified by the Secretary under section 353 of the 
                Public Health Service Act that meets the requirements 
                to perform high-complexity testing and that is the 
                developer of the in vitro clinical test, and the 
                certificate number under such section for any 
                laboratory that is performing the test, is within the 
                same corporate organization, and has common ownership 
                by the same parent corporation.
                    ``(E) Whether the in vitro clinical test is, as 
                applicable, offered as a test approved under section 
                587B, cleared to be offered under a granted technology 
                certification order, or offered as an exempt in vitro 
                clinical test under section 587A.
                    ``(F) Indications for use information under section 
                587(10).
                    ``(G) A brief summary of the analytical and 
                clinical performance of the in vitro clinical test, and 
                as applicable, the lot release criteria.
                    ``(H) A brief description of conformance with any 
                applicable mitigating measures, restrictions, and 
                standards.
                    ``(I) Representative labeling for the in vitro 
                clinical test, as appropriate.
            ``(3) Test listing number.--The Secretary may assign a test 
        listing number to each in vitro clinical test that is the 
        subject of a listing under this section. The process for 
        assigning test listing numbers may be established through 
        guidance, and may include the recognition of standards, 
        formats, or conventions developed by a third-party 
        organization.
            ``(4) Abbreviated listing.--A person who is not a developer 
        but is otherwise required to register pursuant to subsection 
        (a) shall submit an abbreviated listing to the Secretary 
        containing the information described in subparagraphs (A) 
        through (C) of paragraph (2), and the name of the developer. 
        The information shall be submitted in accordance with the 
        applicable schedule described under subsection (c). Such 
        abbreviated listing shall be prepared in such form and manner 
        as the Secretary may specify through guidance. Listing 
        information shall be submitted to the comprehensive test 
        information system in accordance with section 587T, as 
        appropriate.
            ``(5) Grandfathered tests.--A developer offering a test 
        that is a grandfathered in vitro clinical test under section 
        587G(a) shall submit listing information required under 
        subparagraphs (A) through (F) of paragraph (2), and may submit 
        a statement of the performance specifications for such in vitro 
        clinical tests.
            ``(6) Exempt tests.--A developer of an in vitro clinical 
        test who introduces or proposes to begin the introduction or 
        delivery for introduction into interstate commerce that is 
        otherwise exempt from the requirement to submit listing 
        information pursuant to an exemption under section 587C may 
        submit listing information under this subsection.
    ``(c) Timelines for Submission of Listing Information.--
            ``(1) In general.--The timelines for submission of 
        registration and listing under subsections (a) and (b) are as 
        follows:
                    ``(A) For an in vitro clinical test that was listed 
                as a device under section 510(j) prior to the effective 
                date of this section, a person shall maintain a device 
                listing under section 510 until such time as the system 
                for submitting the listing information required under 
                subsection (b) becomes available and thereafter shall 
                submit the listing information not later than the later 
                of 1 year after the system for submitting the listing 
                under this section becomes available or the effective 
                date of this section.
                    ``(B) For an in vitro clinical test that is subject 
                to grandfathering under section 587G(a) a person shall 
                submit the listing information required under 
                subsection (b)(5) not later that the later of 1 year 
                after the system for submitting the listing under this 
                section becomes available or the effective date of this 
                section.
                    ``(C) For an in vitro clinical test that is not 
                described in subparagraph (A) or (B), a person shall 
                submit the required listing information as follows:
                            ``(i) For an in vitro clinical test that is 
                        not exempt from premarket approval under 
                        section 587B, a person shall submit the 
                        required listing information, prior to offering 
                        the in vitro clinical test and not later than 
                        30 business days after the date of approval of 
                        the premarket approval application.
                            ``(ii) For an in vitro clinical test that 
                        is exempt from premarket review under section 
                        587C, the required listing information shall be 
                        submitted prior to offering the in vitro 
                        clinical test.
            ``(2) Updates.--
                    ``(A) Updates after changes.--Each developer 
                required to submit listing information under this 
                section shall update such information within 10 
                business days of any change that causes any previously 
                listed information to be inaccurate or incomplete.
                    ``(B) Annual updates.--Each developer required to 
                submit listing information under this section shall 
                update its information annually during the period 
                beginning on October 1 and ending on December 31 of 
                each year.
    ``(d) Public Availability of Listing Information.--
            ``(1) In general.--Listing information submitted pursuant 
        to this section shall be made publicly available on the website 
        of the Food and Drug Administration in accordance with 
        paragraph (3).
            ``(2) Confidentiality.--Listing information for an in vitro 
        clinical test that is subject to premarket approval or 
        technology certification shall remain confidential until such 
        date as the in vitro clinical test receives the applicable 
        premarket approval or the developer receives a technology 
        certification order and for subsequent tests introduced under a 
        technology certification order until their introduction.
            ``(3) Exceptions from public availability requirements.--
        The public listing requirements of this subsection shall not 
        apply to any registration and listing information submitted 
        under subsection (a) or (b), if the Secretary determines that 
        such information--
                    ``(A) is a trade secret or confidential commercial 
                information; or
                    ``(B) if posted, would present a risk to national 
                security.
    ``(e) Submission of Information by Accredited Persons.--If agreed 
upon by the developer, the information required under this section may 
be submitted by a person accredited under section 587Q.

``SEC. 587K. TEST DESIGN AND QUALITY REQUIREMENTS.

    ``(a) Applicability.--
            ``(1) In general.--Each developer and each other person 
        required to register under section 587I(b)(1) shall establish 
        and maintain quality requirements in accordance with the 
        applicable requirements set forth in subsection (b).
            ``(2) Certified laboratory requirements.--A developer shall 
        establish and maintain quality requirement under subsection 
        (b)(2) or (b)(3), as applicable, if such developer is a 
        clinical laboratory certified by the Secretary under section 
        353 of the Public Health Service Act that--
                    ``(A) is certified to perform high-complexity 
                testing;
                    ``(B) develops an in vitro clinical test that is 
                for use only--
                            ``(i) within the laboratory certified by 
                        the Secretary under such section 353 in which 
                        such test was developed; or
                            ``(ii) within another laboratory certified 
                        by the Secretary under such section 353 if such 
                        laboratory is--
                                    ``(I) within the same corporate 
                                organization and has common ownership 
                                by the same parent corporation as the 
                                laboratory in which the test was 
                                developed; or
                                    ``(II) within a public health 
                                laboratory network coordinated or 
                                managed by the Centers for Disease 
                                Control and Prevention, if the test is 
                                developed by a public health laboratory 
                                or the Centers for Disease Control and 
                                Prevention; and
                    ``(C) does not manufacture, produce, or distribute 
                in vitro clinical tests other than laboratory test 
                protocols.
            ``(3) Regulations.--The Secretary shall promulgate quality 
        system regulations implementing this section. In promulgating 
        such regulations under this section, the Secretary shall 
        consider whether, and to what extent, international 
        harmonization is appropriate.
            ``(4) Quality systems for hybrid developers of both 
        laboratory test protocols and other in vitro clinical tests.--
        An entity that develops both finished products and laboratory 
        test protocols and other in vitro clinical tests shall comply 
        with subsection (b)(1) for activities related to the 
        development of any in vitro clinical test that is not a 
        laboratory test protocol product and with subsection (b)(2) or 
        (b)(3), as applicable, for activities related to the 
        development of any laboratory test protocol.
    ``(b) Quality Requirements.--
            ``(1) In general.--The quality requirements applicable 
        under this section shall--
                    ``(A) avoid duplication of regulations under 
                section 353 of the Public Health Service Act; and
                    ``(B) shall include the following, as applicable, 
                subject to subparagraph (A) and paragraphs (2) and 
                (3)--
                            ``(i) management responsibilities;
                            ``(ii) quality audits;
                            ``(iii) personnel;
                            ``(iv) design controls;
                            ``(v) document controls;
                            ``(vi) purchasing controls;
                            ``(vii) identification and traceability;
                            ``(viii) production and process controls;
                            ``(ix) acceptance activities;
                            ``(x) nonconforming in vitro clinical 
                        tests;
                            ``(xi) corrective and preventive action;
                            ``(xii) labeling and packaging controls;
                            ``(xiii) handling, storage, distribution, 
                        and installation;
                            ``(xiv) complaints and records;
                            ``(xv) servicing; and
                            ``(xvi) statistical techniques.
            ``(2) Exception for laboratory test protocols.--Developers 
        that are developing test protocols for use as described in 
        subsection (a)(2)(B)(i) are exempt from the requirements under 
        paragraph (1)(B) except for the requirements described in 
        clauses (iv), (vi), (ix), (xi), and (xiv) of such paragraph.
            ``(3) Quality requirements for certain laboratories 
        distributing laboratory test protocols within organizations or 
        public health networks.--Quality requirements applicable to the 
        developer who is distributing a laboratory test protocol as 
        described in subsection (a)(2)(B)(ii) shall consist of the 
        following:
                    ``(A) Clauses (iv), (vi), (ix), (xi), (xiv), (xii) 
                of paragraph (1)(B).
                    ``(B) The requirement to maintain records of the 
                laboratories to which the laboratory test protocol is 
                distributed.
    ``(c) Regulations.--In implementing quality requirements for test 
developers that participate in international audit programs under this 
section, the Secretary shall--
            ``(1) for purposes of facilitating international 
        harmonization, consider whether the developer participates in 
        an international audit program in which the United States 
        participates and recognizes compliance with, or conformance to, 
        such standards recognized by the Secretary; and
            ``(2) ensure a least burdensome approach described in 
        section 587AA(c) by leveraging, to the extent applicable, the 
        quality assurance requirements applicable to developers 
        certified by the Secretary under section 353 of the Public 
        Health Service Act.

``SEC. 587L. LABELING REQUIREMENTS.

    ``(a) In General.--An in vitro clinical test shall bear or be 
accompanied by labeling, as applicable, that meets the requirements set 
forth in subsections (b) and (c), unless such test is exempt under 
subsection (d) or (e).
    ``(b) Labels.--
            ``(1) In general.--The label of an in vitro clinical test, 
        shall meet the requirements set forth in paragraph (2) if there 
        is an immediate container to which the label is applied.
            ``(2) Regulations.--The label of an in vitro clinical test 
        shall state the name and place of business of its developer and 
        meet the requirements set forth in regulations promulgated in 
        accordance with this section.
    ``(c) Labeling.--
            ``(1) In general.--Labeling of an in vitro clinical test, 
        including labeling in the form of a package insert, website, 
        standalone laboratory reference document, or other similar 
        document shall include--
                    ``(A) adequate directions for use and shall meet 
                the requirements set forth in regulations promulgated 
                under this section, except as provided in subsection 
                (d) or (e); and
                    ``(B) the information described in paragraph (2), 
                as applicable.
            ``(2) Content.--Labeling of an in vitro clinical test shall 
        include--
                    ``(A) the test listing number that was provided to 
                the developer at the time of listing;
                    ``(B) information to facilitate reporting an 
                adverse event;
                    ``(C) information regarding accessing the 
                performance summary data displayed in the listing 
                database for the test;
                    ``(D) the indications of use of the in vitro 
                clinical test; and
                    ``(E) any warnings, contraindications, or 
                limitations.
            ``(3) Public availability of information.--The Secretary 
        shall make all of the information described in paragraph (2) 
        with respect to each in vitro clinical test available to the 
        public, as applicable, in accordance with section 587T, except 
        to the extent that the Secretary determines that such 
        information--
                    ``(A) is trade secret or confidential commercial 
                information; or
                    ``(B) if posted, would present a risk to national 
                security.
            ``(4) Additional requirements.--Labeling for an in vitro 
        clinical test used for immunohematology testing shall meet the 
        applicable requirements set forth in part 660 of title 21, Code 
        of Federal Regulations (or any successor regulations), related 
        to the labeling of blood grouping reagents, reagent red blood 
        cells, and anti-human globulin.
    ``(d) Exemptions and Alternative Requirements.--
            ``(1) In general.--
                    ``(A) In general.--With respect to an in vitro 
                clinical test that meets the criteria of subparagraph 
                (B), the `state in one place' regulations under section 
                809.10(b) of title 21, Code of Federal Regulations (or 
                any successor regulations) may be satisfied by the 
                laboratory posting such information on its website or 
                in multiple documents, if such documents are maintained 
                and accessible in one place.
                    ``(B) Applicable tests.--An in vitro clinical test 
                meets the criteria of this subparagraph if such test 
                is--
                            ``(i) developed by a laboratory certified 
                        by the Secretary under section 353 of the 
                        Public Health Service Act that meets the 
                        requirements to perform tests of high-
                        complexity; and
                            ``(ii) performed in--
                                    ``(I) the same laboratory in which 
                                such test was developed; or
                                    ``(II) by another laboratory 
                                certified by the Secretary under 
                                section 353 of the Public Health 
                                Service Act that--
                                            ``(aa) meets the 
                                        requirements to perform tests 
                                        of high complexity; and
                                            ``(bb) is under common 
                                        ownership and control as the 
                                        laboratory that developed the 
                                        test.
            ``(2) Test instrument labeling.--Unless the instrument is 
        the entire test system, the labeling for an instrument is not 
        required to bear the information indicated in paragraphs (3), 
        (4), (5), (7), (8), (9), (10), (11), (12), and (13) of section 
        809.10(b) of title 21, Code of Federal Regulations (or any 
        successor regulations).
            ``(3) Reagent labeling.--For purposes of compliance with 
        subsection (c)(1), the labeling for a reagent intended for use 
        as a replacement in an in vitro clinical test may be limited to 
        that information necessary to identify the reagent adequately 
        and to describe its proper use in the test.
            ``(4) Investigational use.--A shipment or other delivery of 
        an in vitro clinical test for investigational use pursuant to 
        section 587S shall be exempt from the labeling requirements of 
        subsections (b) and (c)(1) and from any standard promulgated 
        through regulations, except as required under section 353 of 
        the Public Health Service Act or section 587R of this Act.
            ``(5) General purpose laboratory reagents.--The labeling of 
        general purpose laboratory reagents (such as hydrochloric acid) 
        whose uses are generally known by persons trained in their use 
        need not bear the directions for use required by subsection 
        (c)(1)(A).
            ``(6) Over-the-counter test specimen receptacle labeling.--
        The labeling for over-the-counter test specimen receptacles for 
        drugs of abuse testing shall bear the name and place of 
        business of the developer included in the registration under 
        section 587J and any information specified in applicable 
        regulations promulgated under this section, in language 
        appropriate for the intended users.
    ``(e) Tests in the Strategic National Stockpile.--
            ``(1) In general.--The Secretary may grant an exception or 
        alternative to any provision listed in this section, unless 
        explicitly required by a statutory provision outside this 
        subchapter, for specified lots, batches, or other units of an 
        in vitro clinical test, if the Secretary determines that 
        compliance with such labeling requirement could adversely 
        affect the availability of such products that are, or will be, 
        included in the Strategic National Stockpile under section 
        319F-2 of the Public Health Service Act.
            ``(2) Regulations.--The Secretary may issue regulations 
        amending section 809.11 of title 21, Code of Federal 
        Regulations (or any successor regulation) to apply in full or 
        in part to in vitro clinical tests and in vitro clinical test 
        developers.
    ``(f) Regulations.--The Secretary shall issue or revise regulations 
related to standardized, general content and format for in vitro 
clinical test labeling pursuant to this subsection.

``SEC. 587M. ADVERSE EVENT REPORTING.

    ``(a) In General.--Each in vitro clinical test developer shall 
establish and maintain a system for establishing and maintaining 
records of adverse events and reporting adverse events in accordance 
with this section.
    ``(b) Submission of Individual Reports.--A developer shall submit 
an individual adverse event not later than 5 calendar days after the 
developer receives or becomes aware of an adverse event that reasonably 
suggests that an in vitro clinical test may--
            ``(1) have caused or contributed to a patient or user 
        death; or
            ``(2) present an imminent threat to public health.
    ``(c) Submission of Quarterly Reports.--As applicable, a developer 
shall submit quarterly reports that include any in vitro clinical test 
errors and serious injuries that occurred during the applicable 
quarter. Such quarterly reports shall be submitted not later than the 
end of the quarter following the quarter in which the developer 
receives or becomes aware of such adverse events.
    ``(d) Definitions.--For the purposes of this section--
            ``(1) the term `in vitro clinical test error' means a 
        failure of an in vitro clinical test to meet its performance 
        specifications, or to otherwise perform as intended by the 
        developer, including an inaccurate result resulting from such 
        failure; and
            ``(2) the term `serious injury' means--
                    ``(A) a significant delay in a diagnosis that 
                results in the absence, delay, or discontinuation of 
                critical medical treatment or that irreversibly or 
                seriously and negatively alters the course of a disease 
                or condition; or
                    ``(B) an injury that--
                            ``(i) is life threatening;
                            ``(ii) results in permanent impairment of a 
                        body function or permanent damage to a body 
                        structure; or
                            ``(iii) necessitates medical or surgical 
                        intervention to preclude permanent impairment 
                        of a body function or permanent damage to a 
                        body structure.
    ``(e) Regulations.--The Secretary shall promulgate regulations to 
implement this section.

``SEC. 587N. CORRECTIONS AND REMOVALS.

    ``(a) Regulations.--The Secretary shall promulgate regulations, or 
amend existing regulations, as appropriate, to implement this section.
    ``(b) Reports of Corrections and Removals.--
            ``(1) In general.--Each in vitro clinical test developer 
        shall report to the Secretary any correction or removal of an 
        in vitro clinical test undertaken by such developer if the 
        correction or removal was undertaken--
                    ``(A) to reduce the risk to health posed by the in 
                vitro clinical test; or
                    ``(B) to remedy a violation of this Act caused by 
                the in vitro clinical test which may present a risk to 
                health.
            ``(2) Exception for in vitro clinical tests offered under a 
        technology certification order.--For any eligible test offered 
        under a technology certification order under section 587D, a 
        correction and removal report for any correction or removal of 
        an in vitro clinical test should demonstrate that the issue or 
        issues causing the correction or removal do not adversely 
        impact the ability of other in vitro clinical tests offered 
        under the same technology certification order to meet the 
        applicable standard.
    ``(c) Timing.--A developer shall submit any report required under 
this subsection to the Secretary within 15 business days of initiating 
such correction or removal.
    ``(d) Recordkeeping.--A developer of an in vitro clinical test that 
undertakes a correction or removal of an in vitro clinical test which 
is not required to be reported under this subsection shall keep a 
record of such correction or removal.
    ``(e) Recall Communications.--Upon the voluntary reporting of a 
correction or removal by the developer--
            ``(1) the Secretary shall classify such correction or 
        removal under this section within 15 calendar days; and
            ``(2) not later than 45 calendar days after the developer 
        or other responsible party notifies the Secretary that it has 
        completed a recall action, the Secretary shall provide the 
        developer or other responsible party with a written statement 
        closing the recall action or stating the reasons the Secretary 
        cannot close the recall at that time.

``SEC. 587O. RESTRICTED IN VITRO CLINICAL TESTS.

    ``(a) Applicability.--
            ``(1) In general.--For the types of in vitro clinical tests 
        described in paragraph (3) the Secretary may require, in 
        issuing an approval of an in vitro clinical test under section 
        587B, granting a technology certification order under section 
        587D, or in issuing a determination under section 587F(a), or 
        by issuing a regulation, that such test, or category of tests, 
        be restricted to sale, distribution, or use upon such 
        conditions as the Secretary may prescribe under paragraph (2).
            ``(2) Conditions.-- The Secretary may prescribe conditions 
        under this section, based on available evidence, with respect 
        to an in vitro clinical test described in paragraph (3), that 
        are determined to be needed due to the potential for harmful 
        effect of such test (including any resulting absence, 
        significant delay, or discontinuation of appropriate medical 
        treatment), and are necessary to ensure that the test meets the 
        applicable standard.
            ``(3) In vitro clinical tests subject to restrictions.--The 
        restrictions or conditions authorized under this section may be 
        applied by the Secretary to any high-risk or moderate-risk in 
        vitro clinical test, prescription home-use in vitro clinical 
        test, direct-to-consumer in vitro clinical test, or over-the-
        counter in vitro clinical test.
    ``(b) Labeling and Advertising of a Restricted in Vitro Clinical 
Test.--The labeling and advertising of an in vitro clinical test to 
which restrictions apply under subsection (a) shall bear such 
appropriate statements of the restrictions as the Secretary may 
prescribe in an approval under section 587B, an order under section 
587D, a determination under section 587F(a), or in regulation, as 
applicable.
    ``(c) Device Restrictions.--An in vitro clinical test that was 
offered as a restricted device prior to the date of enactment of this 
subchapter--
            ``(1) shall continue to comply with the applicable 
        restrictions under section 515 or section 520(e) until the this 
        subchapter takes effect; and
            ``(2) except for in vitro clinical tests required to meet 
        section 809.30 of title 21, Code of Federal Regulations prior 
        to the effective date of this subchapter specified in section 
        825(a)(1)(A) of the VALID Act of 2022, such restrictions shall 
        be deemed to be restrictions under this Act as of such 
        effective date.

``SEC. 587P. APPEALS.

    ``(a) Significant Decision.--
            ``(1) In general.--The Secretary shall maintain a 
        substantive summary of the scientific and regulatory rationale 
        for any significant decision of the Food and Drug 
        Administration pursuant to section 587F, regarding--
                    ``(A) the submission of an application for, or a 
                review of, an in vitro clinical test under section 587B 
                or section 587D;
                    ``(B) an exemption under section 587C; or
                    ``(C) any requirements for mitigation measures to 
                an in vitro clinical test or category of in vitro 
                clinical tests.
        Such summaries shall include documentation of significant 
        controversies or differences of opinion and the resolution of 
        such controversies or differences of opinion.
            ``(2) Provision of documentation.--Upon request, the 
        Secretary shall furnish a substantive summary described in 
        paragraph (1) to the person who has made, or is seeking to 
        make, a submission described in such paragraph.
            ``(3) Application of least burdensome requirements.--The 
        substantive summary required under this subsection shall 
        include a brief statement regarding how the least burdensome 
        requirements were considered and applied consistent with 
        section 587AA(c), as applicable.
    ``(b) Review of Significant Decisions.--
            ``(1) Request for supervisory review of significant 
        decision.--A developer may request a supervisory review of the 
        significant decision described in subsection (a)(1). Such 
        review may be conducted at the next supervisory level or higher 
        above the agency official who made the significant decision.
            ``(2) Submission of request.--A developer requesting a 
        supervisory review under paragraph (1) shall submit such 
        request to the Secretary not later than 30 days after the 
        decision for which the review is requested and shall indicate 
        in the request whether such developer seeks an in-person 
        meeting or a teleconference review.
            ``(3) Timeframe.--The Secretary shall schedule an in-person 
        or teleconference review, if so requested, not later than 30 
        days after such request is made. The Secretary shall issue a 
        decision to the developer requesting a review under this 
        subsection not later than 45 days after the request is made 
        under paragraph (1), or, in the case of a developer who 
        requests an in-person meeting or teleconference, 30 days after 
        such meeting or teleconference.
    ``(c) Advisory Panels.--The process established under subsection 
(a) shall permit the appellant to request review by an advisory 
committee established under section 587G when there is a dispute 
involving substantial scientific fact. If an advisory panel meeting is 
held, the Secretary shall make a determination under this subsection 
not later than 45 days after the requested advisory committee meeting 
has concluded.
    ``(d) Least Burdensome Review.--Any developer who has submitted an 
application under section 587B or 587D may request a supervisory review 
of a request for additional information during an evaluation of such 
submission within 60 calendar days of receipt of the additional 
information request from the Secretary.
    ``(e) Availability of All Remedies.--The procedures set forth in 
this section shall be in addition to, and not in lieu of, other 
remedies available to the developer.

``SEC. 587Q. ACCREDITED PERSONS.

    ``(a) In General.--
            ``(1) Authorization.--Beginning on the date of enactment of 
        the VALID Act of 2022, the Secretary shall accredit persons for 
        any of the following purposes:
                    ``(A) Reviewing applications for premarket approval 
                under section 587B and making findings with respect to 
                such applications.
                    ``(B) Reviewing applications for technology 
                certification under section 587D and making 
                recommendations to the Secretary with respect to such 
                applications.
                    ``(C) Conducting inspections as specified in 
                subsection (c) of in vitro clinical test developers and 
                other persons required to register pursuant to section 
                587I.
            ``(2) Persons submitting applications.--A person submitting 
        an application for premarket approval under section 587B or an 
        application for technology certification under section 587D may 
        submit such application to the Secretary or to a person 
        accredited pursuant to subparagraph (A) or (B) of paragraph 
        (1).
    ``(b) Accredited Persons Application Reviews, Findings and 
Recommendations.--
            ``(1) Requirements for premarket application.--
                    ``(A) Review and finding requirements.--An 
                accredited person receiving an application for 
                premarket approval under section 587B shall either--
                            ``(i) provide to the Secretary, together 
                        with the application for premarket approval 
                        submitted by the applicant, a finding that the 
                        criteria for approval of the application under 
                        section 587B(g)(2)(A) are met and issue a copy 
                        of such finding to the applicant, which finding 
                        shall plainly state--
                                    ``(I) the basis for the accredited 
                                person's finding that the criteria 
                                under section 587B(g)(2)(A) are met; 
                                and
                                    ``(II) any proposed restrictions, 
                                mitigating measures, or conditions of 
                                approval under section 587B(g)(2)(B), 
                                as applicable; or
                            ``(ii) provide a notification to the 
                        applicant that the accredited person cannot 
                        find that the criteria for approval of the 
                        application under section 587B(g)(2)(A) are met 
                        and the reasons for such decision.
                    ``(B) Requesting missing or clarifying 
                information.--After receipt of an application under 
                this section, the Secretary may request missing or 
                clarifying information from the applicant concerning 
                the application, which the applicant shall promptly 
                provide.
                    ``(C) Secretary action on finding that approval 
                criteria are met.--If the accredited person transmits a 
                finding to the Secretary under clause (i) of 
                subparagraph (A), then prior to the date that is 45 
                calendar days after the transmittal date the Secretary 
                shall--
                            ``(i) approve the application for premarket 
                        approval under section 587B(g)(2) with 
                        appropriate restrictions, mitigating measures, 
                        or conditions of approval, as applicable; or
                            ``(ii) deny approval of the application by 
                        issuing a written notice that reflects 
                        appropriate management input and concurrence to 
                        the accredited person and the applicant 
                        detailing the scientific basis for the 
                        Secretary's determination that the criteria for 
                        issuance of an approval under section 
                        587B(g)(2)(A) have not been met.
                    ``(D) Effect of inaction on finding.--If the 
                Secretary fails to take an action under subparagraph 
                (C) the Secretary shall--
                            ``(i) within 45 calendar days after the 
                        transmittal date, provide written feedback to 
                        the applicant that--
                                    ``(I) includes all outstanding 
                                issues with the application preventing 
                                the Secretary from taking an action 
                                under subparagraph (B);
                                    ``(II) reflects appropriate 
                                management input and concurrence; and
                                    ``(III) includes action items for 
                                the Secretary, the applicant, or both, 
                                as appropriate, with an estimated date 
                                of completion for the Secretary and the 
                                applicant to complete their respective 
                                tasks, as applicable; and
                            ``(ii) promptly schedule a meeting or 
                        teleconference to discuss the feedback provided 
                        under clause (i), unless the Secretary and 
                        applicant agree that the outstanding issues are 
                        adequately presented through written 
                        correspondence and a meeting or teleconference 
                        is not necessary.
            ``(2) Requirements for technology certification.--
                    ``(A) Review and recommendation requirements.--An 
                accredited person receiving an application for 
                technology certification under section 587D shall 
                either--
                            ``(i) provide to the Secretary, together 
                        with the application for technology 
                        certification submitted by the applicant, a 
                        recommendation that the criteria for issuance 
                        of a technology certification order under 
                        section 587D(f)(3) are met and issue a copy of 
                        such recommendation to the applicant, which 
                        recommendation shall plainly state the basis 
                        for the accredited person's recommendation that 
                        the criteria under section 587D(f)(3) are met; 
                        or
                            ``(ii) provide a notification to the 
                        applicant that the accredited person cannot 
                        recommend that the criteria for issuance of a 
                        technology certification order under section 
                        587D(f)(3) are met and the reasons for such 
                        decision.
                    ``(B) Requesting missing or clarifying 
                information.--After receipt of an application under 
                this section, the Secretary may request missing or 
                clarifying information from the applicant concerning 
                the application, which the applicant shall promptly 
                provide.
                    ``(C) Secretary action on recommendation for 
                issuance of a technology certification order.--If the 
                accredited person transmits a recommendation to the 
                Secretary under clause (i) of subparagraph (A), then 
                prior to the date that is 60 calendar days after the 
                transmittal date the Secretary shall--
                            ``(i) issue the technology certification 
                        order under section 587D(f)(3), consistent with 
                        such recommendation from the accredited person; 
                        or
                            ``(ii) deny approval of the application by 
                        issuing a written notice to the accredited 
                        person and the applicant detailing the 
                        scientific basis for a determination by the 
                        Secretary that the criteria for issuance of a 
                        technology certification order under section 
                        587D(f)(3) have not been met.
    ``(c) Requirements for Inspections.--
            ``(1) In general.--When conducting inspection, persons 
        accredited under subparagraph (a)(1)(B) shall record in writing 
        their specific observations and shall present their 
        observations to the designated representative of the inspected 
        establishment.
            ``(2) Inspection report requirements.--Each person 
        accredited under this subparagraph (a)(1)(C) shall prepare and 
        submit to the Secretary an inspection report in a form and 
        manner designated by the Secretary for conducting inspections. 
        Any statement or representation made by an employee or agent of 
        an establishment to a person accredited to conduct inspections 
        under subparagraph (a)(1)(C) shall be subject to section 1001 
        of title 18, United States Code.
            ``(3) Savings clause.--Nothing in this section affects the 
        authority of the Secretary to inspect any in vitro clinical 
        test developer or other person registered under section 587I or 
        recognize inspections conducted by auditing organizations as 
        described under section 704(g)(15).
            ``(4) Inspection limitations.--The Secretary shall ensure 
        that inspections carried out under this section are not 
        duplicative of inspections carried out under section 353 of the 
        Public Health Service Act. Inspections under this section shall 
        be limited to the data and information necessary--
                    ``(A) for routine surveillance activities of 
                facilities associated with an approved application 
                under section 587B or issuance of a technology 
                certification order under section 587D; or
                    ``(B) to meet the requirements for premarket 
                approval under section 587B or issuance of a technology 
                certification order under section 587D, as applicable.
    ``(d) Accreditation.--
            ``(1) Accreditation program.--The Secretary may provide for 
        accreditation under this section through programs administered 
        by the Food and Drug Administration, by other non-Federal 
        government agencies, or by qualified nongovernmental 
        organizations. A person may be accredited for the review of 
        applications submitted under sections 587B as described in 
        subsection (a)(1)(A), for the review of applications submitted 
        under section 587D as described in subsection (a)(1)(B) and to 
        conduct inspection activities under subsection (a)(1)(C), or 
        for a subset of such reviews or activities.
            ``(2) Eligible persons.--
                    ``(A) Minimum qualifications.--An accredited 
                person, at a minimum, shall--
                            ``(i) not be an employee of the Federal 
                        Government;
                            ``(ii) not engage in the activities of a 
                        developer, as defined in section 587(7);
                            ``(iii) not be a person required to 
                        register under section 587I, unless such person 
                        has established sufficient processes and 
                        protocols to separate activities to develop in 
                        vitro clinical tests and the activities for 
                        which such person would be accredited under 
                        subsection (a) and discloses applicable 
                        information under this section;
                            ``(iv) not be owned or controlled by, and 
                        shall have no organizational, material, or 
                        financial affiliation with, an in vitro 
                        clinical test developer or other person 
                        required to register under section 587I;
                            ``(v) be a legally constituted entity 
                        permitted to conduct the activities for which 
                        it seeks accreditation;
                            ``(vi) ensure that the operations of such 
                        person are in accordance with generally 
                        accepted professional and ethical business 
                        practices; and
                            ``(vii) include in its request for 
                        accreditation a commitment to, at the time of 
                        accreditation and at any time it is performing 
                        activities pursuant to this section--
                                    ``(I) certify that the information 
                                reported to the Secretary accurately 
                                reflects the data or protocol reviewed, 
                                and the documented inspection findings, 
                                as applicable;
                                    ``(II) limit work to that for which 
                                competence and capacity are available;
                                    ``(III) treat information received 
                                or learned, records, reports, and 
                                recommendations as proprietary 
                                information of the person submitting 
                                such information; and
                                    ``(IV) in conducting the activities 
                                for which the person is accredited in 
                                respect to a particular in vitro 
                                clinical test, protect against the use 
                                of any employee or consultant who has a 
                                financial conflict of interest 
                                regarding that in vitro clinical test.
                    ``(B) Waiver.--The Secretary may waive any 
                requirements in clauses (i), (ii), (iii), or (iv) of 
                subparagraph (A) upon making a determination that such 
                person has implemented other appropriate controls 
                sufficient to ensure a competent and impartial review.
            ``(3) Accreditation process.--
                    ``(A) Accreditation process guidance and 
                regulations.--Not later than 180 days after the date of 
                enactment of the VALID Act of 2022, the Secretary shall 
                issue draft guidance specifying the process for 
                submitting a request for accreditation and 
                reaccreditation under this section, including the form 
                and content of information to be submitted, including 
                the criteria that the Secretary will consider to 
                accredit or deny accreditation and, not later than 1 
                year after the close of the comment period for the 
                draft guidance, issue final guidance.
                    ``(B) Response to request.--The Secretary shall 
                respond to a request for accreditation or 
                reaccreditation within 60 calendar days of the receipt 
                of the request. The Secretary's response may be to 
                accredit or reaccredit the person, to deny 
                accreditation, or to request additional information in 
                support of the request. If the Secretary requests 
                additional information, the Secretary shall respond 
                within 60 calendar days of receipt of such additional 
                information to accredit or deny the accreditation.
                    ``(C) Type of accreditation.--The accreditation or 
                reaccreditation of a person shall specify the 
                particular activity or activities under subsection (a) 
                for which such person is accredited, and shall include 
                any limitation to certain eligible in vitro clinical 
                tests.
                    ``(D) Public list.--The Secretary shall publish on 
                the website of the Food and Drug Administration a list 
                of persons who are accredited under this section. Such 
                list shall be updated on at least a monthly basis. The 
                list shall specify the particular activity or 
                activities under this section for which the person is 
                accredited.
                    ``(E) Audit.--The Secretary may audit the 
                performance of persons accredited under this section 
                for purposes of ensuring that such persons continue to 
                meet the published criteria for accreditation, and may 
                modify the scope or particular activities for which a 
                person is accredited if the Secretary determines that 
                such person fails to meet one or more criteria for 
                accreditation.
                    ``(F) Suspension or withdrawal.--The Secretary may 
                suspend or withdraw accreditation of any person 
                accredited under this section, after providing notice 
                and an opportunity for an informal hearing, when such 
                person is substantially not in compliance with the 
                requirements of this section or the published criteria 
                for accreditation, or poses a threat to public health, 
                or fails to act in a manner that is consistent with the 
                purposes of this section.
                    ``(G) Reaccreditation.--Accredited persons may be 
                initially accredited for up to 3 years. After 
                expiration of such initial period, persons may be 
                reaccredited for unlimited additional 35-year periods, 
                as determined by the Secretary.
    ``(e) Compensation of Accredited Persons.--Compensation of an 
accredited person shall be determined by agreement between the 
accredited person and the person who engages the services of the 
accredited person, and shall be paid by the person who engages such 
services.
    ``(f) International Harmonization.--Notwithstanding any other 
provision of this section, to facilitate international harmonization 
the Secretary may recognize persons accredited or recognized by 
governments, who have also entered into information sharing agreements, 
including confidentiality commitments, with the Commissioner of Food 
and Drugs.
    ``(g) Information Sharing Agreements.--An accredited person may 
enter into an agreement with a test developer to provide information to 
the comprehensive test information system under section 587T, including 
any requirements under section 587I.
    ``(h) Reports.--Not later than 2 years after the effective date of 
the VALID Act of 2022, and annually thereafter for the next 4 years, 
the Secretary shall post on the website of the Food and Drug 
Administration, a report describing the Secretary's performance in 
implementing this section, including the Secretary's progress in 
minimizing duplicative reviews of applications for which an accredited 
person finds the criteria for approval are met. Such reports shall 
include, for each period--
            ``(1) with regard to premarket approval applications--
                    ``(A) the total number of findings transmitted to 
                the Secretary under subsection (b)(1)(A)(i);
                    ``(B) the total number of determinations made by 
                the Secretary under subsection (b)(1)(B)(i) within 30 
                calendar days of the transmittal date to approve an 
                application;
                    ``(C) the total number of determinations made by 
                the Secretary under subsection (b)(1)(B)(ii) within 30 
                calendar days of the transmittal date to deny approval 
                of an application; and
                    ``(D) the total number of applications that were 
                approved and the total number of applications that were 
                denied approval, after the Secretary failed to make a 
                determination within 30 calendar days of the 
                transmittal date under subsection (b)(1)(B); and
            ``(2) with regard to applications for technology 
        certification--
                    ``(A) the total number of recommendations 
                transmitted to the Secretary under subsection 
                (b)(2)(A)(i);
                    ``(B) the total number of determinations made by 
                the Secretary under subsection (b)(2)(B)(i) to issue a 
                technology certification order, including 
                determinations made within 30 days of the transmittal 
                date;
                    ``(C) the total number of determinations made by 
                the Secretary under subsection (b)(2)(B)(ii) to deny 
                the application for technology certification, including 
                determinations made within 30 calendar days of the 
                transmittal date; and
                    ``(D) the total number of technology certification 
                orders issued, and the total number of applications for 
                technology certification that were denied, including 
                applications denied after the Secretary failed to make 
                a determination within 30 calendar days of the 
                transmittal date under subsection (b)(2)(B).

``SEC. 587R. RECOGNIZED STANDARDS.

    ``(a) In General.--The Secretary may recognize all or part of 
appropriate standards established by nationally or internationally 
recognized standards development organizations for which a person may 
submit a declaration of conformity in order to meet a requirement under 
this subchapter to which that standard is applicable. Standards for in 
vitro diagnostic devices previously recognized under section 514(c) 
shall be considered recognized standards under this section. Recognized 
and proposed standards shall be accessible to the public at no charge. 
The application of any such consensus standard shall only apply 
prospectively. The Secretary shall issue regulations establishing the 
criteria and process, for such recognition and adoption.
    ``(b) Amendment Process.--The procedures established in this 
section or in regulation or guidance issued under this section shall 
apply to amendment of an existing standard.

``SEC. 587S. INVESTIGATIONAL USE.

    ``(a) In General.--Subject to the conditions prescribed in 
subsections (c), (d), (e), (f), and (g) of this section, an in vitro 
clinical test for investigational use shall be exempt from the 
requirements of this subchapter other than sections 587A, 587P, 587T, 
and 587V. The Secretary may amend parts 50, 54, and 56 of title 21 of 
the Code of Federal Regulations, or any successor regulations, to apply 
to in vitro clinical tests to permit the investigational use of such 
tests by experts qualified by scientific training and experience.
    ``(b) Regulations.--
            ``(1) In general.--Not later than 2 years after the date of 
        enactment of the VALID Act of 2022, the Secretary shall 
        promulgate regulations, or amend existing regulations, to 
        implement this section.
            ``(2) Variation.--The requirements in the regulations 
        promulgated under this section shall take into account 
        variations based on--
                    ``(A) the scope and duration of clinical testing to 
                be conducted under investigation that is the subject of 
                such application;
                    ``(B) the number of human subjects that are to be 
                involved in such testing;
                    ``(C) the need to permit changes to be made to the 
                in vitro clinical test involved during testing 
                conducted in accordance with a plan required under 
                subsection (c)(5); or
                    ``(D) whether the clinical testing of such in vitro 
                clinical test is for the purpose of developing data to 
                obtain approval to offer such test.
    ``(c) Application for Investigational Use.--The following shall 
apply with respect to in vitro clinical tests for investigational use:
            ``(1) Significant risk and other studies.--In the case of 
        an in vitro clinical test the investigational use of which 
        poses a significant risk to the human subject, a sponsor of an 
        investigation of such a test seeking an investigational use 
        exemption shall submit to the Secretary an investigational use 
        application with respect to the in vitro clinical test in 
        accordance with paragraphs (3) and (4). For purposes of this 
        subparagraph, the term `significant risk' means, with respect 
        to an in vitro clinical test and that the use of such in vitro 
        clinical test--
                    ``(A) is of substantial importance in performing an 
                activity or activities described in section 201(ss)(1) 
                for, a serious or life-threatening disease or condition 
                without confirmation of the diagnosis by a medically 
                established diagnostic product or procedure;
                    ``(B) requires an invasive sampling procedure that 
                presents a significant risk to the human subject, 
                provided that routine venipuncture shall not be 
                considered an invasive sampling procedure; or
                    ``(C) otherwise presents a potential for serious 
                risk to the health of a human subject.
            ``(2) Non-significant risk studies.--In the case of an in 
        vitro clinical test, the investigational use of which is not 
        described in paragraph (1)--
                    ``(A) the sponsor of such investigation shall--
                            ``(i) ensure such investigation is 
                        conducted in compliance with an investigational 
                        plan approved by an institutional review 
                        committee and the labeling of the in vitro 
                        clinical test involved clearly and 
                        conspicuously states, `For investigational use 
                        only', as specified in paragraph (4)(A)(ii);
                            ``(ii) ensure each investigator obtains 
                        informed consent as required under part 50, 54, 
                        and 56 of title 21, Code of Federal Regulations 
                        (or any successor regulations), subject to the 
                        exceptions set forth in paragraph (6)(C);
                            ``(iii) establish and maintain records with 
                        respect to all requirements in this 
                        subparagraph;
                            ``(iv) maintain records and make reports as 
                        established by the Secretary in regulations 
                        issued under subsection (b); and
                            ``(v) ensure that investigators monitor 
                        investigations, maintain records and make 
                        reports as established by the Secretary in 
                        regulations issued under subsection (b); and
                    ``(B) the sponsor may rely on any exception or 
                exemption described in paragraph (5)(B) or as 
                established by the Secretary in regulations issued 
                under subsection (b).
            ``(3) Application.--An investigational use application 
        shall be submitted in such time and manner and contain such 
        information as the Secretary may require in regulation, and 
        shall include an investigational plan for proposed clinical 
        testing and assurances that the sponsor submitting the 
        application will--
                    ``(A) establish and maintain records relevant to 
                the investigation of such in vitro clinical test; and
                    ``(B) submit to the Secretary annual reports of 
                data obtained as a result of the investigational use of 
                the in vitro clinical test during the period covered by 
                the exemption that the Secretary reasonably determines 
                will enable the Secretary--
                            ``(i) to ensure compliance with the 
                        conditions for the exemption specified in 
                        paragraph (4);
                            ``(ii) to review the progress of the 
                        investigation involved; and
                            ``(iii) to evaluate the ability to meet the 
                        applicable standard.
            ``(4) Conditions for exemption.--
                    ``(A) In general.--An application for an 
                investigational use exemption with respect to a 
                significant risk study shall be granted if each of the 
                following conditions is met:
                            ``(i) The risks to the subjects of the in 
                        vitro clinical test are outweighed by the 
                        anticipated benefits of the test to the 
                        subjects and the importance of the knowledge to 
                        be gained, and adequate assurance of informed 
                        consent is provided in accordance with 
                        paragraphs (6)(A)(iii) and (6)(B).
                            ``(ii) The proposed labeling for the in 
                        vitro clinical test involved clearly and 
                        conspicuously states `For investigational use 
                        only'.
                            ``(iii) Such other requirements the 
                        Secretary determines--
                                    ``(I) are necessary for the 
                                protection of the public health and 
                                safety; and
                                    ``(II) do not unduly delay 
                                investigation.
                    ``(B) Certain significant risk studies of in vitro 
                clinical tests for an unmet need.--The Secretary shall 
                not impose a limit on the sample size for a significant 
                risk study of an in vitro clinical test that has 
                received breakthrough designation under section 587I.
            ``(5) Coordination with investigational new drug 
        applications.--Any requirement for the submission of a report 
        to the Secretary pursuant to an application for an 
        investigational new drug exemption involving an in vitro 
        clinical test shall supersede the reporting requirement in 
        paragraph (3)(B), but only to the extent the requirement with 
        respect to the application for exemption with respect to the 
        drug is duplicative of the reporting requirement under such 
        paragraph.
            ``(6) Investigational plan, procedures, and conditions.--
        With respect to an investigational plan submitted under 
        paragraph (3), the sponsor submitting such plan shall--
                    ``(A) promptly notify the Secretary of the approval 
                or the suspension or termination of the approval of 
                such plan by an institutional review committee;
                    ``(B) in the case of an in vitro clinical test made 
                available to investigators for clinical testing, obtain 
                agreements from each investigator that any testing of 
                the in vitro clinical test involving human subjects 
                will be under such investigator's supervision and in 
                accordance with paragraph (C) and submit such 
                agreements to the Secretary that ensure--
                            ``(i) all investigators will comply with 
                        this section, regulations promulgated or 
                        revised under this section, and applicable 
                        human subjects regulations; and
                            ``(ii) the investigator will ensure that--
                                    ``(I) informed consent is obtained 
                                as required under part 50 of title 21, 
                                Code of Federal Regulations (or any 
                                successor regulations), amended to 
                                apply to in vitro clinical tests; and
                                    ``(II) the requirements for 
                                institutional review board under part 
                                56 of title 21 of the Code of Federal 
                                Regulations (or successor regulations), 
                                amended to apply to in vitro clinical 
                                tests, are met; and
                    ``(C) assure that informed consent will be obtained 
                from each human subject (or the representative of such 
                subject) of proposed clinical testing involving such in 
                vitro clinical test, except where, subject to such 
                other conditions as the Secretary may prescribe--
                            ``(i) the proposed clinical testing poses 
                        no more than minimal risk to the human subject 
                        and includes appropriate safeguards to protect 
                        the rights, safety, and welfare of the human 
                        subject; or
                            ``(ii) the investigator conducting or 
                        supervising the clinical testing determines in 
                        writing that there exists a life-threatening 
                        situation involving the human subject of such 
                        testing which necessitates the use of such in 
                        vitro clinical test and it is not feasible to 
                        obtain informed consent from the subject and 
                        there is not sufficient time to obtain such 
                        consent from a representative of such subject.
            ``(7) Concurred by licensed physician.--The determination 
        required by paragraph (6)(C)(ii) shall be concurred in writing 
        by a licensed physician who is not involved in the testing of 
        the human subject with respect to which such determination is 
        made unless immediate use of the device is required to save the 
        life of the human subject of such testing and there is not 
        sufficient time to obtain such concurrence.
    ``(d) Review of Applications.--
            ``(1) In general.--The Secretary may issue an order 
        approving an investigation as proposed, approving it with 
        conditions or modifications, or disapproving it.
            ``(2) Failure to act.--Unless the Secretary, not later than 
        the date that is 30 calendar days after the date of the 
        submission of an application for an investigational use 
        exemption that meets the requirements of subsection (c), issues 
        an order under paragraph (1) and notifies the sponsor 
        submitting the application, the application shall be treated as 
        approved as of such date without further action by the 
        Secretary.
            ``(3) Denial.--The Secretary may deny an investigational 
        use application submitted under this subsection if the 
        Secretary determines that the investigation with respect to 
        which the application is submitted does not conform to the 
        requirements of subsection (c). A notification of such denial 
        submitted to the sponsor with respect to such a request shall 
        contain the order of disapproval and a complete statement of 
        the reasons for the Secretary's denial of the application.
    ``(e) Withdrawal of Exemption.--
            ``(1) In general.--The Secretary may, by administrative 
        order, withdraw an exemption approved under this section with 
        respect to an in vitro clinical test, including an exemption 
        treated as approved based on the Secretary's failure to act 
        pursuant to subsection (d)(2), if the Secretary determines that 
        an investigation conducted under such an exemption does not 
        meet the applicable conditions under subsection (c)(3) for such 
        exemption.
            ``(2) Opportunity to be heard.--
                    ``(A) In general.--Subject to subparagraph (B), an 
                order withdrawing an investigational use exemption 
                granted under this section may be issued only after the 
                Secretary provides the sponsor of the in vitro clinical 
                test with an opportunity for an informal hearing.
                    ``(B) Exception.--An order referred to in 
                subparagraph (A) with respect to an investigational use 
                exemption granted under this section may be issued on a 
                preliminary basis before the provision of an 
                opportunity for an informal hearing if the Secretary 
                determines that the continuation of testing under the 
                exemption will result in an unreasonable risk to the 
                public health. The Secretary will provide an 
                opportunity for an informal hearing promptly following 
                any preliminary action under this subparagraph.
    ``(f) Changes.--
            ``(1) In general.--The regulations promulgated under 
        subsection (b) shall provide, with respect to an in vitro 
        clinical test for which an exemption under this subsection is 
        in effect, procedures and conditions under which changes are 
        allowed without the additional approval of an application for 
        an exemption or submission of a supplement to such an 
        application. Such regulations shall provide that such a change 
        may be made if--
                    ``(A) the sponsor determines, on the basis of 
                credible information (as defined in regulations) that 
                the change meets the conditions specified in paragraph 
                (2); and
                    ``(B) the sponsor submits to the Secretary, not 
                later than 5 calendar days after making the change, a 
                notice of the change.
            ``(2) Conditions.--The conditions specified in this 
        paragraph are that--
                    ``(A) in the case of developmental changes to an in 
                vitro clinical test, including manufacturing changes, 
                the changes--
                            ``(i) do not constitute a significant 
                        change in design or in basic principles of 
                        operation;
                            ``(ii) do not affect the rights, safety, or 
                        welfare of the human subjects involved in the 
                        investigation; and
                            ``(iii) are made in response to information 
                        gathered during the course of an investigation; 
                        and
                    ``(B) in the case of changes to clinical protocols 
                applicable to the test, the changes do not affect--
                            ``(i) the validity of data or information 
                        resulting from the completion of an approved 
                        clinical protocol, or the relationship of 
                        likely patient risk to benefit relied upon to 
                        approve a product;
                            ``(ii) the scientific soundness of a plan 
                        submitted under subsection (c)(3); or
                            ``(iii) the rights, safety, or welfare of 
                        the human subjects involved in the 
                        investigation.
    ``(g) Clinical Hold.--
            ``(1) In general.--At any time, the Secretary may impose a 
        clinical hold with respect to an investigation of an in vitro 
        clinical test if the Secretary makes a written determination 
        described in paragraph (2). The Secretary shall, in imposing 
        such clinical hold, specify the basis for the clinical hold, 
        including the specific information available to the Secretary 
        which served as the basis for such clinical hold, and confirm 
        such determination in writing. The applicant may immediately 
        appeal any such determination pursuant to section 587P.
            ``(2) Determination.--
                    ``(A) In general.--For purposes of paragraph (1), a 
                determination described in this subparagraph with 
                respect to a clinical hold is a determination that, 
                based on credible evidence, the in vitro clinical test 
                involved represents an unreasonable risk to the safety 
                of the persons who are the subjects of the clinical 
                investigation, taking into account the qualifications 
                of the clinical investigators, information about the in 
                vitro clinical test, the design of the clinical 
                investigation, the condition for which the in vitro 
                clinical test is to be investigated, and the health 
                status of the subjects involved.
                    ``(B) Removal of clinical hold.--Any written 
                request to the Secretary from the sponsor of an 
                investigation that a clinical hold be removed shall 
                receive a decision, in writing and specifying the 
                reasons therefor, within 30 days after receipt of such 
                request. Any such request shall include sufficient 
                information to support the removal of such clinical 
                hold.

``SEC. 587T. COMPREHENSIVE TEST INFORMATION SYSTEM.

    ``(a) Establishment.--Not later than 2 years after the date of 
enactment of the VALID Act of 2022, the Secretary shall make available 
a comprehensive test information system for in vitro clinical tests 
that is designed to--
            ``(1) provide a transparent interface on the website of the 
        Food and Drug Administration for stakeholders, to the extent 
        permitted by applicable law, which may include access to the--
                    ``(A) regulatory pathway designation information 
                for each in vitro clinical test or tests with the same 
                indications for use;
                    ``(B) registration and listing information provided 
                by developers under section 587J, including the use of 
                a link for labels;
                    ``(C) adverse event reports submitted under section 
                587M, as appropriate;
                    ``(D) reports of corrections and removals submitted 
                under section 587N; and
                    ``(E) other information pertaining to an in vitro 
                clinical test or tests with the same indications for 
                use, as the Secretary determines appropriate; and
            ``(2) provide a secure portal for electronic submission, 
        including applications and other in vitro clinical test 
        submissions, registration and listing information, and adverse 
        event reports, which provides protections from unauthorized 
        disclosure of information, including of--
                    ``(A) trade secret or commercial confidential 
                information; and
                    ``(B) national security, countermeasure, or other 
                information restricted from disclosure pursuant to any 
                provision of law.
    ``(b) Submission Function.--The comprehensive test information 
system shall serve as the electronic submission service for test 
developers submitting information for applications under sections 587B 
and 587D.

``SEC. 587U. PREEMPTION.

    ``(a) In General.--Except as provided in subsection (b), no State, 
Tribal, or local government (or political subdivision thereof) may 
establish or continue in effect any requirement that--
            ``(1) is different from, or in addition to, any requirement 
        applicable to an in vitro clinical test under this Act; or
            ``(2) with respect to the analytical validity, clinical 
        validity, or safety for individuals who come into contact with 
        such an in vitro clinical test under this Act.
    ``(b) Exceptions.--Subsection (a) shall not be construed to affect 
the authority of a State, Tribal, or local government to do any of the 
following:
            ``(1) To license laboratory personnel, health care 
        practitioners, or health care facilities or to regulate any 
        aspect of a health care practitioner-patient relationship.
            ``(2) To enforce laws of general applicability, such as 
        zoning laws, environmental laws, labor laws, and general 
        business laws.
            ``(3) To authorize laboratories to develop and perform an 
        in vitro clinical test, pursuant to a law enacted by a State 
        prior to January 1, 2022, as long as such law does not impose 
        requirements that are different from any requirement applicable 
        to an in vitro clinical test under this Act. If a State has 
        enacted such a law, the Secretary may exempt such laboratories 
        in that State from compliance with this subchapter.
    ``(c) Clarification.--Nothing in this section shall be construed 
to--
            ``(1) modify any action for damages or the liability of any 
        person under the law of any State; or
            ``(2) shift liability to health care practitioners or other 
        users.

``SEC. 587V. ADULTERATION.

    ``An in vitro clinical test shall be deemed to be adulterated:
            ``(1) If it consists in whole or in part of any filthy, 
        putrid, or decomposed substance.
            ``(2) If it has been developed, prepared, packed, or held 
        under insanitary conditions whereby it may have been 
        contaminated with filth, or whereby it may have been rendered 
        injurious to health.
            ``(3) If its container or package is composed, in whole or 
        in part, of any poisonous or deleterious substance which may 
        render the contents injurious to health.
            ``(4) If it bears or contains, for purposes of coloring 
        only, a color additive which is unsafe within the meaning of 
        section 721(a).
            ``(5) If its analytical or clinical validity, as 
        applicable, or with respect to a specimen receptacle, its 
        safety, falls below that which it purports or is represented to 
        possess.
            ``(6) If it is required to be, declared to be, purports to 
        be, or is represented as being, in conformity with any 
        performance standard established or recognized under section 
        587R and is not in conformity with such standard.
            ``(7) If it is required to be in compliance with mitigating 
        measures established under section 587E and is not in 
        conformity with such mitigating measures.
            ``(8) If it fails to have in effect an approved premarket 
        application under section 587B unless such in vitro clinical 
        test is in compliance with the requirements for--
                    ``(A) offering without an approved premarket 
                application under section 587D;
                    ``(B) an exemption from premarket approval under 
                section 587C or 587G; or
                    ``(C) investigational use pursuant to section 587S.
            ``(9) If it is not in conformity with any condition 
        established under section 587B or 587D.
            ``(10) If it purports to be an in vitro clinical test 
        subject to an exemption under section 587C and it fails to meet 
        or maintain any criteria, condition, or requirement of such 
        exemption.
            ``(11) If it has been granted an exemption under section 
        587S for investigational use, and the person granted such 
        exemption or any investigator who uses such in vitro clinical 
        test under such exemption fails to comply with a requirement 
        prescribed by or under such section.
            ``(12) If it fails to meet the quality requirements 
        prescribed in or established under section 587K (as 
        applicable), or the methods used in, or facilities or controls 
        used for, its development, packaging, storage, or installation 
        are not in conformity with applicable requirements established 
        under such section.
            ``(13) If it has been developed, processed, packaged, or 
        held in any establishment, factory, or warehouse and the owner, 
        operator or agent of such establishment, factory, or warehouse 
        delays, denies, or limits an inspection, or refuses to permit 
        entry or inspection.
            ``(14) If it is not in compliance with any restriction 
        required under section 587O.

``SEC. 587W. MISBRANDING.

    ``An in vitro clinical test shall be deemed to be misbranded:
            ``(1) If its labeling is false or misleading in any 
        particular.
            ``(2) If in a package form unless it bears a label 
        containing--
                    ``(A) the name and place of business of the test 
                developer, packager, or distributor; and
                    ``(B) an accurate statement of the quantity of 
                contents in terms of weight, measure, or numerical 
                count with respect to small packages, unless an 
                exemption is granted by the Secretary by the issuance 
                of guidance.
            ``(3) If any word, statement, or other information required 
        by or under authority of this Act to appear on the label or 
        labeling, including a test report, is not prominently placed 
        thereon with such conspicuousness (as compared with other 
        words, statements, designs, or devices, in the labeling) and in 
        such terms as to render it likely to be read and understood by 
        the ordinary individual under customary conditions of purchase 
        and use.
            ``(4) Unless its labeling bears adequate directions for use 
        and such adequate warnings as are necessary for the protection 
        of users of the in vitro clinical test and recipients of the 
        results of such in vitro clinical test, including patients, 
        consumers, donors, and related health care professionals. 
        Required labeling for in vitro clinical tests intended for use 
        in health care facilities, blood establishments, or by a health 
        care professional may be made available solely by electronic 
        means, provided that the labeling complies with all applicable 
        requirements of law, and that the test developer, or 
        distributor affords such users the opportunity to request the 
        labeling in paper form, and after such request, promptly 
        provides the requested information without additional cost.
            ``(5) If there is a reasonable probability that it could 
        cause serious or adverse health consequences or death, 
        including through absence, delay, or discontinuation in 
        diagnosis or treatment, when used in the manner prescribed, 
        recommended, or suggested in the labeling thereof.
            ``(6) If it was developed, sterilized, packaged, 
        repackaged, relabeled, installed, or imported in an 
        establishment not duly registered under section 587J or it was 
        not included in a listing under section 587J, in accordance 
        with timely reporting requirements under this subchapter.
            ``(7) In the case of any in vitro clinical test subject to 
        restrictions under section 587O, (1) if its advertising is 
        false or misleading in any particular, (2) if it is offered for 
        clinical use, sold, distributed, or used in violation of such 
        restrictions, or (3) unless the test developer or distributor 
        includes in all advertisements and other descriptive printed 
        matter that such person issues or causes to be issued, a brief 
        statement of the indications for use of the in vitro clinical 
        test and relevant warnings, precautions, side effects, and 
        contraindications. This subsection shall not be applicable to 
        any printed matter that the Secretary determines to be labeling 
        as defined in section 201(m).
            ``(8) If it is subject to a mitigating measure established 
        under section 587E and does not bear such labeling as may be 
        prescribed in such mitigating measure.
            ``(9) If it is subject to a standard established under 
        section 587R and it does not bear such labeling as may be 
        prescribed in such standard.
            ``(10) Unless it bears such labeling as may be required by 
        or established under an applicable labeling requirement under 
        this Act.
            ``(11) If there was a failure to comply with any 
        requirement prescribed in or under section 587D, 587J, 587K, 
        587L, 587M, 587N, 587X, 587Y, 587Z, or to provide any report, 
        material, or other information required with respect to in 
        vitro clinical tests under this subchapter.

``SEC. 587X. POSTMARKET SURVEILLANCE.

    ``(a) In General.--
            ``(1) In general.--In addition to other applicable 
        requirements under this Act, the Secretary may issue an order 
        requiring a developer of a high-risk or moderate-risk in vitro 
        clinical test to conduct postmarket surveillance of such in 
        vitro clinical test, if the failure of the in vitro clinical 
        test is reasonably likely to result in serious adverse health 
        consequences or death from use of such in vitro clinical test.
            ``(2) Consideration.--In determining whether to require a 
        developer to conduct postmarket surveillance of an in vitro 
        clinical test, the Secretary shall take into consideration the 
        benefits and risks for the patient and the least burdensome 
        principles under section 587B(j).
    ``(b) Surveillance Approval.--
            ``(1) In general.--Each developer required to conduct 
        surveillance of an in vitro clinical test shall submit, within 
        30 days of receiving an order from the Secretary, a plan for 
        the required surveillance. The Secretary, within 60 days of the 
        receipt of such plan, shall determine if the person designated 
        to conduct the surveillance has the appropriate qualifications 
        and experience to undertake such surveillance and if the plan 
        will result in useful data that can reveal unforeseen adverse 
        events or other information necessary to protect the health of 
        patients or the public.
            ``(2) Timeline.--The developer shall commence surveillance 
        under this section not later than 15 months after the day on 
        which the Secretary orders such postmarket surveillance, unless 
        the Secretary determines more time is needed to commence 
        surveillance.
            ``(3) Prospective surveillance.--The Secretary may order a 
        prospective surveillance period of up to 3 years. Any 
        determination by the Secretary that a longer period is 
        necessary shall be made by mutual agreement between the 
        Secretary and the developer or, if no agreement can be reached, 
        upon the completion of a dispute resolution process pursuant to 
        section 562.

``SEC. 587Y. ELECTRONIC FORMAT FOR SUBMISSIONS.

    ``(a) In General.--All submissions to the Food and Drug 
Administration with respect to an in vitro clinical test, unless 
otherwise agreed to by the Secretary, shall--
            ``(1) be made electronically; and
            ``(2) with respect to the information required under 
        sections 587B and 587D, utilize the system described in section 
        587U.
    ``(b) Electronic Format.--Beginning on such date as the Secretary 
specifies in final guidance issued under subsection (c), submissions 
for in vitro clinical tests, including recommendations submitted by 
accredited and recognized persons under section 587Q, and any appeals 
of action taken by the Secretary with respect to such submissions, 
shall be submitted in such electronic format as specified by the 
Secretary in such guidance.
    ``(c) Guidance.--The Secretary shall issue guidance implementing 
this section. Such guidance may--
            ``(1) provide standards for the electronic submission 
        required under subsection (a) or the submission in electronic 
        format required under subsection (b);
            ``(2) set forth criteria for waivers of, or exemptions 
        from, the requirements of subsection (a) or (b); and
            ``(3) provide any other information for the efficient 
        implementation and enforcement of this section.

``SEC. 587Z. POSTMARKET REMEDIES.

    ``(a) Safety Notice.--
            ``(1) In general.--If the Secretary determines that an in 
        vitro clinical test presents an unreasonable risk of 
        substantial harm to the public health, and notification under 
        this subsection is necessary to eliminate the unreasonable risk 
        of such harm and no more practicable means is available under 
        the provisions of this Act (other than this section) to 
        eliminate the risk, the Secretary may issue such order as may 
        be necessary to ensure that adequate safety notice is provided 
        in an appropriate form, by the persons and means best suited 
        under the circumstances, to all health care professionals who 
        prescribe, order, or use the in vitro clinical test and to any 
        other person (including developers, importers, distributors, 
        retailers, and users) who should properly receive such notice.
            ``(2) Notice to individuals.--An order under this 
        subsection shall require that the individuals subject to the 
        risk with respect to which the order is to be issued be 
        included in the persons to be notified of the risk unless the 
        Secretary determines that notice to such individuals would 
        present a greater danger to the health of such individuals than 
        no such notice. If the Secretary makes such a determination 
        with respect to such individuals, the order shall require the 
        health care professionals who prescribed, ordered, or used the 
        in vitro clinical test provide notification to the individuals 
        for whom the health professionals prescribed, ordered, or used 
        such test, of the risk presented by such in vitro clinical test 
        and of any action which may be taken by or on behalf of such 
        individuals to eliminate or reduce such risk. Before issuing an 
        order under this subsection, the Secretary shall consult with 
        the persons required to give notice under the order.
    ``(b) Repair, Replacement, or Refund.--
            ``(1) Determination after an informal hearing.--
                    ``(A) In general.--If, after affording opportunity 
                for an informal hearing, the Secretary determines 
                that--
                            ``(i) an in vitro clinical test presents an 
                        unreasonable risk of substantial harm to the 
                        public health;
                            ``(ii) there are reasonable grounds to 
                        believe that the in vitro clinical test was not 
                        properly developed or manufactured considering 
                        the state of the art as it existed at the time 
                        of its development;
                            ``(iii) there are reasonable grounds to 
                        believe that the unreasonable risk was not 
                        caused by failure of a person other than a 
                        developer, importer, distributor, or retailer 
                        of the in vitro clinical test to exercise due 
                        care in the installation, maintenance, repair, 
                        or use of the in vitro clinical test; and
                            ``(iv) the notice authorized by subsection 
                        (a) would not by itself be sufficient to 
                        eliminate the unreasonable risk and action 
                        described in paragraph (2) of this subsection 
                        is necessary to eliminate such risk,
                the Secretary may order the developer, importer, or any 
                distributor of such in vitro clinical test, or any 
                combination of such persons, to submit to him within a 
                reasonable time a plan for taking one or more of the 
                actions described in paragraph (2). An order issued 
                under the preceding sentence which is directed to more 
                than one person shall specify which person may decide 
                which action shall be taken under such plan and the 
                person specified shall be the person who the Secretary 
                determines bears the principal, ultimate financial 
                responsibility for action taken under the plan unless 
                the Secretary cannot determine who bears such 
                responsibility or the Secretary determines that the 
                protection of the public health requires that such 
                decision be made by a person (including a health 
                professional or user of the in vitro clinical test) 
                other than the person the Secretary determines bears 
                such responsibility.
                    ``(B) Secretary approval of plan.--The Secretary 
                shall approve a plan submitted pursuant to an order 
                issued under subparagraph (A) unless the Secretary 
                determines (after affording opportunity for an informal 
                hearing) that the action or actions to be taken under 
                the plan or the manner in which such action or actions 
                are to be taken under the plan will not assure that the 
                unreasonable risk with respect to which such order was 
                issued will be eliminated. If the Secretary disapproves 
                a plan, the Secretary shall order a revised plan to be 
                submitted within a reasonable time. If the Secretary 
                determines (after affording opportunity for an informal 
                hearing) that the revised plan is unsatisfactory or if 
                no revised plan or no initial plan has been submitted 
                to the Secretary within the prescribed time, the 
                Secretary shall (i) prescribe a plan to be carried out 
                by the person or persons to whom the order issued under 
                subparagraph (A) was directed, or (ii) after affording 
                an opportunity for an informal hearing, by order 
                prescribe a plan to be carried out by a person who is a 
                developer, importer, distributor, or retailer of the in 
                vitro clinical test with respect to which the order was 
                issued but to whom the order under subparagraph (A) was 
                not directed.
            ``(2) Actions on a plan.--The actions which may be taken 
        under a plan submitted under an order issued under paragraph 
        (1)(A) are as follows:
                    ``(A) To repair the in vitro clinical test so that 
                it does not present the unreasonable risk of 
                substantial harm with respect to which the order under 
                paragraph (1)(A) was issued.
                    ``(B) To replace the in vitro clinical test with a 
                like or equivalent test which is in conformity with all 
                applicable requirements of this Act.
                    ``(C) To refund the purchase price of the in vitro 
                clinical test (less a reasonable allowance for use if 
                such in vitro clinical test has been in the possession 
                of the user for one year or more at the time of notice 
                ordered under subsection (a), or at the time the user 
                receives actual notice of the unreasonable risk with 
                respect to which the order was issued under paragraph 
                (1)(A), whichever occurs first).
            ``(3) No charge.--No charge shall be made to any person 
        (other than a developer, importer, distributor or retailer) for 
        using a remedy described in paragraph (2) and provided under an 
        order issued under paragraph (1), and the person subject to the 
        order shall reimburse each person (other than a developer, 
        manufacturer, importer, distributor, or retailer) who is 
        entitled to such a remedy for any reasonable and foreseeable 
        expenses actually incurred by such person in using such remedy.
    ``(c) Reimbursement.--An order issued under subsection (b)(1)(A) 
with respect to an in vitro clinical test may require any person who is 
a developer, importer, distributor, or retailer of the in vitro 
clinical test to reimburse any other person who is a developer, 
importer, distributor, or retailer of such in vitro clinical test for 
such other person's expenses actually incurred in connection with 
carrying out the order if the Secretary determines such reimbursement 
is required for the protection of the public health. Any such 
requirement shall not affect any rights or obligations under any 
contract to which the person receiving reimbursement or the person 
making such reimbursement is a party.
    ``(d) Recall Authority.--
            ``(1) In general.--If the Secretary finds that there is a 
        reasonable probability that an in vitro clinical test approved 
        under section 587B or offered under a technology certification 
        order under section 587D would cause serious, adverse health 
        consequences or death, including by the absence, significant 
        delay, or discontinuation of appropriate medical treatment, the 
        Secretary shall issue an order requiring the appropriate person 
        (including the developers, importers, distributors, or 
        retailers of the in vitro clinical test)--
                    ``(A) to immediately cease distribution of such in 
                vitro clinical test; and
                    ``(B) to immediately notify health professionals 
                and applicable in vitro clinical test user facilities 
                of the order and to instruct such professionals and 
                facilities to cease use of such in vitro clinical test.
            ``(2) Informal hearing.--The order issued under paragraph 
        (1)(A), shall provide the person subject to the order with an 
        opportunity for an informal hearing, to be held not later than 
        10 calendar days after the date of the issuance of the order, 
        on the actions required by the order and on whether the order 
        should be amended to require a recall of such in vitro clinical 
        test. If, after providing an opportunity for such a hearing, 
        the Secretary determines that inadequate grounds exist to 
        support the actions required by the order, the Secretary shall 
        vacate the order.
            ``(3) Amended order.--
                    ``(A) In general.--If, after providing an 
                opportunity for an informal hearing under paragraph 
                (2), the Secretary determines that the order should be 
                amended to include a recall of the in vitro clinical 
                test with respect to which the order was issued, the 
                Secretary shall, except as provided in subparagraph 
                (B), amend the order to require a recall. The Secretary 
                shall specify a timetable in which the recall will 
                occur and shall require periodic reports describing the 
                progress of the recall.
                    ``(B) Requirements.--An amended order under 
                subparagraph (A)--
                            ``(i) shall not include recall of the in 
                        vitro clinical test from individuals;
                            ``(ii) shall not include recall of an in 
                        vitro clinical test from test user facilities 
                        if the Secretary determines that the risk of 
                        recalling such in vitro clinical test from the 
                        facilities presents a greater health risk than 
                        the health risk of not recalling the in vitro 
                        clinical test from use; and
                            ``(iii) shall provide for notice to 
                        individuals subject to the risks associated 
                        with the use of such in vitro clinical test. In 
                        providing the notice required by this clause, 
                        the Secretary may use the assistance of health 
                        professionals who prescribed, ordered, or used 
                        such an in vitro clinical test for individuals.
            ``(4) Clarification.--The remedy provided by this 
        subsection shall be in addition to remedies provided by 
        subsections (a), (b), and (c).

``SEC. 587AA. APPLICABILITY.

    ``(a) In General.--An in vitro clinical test shall be subject to 
the requirements of this subchapter, except as otherwise provided in 
this subchapter.
    ``(b) Interstate Commerce.--Any in vitro clinical test that is 
offered, including by making available for clinical use in the United 
States is deemed to be an act that constitutes introduction into 
interstate commerce for purposes of enforcing the requirements of this 
Act.
    ``(c) Least Burdensome Requirements.--
            ``(1) In general.--In carrying out this subchapter, the 
        Secretary shall consider the least burdensome means necessary 
        to meet the applicable standard, and other regulatory 
        requirements, as determined by the Secretary.
            ``(2) Necessary defined.--For purposes of paragraph (1) and 
        paragraph (3), the term `necessary' means the minimum required 
        information that would support a determination by the Secretary 
        that the application meet the applicable standard or regulatory 
        requirement, as determined by the Secretary.
    ``(d) Service of Orders.--Orders of the Secretary under this 
section with respect to applications under subsection (a) or (b) of 
section 587B or supplements under subsection (f) of such section shall 
be served--
            ``(1) in person by any officer or employee of the 
        Department of Health and Human Services designated by the 
        Secretary; or
            ``(2) by mailing the order by registered mail or certified 
        mail or electronic equivalent addressed to the applicant at the 
        last known address in the records of the Secretary.
    ``(e) Laboratories and Blood and Tissue Establishments.--
            ``(1) Relation to laboratory certification pursuant to 
        section 353 of the public health service act.--Nothing in this 
        subchapter shall be construed to modify the authority of the 
        Secretary with respect to laboratories or clinical laboratories 
        under section 353 of the Public Health Service Act.
            ``(2) Avoiding duplication.--In implementing this 
        subchapter, the Secretary shall avoid issuing or enforcing 
        regulations or guidance that are duplicative of regulations or 
        guidance under section 353 of the Public Health Service Act.
            ``(3) Blood and tissue.--Nothing in this subchapter shall 
        be construed to modify the authority of the Secretary with 
        respect to laboratories, establishments, or other facilities to 
        the extent they are engaged in the propagation, manufacture, or 
        preparation, including filling, labeling, packaging, and 
        storage, of blood, blood components, human cells, tissues, or 
        tissue products pursuant to any requirements under this Act or 
        section 351 or 361 of the Public Health Service Act.
    ``(f) Not Combination Product.--A product constituted of a device 
and an in vitro clinical test is not a combination product and shall be 
regulated as a device.
    ``(g) Practice of Medicine.--Nothing in this subchapter shall be 
construed to limit or interfere with the authority of a health care 
practitioner to prescribe or administer any lawfully offered in vitro 
clinical test for any condition or disease within a legitimate health 
care practitioner-patient relationship pursuant to applicable Federal 
or State law.
    ``(h) Rules of Construction.--
            ``(1) Sale, distribution, labeling.--Nothing in this 
        paragraph shall be construed to limit the authority of the 
        Secretary to establish or enforce restrictions on the sale, 
        distribution, or labeling of an in vitro clinical test under 
        this Act.
            ``(2) Promotion of unapproved uses.--Nothing in this 
        paragraph shall be construed to alter any prohibition on the 
        promotion of unapproved uses of legally marketed in vitro 
        clinical tests.

``SEC. 587BB. JUDICIAL REVIEW.

    ``(a) In General.--Not later than 30 days after an order issued 
pursuant to sections 587B or 587D, any person adversely affected by 
such order may file a petition with the United States Court of Appeals 
for the District of Columbia or for the circuit wherein such person 
resides or has a principal place of business for judicial review of 
such order, in accordance with the procedure set forth in section 
517(a).
    ``(b) Application of Provisions.--Subsections (a) through (e) of 
section 517 shall apply with respect to a petition under subsection (a) 
of this section in the same manner such subsections apply to a petition 
under section 517. Subsection (f) of section 517 shall apply to an 
order issued under section 587B or 587D.''.

SEC. 824. ENFORCEMENT AND OTHER PROVISIONS.

    (a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), as amended by section 811, is further 
amended--
            (1) in paragraphs (a), (b), (c), (g), (h), (k), (q), (r), 
        and (y), by inserting ``in vitro clinical test,'' after 
        ``device,'' each place it appears;
            (2) in paragraph (g), by inserting after ``misbranded'', 
        ``, and the development within any Territory of any in vitro 
        clinical test that is adulterated or misbranded'';
            (3) in paragraph (y), by inserting ``or 587Q'' after 
        ``section 523'' each place it appears;
            (4) in paragraph (ff), by striking ``or device'' and 
        inserting ``, device, or in vitro clinical test''; and
            (5) by adding at the end, the following:
    ``(jjj)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, stamp, tag, 
label, or other identification upon any in vitro clinical test or 
container, packaging, or labeling thereof so as to render such in vitro 
clinical test a counterfeit in vitro clinical test.
    ``(2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, stone, or 
other thing designed to print, imprint, or reproduce the trademark, 
trade name, or other identifying mark or imprint of another or any 
likeness of any of the foregoing upon any in vitro clinical test or 
container, packaging, or labeling thereof so as to render such in vitro 
clinical test a counterfeit in vitro clinical test.
    ``(3) The doing of any act which causes an in vitro clinical test 
to be a counterfeit in vitro clinical test, or the sale or dispensing, 
or the holding for sale or dispensing, of a counterfeit in vitro 
clinical test.
    ``(kkk)(1) The introduction or delivery for introduction into 
interstate commerce of an in vitro clinical test in violation of 
section 587B(a).
    ``(2) The making of a false, fraudulent, or deceptive statement 
about an in vitro clinical test that is exempt from premarket review 
under section 587C.
    ``(3) The failure to maintain complete and accurate documentation 
for an exemption as required under section 587C or the failure to 
provide labeling required under section 587L.
    ``(4) With respect to an in vitro clinical test, the submission of 
any report or listing under this Act that is false or misleading in any 
material respect.
    ``(5) The failure to comply with a condition of approval, or 
restriction required under an approved application under section 587B; 
the failure to perform a risk analysis required by section 587B; the 
failure to submit an annual update required under section 
587J(c)(2)(B); or the failure to complete postmarket surveillance as 
required under section 587X.
    ``(6) The failure to comply with applicable requirements to submit 
an application or report under section 587D(e).
    ``(7) The failure to comply with applicable mitigating measures 
established under section 587E or to submit, maintain, or make 
available the documentation required under section 587E(b); or the 
failure to comply with applicable performance standards established 
under section 587R.
    ``(8) The failure to register in accordance with section 587J, the 
failure to provide information required under section 587J(b), or the 
failure to maintain or submit information required under section 
587J(c).
    ``(9) The failure to comply with requirements under section 587M or 
587N, the failure to comply with a restriction required under section 
587O, or the failure to comply with labeling and advertising 
requirements under section 587O(b).
    ``(10) The failure to comply with the requirements of section 587Q.
    ``(11) The failure to comply with any requirement of section 587S; 
the failure to furnish any notification, information, material, or 
report required under section 587S; or the failure to comply with an 
order issued under section 587S.
    ``(12) The failure to furnish information requested by the 
Secretary under 587G(d)(2).''.
    (b) Penalties.--Section 303 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 333) is amended--
            (1) in subsection (b)(8), by inserting ``or counterfeit in 
        vitro clinical test'' after ``counterfeit drug'';
            (2) in subsection (c)--
                    (A) by striking ``; or (5)'' and inserting ``; 
                (5)''; and
                    (B) by inserting before the period at the end the 
                following: ``; or (6) for having violated section 
                301(fff)(2) if such person acted in good faith and had 
                no reason to believe that use of the punch, die, plate, 
                stone, or other thing involved would result in an in 
                vitro clinical test being a counterfeit in vitro 
                clinical test, or for having violated section 
                301(fff)(3) if the person doing the act or causing it 
                to be done acted in good faith and had no reason to 
                believe that the in vitro clinical test was a 
                counterfeit in vitro clinical test''; and
            (3) in subsection (f)(1)--
                    (A) in subparagraph (A)--
                            (i) by inserting ``or in vitro clinical 
                        tests'' after ``which relates to devices'';
                            (ii) by inserting ``or section 587Q(a)(2)'' 
                        after ``section 704(g)''; and
                            (iii) by inserting ``or in vitro clinical 
                        tests, as applicable'' before the period at the 
                        end of the second sentence; and
                    (B) in subparagraph (B)(i), by striking ``or 
                520(f)'' and inserting ``, 520(f), 587K, or 587M,''.
    (c) Seizure.--Section 304 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 334) is amended--
            (1) in subsection (a)(2)--
                    (A) by striking ``, and (E)'' and inserting ``, 
                (E)''; and
                    (B) by inserting before the period at the end the 
                following: ``, and (F) Any in vitro clinical test that 
                is a counterfeit in vitro clinical test, (G) Any 
                container, packaging, or labeling of a counterfeit in 
                vitro clinical test, and (H) Any punch, die, plate, 
                stone, labeling, container, or other thing used or 
                designed for use in making a counterfeit in vitro 
                clinical test'';
            (2) in subsection (d)(1), by inserting ``in vitro clinical 
        test,'' after ``device,''; and
            (3) in subsection (g)--
                    (A) in paragraph (1), by inserting ``, in vitro 
                clinical test,'' after ``device'' each place it 
                appears; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by inserting ``, 
                        in vitro clinical test,'' after ``device''; and
                            (ii) in subparagraph (B), by inserting ``or 
                        in vitro clinical test'' after ``device'' each 
                        place it appears.
    (d) Debarment, Temporary Denial of Approval, and Suspension.--
Section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
335a) is amended by adding at the end the following:
    ``(n) In Vitro Clinical Tests; Mandatory Debarment Regarding Third-
Party Inspections and Reviews.--
            ``(1) In general.--If the Secretary finds that a person has 
        been convicted of a felony for a violation of section 301(gg) 
        or 301(jjj)(1), the Secretary shall debar such person from 
        being accredited under section 587Q and from carrying out 
        activities under an agreement described in section 803(b).
            ``(2) Debarment period.--The Secretary shall debar a person 
        under paragraph (1) for the following periods:
                    ``(A) The period of debarment of a person (other 
                than an individual) shall not be less than 1 year or 
                more than 10 years, but if an act leading to a 
                subsequent debarment under such paragraph occurs within 
                10 years after such person has been debarred under such 
                paragraph, the period of debarment shall be permanent.
                    ``(B) The debarment of an individual shall be 
                permanent.
            ``(3) Termination of debarment; judicial review; other 
        matters.--Subsections (c)(3), (d), (e), (i), (j), and (l)(1) 
        apply with respect to a person (other than an individual) or an 
        individual who is debarred under paragraph (1) to the same 
        extent and in the same manner as such subsections apply with 
        respect to a person who is debarred under subsection (a)(1), or 
        an individual who is debarred under subsection (a)(2), 
        respectively.''.
    (e) Expanded Access to Unapproved Therapies and Diagnostics.--
Section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb) is amended--
            (1) in subsections (a) through (d)--
                    (A) by striking ``or investigational devices'' each 
                place it appears and inserting ``, investigational 
                devices, or investigational in vitro clinical tests''; 
                and
                    (B) by striking ``or investigational device'' each 
                place it appears (other than the second such place in 
                paragraph (3)(A)) of subsection (c)) and inserting ``, 
                investigational device, or investigational in vitro 
                clinical test'';
            (2) in subsection (b)(4) by striking ``or 520(g)'' and 
        inserting ``, 520(g), or 587S'' each place it appears;
            (3) in subsection (c)--
                    (A) by amending the subsection heading to read: 
                ``Treatment Investigational New Drug Applications, 
                Treatment Investigational Device Exemptions, and 
                Treatment Investigational in Vitro Clinical Test 
                Exemptions.--'';
                    (B) in paragraph (3)(A), by striking ``or 
                investigational device exemption in effect under 
                section 520(g)'' and inserting ``, investigational 
                device exemption in effect under section 520(g), or 
                investigational in vitro clinical test exemption under 
                section 587S'';
                    (C) by striking ``or treatment investigational 
                device exemption'' each place it appears and inserting 
                ``, treatment investigational device exemption, or 
                treatment investigational in vitro clinical test 
                exemption'';
                    (D) in paragraph (5), by striking ``or 520(g)'' and 
                inserting ``, 520(g), or 587S''; and
                    (E) in the matter following paragraph (7) by 
                striking ``or 520(g)'' each place it appears and 
                inserting ``, 520(g) or 587S''; and
            (4) by amending subsection (e) to read as follows:
    ``(e) Definitions.--In this section, the terms `investigational 
drug', `investigational device', `investigational in vitro clinical 
test', `treatment investigational new drug application', `treatment 
investigational device exemption', and `treatment investigational in 
vitro clinical test exemption' shall have the meanings given the terms 
in regulations prescribed by the Secretary.''.
    (f) Optimizing Global Clinical Trials.--Section 569A(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-8a(b)) is 
amended by inserting ``an in vitro clinical test, as defined in 
subsection (ss) of such section,'' before ``or a biological product''.
    (g) Patient Participation in Medical Product Discussion.--The 
heading of subsection (a) of section 569C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb-8c) is amended by striking ``Drugs 
and Devices'' and inserting ``Drugs, Devices, and In Vitro Clinical 
Tests''.
    (h) Regulations and Hearings.--Section 701(h)(1)(C)(ii) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(ii)) is 
amended by inserting ``and in vitro clinical tests'' after ``devices''.
    (i) Records.--Section 703 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 373) is amended--
            (1) by inserting ``in vitro clinical tests'' after 
        ``devices'' each place such term appears; and
            (2) by inserting ``in vitro clinical test'' after 
        ``device'' each place such term appears.
    (j) Factory Inspection.--Section 704 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374) (other than subsection (g)) is amended--
            (1) by striking ``drugs or devices'' each place it appears 
        and inserting ``drugs, devices, or in vitro clinical tests'';
            (2) in subsection (a)(1), in the fourth sentence, by 
        striking ``or chapter IX'' and inserting ``section 587S, 
        section 587M, section 587N, or chapter IX'';
            (3) after making the amendments in paragraphs (1) and (2), 
        by inserting ``in vitro clinical tests,'' after ``devices,'' 
        each place it appears;
            (4) in subsection (a)(2)(B)--
                    (A) by inserting ``or in vitro clinical tests'' 
                after ``prescribe or use devices''; and
                    (B) by inserting ``or in vitro clinical tests'' 
                after ``process devices'';
            (5) by inserting ``in vitro clinical test,'' after 
        ``device,'' each place it appears;
            (6) in subsection (e), by inserting ``, or section 587M, 
        587N, or 587S,'' after ``section 519 or 520(g)'';
            (7) in subsection (f)(3)--
                    (A) in subparagraph (A), by striking ``or'' at the 
                end;
                    (B) in subparagraph (B), by striking the period at 
                the end and inserting ``; or''; and
                    (C) after subparagraph (B), by inserting the 
                following:
                    ``(C) is accredited under section 587Q.''; and
            (8) by adding at the end the following:
    ``(i) For purposes of this section, the term `establishment' 
includes a laboratory performing an in vitro clinical test.''.
    (k) Publicity.--Section 705(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 375(b)) is amended by inserting ``in vitro 
clinical tests,'' after ``devices,''.
    (l) Presumption.--Section 709 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379a) is amended by inserting ``in vitro 
clinical test,'' after ``device,''.
    (m) Listing and Certification of Color Additives for Foods, Drugs, 
and Cosmetics.--Section 721(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379e(a)) is amended--
            (1) in the matter preceding paragraph (1), by inserting 
        ``or in vitro clinical tests'' after ``or devices''; and
            (2) in the flush text following paragraph (2)--
                    (A) by inserting ``or an in vitro clinical test'' 
                after ``a device''; and
                    (B) by inserting ``or in vitro clinical tests'' 
                after ``devices''.
    (n) Imports and Exports.--Section 801 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 381) is amended--
            (1) in subsection (a)--
                    (A) by inserting ``in vitro clinical tests,'' after 
                ``devices,'' each place it appears; and
                    (B) by inserting ``in the case of an in vitro 
                clinical test, the test does not conform to the 
                applicable requirements of section 587K, or'' after 
                ``requirements of section 520(f), or'';
            (2) in subsection (d)(3)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i), by 
                        inserting ``and no component of an in vitro 
                        clinical test or other article of in vitro 
                        clinical test that requires further 
                        processing,'' after ``health-related 
                        purposes'';
                            (ii) in clause (i), by striking ``drug or 
                        device'' and inserting ``drug, device, or in 
                        vitro clinical test''; and
                            (iii) in clause (i)(I), by inserting ``in 
                        vitro clinical test,'' after ``device,''; and
                    (B) in subparagraph (B), by inserting ``in vitro 
                clinical test,'' after ``device,'';
            (3) in subsection (e)(1), by inserting ``in vitro clinical 
        test,'' after ``device,''; and
            (4) in subsection (o)--
                    (A) by inserting ``or in vitro clinical test'' 
                after ``device''; and
                    (B) by inserting ``section 587J of each foreign 
                establishment'' after ``section 510(i) of each 
                establishment''.
    (o) Office of International Relations.--Section 803 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 383) is amended--
            (1) in subsection (b)--
                    (A) in the matter preceding paragraph (1), by 
                inserting ``and in vitro clinical tests'' after 
                ``devices''; and
                    (B) in paragraph (1), by inserting ``quality 
                requirements established under section 587K; and'' at 
                the end; and
            (2) in subsection (c)--
                    (A) in paragraph (2), by inserting ``in vitro 
                clinical tests,'' after ``devices,''; and
                    (B) in paragraph (4), by inserting ``or in vitro 
                clinical tests'' after ``devices''.
    (p) Recognition of Foreign Government Inspections.--Section 
809(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
384e(a)(1)) is amended by inserting ``, or of foreign establishments 
registered under section 587J'' after ``510(h)''.
    (q) Food and Drug Administration.--Section 1003(b)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(b)(2)) is amended--
            (1) in subparagraph (D), by striking ``and'' at the end;
            (2) in subparagraph (E), by striking the semicolon at the 
        end and inserting ``; and''; and
            (3) by adding at the end the following:
                    ``(F) in vitro clinical tests are analytically and 
                clinically valid;''.
    (r) Office of Women's Health.--Section 1011(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 399b(b)) is amended--
            (1) in paragraph (1), by inserting ``in vitro clinical 
        tests,'' after ``devices,''; and
            (2) in paragraph (4), by striking ``and device 
        manufacturers'' and inserting ``device manufacturers, and in 
        vitro clinical test developers,''.
    (s) Countermeasure Provisions of the Public Health Service Act.--
Title III of the Public Health Service Act is amended--
            (1) in section 319F-1(a)(2)(A) (42 U.S.C. 247d-
        6a(a)(2)(A))--
                    (A) in the matter preceding clause (i)--
                            (i) by striking ``or device'' and inserting 
                        ``device''; and
                            (ii) by inserting ``or an in vitro clinical 
                        tests (as that term is defined in section 
                        201(ss) of the Federal Food, Drug, and Cosmetic 
                        Act (21 U.S.C. 321(ss))),'' after ``Act (21 
                        U.S.C. 321(h))),''; and
                    (B) in each of clauses (ii) and (iii), by striking 
                ``or device'' and inserting ``device, or in vitro 
                clinical test'';
            (2) in section 319F-2(c)(1)(B) (42 U.S.C. 247d-
        6b(c)(1)(B))--
                    (A) by striking ``or device'' and inserting 
                ``device''; and
                    (B) by inserting ``, or an in vitro clinical test 
                (as that term is defined in section 201(ss) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                321(ss)))'' after ``Act (21 U.S.C. 321(h))),''; and
            (3) in section 319F-3(i)(7) (42 U.S.C. 247d-6d(i)(7))--
                    (A) in the matter preceding subparagraph (A)--
                            (i) by striking ``or device'' and inserting 
                        ``device''; and
                            (ii) by inserting ``or an in vitro clinical 
                        tests (as that term is defined in section 
                        201(ss) of the Federal Food, Drug, and Cosmetic 
                        Act (21 U.S.C. 321(ss))),'' after ``Act (21 
                        U.S.C. 321(h))'';
                    (B) in subparagraph (A)--
                            (i) by moving the margin of clause (iii) 2 
                        ems to the left; and
                            (ii) in clause (iii), by striking ``or 
                        device'' and inserting ``device, or in vitro 
                        clinical test''; and
                    (C) in subparagraph (B)--
                            (i) in clause (i), by inserting ``or the 
                        subject of a technology certification order'' 
                        after ``approved or cleared''; and
                            (ii) in clause (ii), by striking ``or 
                        520(g)'' and inserting ``, 520(g), or 587S''.

SEC. 825. TRANSITION.

    (a) Implementation.--
            (1) Effective date.--
                    (A) In general.--Except as otherwise provided in 
                this section, the amendments made by this Act shall 
                take effect on October 1, 2027 (in this section and in 
                subchapter J of chapter V of the Federal Food, Drug, 
                and Cosmetic Act, as added by this Act, referred to in 
                this section as the ``effective date of this Act'').
                    (B) Exceptions.--
                            (i) In general.--The Secretary of Health 
                        and Human Services (in this section referred to 
                        as the ``Secretary'') may take the actions 
                        described in paragraph (3), and may expend such 
                        funds as the Secretary determines necessary to 
                        ensure an orderly transition, including prior 
                        to the effect date of this Act.
                            (ii) Implementation of certain 
                        provisions.--The Secretary may implement 
                        sections 587J and 587U of the Federal Food, 
                        Drug, and Cosmetic Act (as added by section 3) 
                        beginning on October 1, 2024, and such sections 
                        may take effect not earlier than October 1, 
                        2027, to the extent and for the purposes 
                        indicated in such sections. In the case of a 
                        developer who, between October 1, 2024, and the 
                        effective date of this Act specified in 
                        subparagraph (A), registers under such section 
                        587K with respect to an article that is an in 
                        vitro clinical test, such developer shall not 
                        be required to register with respect to such 
                        article under section 510 of such Act (21 
                        U.S.C. 360).
            (2) Actions.--The Secretary--
                    (A) shall--
                            (i) within 1 year of the date of enactment 
                        of this Act, hold the public meetings described 
                        in section 587D(c) of the Federal Food, Drug, 
                        and Cosmetic Act (as added by section 3);
                            (ii) within 3 years of the date of 
                        enactment of this Act, promulgate final 
                        regulations required under the amendments made 
                        by this Act; and
                            (iii) within 30 months of the date of 
                        enactment of this Act, issue final guidance on 
                        applicability requirements under amendments 
                        made by this Act; and
                    (B) may take additional actions after the date of 
                enactment that the Secretary determines necessary to 
                ensure an orderly transition, which may not take effect 
                until after the effective date, including--
                            (i) establishment of mitigating measures 
                        for an in vitro clinical test or category of in 
                        vitro clinical tests; and
                            (ii) establishment of the comprehensive 
                        test information system under section 587T.
            (3) Applicability of guidance and regulations.--
        Notwithstanding the date on which guidance or regulations are 
        issued under paragraph (3) and section 587K, no guidance or 
        regulations issued pursuant to the amendments made by this Act 
        shall be implemented or take effect until the effective date of 
        this Act, as described in paragraph (1), except as otherwise 
        specified in this Act (including the amendments made by this 
        Act).
    (b) Application of Authorities to in Vitro Clinical Tests Under 
Review on the Effective Date of This Act.--For any in vitro clinical 
test, as defined in section 201(ss) of the Federal Food, Drug, and 
Cosmetic Act, as added by section 822, for which a submission for 
approval under section 515 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360e), clearance under section 510(k) of such Act (21 U.S.C. 
360(k)), authorization under section 513(f)(2) of such Act (21 U.S.C. 
360c(f)(2)), or licensure under section 351 of the Public Health 
Service Act (42 U.S.C. 262) is pending on the effective date of this 
Act, including transitional in vitro clinical tests as described in 
subsection (c), the Secretary may review and take action on such 
submission after the effective date of this Act according to the 
statutory provision under which such submission was submitted.
    (c) Application of Authorities to Transitional In Vitro Clinical 
Tests.--
            (1) Definition.--For purposes of this section, the term 
        ``transitional in vitro clinical test'' means an in vitro 
        clinical test, as defined in section 201(ss) of the Federal 
        Food, Drug, and Cosmetic Act, as added by this Act, that--
                    (A) is first offered for clinical use during the 
                period beginning on the date of enactment of this Act 
                and ending on the effective date of this Act;
                    (B) is developed by a clinical laboratory certified 
                by the Secretary under section 353 of the Public Health 
                Service Act (42 U.S.C. 263a) that meets the 
                requirements for performing high-complexity testing and 
                performed--
                            (i) in the same clinical laboratory in 
                        which the test was developed and for which a 
                        certification is still in effect under such 
                        section 353 that meets the requirements to 
                        perform tests of high complexity;
                            (ii) by another laboratory for which a 
                        certificate is in effect under such section 353 
                        that meets the requirements to perform tests of 
                        high complexity, is within the same corporate 
                        organization, and has common ownership by the 
                        same parent corporation as the laboratory in 
                        which the test was developed; or
                            (iii) in the case of a test that was 
                        developed by the Centers for Disease Control 
                        and Prevention or another laboratory a public 
                        health laboratory network coordinated or 
                        managed by the Centers for Disease Control and 
                        Prevention, by a clinical laboratory for which 
                        a certificate is in effect under section 353 of 
                        such Act that meets the requirements to perform 
                        tests of high complexity, and that is within a 
                        public health laboratory network coordinated or 
                        managed by the Centers for Disease Control and 
                        Prevention; and
                    (C) when first offered, is not approved under 
                section 515 of the Federal Food, Drug, and Cosmetic 
                Act, cleared under section 510(k) of such Act, 
                authorized under section 513(f)(2) of such Act, subject 
                to a humanitarian device exemption under section 520(m) 
                of such Act (21 U.S.C. 360j(m)), subject to an 
                exemption for investigation use under section 520(g) of 
                such Act (21 U.S.C. 360j(g)), authorized under section 
                564 of such Act (21 U.S.C. 360bbb-3), or licensed under 
                section 351 of the Public Health Service Act (42 U.S.C. 
                262).
            (2) Premarket review or technology certification.--A 
        transitional in vitro clinical test that is the subject of an 
        application for premarket review under section 587B of the 
        Federal Food, Drug, and Cosmetic Act or technology 
        certification application under section 587D of such Act, as 
        added by this Act, may continue to be offered, sold, or 
        distributed until completion of the Secretary's review of the 
        premarket application or technology certification application, 
        if such application is submitted no later than 90 days after 
        the effective date of this Act.
            (3) Tests approved by new york state.--Notwithstanding 
        paragraph (2), a transitional in vitro clinical test that has 
        been approved by the New York State Department of Health may 
        continue to be offered, sold, or distributed after the 
        effective date if--
                    (A) starting on the effective date of this Act, the 
                in vitro clinical test complies with the requirements 
                of subchapter J of the Federal Food, Drug, and Cosmetic 
                Act, as added by this Act, except for sections 587B and 
                design control provisions of section 587K;
                    (B) each test report template for the test bears a 
                statement of adequate prominence that reads as follows: 
                ``This in vitro clinical test was developed and first 
                introduced prior to the effective date of the VALID Act 
                of 2022. This test was approved by the New York State 
                Department of Health, but the test has not been 
                reviewed by the Food and Drug Administration.'';
                    (C) a premarket application under section 587B or 
                technology certification application under section 587D 
                is submitted no later than--
                            (i) 5 years after the effective date of 
                        this Act, if the in vitro clinical test is 
                        approved by the New York State Department of 
                        Health as a genetic testing molecular test, a 
                        microbiology molecular test, an oncology 
                        molecular test, or any other type of molecular 
                        test; or
                            (ii) 2 years after the effective date of 
                        this Act, if the in vitro clinical test is 
                        approved by the New York State Department of 
                        Health as a type of test not described in 
                        clause (i); and
                    (D) a test in compliance with this paragraph (3) 
                may continue to be offered, sold, or distributed until 
                the completion of the Secretary's review of the 
                premarket application or technology certification 
                application referenced in subparagraph (C).
    (d) Conversion.--
            (1) Deemed premarket approval.--Beginning on the effective 
        date of this Act--
                    (A) any in vitro clinical test (as defined in 
                section 201(ss) of the Federal Food, Drug, and Cosmetic 
                Act, as added by section 822) with a premarket approval 
                under section 515 of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 360e) or a licensure under 
                section 351 of the Public Health Service Act (42 U.S.C. 
                262) is deemed to be approved pursuant to an 
                application under section 587B(c) of the Federal Food, 
                Drug, and Cosmetic Act, as added by this Act; and
                    (B) any in vitro clinical test (as so defined) that 
                was cleared under section 510(k) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 360(k)) or authorized 
                under section 513(f)(2) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 360c(f)(2)) is deemed to be 
                approved pursuant to an application under section 
                587B(d) of the Federal Food, Drug, and Cosmetic Act, as 
                added by this Act.
            (2) Deemed investigational use exemption.--Any in vitro 
        clinical test (as defined in section 201(ss) of the Federal 
        Food, Drug, and Cosmetic Act, as added by section 822) that has 
        an investigational device exemption in effect under section 
        520(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        360j(g)) is deemed to have an investigational use exemption in 
        effect under section 587S of such Act, as added by this Act, 
        beginning on the effective date of this Act.
            (3) Deemed humanitarian device exemption.--Any in vitro 
        clinical test (as defined in section 201(ss) of the Federal 
        Food, Drug, and Cosmetic Act, as added by section 822) that has 
        an approved humanitarian device exemption under section 520(m) 
        of such Act is deemed to have a humanitarian test exemption 
        under section 587A(g) of such Act, as added by this Act, 
        beginning on the effective date of this Act.
            (4) Deemed designated breakthrough.--Any in vitro clinical 
        test (as defined in section 201(gg) of the Federal Food, Drug, 
        and Cosmetic Act, as added by section 822) that has received a 
        breakthrough device designation under section 515B(e)(1)(D) of 
        such Act (21 U.S.C. 360e-3(e)(1)(D)) is deemed to have a 
        breakthrough in vitro clinical test designation under section 
        587C of such Act, as added by this Act, beginning on the 
        effective date of this Act.
            (5) Deemed request for informal feedback.--With regard to 
        any in vitro clinical test that is the subject of a pre-
        submission request described in the guidance, ``Requests for 
        Feedback and Meetings for Medical Device Submissions: The Q-
        Submission Program'', issued by the Food and Drug 
        Administration on January 6, 2021, such request is deemed to 
        constitute a request for informal feedback under section 587F 
        of the Federal Food, Drug, and Cosmetic Act, as added by 
        section 823, beginning on the effective date of this Act.
    (e) Previously Classified Devices.--Notwithstanding section 587 of 
the Federal Food, Drug, and Cosmetic Act, as added by section 823, for 
purposes of subchapter J of chapter V of such Act, as added by section 
823, the following apply:
            (1) In the case of an in vitro clinical test type that has 
        been classified by the Secretary as a class I device pursuant 
        to section 513 of such Act (21 U.S.C. 360c), such in vitro 
        clinical test shall be low-risk, unless the in vitro clinical 
        test is a test described in section 510(l) or the test is 
        redesignated by the Secretary pursuant to section 587F of such 
        Act.
            (2) In the case of an in vitro clinical test type that has 
        been classified by the Secretary as a class II device pursuant 
        to section 513 of such Act (21 U.S.C. 360c), such in vitro 
        clinical test shall be moderate-risk, unless inaccurate results 
        from the test would be immediately life threatening or the test 
        is redesignated by the Secretary pursuant to section 587F of 
        such Act.
            (3) In the case of an in vitro clinical test type that is a 
        class III device pursuant to section 513 of such Act (21 U.S.C. 
        360c), such in vitro clinical test shall be high-risk, unless 
        redesignated by the Secretary pursuant to section 587F of such 
        Act.

SEC. 826. EMERGENCY USE AUTHORIZATION.

    (a) In General.--Section 564 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb-3) is amended--
            (1) in subsection (a)--
                    (A) in paragraphs (1) and (4)(C), by inserting ``in 
                vitro clinical test,'' before ``or biological product'' 
                each place such term appears; and
                    (B) in paragraph (2)(A), by striking ``or 515'' and 
                inserting ``515, or 587B'';
            (2) in subsection (e)--
                    (A) in paragraph (3)--
                            (i) in subparagraph (B), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (C), by striking the 
                        period and inserting ``; and''; and
                            (iii) by adding at the end the following:
                    ``(D) quality requirements (with respect to in 
                vitro clinical tests) under section 587K.''; and
                    (B) in paragraph (4)--
                            (i) in subparagraph (A), by striking ``; 
                        or'' and inserting a semicolon;
                            (ii) in subparagraph (B), by striking the 
                        period and inserting ``; or''; and
                            (iii) by adding at the end the following:
                    ``(C) with respect to in vitro clinical tests, 
                requirements applicable to restricted in vitro clinical 
                tests pursuant to section 587O.'';
            (3) in subsection (m)--
                    (A) in the subsection heading, by striking 
                ``Laboratory Tests Associated With Devices'' inserting 
                ``in Vitro Clinical Tests'' after ``Devices''; and
                    (B) in paragraph (1)--
                            (i) by striking ``to a device'' and 
                        inserting ``to an in vitro clinical test''; and
                            (ii) by striking ``such device'' and 
                        inserting ``such in vitro clinical test''.
    (b) Emergency Use of Medical Products.--Section 564A(a)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a(a)(2)) is 
amended by inserting ``in vitro clinical test,'' after ``device,''.
    (c) Products Held for Emergency Use.--Section 564B(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3b(2)) is 
amended--
            (1) in subparagraph (A), by striking ``or 515'' and 
        inserting ``515, or 587B''; and
            (2) in subparagraph (B), by striking ``or 520'' and 
        inserting 520, or 587S.

SEC. 827. ANTIMICROBIAL SUSCEPTIBILITY TESTS.

    Section 511A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360a-2) is amended--
            (1) in subsection (a)(1)(C)--
                    (A) by striking ``clear under section 510(k), 
                classify under section 513(f)(2), or approve under 
                section 515'' and inserting ``approve under section 
                587B, exempt from premarket review under section 587C, 
                or grant a technology certification order under section 
                587D''; and
                    (B) by striking ``testing devices'' and inserting 
                ``in vitro clinical tests'';
            (2) in subsection (c)(5), by striking ``drug or device'' 
        each place it appears and inserting ``drug, device, or in vitro 
        clinical test'';
            (3) in subsection (e)--
                    (A) in the heading, by striking ``Testing Devices'' 
                and inserting ``In Vitro Clinical Tests'';
                    (B) in paragraph (1)--
                            (i) by striking ``510, 513, and 515,'' and 
                        inserting ``587B, and 587D'';
                            (ii) by striking ``antimicrobial 
                        susceptibility testing device'' and inserting 
                        ``antimicrobial susceptibility in vitro 
                        clinical test''; and
                            (iii) by striking ``such device'' and 
                        inserting ``such in vitro clinical test''; and
                    (C) in paragraph (2)--
                            (i) in the heading, by striking ``testing 
                        devices'' and inserting ``in vitro clinical 
                        tests'';
                            (ii) in subparagraphs (A) and (B) (other 
                        than clause (iii) of such subparagraph (B)), by 
                        striking ``device'' each place it appears and 
                        inserting ``in vitro clinical test'';
                            (iii) in subparagraph (B)(iii), by striking 
                        ``a device'' and inserting ``an in vitro 
                        clinical test''; and
                            (iv) by amending subparagraph (C) to read 
                        as follows:
                    ``(C) The antimicrobial susceptibility in vitro 
                clinical test meets all other requirements to be 
                approved under section 587B, exempted from premarket 
                review under section 587C, or offered under a 
                technology certification order under section 587D.'';
            (4) in subsection (f), by amending paragraph (1) to read as 
        follows:
            ``(1) The term `antimicrobial susceptibility in vitro 
        clinical test' means an in vitro clinical test that utilizes 
        susceptibility test interpretive criteria to determine and 
        report the in vitro susceptibility of certain microorganisms to 
        a drug (or drugs).''; and
            (5) in subsection (g)(2)--
                    (A) by amending the matter preceding subparagraph 
                (A) to read as follows:
            ``(2) with respect to approving an application under 
        section 587B or granting a technology certification order under 
        section 587D--''; and
                    (B) in subparagraph (A)--
                            (i) by striking ``device'' and inserting 
                        ``in vitro clinical test''; and
                            (ii) by striking ``antimicrobial 
                        susceptibility testing device'' and inserting 
                        ``antimicrobial susceptibility in vitro 
                        clinical test''.

SEC. 828. COMBINATION PRODUCTS.

    (a) In General.--Section 503(g) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353(g)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A), by striking ``or 
                biological product'' and inserting ``in vitro clinical 
                test, or biological product (except for a product 
                constituted of a device and an in vitro clinical 
                test)'';
                    (B) in subparagraph (B), by adding at the end the 
                following: ``For purposes of this Act, a product that 
                constitutes a combination of a drug and an in vitro 
                clinical test is not a combination product within the 
                meaning of this subsection.''; and
                    (C) in subparagraph (D)(ii)--
                            (i) by inserting ``or in vitro clinical 
                        test'' after ``device''; and
                            (ii) by inserting ``and in vitro clinical 
                        tests'' before ``shall'';
            (2) in paragraph (3), by striking ``safety and 
        effectiveness or substantial equivalence'' and inserting 
        ``safety and effectiveness, substantial equivalence, or 
        analytical validity and clinical validity'' before ``for the 
        approved constituent part'';
            (3) in paragraph (4)--
                    (A) in subparagraph (A), by striking ``or 513(f)(2) 
                (submitted in accordance with paragraph (5))'' and 
                inserting ``513(f)(2) (submitted in accordance with 
                paragraph (5)), 587B, or 587D, or an exempt test under 
                section 587C, as applicable''; and
                    (B) in subparagraph (B), by inserting ``, 587B, or 
                587D'' after ``section 515'';
            (4) in paragraph (5)(A), by striking ``or 510(k)'' and 
        inserting ``, 510(k), 587B, or 587D'';
            (5) in paragraph (7), by striking ``or substantial 
        equivalence'' and inserting ``, substantial equivalence, or 
        analytical validity and clinical validity'';
            (6) in paragraph (8), by adding at the end the following:
                    ``(I) This paragraph shall not apply to a product 
                constituted of a device and an in vitro clinical 
                test.''; and
            (7) in paragraph (9)--
                    (A) in subparagraph (C)(i), by striking ``or 
                520(g)'' and inserting ``520(g), 587B, or 587D''; and
                    (B) in subparagraph (D), by striking ``or 520'' and 
                inserting ``520, 587B, or 587D''.
    (b) Classification of Products.--Section 563 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb-2) is amended by adding at the 
end the following:
    ``(d) Exemption.--This section shall not apply to a product 
constituted of a device and an in vitro clinical test.''.

SEC. 829. RESOURCES.

    (a) Findings.--Congress finds that the fees authorized by this 
section will be dedicated to meeting the goals identified in the 
letters from the Secretary of Health and Human Services to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives, 
as set forth in the Congressional Record.
    (b) Authorization of Appropriations.--For purposes of funding 
implementation of subchapter J of title V of the Federal Food, Drug, 
and Cosmetic Act, as added by this Act, including undertaking 
activities for the development of regulations and guidances, hiring of 
necessary staff, and the development of technology systems to implement 
this subchapter in a timely, effective, and efficient manner there is 
authorized to be appropriated $480,000,000.
    (c) Establishment of User Fee Program.--
            (1) Development of user fees for in vitro clinical tests.--
                    (A) In general.--Beginning not later than October 
                1, 2021, the Secretary of Health and Human Services (in 
                this section referred to as the ``Secretary'') shall 
                develop recommendations to present to Congress with 
                respect to the goals, and plans for meeting the goals, 
                for the process for the review of in vitro clinical 
                test submissions and applications under subchapter J of 
                chapter V of the Federal Food, Drug, and Cosmetic Act, 
                as added by this Act, for the first 5 fiscal years 
                after fiscal year 2022. In developing such 
                recommendations, the Secretary shall consult with--
                            (i) the Committee on Health, Education, 
                        Labor, and Pensions of the Senate;
                            (ii) the Committee on Energy and Commerce 
                        of the House of Representatives;
                            (iii) scientific and academic experts;
                            (iv) health care professionals;
                            (v) representatives of patient and consumer 
                        advocacy groups; and
                            (vi) the regulated industry.
                    (B) Prior public input.--Prior to beginning 
                negotiations with the regulated industry on the 
                authorization of such subchapter J, the Secretary 
                shall--
                            (i) publish a notice in the Federal 
                        Register requesting public input on the 
                        authorization of user fees;
                            (ii) hold a public meeting at which the 
                        public may present its views on the 
                        authorization, including specific suggestions 
                        for the recommendations submitted under 
                        subparagraph (E);
                            (iii) provide a period of 30 days after the 
                        public meeting to obtain written comments from 
                        the public suggesting changes to such 
                        subchapter J; and
                            (iv) publish any comments received under 
                        clause (iii) on the website of the Food and 
                        Drug Administration.
                    (C) Periodic consultation.--Not less frequently 
                than once every month during negotiations with the 
                regulated industry, the Secretary shall hold 
                discussions with representatives of patient and 
                consumer advocacy groups to continue discussions of the 
                authorization under such subchapter J and to solicit 
                suggestions to be included in the recommendations 
                transmitted to Congress under subparagraph (E).
                    (D) Public review of recommendations.--After 
                negotiations with the regulated industry, the Secretary 
                shall--
                            (i) present the recommendations developed 
                        under subparagraph (A) to the Committee on 
                        Health, Education, Labor, and Pensions of the 
                        Senate and the Committee on Energy and Commerce 
                        of the House of Representatives;
                            (ii) publish such recommendations in the 
                        Federal Register;
                            (iii) provide for a period of 30 days for 
                        the public to provide written comments on such 
                        recommendations;
                            (iv) hold a meeting at which the public may 
                        present its views on such recommendations; and
                            (v) after consideration of such public 
                        views and comments, revise such recommendations 
                        as necessary.
                    (E) Transmittal of recommendations.--
                            (i) In general.--Not later than January 15, 
                        2027, the Secretary shall transmit to Congress 
                        the revised recommendations under subparagraph 
                        (A), a summary of the views and comments 
                        received under such subparagraph, and any 
                        changes made to the recommendations in response 
                        to such views and comments.
                            (ii) Recommendation requirements.--The 
                        recommendations transmitted under this 
                        subparagraph shall--
                                    (I) include the number of full-time 
                                equivalent employees per fiscal year 
                                that are agreed to be hired to carry 
                                out the goals included in such 
                                recommendations for each year of the 5-
                                year period;
                                    (II) provide that the amount of 
                                operating reserve balance in the user 
                                fee program established under this 
                                section is not more than the equivalent 
                                of 10 weeks of operating reserve;
                                    (III) require the development of a 
                                strategic plan for any surplus within 
                                the operating reserve account above the 
                                10-week operating reserve within 2 
                                years of the establishment of the 
                                program;
                                    (IV) include an operating reserve 
                                adjustment such that, if the Secretary 
                                has an operating reserve balance in 
                                excess of 10 weeks of such operating 
                                reserves, the Secretary shall decrease 
                                such fee revenue and fees to provide 
                                for not more than 10 weeks of such 
                                operating reserves;
                                    (V) if an adjustment is made as 
                                described in subclause (IV), provide 
                                the rationale for the amount of the 
                                decrease in fee revenue and fees shall 
                                be contained in the Federal Register; 
                                and
                                    (VI) provide that the fees assessed 
                                and collected for the full-time 
                                equivalent employees at the Center for 
                                Devices and Radiological Health, with 
                                respect to which the majority of time 
                                reporting data indicates are dedicated 
                                to the process for the review of in 
                                vitro clinical test submissions and 
                                applications under paragraph (5), are 
                                not supported by the funds authorized 
                                to be collected and assessed under 
                                section 738 of the Federal Food, Drug, 
                                and Cosmetic Act (21 U.S.C. 379j).
                    (F) Publication of recommendations.--The Secretary 
                shall publish on the website of the Food and Drug 
                Administration the revised recommendations under 
                subparagraph (A), a summary of the views and comments 
                received under subparagraphs (B) through (D), and any 
                changes made to the recommendations originally proposed 
                by the Secretary in response to such views and 
                comments.
                    (G) Minutes of negotiation meetings.--
                            (i) Public availability.--The Secretary 
                        shall make publicly available, on the website 
                        of the Food and Drug Administration, minutes of 
                        all negotiation meetings conducted under this 
                        subsection between the Food and Drug 
                        Administration and the regulated industry not 
                        later than 30 days after such meeting.
                            (ii) Content.--The minutes described under 
                        clause (i) shall summarize any substantive 
                        proposal made by any party to the negotiations, 
                        any significant controversies or differences of 
                        opinion during the negotiations, and the 
                        resolution of any such controversy or 
                        difference of opinion.
            (2) Establishment of user fee program.--Effective on 
        October 1, 2027, provided that the Secretary transmits the 
        recommendations under paragraph (1)(E), the Secretary is 
        authorized to collect user fees relating to the review of in 
        vitro clinical test submissions and applications under 
        subchapter J of chapter V of the Federal Food, Drug, and 
        Cosmetic Act, as added by this Act. Fees under such program 
        shall be assessed and collected only if the requirements under 
        paragraph (4) are met.
            (3) Audit.--
                    (A) In general.--On the date that is 2 years after 
                first receiving a user fee applicable to submission of 
                an in vitro clinical test application submitted under 
                subchapter J of chapter V of the Federal Food, Drug, 
                and Cosmetic Act, as added by this Act, and on a 
                biennial basis thereafter, the Secretary shall perform 
                an audit of the costs of reviewing such applications 
                under such subchapter J. Such an audit shall compare 
                the costs of reviewing such applications under such 
                subchapter J to the amount of the user fee applicable 
                to such applications.
                    (B) Alteration of user fee.--If the audit performed 
                under subparagraph (A) indicates that the user fees 
                applicable to applications submitted under such 
                subchapter J exceed 49 percent of the costs of 
                reviewing such applications, the Secretary shall alter 
                the user fees applicable to applications submitted 
                under such subchapter J such that the user fees do not 
                exceed such percentage.
                    (C) Accounting standards.--The Secretary shall 
                perform an audit under subparagraph (A) in conformance 
                with the accounting principles, standards, and 
                requirements prescribed by the Comptroller General of 
                the United States under section 3511 of title 31, 
                United States Code, to ensure the validity of any 
                potential variability.
            (4) Conditions.--The user fee program described in this 
        subsection shall take effect only if the Food and Drug 
        Administration issues draft guidance related to the review 
        requirements for in vitro diagnostic tests that would be 
        subject to premarket review under section 587B of the Federal 
        Food, Drug, and Cosmetic Act, as added by section 823, the 
        review requirements for test categories eligible for technology 
        certification under section 587D of such Act, as added by 
        section 823, and the parameters for the test categories that 
        would be exempt from any review under subchapter J of chapter V 
        of such Act.
            (5) User fee program definitions and resource 
        requirements.--
                    (A) In general.--The term ``process for the review 
                of in vitro clinical test submissions and 
                applications'' means the following activities of the 
                Secretary with respect to the review of in vitro 
                clinical test premarket and technology certification 
                applications including supplements for such 
                applications:
                            (i) The activities necessary for the review 
                        of premarket applications, premarket reports, 
                        technology certification applications, and 
                        supplements to such applications.
                            (ii) Actions related to submissions in 
                        connection with in vitro clinical test 
                        development, the issuance of action letters 
                        that allow the marketing of in vitro clinical 
                        tests or which set forth in detail the specific 
                        deficiencies in such applications, reports, 
                        supplements, or submissions and, where 
                        appropriate, the actions necessary to support 
                        the development of in vitro clinical tests.
                            (iii) The inspection of manufacturing 
                        establishments and other facilities undertaken 
                        as part of the Secretary's review of pending 
                        premarket applications, technology 
                        certifications, and supplements.
                            (iv) Monitoring of research conducted in 
                        connection with the review of such 
                        applications, supplements, and submissions.
                            (v) Review of in vitro clinical test 
                        applications subject to section 351 of the 
                        Public Health Service Act (42 U.S.C. 262) and 
                        activities conducted in anticipation of the 
                        submission of such applications for 
                        investigational use under section 587S of the 
                        Federal Food, Drug, and Cosmetic Act (as added 
                        by section 823).
                            (vi) The development of guidance, policy 
                        documents, or regulations to improve the 
                        process for the review of premarket 
                        applications, technology certification 
                        applications, and supplements.
                            (vii) The development of voluntary test 
                        methods, consensus standards, or mandatory 
                        performance standards in connection with the 
                        review of such applications, supplements, or 
                        submissions and related activities.
                            (viii) The provision of technical 
                        assistance to in vitro clinical test developers 
                        in connection with the submission of such 
                        applications, reports, supplements, or 
                        submissions.
                            (ix) Any activity undertaken in connection 
                        with the initial classification or 
                        reclassification of an in vitro clinical test 
                        in connection with any requirement for approval 
                        or eligibility for an exemption from premarket 
                        review of an in vitro clinical test.
                            (x) Any activity undertaken in connection 
                        with making a pathway determination of an in 
                        vitro clinical test, including the 
                        identification, establishment, and 
                        implementation of mitigation measures.
                            (xi) Evaluation of postmarket studies 
                        required as a condition of an approval of a 
                        premarket application of an in vitro clinical 
                        test and ensuring such studies are conducted as 
                        required.
                            (xii) Any activity undertaken in connection 
                        with ensuring in vitro clinical tests marketed 
                        under an exemption from premarket review 
                        pursuant to section 587C or 587G meet the 
                        criteria for such exemption and the applicable 
                        standard.
                            (xiii) Compiling, developing, and reviewing 
                        information on in vitro clinical tests 
                        necessary to identify issues with the ability 
                        of in vitro clinical tests to meet the 
                        applicable standard, as applicable.
                    (B) Resource requirements.--Fees collected and 
                assessed under this section shall be used for the 
                process for the review of in vitro clinical test 
                applications, as described in subparagraph (A), and 
                shall--
                            (i) be subject to the limitation under 
                        section 738(g)(3) of the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 379j(g)(3)), in the 
                        same manner that fees collected and assessed 
                        under section 737(9)(C) of such Act (21 U.S.C. 
                        379i(9)(C)) are subject to such limitation;
                            (ii) include travel expenses for officers 
                        and employees of the Food and Drug 
                        Administration only if the Secretary determines 
                        that such travel is directly related to an 
                        activity described in subparagraph (A); and
                            (iii) not be allocated to purposes 
                        described under section 722(a) of the 
                        Consolidated Appropriations Act, 2018 (Public 
                        Law 115-141).
    (d) Reports.--
            (1) Performance report.--
                    (A) In general.--
                            (i) General requirements.--Beginning with 
                        fiscal year 2027, for each fiscal year for 
                        which fees are collected under this section, 
                        the Secretary shall prepare and submit to the 
                        Committee on Health, Education, Labor, and 
                        Pensions of the Senate and the Committee on 
                        Energy and Commerce of the House of 
                        Representatives annual reports concerning the 
                        progress of the Food and Drug Administration in 
                        achieving the goals identified in the 
                        recommendations transmitted to Congress by the 
                        Secretary pursuant to subsection (b)(1)(E) 
                        during such fiscal year and the future plans of 
                        the Food and Drug Administration for meeting 
                        the goals.
                            (ii) Additional information.--Beginning 
                        with fiscal year 2021, the annual report under 
                        this subparagraph shall include the progress of 
                        the Food and Drug Administration in achieving 
                        the goals, and future plans for meeting the 
                        goals, including--
                                    (I) the number of premarket 
                                applications filed under section 587B 
                                of the Federal Food, Drug, and Cosmetic 
                                Act during the applicable fiscal year;
                                    (II) the number of technology 
                                certification applications submitted 
                                under section 587D of the Federal Food, 
                                Drug, and Cosmetic Act during the 
                                applicable fiscal year for each review 
                                division;
                                    (III) the number of breakthrough 
                                designations under section 587I of the 
                                Federal Food, Drug, and Cosmetic Act 
                                during the applicable fiscal year; and
                                    (IV) the number of information 
                                requests requested by the Secretary 
                                pursuant to section 587G(d) of such 
                                Act.
                            (iii) Real-time reporting.--
                                    (I) In general.--Not later than 30 
                                calendar days after the end of the 
                                second quarter of fiscal year 2027, and 
                                not later than 30 calendar days after 
                                the end of each quarter of each fiscal 
                                year thereafter, the Secretary shall 
                                post the data described in subclause 
                                (II) on the website of the Food and 
                                Drug Administration for such quarter 
                                and on a cumulative basis for such 
                                fiscal year, and may remove duplicative 
                                data from the annual report under this 
                                subparagraph.
                                    (II) Data.--The Secretary shall 
                                post the following data in accordance 
                                with subclause (I):
                                            (aa) The number and titles 
                                        of draft and final regulations 
                                        on topics related to the 
                                        process for the review of in 
                                        vitro clinical test submissions 
                                        and applications, and whether 
                                        such guidances were required by 
                                        statute or pursuant to the 
                                        recommendations transmitted to 
                                        Congress by the Secretary 
                                        pursuant to subsection 
                                        (b)(1)(E).
                                            (bb) The number and titles 
                                        of draft and final guidance on 
                                        topics related to the process 
                                        for the review of in vitro 
                                        clinical test submissions and 
                                        applications, and whether such 
                                        guidances were issued as 
                                        required by statute or pursuant 
                                        to the recommendations 
                                        transmitted to Congress by the 
                                        Secretary pursuant to 
                                        subsection (c)(1)(E).
                                            (cc) The number and titles 
                                        of public meetings held on 
                                        topics related to the process 
                                        for the review of in vitro 
                                        clinical tests, and if such 
                                        meetings were required by 
                                        statute or pursuant to the 
                                        recommendations transmitted to 
                                        Congress by the Secretary 
                                        pursuant to subsection 
                                        (c)(1)(E).
                            (iv) Rationale for ivct user fee program 
                        changes.--Beginning with fiscal year 2027, the 
                        Secretary shall include in the annual 
                        performance report under paragraph (1)--
                                    (I) data, analysis, and discussion 
                                of the changes in the number of full-
                                time equivalents hired as agreed upon 
                                in the recommendations transmitted to 
                                Congress by the Secretary pursuant to 
                                subsection (b)(1)(E) and the number of 
                                full-time equivalents funded by budget 
                                authority at the Food and Drug 
                                Administration by each division within 
                                the Center for Devices and Radiological 
                                Health, the Center for Biologics 
                                Evaluation and Research, the Office of 
                                Regulatory Affairs, and the Office of 
                                the Commissioner;
                                    (II) data, analysis, and discussion 
                                of the changes in the fee revenue 
                                amounts and costs for the process for 
                                the review of in vitro clinical test 
                                submissions and applications, including 
                                identifying drivers of such changes; 
                                and
                                    (III) for each of the Center for 
                                Devices and Radiological Health, the 
                                Center for Biologics Evaluation and 
                                Research, the Office of Regulatory 
                                Affairs, and the Office of the 
                                Commissioner, the number of employees 
                                for whom time reporting is required and 
                                the number of employees for whom time 
                                reporting is not required.
                            (v) Analysis.--For each fiscal year, the 
                        Secretary shall include in the report under 
                        clause (i) an analysis of the following:
                                    (I) The difference between the 
                                aggregate number of premarket 
                                applications filed under section 587B 
                                or section 587D of the Federal Food, 
                                Drug, and Cosmetic Act and the 
                                aggregate number of major deficiency 
                                letters, not approvable letters, and 
                                denials for such applications issued by 
                                the agency, accounting for--
                                            (aa) the number of 
                                        applications filed under each 
                                        of sections 587B and 587D of 
                                        the Federal Food, Drug, and 
                                        Cosmetic Act during one fiscal 
                                        year for which a decision is 
                                        not scheduled to be made until 
                                        the following fiscal year; and
                                            (bb) the aggregate number 
                                        of applications under each of 
                                        sections 587B and 587D of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act for each fiscal 
                                        year that did not meet the 
                                        goals as identified by the 
                                        recommendations transmitted to 
                                        Congress by the Secretary 
                                        pursuant to subsection 
                                        (b)(1)(E).
                                    (II) Relevant data to determine 
                                whether the Center for Devices and 
                                Radiological Health has met performance 
                                enhancement goals identified by the 
                                recommendations transmitted to Congress 
                                by the Secretary pursuant to subsection 
                                (b)(1)(E).
                                    (III) The most common causes and 
                                trends for external or other 
                                circumstances affecting the ability of 
                                the Food and Drug Administration to 
                                meet review time and performance 
                                enhancement goals identified by the 
                                recommendations transmitted to Congress 
                                by the Secretary pursuant to subsection 
                                (b)(1)(E).
                    (B) Publication.--With regard to information to be 
                reported by the Food and Drug Administration to 
                industry on a quarterly and annual basis pursuant to 
                recommendations transmitted to Congress by the 
                Secretary pursuant to subsection (b)(1)(E), the 
                Secretary shall make such information publicly 
                available on the website of the Food and Drug 
                Administration not later than 60 days after the end of 
                each quarter or 120 days after the end of each fiscal 
                year, respectively, to which such information applies.
                    (C) Updates.--The Secretary shall include in each 
                report under subparagraph (A) information on all 
                previous cohorts for which the Secretary has not given 
                a complete response on all in vitro clinical test 
                premarket applications and technology certification 
                orders and supplements, premarket, and technology 
                certification notifications in the cohort.
            (2) Corrective action report.--Beginning with fiscal year 
        2022, for each fiscal year for which fees are collected under 
        this section, the Secretary shall prepare and submit a 
        corrective action report to the Committee on Health, Education, 
        Labor, and Pensions and the Committee on Appropriations of the 
        Senate and the Committee on Energy and Commerce and the 
        Committee on Appropriations of the House of Representatives. 
        The report shall include the following information, as 
        applicable:
                    (A) Goals met.--For each fiscal year, if the 
                Secretary determines, based on the analysis under 
                paragraph (1)(A)(v), that each of the goals identified 
                by the recommendations transmitted to Congress by the 
                Secretary pursuant to subsection (b)(1)(E) for the 
                applicable fiscal year have been met, the corrective 
                action report shall include recommendations on ways in 
                which the Secretary can improve and streamline the in 
                vitro clinical test premarket application and 
                technology certification review process.
                    (B) Goals missed.--For each of the goals identified 
                by the letters described in recommendations transmitted 
                to Congress by the Secretary pursuant to subsection 
                (b)(1)(E) for the applicable fiscal year that the 
                Secretary determines to not have been met, the 
                corrective action report shall include--
                            (i) a justification for such determination;
                            (ii) a description of the types of 
                        circumstances, in the aggregate, under which 
                        applications or reports submitted under 
                        sections 587B and 587D of the Federal Food, 
                        Drug, and Cosmetic Act missed the review goal 
                        times but were approved during the first cycle 
                        review, as applicable;
                            (iii) a summary and any trends with regard 
                        to the circumstances for which a review goal 
                        was missed; and
                            (iv) the performance enhancement goals that 
                        were not achieved during the previous fiscal 
                        year and a description of efforts the Food and 
                        Drug Administration has put in place for the 
                        fiscal year in which the report is submitted to 
                        improve the ability of such agency to meet each 
                        such goal for the such fiscal year.
            (3) Fiscal report.--For fiscal years 2027 and annually 
        thereafter, not later than 120 days after the end of each 
        fiscal year during which fees are collected under this subpart, 
        the Secretary shall prepare and submit to the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives, a report on the implementation of the 
        authority for such fees during such fiscal year and the use, by 
        the Food and Drug Administration, of the fees collected during 
        such fiscal year for which the report is made.
                    (A) Contents.--Such report shall include 
                expenditures delineated by budget authority and user 
                fee dollars related to administrative expenses and 
                information technology infrastructure contracts and 
                expenditures.
                    (B) Operating reserve.--Such report shall provide 
                the amount of operating reserve balance available each 
                year, and any planned allocations or obligations of 
                such balance that is above 10 weeks of operating 
                reserve for the program.
            (4) Public availability.--The Secretary shall make the 
        reports required under paragraphs (1) through (3) available to 
        the public on the website of the Food and Drug Administration.
            (5) Enhanced communication.--
                    (A) Communications with congress.--Each fiscal 
                year, as applicable and requested, representatives from 
                the Centers with expertise in the review of in vitro 
                clinical tests shall meet with representatives from the 
                Committee on Health, Education, Labor, and Pensions of 
                the Senate and the Committee on Energy and Commerce of 
                the House of Representatives to report on the contents 
                described in the reports under this section.
                    (B) Participation in congressional hearing.--Each 
                fiscal year, as applicable and requested, 
                representatives from the Food and Drug Administration 
                shall participate in a public hearing before the 
                Committee on Health, Education, Labor, and Pensions of 
                the Senate and the Committee on Energy and Commerce of 
                the House of Representatives, to report on the contents 
                described in the reports under this section. Such 
                hearing shall occur not later than 120 days after the 
                end of each fiscal year for which fees are collected 
                under this section.

SEC. 830. AUTHORIZATION OF APPROPRIATIONS.

    For purposes of funding implementation of this subtitle (including 
the amendments made by this subtitle), including undertaking activities 
for the development of regulations and guidances, hiring of necessary 
staff, and the development of technology systems to implement this 
subtitle (including the amendments made by this subtitle) in a timely, 
effective, and efficient manner, there is authorized to be appropriated 
not more than $480,000,000, to remain available through the end of 
fiscal year 2027.

                       TITLE IX--OTHER PROVISIONS

SEC. 901. FACILITIES MANAGEMENT.

    (a) PDUFA Authority.--Section 736(g)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h(g)(2))--
            (1) in subparagraph (A)(ii)--
                    (A) by striking ``shall be available to defray'' 
                and inserting the following: ``shall be available--
                                    ``(I) for fiscal year 2023, to 
                                defray'';
                    (B) by striking the period and inserting ``; and''; 
                and
                    (C) by adding at the end the following:
                                    ``(II) for fiscal year 2024 and 
                                each subsequent fiscal year, to defray 
                                the costs of the resources allocated 
                                for the process for the review of human 
                                drug applications (including such costs 
                                for an additional number of full-time 
                                equivalent positions in the Department 
                                of Health and Human Services to be 
                                engaged in such process), only if the 
                                sum of the amounts allocated by the 
                                Secretary for such costs, excluding 
                                costs paid from fees collected under 
                                this section, plus other costs for the 
                                maintenance, renovation, and repair of 
                                facilities and acquisition, 
                                maintenance, and repair of fixtures, 
                                furniture, and other necessary 
                                materials and supplies in connection 
                                with the process for the review of 
                                human drug applications, is no less 
                                than the amount allocated for such 
                                costs, excluding any such costs paid 
                                from fees collected under this section, 
                                for fiscal year 1997, multiplied by the 
                                adjustment factor.''; and
            (2) in subparagraph (B), by striking ``for the process for 
        the review of human drug applications'' and inserting ``as 
        described in subclause (I) or (II) of such subparagraph, as 
        applicable''.
    (b) BsUFA Authority.--Section 744H(f)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-52(f)(2)) is amended--
            (1) in subparagraph (B)(i)--
                    (A) by striking ``available for a fiscal year 
                beginning after fiscal year 2012'' and inserting the 
                following: ``available--
                                    ``(I) for fiscal year 2023'';
                    (B) by striking ``the fiscal year involved.'' and 
                inserting ``such fiscal year; and''; and
                    (C) by adding at the end the following:
                                    ``(II) for fiscal year 2024 and 
                                each subsequent fiscal year, to defray 
                                the costs of the process for the review 
                                of biosimilar biological product 
                                applications (including such costs for 
                                an additional number of full-time 
                                equivalent positions in the Department 
                                of Health and Human Services to be 
                                engaged in such process), only if the 
                                sum of the amounts allocated by the 
                                Secretary for such costs, excluding 
                                costs paid from fees collected under 
                                this section, plus other costs for the 
                                maintenance, renovation, and repair of 
                                facilities and acquisition, 
                                maintenance, and repair of fixtures, 
                                furniture, and other necessary 
                                materials and supplies in connection 
                                with the process for the review of 
                                biosimilar biological product 
                                applications, is no less than 
                                $20,000,000, multiplied by the 
                                adjustment factor applicable to the 
                                fiscal year involved.''; and
            (2) in subparagraph (C), by striking ``subparagraph (B) in 
        any fiscal year if the costs described in such subparagraph'' 
        and inserting ``subparagraph (B)(i) in any fiscal year if the 
        costs allocated as described in subclause (I) or (II) of such 
        subparagraph, as applicable,''.
    (c) GDUFA Authority.--Section 744B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-42) is amended--
            (1) in subsection (e)(2), by striking ``744A(11)(C)'' and 
        inserting ``744A(12)(C)''; and
            (2) in subsection (i)(2)--
                    (A) in subparagraph (A)(ii)--
                            (i) by striking ``available for a fiscal 
                        year beginning after fiscal year 2012'' and 
                        inserting the following: ``available--
                                    ``(I) for fiscal year 2023; and'';
                            (ii) by striking ``the fiscal year 
                        involved.'' and inserting ``such fiscal year; 
                        and''; and
                            (iii) by adding at the end the following:
                                    ``(II) for fiscal year 2024 and 
                                each subsequent fiscal year, to defray 
                                the costs of human generic drug 
                                activities (including such costs for an 
                                additional number of full-time 
                                equivalent positions in the Department 
                                of Health and Human Services to be 
                                engaged in such activities), only if 
                                the sum of the amounts allocated by the 
                                Secretary for such costs, excluding 
                                costs paid from fees collected under 
                                this section, plus other costs for the 
                                maintenance, renovation, and repair of 
                                facilities and acquisition, 
                                maintenance, and repair of fixtures, 
                                furniture, and other necessary 
                                materials and supplies in connection 
                                with human generic drug activities, is 
                                no less than $97,000,000 multiplied by 
                                the adjustment factor defined in 
                                section 744A(3) applicable to the 
                                fiscal year involved.''; and
                    (B) in subparagraph (B), by striking ``for human 
                generic activities'' and inserting ``as described in 
                subclause (I) or (II) of such subparagraph, as 
                applicable''.
    (d) MDUFA Authority.--Section 738 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j) is amended--
            (1) in subsection (h)(2)--
                    (A) in subparagraph (A)(ii)--
                            (i) by striking ``shall be available to 
                        defray'' and inserting the following: ``shall 
                        be available--
                                    ``(I) for fiscal year 2023, to 
                                defray'';
                            (ii) by striking the period and inserting 
                        ``; and''; and
                            (iii) by adding at the end the following:
                                    ``(II) for fiscal year 2024 and 
                                each subsequent fiscal year, to defray 
                                the costs of the resources allocated 
                                for the process for the review of 
                                device applications (including such 
                                costs for an additional number of full-
                                time equivalent positions in the 
                                Department of Health and Human Services 
                                to be engaged in such process), only if 
                                the sum of the amounts allocated by the 
                                Secretary for such costs, excluding 
                                costs paid from fees collected under 
                                this section, plus other costs for the 
                                maintenance, renovation, and repair of 
                                facilities and acquisition, 
                                maintenance, and repair of fixtures, 
                                furniture and other necessary materials 
                                and supplies in connection with the 
                                process for the review of device 
                                applications, is no less than the 
                                amount allocated for such costs, 
                                excluding any such costs paid from fees 
                                collected under this section, for 
                                fiscal year 2009 multiplied by the 
                                adjustment factor.''; and
                    (B) in subparagraph (B)(i), in the matter preceding 
                subclause (I), by striking ``for the process for the 
                review of device applications'' and inserting ``as 
                described in subclause (I) or (II) of such 
                subparagraph, as applicable''; and
            (2) in subsection (g)(3), by striking ``737(9)(C)'' and 
        inserting ``737(10)(C)''.
    (e) Technical Correction.--
            (1) In general.--Section 905(b)(2) of the FDA 
        Reauthorization Act of 2017 (Public Law 115-52) is amended by 
        striking ``Section 738(h) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379j(h)) is amended'' and inserting 
        ``Subsection (g) of section 738 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379j), as so redesignated by section 
        203(f)(2)(B)(i), is amended''.
            (2) Effective date.--The amendment made by paragraph (1) 
        shall take effect as though included in the enactment of 
        section 905 of the FDA Reauthorization Act of 2017 (Public Law 
        115-52).

SEC. 902. ANNUAL REPORT ON INSPECTIONS.

    Section 902 of the FDA Reauthorization Act of 2017 (Public Law 115-
52) is amended, in the matter preceding paragraph (1)--
            (1) by striking ``March 1 of each year'' and inserting 
        ``120 days after the end of each fiscal year''; and
            (2) by striking ``previous calendar year'' and inserting 
        ``previous fiscal year''.

SEC. 903. USER FEE PROGRAM TRANSPARENCY AND ACCOUNTABILITY.

    (a) PDUFA.--
            (1) Reauthorization; reporting requirements.--
                    (A) Performance report.--Section 736B(a) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-
                2(a)) is amended--
                            (i) in paragraph (1)--
                                    (I) in subparagraph (B)--
                                            (aa) in clause (vii), by 
                                        striking ``; and'' and 
                                        inserting a semicolon;
                                            (bb) in clause (viii), by 
                                        striking the period and 
                                        inserting ``; and''; and
                                            (cc) by adding at the end 
                                        the following:
                            ``(ix) the number of investigational new 
                        drug applications submitted per fiscal year, 
                        including for each review division.''; and
                                    (II) by adding at the end the 
                                following flush text:
        ``Nothing in subparagraph (B) shall be construed to authorize 
        the disclosure of confidential commercial information or other 
        information considered proprietary or trade secret, as 
        prohibited under section 301(j) of this Act of section 1905 of 
        title 18, United States Code.''; and
                            (ii) in paragraph (4)--
                                    (I) by amending subparagraph (A) to 
                                read as follows:
                    ``(A) data, analysis, and discussion of the changes 
                in the number of individuals hired as agreed upon in 
                the letters described in section 101(b) of the 
                Prescription Drug User Fee Amendments of 2022 and the 
                number of remaining vacancies, the number of full-time 
                equivalents funded by fees collected pursuant to 
                section 736, and the number of full-time equivalents 
                funded by budget authority at the Food and Drug 
                Administration by each division within the Center for 
                Drug Evaluation and Research, the Center for Biologics 
                Evaluation and Research, the Office of Regulatory 
                Affairs, and the Office of the Commissioner;'';
                                    (II) by amending subparagraph (B) 
                                to read as follows:
                    ``(B) data, analysis, and discussion of the changes 
                in the fee revenue amounts and costs for the process 
                for the review of human drug applications, including 
                identifying--
                            ``(i) drivers of such changes; and
                            ``(ii) changes in the average total cost 
                        per full-time equivalent in the prescription 
                        drug review program;'';
                                    (III) in subparagraph (C), by 
                                striking the period and inserting ``; 
                                and''; and
                                    (IV) by adding at the end the 
                                following:
                    ``(D) data, analysis, and discussion of the changes 
                in the average full-time equivalent hours required to 
                complete review of each type of human drug 
                application.''.
            (2) Reauthorization.--Section 736B(f) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 379h-2(f)) is amended--
                    (A) by redesignating paragraphs (4) through (6) as 
                paragraphs (5) through (7), respectively;
                    (B) by inserting after paragraph (3) the following:
            ``(4) Updates to congress.--The Secretary, in consultation 
        with regulated industry, shall provide regular updates on 
        negotiations on the reauthorization of this part to the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives.''; and
                    (C) in paragraph (7), as so redesignated--
                            (i) in subparagraph (A)--
                                    (I) by striking ``Before presenting 
                                the recommendations developed under 
                                paragraphs (1) through (5) to the 
                                Congress, the'' and inserting ``The''; 
                                and
                                    (II) by inserting ``, not later 
                                than 30 days after each such 
                                negotiation meeting'' before the period 
                                at the end; and
                            (ii) in subparagraph (B), by inserting ``, 
                        in sufficient detail,'' after ``shall 
                        summarize''.
    (b) MDUFA.--
            (1) Reauthorization; reporting requirements.--
                    (A) Reports.--Section 738A(a)(1)(A) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
                1(a)(1)(A)) is amended--
                            (i) in clause (ii)--
                                    (I) in subclause (II), by striking 
                                ``; and'' and inserting a semicolon;
                                    (II) in subclause (III), by 
                                striking the period and inserting a 
                                semicolon;
                                    (III) by adding at the end the 
                                following:
                                    ``(IV) the number of 
                                investigational device exemption 
                                applications submitted under section 
                                520(g) per fiscal year, including for 
                                each review division; and
                                    ``(V) the number of expedited 
                                development and priority review 
                                requests and designations under section 
                                515B per fiscal year, including for 
                                each review division.''; and
                                    (IV) by adding at the end the 
                                following flush text:
                        ``Nothing in this clause shall be construed to 
                        authorize the disclosure of confidential 
                        commercial information or other information 
                        considered proprietary or trade secret, as 
                        prohibited under section 301(j) of this Act or 
                        section 1905 of title 18, United States 
                        Code.'';
                            (ii) in the first clause (iv) (relating to 
                        rationale for MDUFA program changes)--
                                    (I) by amending subclause (I) to 
                                read as follows:
                                    ``(I) data, analysis, and 
                                discussion of the changes in the number 
                                of individuals hired as agreed upon in 
                                the letters described in section 201(b) 
                                of the Medical Device User Fee 
                                Amendments of 2022 and the number of 
                                remaining vacancies, the number of 
                                full-time equivalents funded by fees 
                                collected pursuant to section 738, and 
                                the number of full time equivalents 
                                funded by budget authority at the Food 
                                and Drug Administration by each 
                                division within the Center for Devices 
                                and Radiological Health, the Center for 
                                Biologics Evaluation and Research, the 
                                Office of Regulatory Affairs, and the 
                                Office of the Commissioner;'';
                                    (II) by amending subclause (II) to 
                                read as follows:
                                    ``(II) data, analysis, and 
                                discussion of the changes in the fee 
                                revenue amounts and costs for the 
                                process for the review of device 
                                applications, including identifying--
                                            ``(aa) drivers of such 
                                        changes; and
                                            ``(bb) changes in the 
                                        average total cost per full-
                                        time equivalent in the medical 
                                        device review program;'';
                                    (III) in subclause (III), by 
                                striking the period and inserting ``; 
                                and''; and
                                    (IV) by adding at the end the 
                                following:
                                    ``(IV) data, analysis, and 
                                discussion of the changes in the 
                                average full-time equivalent hours 
                                required to complete review of medical 
                                device application types.''; and
                            (iii) by redesignating the second clause 
                        (iv) (relating to analysis) as clause (v).
            (2) Reauthorization.--Section 738A(b) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
                    (A) by redesignating paragraphs (4) through (6) as 
                paragraphs (5) through (7), respectively;
                    (B) by inserting after paragraph (3) the following:
            ``(4) Updates to congress.--The Secretary, in consultation 
        with regulated industry, shall provide regular updates on 
        negotiations on the reauthorization of this part to the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives.''; and
                    (C) in paragraph (7), as so redesignated--
                            (i) in subparagraph (A)--
                                    (I) by striking ``Before presenting 
                                the recommendations developed under 
                                paragraphs (1) through (5) to the 
                                Congress, the'' and inserting ``The''; 
                                and
                                    (II) by inserting ``, not later 
                                than 30 days after each such 
                                negotiation meeting'' before the period 
                                at the end; and
                            (ii) in subparagraph (B), by inserting ``, 
                        in sufficient detail,'' after ``shall 
                        summarize''.
    (c) GDUFA.--
            (1) Reauthorization; reporting requirements.--
                    (A) Performance report.--Section 744C(a)(3) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
                43(a)(3)) is amended--
                            (i) by amending subparagraph (A) to read as 
                        follows:
                    ``(A) data, analysis, and discussion of the changes 
                in the number of individuals hired as agreed upon in 
                the letters described in section 301(b) of the Generic 
                Drug User Fee Amendments of 2022 and the number of 
                remaining vacancies, the number of full-time 
                equivalents funded by fees collected pursuant to 
                section 744B, and the number of full time equivalents 
                funded by budget authority at the Food and Drug 
                Administration by each division within the Center for 
                Drug Evaluation and Research, the Center for Biologics 
                Evaluation and Research, the Office of Regulatory 
                Affairs, and the Office of the Commissioner;'';
                            (ii) by amending subparagraph (B) to read 
                        as follows:
                    ``(B) data, analysis, and discussion of the changes 
                in the fee revenue amounts and costs for human generic 
                drug activities, including--
                            ``(i) identifying drivers of such changes; 
                        and
                            ``(ii) changes in the total average cost 
                        per full-time equivalent in the generic drug 
                        review program;'';
                            (iii) in subparagraph (C), by striking the 
                        period at the end and inserting ``; and''; and
                            (iv) by adding at the end the following:
                    ``(D) data, analysis, and discussion of the changes 
                in the average full-time equivalent hours required to 
                complete review of each type of abbreviated new drug 
                application.''.
            (2) Reauthorization.--Section 744C(f) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 379j-43(f)) is amended--
                    (A) by redesignating paragraphs (4) through (6) as 
                paragraphs (5) through (7), respectively;
                    (B) by inserting after paragraph (3) the following:
            ``(4) Updates to congress.--The Secretary, in consultation 
        with regulated industry, shall provide regular updates on 
        negotiations on the reauthorization of this part to the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives.''; and
                    (C) in paragraph (7), as so redesignated--
                            (i) in subparagraph (A)--
                                    (I) by striking ``Before presenting 
                                the recommendations developed under 
                                paragraphs (1) through (5) to the 
                                Congress, the'' and inserting ``The''; 
                                and
                                    (II) by inserting ``, not later 
                                than 30 days after each such 
                                negotiation meeting'' before the period 
                                at the end; and
                            (ii) in subparagraph (B), by inserting ``, 
                        in sufficient detail,'' after ``shall 
                        summarize''.
    (d) BSUFA.--
            (1) Reauthorization; reporting requirements.--Section 
        744I(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379j-53(a)(4)) is amended--
                    (A) by amending subparagraph (A) to read as 
                follows:
                    ``(A) data, analysis, and discussion of the changes 
                in the number of individuals hired as agreed upon in 
                the letters described in section 401(b) of the 
                Biosimilar User Fee Amendments of 2022 and the number 
                of remaining vacancies, the number of full-time 
                equivalents funded by fees collected pursuant to 
                section 744H, and the number of full time equivalents 
                funded by budget authority at the Food and Drug 
                Administration by each division within the Center for 
                Drug Evaluation and Research, the Center for Biologics 
                Evaluation and Research, the Office of Regulatory 
                Affairs, and the Office of the Commissioner;'';
                    (B) by amending subparagraph (B) to read as 
                follows:
                    ``(B) data, analysis, and discussion of the changes 
                in the fee revenue amounts and costs for the process 
                for the review of biosimilar biological product 
                applications, including identifying--
                            ``(i) drivers of such changes; and
                            ``(ii) changes in the average total cost 
                        per full-time equivalent in the biosimilar 
                        biological product review program;'';
                    (C) in subparagraph (C), by striking the period at 
                the end and inserting ``; and''; and
                    (D) by adding at the end the following:
                    ``(D) data, analysis, and discussion of the changes 
                in the average full-time equivalent hours required to 
                complete review of each type of biosimilar biological 
                product application.''.
            (2) Reauthorization.--Section 744I(f) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 379j-53(f)) is amended--
                    (A) by redesignating paragraphs (2) and (3) as 
                paragraphs (5) and (6), respectively;
                    (B) by inserting after paragraph (1) the following:
            ``(2) Prior public input.--Prior to beginning negotiations 
        with the regulated industry on the reauthorization of this 
        part, the Secretary shall--
                    ``(A) publish a notice in the Federal Register 
                requesting public input on the reauthorization;
                    ``(B) hold a public meeting at which the public may 
                present its views on the reauthorization;
                    ``(C) provide a period of 30 days after the public 
                meeting to obtain written comments from the public 
                suggesting changes to this part; and
                    ``(D) publish the comments on the Food and Drug 
                Administration's website.
            ``(3) Periodic consultation.--Not less frequently than once 
        every month during negotiations with the regulated industry, 
        the Secretary shall hold discussions with representatives of 
        patient and consumer advocacy groups to continue discussions of 
        their views on the reauthorization and their suggestions for 
        changes to this part as expressed under paragraph (2).
            ``(4) Updates to congress.--The Secretary, in consultation 
        with regulated industry, shall provide regular updates on 
        negotiations on the reauthorization of this part to the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives.''; and
                    (C) by adding at the end the following:
            ``(7) Minutes of negotiation meetings.--
                    ``(A) Public availability.--The Secretary shall 
                make publicly available, on the public website of the 
                Food and Drug Administration, minutes of all 
                negotiation meetings conducted under this subsection 
                between the Food and Drug Administration and the 
                regulated industry, not later than 30 days after each 
                such negotiation meeting.
                    ``(B) Content.--The minutes described under 
                subparagraph (A) shall summarize, in sufficient detail, 
                any substantive proposal made by any party to the 
                negotiations as well as significant controversies or 
                differences of opinion during the negotiations and 
                their resolution.''.

SEC. 904. OTC HEARING AIDS FINAL RULE.

    Not later than 30 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall issue a final rule to 
establish a category of over-the-counter hearing aids, as defined in 
subsection (q) of section 520 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j), as described in section 709(b) of the FDA 
Reauthorization Act of 2017 (Public Law 115-52).

SEC. 905. ENHANCE 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--
            (1) 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 the reviews of reports shared pursuant to 
section 704(b)(2), and any feedback or corrective or preventive actions 
in response to such reports.''; and
            (2) by amending subsection (f) to read as follows:
    ``(f) Temporary Sunset.--Subsection (a) shall cease to be effective 
on the date that is 5 years after the date of enactment of the Food and 
Drug Administration Safety and Innovation Act. Subsections (b), (c), 
and (e) shall not be in effect during the period beginning 5 years 
after the date of enactment of the Food and Drug Administration Safety 
and Innovation Act and ending on the date of enactment of the Food and 
Drug Administration Safety and Landmark Advancements Act of 2022. 
Subsections (b), (c), and (e) shall be in effect beginning on the date 
of enactment of the Food and Drug Administration Safety and Landmark 
Advancements Act of 2022.''.
    (b) Reporting.--Section 506C-1(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356c-1(a)) is amended--
            (1) by redesignating paragraphs (3) through (7) as 
        paragraphs (4) through (8), respectively;
            (2) by inserting after paragraph (2) the following:
            ``(3) provides the number of reports that were required 
        under section 704(b)(2) to be sent to the appropriate offices 
        of the Food and Drug Administration with expertise regarding 
        drug shortages, and the number of such reports that were 
        sent;''; and
            (3) in paragraph (3)(A), by striking ``paragraph (7)'' and 
        inserting ``paragraph (8)''.
    (c) Applicability.--
            (1) Subsection (a).--The amendments made by subsection (a) 
        shall apply beginning on the date of enactment of this Act.
            (2) Subsection (b).--The amendments made by subsection (b) 
        shall apply beginning on the date that is 1 year after the date 
        of enactment of this Act.
    (d) Reporting of Mutual Recognition Agreements for Inspections and 
Review Activities.--Section 510(h) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(h)) is amended--
            (1) in paragraph (6)--
                    (A) in subparagraph (A), by striking clause (ii) 
                and inserting the following:
                    ``(ii) the number of such registered establishments 
                in each region of interest;
                    ``(iii) the number of such domestic establishments 
                and the number of such foreign establishments, 
                including the number of establishments in each region 
                of interest, that the Secretary inspected in the 
                previous calendar year;
                    ``(iv) the number of inspections to support actions 
                by the Secretary on applications under section 505 of 
                this Act or section 351 of the Public Health Service 
                Act, including the number of inspections to support 
                actions by the Secretary on supplemental applications, 
                including changes to manufacturing processes, the 
                Secretary conducted in the previous fiscal year;
                    ``(v) the number of routine surveillance 
                inspections the Secretary conducted in the previous 
                fiscal year;
                    ``(vi) the number of for-cause inspections the 
                Secretary conducted in the previous fiscal year, not 
                including inspections described in clause (iv); and
                    ``(vii) the number of inspections the Secretary has 
                recognized pursuant to an agreement entered into 
                pursuant to section 809, or otherwise recognized, for 
                each of the types of inspections described in clauses 
                (v) and (vi);'';
                    (B) in subparagraph (B), by striking ``; and'' and 
                inserting a semicolon;
                    (C) in subparagraph (C), by striking the period and 
                inserting ``; and''; and
                    (D) by adding at the end the following:
                    ``(D) the status of the efforts of the Food and 
                Drug Administration to expand its recognition of 
                inspections conducted or recognized by foreign 
                regulatory authorities under section 809, including any 
                obstacles to expanding the use of such recognition.''; 
                and
            (2) by adding at the end the following:
            ``(7) Region of interest.--For purposes of paragraph 
        (6)(A), the term `region of interest' means a foreign 
        geographic region or country, including the People's Republic 
        of China, India, the European Union, the United Kingdom, and 
        any other country or geographic region, as the Secretary 
        determines appropriate.''.
    (e) 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 March 1 of each year, the Secretary of Health and 
Human Services shall post on the website of the Food and Drug 
Administration information related to inspections of facilities 
necessary for approval of a drug under subsection (c) or (j) of section 
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), 
approval of a device under section 515 of such Act (21 U.S.C. 360e), or 
clearance of a device under section 510(k) of such Act (21 U.S.C. 
360(k)) that were conducted during the previous calendar year. Such 
information shall include the following:
            ``(1) The median time following a request from staff of the 
        Food and Drug Administration reviewing an application or report 
        to the beginning of the inspection, including--
                    ``(A) the median time for drugs described in 
                505(j)(11)(A)(i) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355(j)(11)(A)(i));
                    ``(B) the median time for drugs described in 
                section 506C(a) of such Act (21 U.S.C. 356c(a)) only; 
                and
                    ``(C) the median time for drugs on the drug 
                shortage list in effect under section 506E of such Act 
                (21 U.S.C. 356f).
            ``(2) The median time from the issuance of a report 
        pursuant to section 704(b) of the Federal Food, Drug, and 
        Cosmetic 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 
        related to conditions observed by the Secretary during an 
        inspection, to the time at which the Secretary concludes that 
        corrective actions to resolve such conditions have been taken.
            ``(4) The median time spent by staff of the Food and Drug 
        Administration at a facility during an inspection, including--
                    ``(A) the median time when records were provided 
                remotely in accordance with a request under section 
                704(a)(4) of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 374(a)(4)) in advance of the inspection; and
                    ``(B) the median time when a request for records 
                pursuant to such section 704(a)(4) was not issued, or 
                complied with, in advance of the inspection.
            ``(5) The number and type of violations identified during 
        inspections when a request for records pursuant to such section 
        704(a)(4) was issued and complied with in advance of the 
        inspection, versus when a request for records pursuant to such 
        section 704(a)(4) was not issued or complied with.
            ``(6) The number of facilities that did not implement 
        requested corrective or preventive actions following a report 
        issued 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).''.
                                 <all>
```