FDASLA Act of 2022

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. 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 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. I Fees relating to drugs 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. 102. Definitions Section 735 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379g (1) in paragraph (1), in the matter following subparagraph (B), by striking an allergenic extract product, or does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to (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, 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. (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). . 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) (1) in the matter preceding paragraph (1), by striking 2018 2023 (2) in paragraph (1)— (A) in subparagraph (A), by striking subsection (c)(5) subsection (c)(6) (B) in subparagraph (C), by inserting prior to approval or was withdrawn (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) subsection (c)(6) (ii) by striking Except as provided (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) (1) in paragraph (1)— (A) in the matter preceding subparagraph (A), by striking 2018 through 2022 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) (c)(3) (E) in subparagraph (E), as so redesignated, by striking (c)(3) (c)(4) (F) in subparagraph (F), as so redesignated, by striking (c)(4) (c)(5) (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 2023, $1,151,522,958 (B) in subparagraph (B)— (i) by striking 2019 through 2022 2024 through 2027 (ii) by striking subsection (c)(3) or (c)(4) 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) (1) in paragraph (1)(B)(ii), by striking Washington-Baltimore, DC–MD–VA–WV 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 (ii) by striking paragraph (1) 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 ; (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 year), (ii) by inserting , and subsection (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment). (F) in subparagraph (D), as so redesignated, by striking paragraph (5) 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) 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 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) 2018 through 2022 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) (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) (1) in paragraph (1)(B), by striking during the previous year , as determined under paragraph (2) (2) in paragraph (2), by striking that its gross annual revenues 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. 104. Reauthorization; reporting requirement Section 736B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2 (1) by striking 2018 2023 (2) by striking Prescription Drug User Fee Amendments of 2017 Prescription Drug User Fee Amendments of 2022 (3) in subsection (a)(4), by striking 2020 2023 (4) in subsection (f), by striking 2022 2027 105. Sunset dates (a) Authorization Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379g (b) Reporting requirements Section 736B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2 (c) Previous sunset provision Effective October 1, 2022, subsections (a) and (b) of section 104 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 106. 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. 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. II Fees relating to devices 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. 202. Definitions Section 737 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379i (1) in paragraph (9)— (A) in the matter preceding subparagraph (A), by striking and premarket notification submissions premarket notification submissions, and de novo classification requests (B) in subparagraph (D), by striking and submissions submissions, and de novo classification requests (C) in subparagraph (F), by striking and premarket notification submissions premarket notification submissions, and de novo classification requests (D) in subparagraphs (G) and (H), by striking or submissions submissions, or requests (E) in subparagraph (K), by striking or premarket notification submissions premarket notification submissions, or de novo classification requests (2) in paragraph (11), by striking 2016 2021 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) (1) in paragraph (1), by striking 2018 2023 (2) in paragraph (2)— (A) in subparagraph (A)— (i) in the matter preceding clause (i), by striking 2017 2022 (ii) in clause (iii), by striking 75 percent 80 percent (iii) in clause (viii), by striking 3.4 percent 4.5 percent (B) in subparagraph (B)(iii), by striking or premarket notification submission premarket notification submission, or de novo classification request (C) in subparagraph (C), by striking or periodic reporting concerning a class III device 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) (1) in paragraph (1), by striking 2018 through 2022 2023 through 2027 (2) by amending the table in paragraph (2) to read as follows: Fee Type Fiscal Year 2023 Fiscal Year 2024 Fiscal Year 2025 Fiscal Year 2026 Fiscal Year 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) (1) in paragraph (1), by striking 2017 2022 (2) in paragraph (2)— (A) by striking 2018 2023 (B) in subparagraph (B)(ii), by striking 2016 2022 (C) in subparagraph (C)(i)(II), by striking Washington-Baltimore, DC–MD–VA–WV Washington–Arlington–Alexandria, DC–VA–MD–WV (D) in subparagraph (D), by striking 2022 2027 (3) in paragraph (3), by striking 2018 through 2022 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 PMA shared outcome total time to decision goal (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 (1) in subsection (d)(2)(B)(iii), by inserting , if extant, national taxing authority (2) in subsection (e)(2)(B)(iii), by inserting , if extant, national taxing authority (e) Conditions Section 738(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(g) (1) in paragraph (1)(A), by striking $320,825,000 $398,566,000 (2) in paragraph (2), by inserting de novo classification requests, 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) (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. . 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) (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 testing laboratories (ii) by inserting in guidance by the Secretary (iii) by striking assess the conformance of a device with conduct testing to support the assessment of the conformance of a device to (C) in subparagraph (B)— (i) by striking determinations results (ii) by inserting to support so accredited (iii) by striking a particular such determination particular such results (3) in paragraph (2)— (A) in the paragraph heading, by striking determinations results (B) in subparagraph (A)— (i) by striking determinations by testing laboratories such determinations or 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 accreditation of such testing laboratory (iv) by striking such device a device (C) in subparagraph (B)— (i) by striking by a testing laboratory so accredited under this subsection (ii) by inserting or recognition of an accreditation body under paragraph (1)(A) (4) in paragraph (3)(C)— (A) in the subparagraph heading, by inserting and transition initiation (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. (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) 2022 2027 205. Sunset dates (a) Authorization Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379i (b) Reporting requirements Section 738A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1 (c) Previous sunset provision Effective October 1, 2022, subsections (a) and (b) of section 210 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 206. 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. 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. III Fees relating to generic drugs 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. 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) (1) in the matter preceding paragraph (1), by striking 2018 2023 (2) in paragraph (2)(C), by striking fiscal years 2018 through 2022 fiscal years 2023 through 2027 (3) in paragraph (3)(B), by striking fiscal years 2018 through 2022 fiscal years 2023 through 2027 (4) in paragraph (4)(D), by striking fiscal years 2018 through 2022 fiscal years 2023 through 2027 (5) in paragraph (5)(D), by striking fiscal years 2018 through 2022 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) (1) in paragraph (1)— (A) in subparagraph (A)— (i) in the heading, by striking 2018 2023 (ii) by striking 2018 2023 (iii) by striking $493,600,000 $582,500,000 (B) in subparagraph (B)— (i) in the heading, by striking 2019 through 2022 2024 through 2027 (ii) by striking For each (i) In general For each ; (iii) by striking 2019 through 2022 2024 through 2027 (iv) by striking $493,600,000 the base revenue amount under clause (ii) (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 24 percent (B) in subparagraph (D), by striking Seven Six (C) in subparagraph (E)(i), by striking Thirty-five Thirty-six (c) Adjustments Section 744B(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(c) (1) in paragraph (1)— (A) in the matter preceding subparagraph (A)— (i) by striking 2019 2024 (ii) by striking the product of the total revenues established in such notice for the prior fiscal year the base revenue amount for the fiscal year determined under subsection (b)(1)(B)(ii) (B) in subparagraph (C), by striking Washington-Baltimore, DC–MD–VA–WV Washington-Arlington-Alexandria, DC–VA–MD–WV (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 (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) (1) in the heading, by striking 2018 through 2022 2023 through 2027 (2) by striking more later (3) by striking 2018 through 2022 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) 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) 2018 through 2022 2023 through 2027 303. Reauthorization; reporting requirements Section 744C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–43 (1) in subsection (a)— (A) by striking 2018 2023 (B) by striking Generic Drug User Fee Amendments of 2017 Generic Drug User Fee Amendments of 2022 (2) in subsection (b), by striking 2018 2023 (3) in subsection (c)— (A) by striking 2018 2023 (B) by striking Generic Drug User Fee Amendments of 2017 Generic Drug User Fee Amendments of 2022 (4) in subsection (f)— (A) in paragraph (1), by striking 2022 2027 (B) in paragraph (5), by striking January 15, 2022 January 15, 2027 304. Sunset dates (a) Authorization Sections 744A and 744B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–41 (b) Reporting requirements Section 744C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–43 (c) Previous sunset provision Effective October 1, 2022, subsections (a) and (b) of section 305 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 305. 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. 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) IV Fees relating to biosimilar biological products 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. 402. Definitions Section 744G of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–51 (1) in paragraph (1)— (A) by striking Washington-Baltimore, DC–MD–VA–WV Washington–Arlington–Alexandria, DC–VA–MD–WV (B) by striking October of September of (C) by striking October 2011 September 2011 (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. 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) (1) in the matter preceding paragraph (1), by striking 2018 2023 (2) in paragraph (1)— (A) in subparagraph (A)— (i) in clause (iv)(I), by striking 5 days 7 days (ii) in clause (v)(II), by striking 5 days 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 (ii) in clause (iii)— (I) in subclause (I), by striking ; or (II) in subclause (II), by striking the period and inserting ; or (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 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 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 7 days (bb) by inserting or the date of administrative removal, as applicable discontinued (III) in subclause (II), by inserting or the date of administrative removal, as applicable discontinued (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 (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 withdrawn (4) in paragraph (3)— (A) in subparagraph (A)— (i) in clause (i), by striking ; and (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) (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 In general (B) in the matter preceding subparagraph (A), by striking 2019 through 2022 2023 through 2027 (C) in subparagraph (A), by striking paragraph (4) 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 subsection (c)(3)); (G) in subparagraph (E), as so redesignated, by striking subsection (c)(3)). subsection (c)(4)); 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) (1) in paragraph (1)— (A) in subparagraph (A)— (i) in the matter preceding clause (i), by striking subsection (b)(2)(B) subsection (b)(1)(B) (ii) in clause (i), by striking subsection (b) subsection (b)(1)(A) (B) in subparagraph (B)(ii), by striking Washington-Baltimore, DC–MD–VA–WV 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) For each fiscal year (ii) by striking adjustment under paragraph (1), further increase adjustments under paragraphs (1) and (2), further adjust (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 ; and (C) in subparagraph (C)— (i) by striking subsections (b)(2)(A) subsections (b)(1)(A) (ii) by striking and (b)(2)(B) , (b)(1)(B) (iii) by inserting , and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment) (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 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) 2018 through 2022 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 (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. . 404. Reauthorization; reporting requirements Section 744I of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–53 (1) by striking 2018 2023 (2) by striking Biosimilar User Fee Amendments of 2017 Biosimilar User Fee Amendments of 2022 (3) in subsection (a)(4), by striking 2020 2023 (4) in subsection (f), by striking 2022 2027 405. Sunset dates (a) Authorization Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–51 (b) Reporting requirements Section 744I of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–53 (c) Previous sunset provision Effective October 1, 2022, subsections (a) and (b) of section 405 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 406. 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. 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. V Improving regulation of drugs and biological products 501. Alternatives to animal testing (a) In general Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 (1) in subsection (i)— (A) in paragraph (1)(A), by striking preclinical tests (including tests on animals) nonclinical tests (B) in paragraph (2)(B), by striking animal nonclinical tests (2) after subsection (y), by inserting the following: (z) Nonclinical test defined For purposes of this section, the term nonclinical test . (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) (bb) an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)); and . 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) for purposes of rendering drugs nonretrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation)) 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) (1) in the matter preceding subparagraph (A)— (A) by striking Upon review of The Secretary shall not make licensure as an interchangeable biological product effective with respect to (B) by striking relying on that relies on (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 (2) in the flush text that follows subparagraph (C), by striking the period and inserting , and the term first interchangeable biosimilar biological product 504. Improvements to the Purple Book (a) In general Section 506I of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356i (1) in subsection (a)— (A) by striking The holder of an application approved under subsection (c) or (j) of section 505 The holder of an application approved under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act (B) in paragraph (2), by inserting (in the case of a biological product, the proper name) established name (C) in paragraph (3), by striking or abbreviated application number , abbreviated application number, or biologics license application number (2) in subsection (b)— (A) in the matter preceding paragraph (1), by striking The holder of an application approved under subsection (c) or (j) The holder of an application approved under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act (B) in paragraph (1), by inserting (in the case of a biological product, the proper name) established name (C) in paragraph (2), by striking or abbreviated application number , 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 (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 (1) in subsection (d)— (A) by striking or (c), the Secretary (1) the Secretary ; (B) by striking the period at the end, and inserting ; 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. (B) in the last sentence— (i) by striking updates to the list 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 (ii) by striking update the list update such lists 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) (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. . 506. Modernizing accelerated approval (a) In general Section 506(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(c) (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 (A) In general Approval of a product ; (C) in clause (i) of such subparagraph (A), as so redesignated, by striking appropriate postapproval studies an appropriate postapproval study or studies (which may be augmented or supported by real world evidence) (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 (A) In general The Secretary may ; (C) in clause (i) of such subparagraph (A), as so redesignated, by striking drug with due diligence 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 product is not (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) (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 (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) VI Other reauthorizations 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) 2018 through 2022 2023 through 2027 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) 2018 through 2022 2023 through 2027 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) 2022 2027 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 $5,250,000 for each of fiscal years 2018 through 2022 $7,000,000 for each of fiscal years 2023 through 2027 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) (1) in paragraph (1)(A)(ii)(II), by adding (other than bioavailability studies) any clinical investigations (2) in paragraph (4), by striking October 1, 2022 October 1, 2027 606. Reauthorization of orphan drug grants Section 5(c) of the Orphan Drug Act ( 21 U.S.C. 360ee(c) 2018 through 2022 2023 through 2027 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) 2022 2027 VII Enhancing FDA hiring authorities 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 (1) in subsection (a)— (A) by inserting , including cross-cutting operational positions, professional positions (B) by inserting and the regulation of food medical products (2) in subsection (d)(1)— (A) in the matter preceding subparagraph (A)— (i) by striking the 21st Century Cures Act the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (ii) by striking that examines the extent , including that addresses (B) in subparagraph (A)— (i) by inserting updated analysis (ii) by striking ; and (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 an updated recruitment 702. Strategic workforce plan and report Chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 371 et seq. 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. . VIII Advancing regulation of cosmetics, dietary supplements, and laboratory developed tests A Cosmetics 801. Short title This subtitle may be cited as the Modernization of Cosmetics Regulation Act of 2022 802. Amendments to cosmetic requirements Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 604. Definitions In this chapter: (1) Adverse event The term adverse event (2) Cosmetic product The term cosmetic product (3) Facility (A) In general The term facility (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 repackaging (4) Responsible person The term responsible person (5) Serious adverse event The term serious adverse event (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). 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 (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 Freedom of Information Act (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. 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 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 (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 (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 Modernization of Cosmetics Regulation Act of 2022 (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. 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 (2) Safe The term safe 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 (c) Cosmetic products for professional use (1) Definition of professional For purposes of this subsection, the term professional (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. 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. 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. 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. 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. 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 Modernization of Cosmetics Regulation Act of 2022 (c) Savings Nothing in the amendments to this Act made by the Modernization of Cosmetics Regulation Act of 2022 (d) Rule of construction Nothing in this section shall be construed to amend, expand, or limit the provisions under section 752. . 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 (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 , 564, or 607 (2) Adulterated products Section 601 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 (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) (A) by striking and (2) (2) (B) by inserting after numerical count ; 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. (A) in section 301(e) ( 21 U.S.C. 331(e) (i) by striking 564, 703 564, 605, 703 (ii) by striking 564, 760 564, 605, 611, 760 (B) in section 301(ii) ( 21 U.S.C. 331(ii) (i) by striking 760 or 761) or 604, 760, or 761) or (ii) by inserting or required under section 605(a) 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 under section 605, 760, or 761 (ii) by striking defined in such section 760 or 761 defined in section 604, 760, or 761 (iii) by striking of such section 760 or 761 of such section 605, 760, or 761 (iv) by striking described in such section 760 or 761 described in such section 605, 760, or 761 (D) in section 801(b) ( 21 U.S.C. 381(b) (i) by striking requirements of sections 760 or 761, requirements of section 605, 760, or 761 (ii) by striking as defined in section 760 or 761 as defined in section 604, 760, or 761 (iii) by striking with section 760 or 761 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. 804. Records inspection Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(a)(1) 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. 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. 806. PFAS in cosmetics (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary (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). 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). B Dietary supplements 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. 21 U.S.C. 343–3 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 (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 (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 (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 (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 (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. . C In vitro clinical tests 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 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. 822. Definitions (a) In general Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 (1) by adding at the end the following: (ss) (1) The term in vitro clinical test (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 ; and (3) in section 201(h)(1), in the matter following clause (C), by striking section 520(o) 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) (1) by striking (1) The term biological product (1)(A) The term biological product (2) by adding at the end the following: (B) The term biological product . (c) In vitro clinical test definition In this Act, the term in vitro clinical test 823. Regulation of in vitro clinical tests The Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. (1) by amending the heading of chapter V to read as follows: Drugs, Devices, and In Vitro Clinical Tests (2) by adding at the end of chapter V the following: J In Vitro Clinical Tests 587. Definitions In this subchapter: (1) Analytical validity The term analytical validity (2) Applicable standard The term applicable standard (3) Clinical use The term clinical use (4) Clinical validity The term clinical validity (5) Component or part The term component or part (6) Develop The term develop (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 (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 (9) High-risk The term high-risk (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 (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 (B) Analytic instrument The term analytic instrument (C) Pre-analytical instrument The term pre-analytical instrument (12) Instrument family The term instrument family (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 (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 (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 (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 (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. 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. 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 (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 (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. 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 (D) Near-patient testing Not later than 1 year after the date of enactment of the VALID Act of 2022 (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 (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 (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 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 (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. 587D. Technology certification (a) Definitions In this section: (1) Eligible in vitro clinical test The term eligible in vitro clinical test (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 (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 (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 (2) Public meeting Not later than 180 days after the date of enactment of the VALID Act of 2022 technology (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). 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 (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 VALID Act of 2022 (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. 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 (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 (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 (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. 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 (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. (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. 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 (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). 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 (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. 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. 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. 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 (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. 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 (2) the term serious injury (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. 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. 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 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. 587Q. Accredited persons (a) In general (1) Authorization Beginning on the date of enactment of the VALID Act of 2022 (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 (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 (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). 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. 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 (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 (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 (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. 587T. Comprehensive test information system (a) Establishment Not later than 2 years after the date of enactment of the VALID Act of 2022 (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. 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. 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. 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. 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. 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. 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). 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 (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. 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. . 824. Enforcement and other provisions (a) Prohibited acts Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 (1) in paragraphs (a), (b), (c), (g), (h), (k), (q), (r), and (y), by inserting in vitro clinical test, device, (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 section 523 (4) in paragraph (ff), by striking or device , device, or in vitro clinical test (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 (1) in subsection (b)(8), by inserting or counterfeit in vitro clinical test counterfeit drug (2) in subsection (c)— (A) by striking ; or (5) ; (5) (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 (3) in subsection (f)(1)— (A) in subparagraph (A)— (i) by inserting or in vitro clinical tests which relates to devices (ii) by inserting or section 587Q(a)(2) section 704(g) (iii) by inserting or in vitro clinical tests, as applicable (B) in subparagraph (B)(i), by striking or 520(f) , 520(f), 587K, or 587M, (c) Seizure Section 304 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 334 (1) in subsection (a)(2)— (A) by striking , and (E) , (E) (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, device, (3) in subsection (g)— (A) in paragraph (1), by inserting , in vitro clinical test, device (B) in paragraph (2)— (i) in subparagraph (A), by inserting , in vitro clinical test, device (ii) in subparagraph (B), by inserting or in vitro clinical test device (d) Debarment, temporary denial of approval, and suspension Section 306 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 335a (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 (1) in subsections (a) through (d)— (A) by striking or investigational devices , investigational devices, or investigational in vitro clinical tests (B) by striking or investigational device , investigational device, or investigational in vitro clinical test (2) in subsection (b)(4) by striking or 520(g) , 520(g), or 587S (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) , 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 , treatment investigational device exemption, or treatment investigational in vitro clinical test exemption (D) in paragraph (5), by striking or 520(g) , 520(g), or 587S (E) in the matter following paragraph (7) by striking or 520(g) , 520(g) or 587S (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 treatment investigational in vitro clinical test exemption . (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, 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 Drugs and Devices 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) and in vitro clinical tests devices (i) Records Section 703 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 373 (1) by inserting in vitro clinical tests devices (2) by inserting in vitro clinical test device (j) Factory inspection Section 704 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374 (1) by striking drugs or devices drugs, devices, or in vitro clinical tests (2) in subsection (a)(1), in the fourth sentence, by striking or chapter IX 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, devices, (4) in subsection (a)(2)(B)— (A) by inserting or in vitro clinical tests prescribe or use devices (B) by inserting or in vitro clinical tests process devices (5) by inserting in vitro clinical test, device, (6) in subsection (e), by inserting , or section 587M, 587N, or 587S, section 519 or 520(g) (7) in subsection (f)(3)— (A) in subparagraph (A), by striking or (B) in subparagraph (B), by striking the period at the end and inserting ; or (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 . (k) Publicity Section 705(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 375(b) in vitro clinical tests, devices, (l) Presumption Section 709 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379a in vitro clinical test, 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) (1) in the matter preceding paragraph (1), by inserting or in vitro clinical tests or devices (2) in the flush text following paragraph (2)— (A) by inserting or an in vitro clinical test a device (B) by inserting or in vitro clinical tests devices (n) Imports and exports Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 (1) in subsection (a)— (A) by inserting in vitro clinical tests, devices, (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 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, health-related purposes (ii) in clause (i), by striking drug or device drug, device, or in vitro clinical test (iii) in clause (i)(I), by inserting in vitro clinical test, device, (B) in subparagraph (B), by inserting in vitro clinical test, device, (3) in subsection (e)(1), by inserting in vitro clinical test, device, (4) in subsection (o)— (A) by inserting or in vitro clinical test device (B) by inserting section 587J of each foreign establishment 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 (1) in subsection (b)— (A) in the matter preceding paragraph (1), by inserting and in vitro clinical tests devices (B) in paragraph (1), by inserting quality requirements established under section 587K; and (2) in subsection (c)— (A) in paragraph (2), by inserting in vitro clinical tests, devices, (B) in paragraph (4), by inserting or in vitro clinical tests 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) , or of foreign establishments registered under section 587J 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) (1) in subparagraph (D), by striking and (2) in subparagraph (E), by striking the semicolon at the end and inserting ; 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) (1) in paragraph (1), by inserting in vitro clinical tests, devices, (2) in paragraph (4), by striking and device manufacturers 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 device (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) Act ( 21 U.S.C. 321(h) (B) in each of clauses (ii) and (iii), by striking or device 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 device (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) Act ( 21 U.S.C. 321(h) (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 device (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) 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 device, or in vitro clinical test (C) in subparagraph (B)— (i) in clause (i), by inserting or the subject of a technology certification order approved or cleared (ii) in clause (ii), by striking or 520(g) , 520(g), or 587S 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 (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 21 U.S.C. 360(k) 21 U.S.C. 360c(f)(2) 42 U.S.C. 262 (c) Application of authorities to transitional In vitro clinical tests (1) Definition For purposes of this section, the term transitional in vitro clinical test (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 (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) 21 U.S.C. 360j(g) 21 U.S.C. 360bbb–3 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 (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 42 U.S.C. 262 (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) 21 U.S.C. 360c(f)(2) (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) (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) (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 (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 (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 (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 826. Emergency use authorization (a) In general Section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 (1) in subsection (a)— (A) in paragraphs (1) and (4)(C), by inserting in vitro clinical test, or biological product (B) in paragraph (2)(A), by striking or 515 515, or 587B (2) in subsection (e)— (A) in paragraph (3)— (i) in subparagraph (B), by striking and (ii) in subparagraph (C), by striking the period and inserting ; 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 (ii) in subparagraph (B), by striking the period and inserting ; or (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 in vitro clinical tests devices (B) in paragraph (1)— (i) by striking to a device to an in vitro clinical test (ii) by striking such device 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, 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 515 515, or 587B (2) in subparagraph (B), by striking or 520 827. Antimicrobial susceptibility tests Section 511A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360a–2 (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 approve under section 587B, exempt from premarket review under section 587C, or grant a technology certification order under section 587D (B) by striking testing devices in vitro clinical tests (2) in subsection (c)(5), by striking drug or device drug, device, or in vitro clinical test (3) in subsection (e)— (A) in the heading, by striking testing devices In vitro clinical tests (B) in paragraph (1)— (i) by striking 510, 513, and 515, 587B, and 587D (ii) by striking antimicrobial susceptibility testing device antimicrobial susceptibility in vitro clinical test (iii) by striking such device such in vitro clinical test (C) in paragraph (2)— (i) in the heading, by striking testing devices in vitro clinical tests (ii) in subparagraphs (A) and (B) (other than clause (iii) of such subparagraph (B)), by striking device in vitro clinical test (iii) in subparagraph (B)(iii), by striking a device an in vitro clinical test (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 ; 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 in vitro clinical test (ii) by striking antimicrobial susceptibility testing device antimicrobial susceptibility in vitro clinical test 828. Combination products (a) In general Section 503(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(g) (1) in paragraph (1)— (A) in subparagraph (A), by striking or biological product 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. (C) in subparagraph (D)(ii)— (i) by inserting or in vitro clinical test device (ii) by inserting and in vitro clinical tests shall (2) in paragraph (3), by striking safety and effectiveness or substantial equivalence safety and effectiveness, substantial equivalence, or analytical validity and clinical validity 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)) 513(f)(2) (submitted in accordance with paragraph (5)), 587B, or 587D, or an exempt test under section 587C, as applicable (B) in subparagraph (B), by inserting , 587B, or 587D section 515 (4) in paragraph (5)(A), by striking or 510(k) , 510(k), 587B, or 587D (5) in paragraph (7), by striking or substantial equivalence , 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) 520(g), 587B, or 587D (B) in subparagraph (D), by striking or 520 520, 587B, or 587D (b) Classification of products Section 563 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–2 (d) Exemption This section shall not apply to a product constituted of a device and an in vitro clinical test. . 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 (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 (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 (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) 21 U.S.C. 379i(9)(C) (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. 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. IX Other provisions 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 (I) for fiscal year 2023, to defray ; (B) by striking the period and inserting ; 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 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) (1) in subparagraph (B)(i)— (A) by striking available for a fiscal year beginning after fiscal year 2012 (I) for fiscal year 2023 ; (B) by striking the fiscal year involved. such fiscal year; 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 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 (1) in subsection (e)(2), by striking 744A(11)(C) 744A(12)(C) (2) in subsection (i)(2)— (A) in subparagraph (A)(ii)— (i) by striking available for a fiscal year beginning after fiscal year 2012 (I) for fiscal year 2023; and ; (ii) by striking the fiscal year involved. such fiscal year; 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 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 (1) in subsection (h)(2)— (A) in subparagraph (A)(ii)— (i) by striking shall be available to defray (I) for fiscal year 2023, to defray ; (ii) by striking the period and inserting ; 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 as described in subclause (I) or (II) of such subparagraph, as applicable (2) in subsection (g)(3), by striking 737(9)(C) 737(10)(C) (e) Technical correction (1) In general Section 905(b)(2) of the FDA Reauthorization Act of 2017 ( Public Law 115–52 Section 738(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(h) Subsection (g) of section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j (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 115–52 902. Annual report on inspections Section 902 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 (1) by striking March 1 of each year 120 days after the end of each fiscal year (2) by striking previous calendar year previous fiscal year 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) (i) in paragraph (1)— (I) in subparagraph (B)— (aa) in clause (vii), by striking ; and (bb) in clause (viii), by striking the period and inserting ; 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 ; (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 (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) (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 The (II) by inserting , not later than 30 days after each such negotiation meeting (ii) in subparagraph (B), by inserting , in sufficient detail, 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) (i) in clause (ii)— (I) in subclause (II), by striking ; and (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 ; (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 (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) (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 The (II) by inserting , not later than 30 days after each such negotiation meeting (ii) in subparagraph (B), by inserting , in sufficient detail, 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) (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 ; (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 (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) (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 The (II) by inserting , not later than 30 days after each such negotiation meeting (ii) in subparagraph (B), by inserting , in sufficient detail, 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) (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 ; (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 (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) (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. . 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 Public Law 115–52 905. 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 (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 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) (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) 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) (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 (C) in subparagraph (C), by striking the period and inserting ; 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 . (e) Enhancing transparency of drug facility inspection timelines Section 902 of the FDA Reauthorization Act of 2017 ( 21 U.S.C. 355 902. 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 21 U.S.C. 360e 21 U.S.C. 360(k) (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) (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) (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) (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). . 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 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. Reauthorization; reporting requirement. Sec. 205. Accreditation programs. Sec. 206. Sunset dates. Sec. 207. Effective date. Sec. 208. 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. Sec. 507. Rare disease pilot program. Sec. 508. Supporting review and development of drugs to treat rare diseases. Sec. 509. Generic drug labeling changes. Sec. 510. Limitations on exclusive approval or licensure of orphan drugs. Sec. 511. Ensuring timely access to generics. Sec. 512. Increasing transparency in generic drug applications. Sec. 513. GAO report on nonprofit pharmaceutical organizations. Sec. 514. FDA public meeting on nonprofit prescription drug manufacturers. Sec. 515. 180-day exclusivity period. 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 in vitro clinical 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. Sense of the Senate on animal testing. Sec. 808. Funding. Subtitle B—Dietary supplements Sec. 811. Regulation of dietary supplements. Subtitle C—In vitro clinical tests Sec. 821. Short title. 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. Sec. 831. Guidance on Diagnostic Innovation. Sec. 832. GAO report on unique considerations. TITLE IX—Other provisions Sec. 901. Facilities management. Sec. 902. User fee program transparency and accountability. Sec. 903. OTC hearing aids final rule. Sec. 904. Enhancing coordination and transparency on inspections. Sec. 905. Certificates to foreign governments. Sec. 906. Importation of drugs. Sec. 907. Improving information technology systems of the Food and Drug Administration. Sec. 908. Regulation of certain products as drugs. Sec. 909. Reporting on mailroom and Office of the Executive Secretariat of the Food and Drug Administration. Sec. 910. Protecting infants and improving formula supply. Sec. 911. Predetermined change control plans for devices. Sec. 912. Prohibition against food packaging containing intentionally added PFAS. Sec. 913. Requirements regarding conflicts of interest. Sec. 914. Third party data transparency. Sec. 915. Banned devices. Sec. 916. Medical device cybersecurity. Sec. 917. Women's Health Research Roadmap. Sec. 918. GAO report on deaths due to the cost of drugs in the United States. I Fees relating to drugs 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. 102. Definitions Section 735 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379g (1) in paragraph (1), in the matter following subparagraph (B), by striking an allergenic extract product, or does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to (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, 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. (3) 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). . 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) (1) in the matter preceding paragraph (1), by striking 2018 2023 (2) in paragraph (1)— (A) in subparagraph (A), by striking subsection (c)(5) subsection (c)(6) (B) in subparagraph (C), by inserting prior to approval or was withdrawn (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) subsection (c)(6) (ii) by striking Except as provided (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) (1) in paragraph (1)— (A) in the matter preceding subparagraph (A), by striking 2018 through 2022 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) (c)(3) (E) in subparagraph (E), as so redesignated, by striking (c)(3) (c)(4) (F) in subparagraph (F), as so redesignated, by striking (c)(4) (c)(5) (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 2023, $1,151,522,958 (B) in subparagraph (B)— (i) by striking 2019 through 2022 2024 through 2027 (ii) by striking subsection (c)(3) or (c)(4) 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) (1) in paragraph (1)(B)(ii), by striking Washington-Baltimore, DC–MD–VA–WV 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 (ii) by striking paragraph (1) 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 ; (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 year), (ii) by striking the period and inserting , and subsection (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment). (F) in subparagraph (D), as so redesignated, by striking paragraph (5) 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) 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 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) 2018 through 2022 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) (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) (1) in paragraph (1)(B), by striking during the previous year , as determined under paragraph (2) (2) in paragraph (2), by striking that its gross annual revenues 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. 104. Reauthorization; reporting requirement Section 736B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2 (1) by striking 2018 2023 (2) by striking Prescription Drug User Fee Amendments of 2017 Prescription Drug User Fee Amendments of 2022 (3) in subsection (a)(4), by striking 2020 2023 (4) in subsection (f), by striking 2022 2027 105. Sunset dates (a) Authorization Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379g (b) Reporting requirements Section 736B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2 (c) Previous sunset provision Effective October 1, 2022, subsections (a) and (b) of section 104 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 106. 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. 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. II Fees relating to devices 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. 202. Definitions Section 737 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379i (1) in paragraph (9)— (A) in the matter preceding subparagraph (A), by striking and premarket notification submissions premarket notification submissions, and de novo classification requests (B) in subparagraph (D), by striking and submissions submissions, and de novo classification requests (C) in subparagraph (F), by striking and premarket notification submissions premarket notification submissions, and de novo classification requests (D) in subparagraphs (G) and (H), by striking or submissions submissions, or requests (E) in subparagraph (K), by striking or premarket notification submissions premarket notification submissions, or de novo classification requests (2) in paragraph (11), by striking 2016 2021 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) (1) in paragraph (1), by striking 2018 2023 (2) in paragraph (2)— (A) in subparagraph (A)— (i) in the matter preceding clause (i), by striking 2017 2022 (ii) in clause (iii), by striking 75 percent 80 percent (iii) in clause (viii), by striking 3.4 percent 4.5 percent (B) in subparagraph (B)(iii), by striking or premarket notification submission premarket notification submission, or de novo classification request (C) in subparagraph (C), by striking or periodic reporting concerning a class III device 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) (1) in paragraph (1), by striking 2018 through 2022 2023 through 2027 (2) by amending the table in paragraph (2) to read as follows: Fee Type Fiscal Year 2023 Fiscal Year 2024 Fiscal Year 2025 Fiscal Year 2026 Fiscal Year 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) (1) in paragraph (1), by striking 2017 2022 (2) in paragraph (2)— (A) by striking 2018 2023 (B) in subparagraph (B)(ii), by striking 2016 2022 (C) in subparagraph (C)(i)(II), by striking Washington-Baltimore, DC–MD–VA–WV Washington–Arlington–Alexandria, DC–VA–MD–WV (D) in subparagraph (D), by striking 2022 2027 (3) in paragraph (3), by striking 2018 through 2022 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 PMA shared outcome total time to decision goal (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 (1) in subsection (a)(3)(B)— (A) by striking No fee (i) In general No fee ; and (B) by adding at the end the following: (ii) Small businesses fee waiver (I) Definition of small business For the purposes of this clause, the term small business (II) Waiver The Secretary may grant a waiver of the fee required under subparagraph (A) for the annual registration (excluding the initial registration) of an establishment for a year, if the Secretary finds that the establishment is a small business and paying the fee for such year represents a financial hardship to the establishment as determined on the basis of criteria established by the Secretary. (III) Firms submitting tax returns to the united states internal revenue service The establishment shall support its claim that it meets the definition under subclause (I) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subclause (I). The establishment, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the establishment shall certify that the establishment has no affiliates. (IV) Firms not submitting tax returns to the united states internal revenue service In the case of an establishment that has not previously submitted a Federal income tax return, the establishment and each of its affiliates shall demonstrate that it meets the definition under subclause (I) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the establishment or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the establishment or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the establishment's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The establishment shall also submit a statement signed by the head of the establishment's firm or by its chief financial officer that the establishment has submitted certifications for all of its affiliates, or that the establishment has no affiliates. (V) Request for waiver An establishment seeking a fee waiver for a year under this clause shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subparagraph (C). The decision of the Secretary regarding whether an entity may receive the waiver for such year is not reviewable. ; (2) in subsection (d)(2)(B)(iii), by inserting , if extant, national taxing authority (3) in subsection (e)(2)(B)(iii), by inserting , if extant, national taxing authority (e) Conditions Section 738(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(g) (1) in paragraph (1)(A), by striking $320,825,000 $398,566,000 (2) in paragraph (2), by inserting de novo classification requests, 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) (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. . 204. Reauthorization; reporting requirement (a) Performance reports Section 738A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1(a) (1) by striking fiscal year 2018 fiscal year 2023 (2) by striking Medical Device User Fee Amendments of 2017 Medical Device User Fee Amendments of 2022 (3) in paragraph (1)— (A) in subparagraph (A), by redesignating the second clause (iv) (relating to analysis) as clause (v); and (B) in subparagraph (A)(iv) (relating to rationale for MDUFA program changes), by striking fiscal year 2020 fiscal year 2023 (4) in paragraph (4), by striking 2018 through 2022 2023 through 2027. (b) Reauthorization Section 738A(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1(b) (1) in paragraph (1), by striking 2022 2027 (2) in paragraph (5), by striking 2022 2027 205. 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) (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 testing laboratories (ii) by inserting in guidance by the Secretary (iii) by striking assess the conformance of a device with conduct testing to support the assessment of the conformance of a device to (C) in subparagraph (B)— (i) by striking determinations results (ii) by inserting to support so accredited (iii) by striking a particular such determination particular such results (3) in paragraph (2)— (A) in the paragraph heading, by striking determinations results (B) in subparagraph (A)— (i) by striking determinations by testing laboratories such determinations or 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 accreditation of such testing laboratory (iv) by striking such device a device (C) in subparagraph (B)— (i) by striking by a testing laboratory so accredited under this subsection (ii) by inserting or recognition of an accreditation body under paragraph (1)(A) (4) in paragraph (3)(C)— (A) in the subparagraph heading, by inserting and transition initiation (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. (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) 2022 2027 206. Sunset dates (a) Authorization Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379i (b) Reporting requirements Section 738A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1 (c) Previous sunset provision Effective October 1, 2022, subsections (a) and (b) of section 210 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 207. 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. 208. 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. III Fees relating to generic drugs 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. 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) (1) in the matter preceding paragraph (1), by striking 2018 2023 (2) in paragraph (2)(C), by striking fiscal years 2018 through 2022 fiscal years 2023 through 2027 (3) in paragraph (3)(B), by striking fiscal years 2018 through 2022 fiscal years 2023 through 2027 (4) in paragraph (4)(D), by striking fiscal years 2018 through 2022 fiscal years 2023 through 2027 (5) in paragraph (5)(D), by striking fiscal years 2018 through 2022 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) (1) in paragraph (1)— (A) in subparagraph (A)— (i) in the heading, by striking 2018 2023 (ii) by striking 2018 2023 (iii) by striking $493,600,000 $582,500,000 (B) in subparagraph (B)— (i) in the heading, by striking 2019 through 2022 2024 through 2027 (ii) by striking For each (i) In general For each ; (iii) by striking 2019 through 2022 2024 through 2027 (iv) by striking $493,600,000 the base revenue amount under clause (ii) (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 24 percent (B) in subparagraph (D), by striking Seven Six (C) in subparagraph (E)(i), by striking Thirty-five Thirty-six (c) Adjustments Section 744B(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(c) (1) in paragraph (1)— (A) in the matter preceding subparagraph (A)— (i) by striking 2019 2024 (ii) by striking the product of the total revenues established in such notice for the prior fiscal year the base revenue amount for the fiscal year determined under subsection (b)(1)(B)(ii) (B) in subparagraph (C), by striking Washington-Baltimore, DC–MD–VA–WV Washington-Arlington-Alexandria, DC–VA–MD–WV (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 (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) (1) in the heading, by striking 2018 through 2022 2023 through 2027 (2) by striking more later (3) by striking 2018 through 2022 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) 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) 2018 through 2022 2023 through 2027 303. Reauthorization; reporting requirements Section 744C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–43 (1) in subsection (a)— (A) by striking 2018 2023 (B) by striking Generic Drug User Fee Amendments of 2017 Generic Drug User Fee Amendments of 2022 (2) in subsection (b), by striking 2018 2023 (3) in subsection (c)— (A) by striking 2018 2023 (B) by striking Generic Drug User Fee Amendments of 2017 Generic Drug User Fee Amendments of 2022 (4) in subsection (f)— (A) in paragraph (1), by striking 2022 2027 (B) in paragraph (5), by striking January 15, 2022 January 15, 2027 304. Sunset dates (a) Authorization Sections 744A and 744B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–41 (b) Reporting requirements Section 744C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–43 (c) Previous sunset provision Effective October 1, 2022, subsections (a) and (b) of section 305 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 305. Effective date The amendments made by this title shall take effect on October 1, 2022, or the date of the enactment of this Act, whichever is later, except that fees under part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–41 et seq. 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) IV Fees relating to biosimilar biological products 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. 402. Definitions Section 744G of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–51 (1) in paragraph (1)— (A) by striking Washington-Baltimore, DC–MD–VA–WV Washington–Arlington–Alexandria, DC–VA–MD–WV (B) by striking October of September of (C) by striking October 2011 September 2011 (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. 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) (1) in the matter preceding paragraph (1), by striking 2018 2023 (2) in paragraph (1)— (A) in subparagraph (A)— (i) in clause (iv)(I), by striking 5 days 7 days (ii) in clause (v)(II), by striking 5 days 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 (ii) in clause (iii)— (I) in subclause (I), by striking ; or (II) in subclause (II), by striking the period and inserting ; or (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 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 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 7 days (bb) by inserting or the date of administrative removal, as applicable discontinued (III) in subclause (II), by inserting or the date of administrative removal, as applicable discontinued (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 (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 withdrawn (4) in paragraph (3)— (A) in subparagraph (A)— (i) in clause (i), by striking ; and (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) (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 In general (B) in the matter preceding subparagraph (A), by striking 2019 through 2022 2023 through 2027 (C) in subparagraph (A), by striking paragraph (4) 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 subsection (c)(3)); (G) in subparagraph (E), as so redesignated, by striking subsection (c)(3)). subsection (c)(4)); 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) (1) in paragraph (1)— (A) in subparagraph (A)— (i) in the matter preceding clause (i), by striking subsection (b)(2)(B) subsection (b)(1)(B) (ii) in clause (i), by striking subsection (b) subsection (b)(1)(A) (B) in subparagraph (B)(ii), by striking Washington-Baltimore, DC–MD–VA–WV 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) For each fiscal year (ii) by striking adjustment under paragraph (1), further increase adjustments under paragraphs (1) and (2), further adjust (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 ; and (C) in subparagraph (C)— (i) by striking subsections (b)(2)(A) subsections (b)(1)(A) (ii) by striking and (b)(2)(B) , (b)(1)(B) (iii) by inserting , and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment) (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 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) 2018 through 2022 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 (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. . 404. Reauthorization; reporting requirements Section 744I of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–53 (1) by striking 2018 2023 (2) by striking Biosimilar User Fee Amendments of 2017 Biosimilar User Fee Amendments of 2022 (3) in subsection (a)(4), by striking 2020 2023 (4) in subsection (f), by striking 2022 2027 405. Sunset dates (a) Authorization Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–51 (b) Reporting requirements Section 744I of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–53 (c) Previous sunset provision Effective October 1, 2022, subsections (a) and (b) of section 405 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 406. 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. 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. V Improving regulation of drugs and biological products 501. Alternatives to animal testing (a) In general Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 (1) in subsection (i)— (A) in paragraph (1)(A), by striking preclinical tests (including tests on animals) nonclinical tests (B) in paragraph (2)(B), by striking animal nonclinical tests (2) after subsection (y), by inserting the following: (z) Nonclinical test defined For purposes of this section, the term nonclinical test . (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) (bb) an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)); and . 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) for purposes of rendering drugs nonretrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation)) 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) (1) in the matter preceding subparagraph (A)— (A) by striking Upon review of The Secretary shall not make approval as an interchangeable biological product effective with respect to (B) by striking relying on that relies on (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 (2) in the flush text that follows subparagraph (C), by striking the period and inserting , and the term first interchangeable biosimilar biological product 504. Improvements to the Purple Book (a) In general Section 506I of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356i (1) in subsection (a)— (A) by striking The holder of an application approved under subsection (c) or (j) of section 505 The holder of an application approved under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act (B) in paragraph (2), by inserting (in the case of a biological product, the proper name) established name (C) in paragraph (3), by striking or abbreviated application number , abbreviated application number, or biologics license application number (2) in subsection (b)— (A) in the matter preceding paragraph (1), by striking The holder of an application approved under subsection (c) or (j) The holder of an application approved under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act (B) in paragraph (1), by inserting (in the case of a biological product, the proper name) established name (C) in paragraph (2), by striking or abbreviated application number , 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 (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 (1) in subsection (d)— (A) by striking or (c), the Secretary (1) the Secretary ; (B) by striking the period at the end, and inserting ; 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. (B) in the last sentence— (i) by striking updates to the list 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 (ii) by striking update the list update such lists 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) (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 any 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 pursuant to 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 pursuant to 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 an evaluation 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 approved prior to or on the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022, 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 submitted prior to the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (AA) such request for a therapeutic equivalence 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 amendment or supplement, as applicable, 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. . 506. Modernizing accelerated approval (a) In general Section 506(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(c) (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 (A) In general Approval of a product ; (C) in clause (i) of such subparagraph (A), as so redesignated, by striking appropriate postapproval studies an appropriate postapproval study or studies (which may be augmented or supported by real world evidence) (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 date 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 of the applicable product. ; 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 (A) In general The Secretary may ; (C) in clause (i) of such subparagraph (A), as so redesignated, by striking drug with due diligence 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 product is not (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 proposed 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 proposal to withdraw approval; (iii) the publication of a summary of the public comments received, and the Secretary’s response to such comments, on the website of the Food and Drug Administration; and (iv) convening and consulting an advisory committee on issues related to the proposed withdrawal, if requested by the sponsor and if no such advisory committee has previously advised the Secretary on such issues with respect to the withdrawal of the product prior to the sponsor’s request. . (b) Reports of postmarketing studies Section 506B(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356b(a) (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 pursuant to 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. The Secretary shall promptly publish on the website of the Food and Drug Administration, in an easily searchable format, the information reported under this paragraph. . (c) Enforcement Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 (fff) 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 (referred to in this section as the Secretary (A) how sponsor questions related to the identification of novel surrogate or intermediate clinical endpoints may be addressed in early-stage development meetings with the Food and Drug Administration; (B) the use of novel clinical trial designs that may be used to conduct appropriate postapproval studies as may be required under section 506(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act, 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) 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) Accelerated approval council (1) General Not later than 1 year after the date of enactment of this Act, the Secretary 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 divisions or offices overseeing products approved under accelerated approval, including at least one director 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. (5) Summary approval information With respect to each new drug application for a new molecular entity approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c) 42 U.S.C. 262(a) 21 U.S.C. 356(c) (f) Rule of construction Nothing in this section (including the amendments made by this section) shall be construed to affect products approved pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(c) 507. Rare disease pilot program (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary (1) determining eligibility of participants for such program; and (2) developing and implementing a process for applying to, and participating in, such a program. (b) 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— (1) novel endpoints developed through the pilot program established under this section; and (2) as appropriate, the use of real world evidence and real world data to support the validation of efficacy endpoints, including surrogate and intermediate endpoints, for rare diseases. (c) Report Not later than September 30, 2026, 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 a report describing the outcomes of the pilot program established under this section. (d) 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. (e) Sunset The Secretary may not accept any new application or request to participate in the program established by this section on or after October 1, 2027. 508. Supporting review and development of drugs to treat rare diseases (a) GAO report (1) In general Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States 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, a report assessing the policies, practices, and programs of the Food and Drug Administration with respect to the review of applications for drugs and biological products intended to treat rare diseases and conditions (as defined in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb(a)(2) (2) Content of report The report under paragraph (1) shall— (A) describe the activities of the Food and Drug Administration dedicated to the development and review of drugs and biological products intended to treat rare diseases and conditions; (B) describe challenges with developing and obtaining approval or licensure of drugs and biological products intended to treat rare diseases and conditions, such as challenges related to designing and conducting clinical trials, clinical trial subject recruitment and enrollment, study endpoints, and ensuring data quality, assessing the benefit-risk profile of drugs and biological products intended to treat rare diseases and conditions, and meeting requirements for approval or licensure; (C) assess the effectiveness of policies and practices of the Food and Drug Administration related to the review of applications for drugs and biological products intended to treat rare diseases and conditions, including— (i) initiatives to support the development and review of drugs and biological products intended to treat rare diseases and conditions, including initiatives related to regulatory science, clinical trial design, statistical analysis, and other relevant topics; (ii) consideration of relevant patient-focused drug development data and information, including patient experience data and the views of patients, pursuant to section 569C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8c (iii) training and other efforts to ensure the expertise of personnel of the Food and Drug Administration regarding the review of applications for drugs and biological products intended to treat rare diseases and conditions; and (iv) consultations and engagement with stakeholders, including patients and patient groups, and external experts pursuant to section 569 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8 (D) assess the extent to which the Food and Drug Administration is applying the policies and practices described in subparagraph (C) consistently across review divisions, and the factors that influence the extent to which such application is consistent; and (E) include recommendations to address challenges and deficiencies identified, including recommendations to improve the effectiveness, consistency, and coordination of policies, practices, and programs of the Food and Drug Administration related to the review of applications for drugs and biological products intended to treat rare diseases and conditions. (b) FDA report (1) In general Not later than March 31, 2026, the Secretary of Health and Human Services (referred to in this subsection as the Secretary 21 U.S.C. 360bb(a)(2) (2) Content of report The report under paragraph (1) shall include, with respect to the period of fiscal years 2023 through 2025, broken down by fiscal year and by the responsible review division of the Food and Drug Administration— (A) the number of drugs that have been designated as a drug for a rare disease or condition under section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb (B) the number of applications under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) 42 U.S.C. 262(a) 21 U.S.C. 360bb (C) the number of applications for a drug or biological product for which the sponsor requested written recommendations pursuant to section 525 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360aa (D) the number of applications for which the Secretary consulted patients and patient groups pursuant to subsection (a)(1) of section 569 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8 (E) the number of applications for which the Secretary allowed the sponsor to rely upon data and information pursuant to section 529A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360ff–1 (3) Clarification Nothing in this subsection 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 the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331(j) (c) Guidance Not later than 9 months after the date of enactment of this Act, the Secretary shall publish final guidance related to the draft guidance titled, Rare Diseases: Common Issues in Drug Development (d) Review process (1) Consultation with stakeholders Section 569(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8(a)(1) (A) by striking at a time at any time (B) by striking Consistent with sections (A) In general Consistent with sections ; and (C) by adding at the end the following: (B) Consultation with patients and patient groups (i) In general The Secretary may, as appropriate, consult with patients and relevant patient groups impacted by the rare disease or condition, together with at least one expert included on the list under paragraph (2)(A) and selected by such groups, as applicable, during meetings between the Food and Drug Administration and sponsors prior to the submission of an application for a new drug or biological product for a rare disease or condition or a drug or biological product that is genetically targeted. (ii) Conflicts of interest For purposes of clause (i), to be eligible for consultation pursuant to clause (i), patients and relevant patient groups may not have any financial interest in the applicable drug or biological product, and external experts shall be in compliance with applicable law, including section 208 of title 18, United States Code. (C) Consultation with disproportionately affected communities To the extent an application for a new drug or biological product relates to a rare disease or condition that disproportionately affects communities of color or other historically underrepresented and vulnerable populations, the Secretary is encouraged to consult with patients of that subpopulation, or one or more patient groups that represent that subpopulation. . (2) Requiring appropriate expert consultation Section 569(a)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8(a)(2) (A) in subparagraph (A), by striking the second sentence; and (B) by striking subparagraph (B) and inserting the following: (B) Consultation With respect to any application under section 505 of this Act or section 351 of the Public Health Service Act for a drug designated under section 526 for a rare disease or condition or a drug or biological product that is genetically targeted, the Secretary may, as appropriate, consult— (i) with an expert with respect to the disease or condition referenced in the application who appears on the list described in subparagraph (A); or (ii) if no such expert is available, including because of conflicts of interest, with an expert on the list described in subparagraph (A) in the science of small population studies. (C) Availability at meetings In connection with each drug product advisory committee meeting concerning a drug or biological product for a rare disease or condition, the Secretary may, as appropriate— (i) include— (I) an expert in the rare disease or condition; or (II) if no such expert is available, including because of conflicts of interest, an expert in the science of small population studies; and (ii) invite at least one disease or condition expert identified by the relevant patient groups to participate as a nonvoting member of the advisory committee. . (3) Additional topic for consultation Section 569(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8(b) (A) in paragraph (6), by striking ; and ; (B) in paragraph (7), by striking the period and inserting ; and (C) by adding at the end the following: (8) the science of small population studies. . 509. Generic drug labeling changes Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(10)(A) (i) a revision to the labeling of the listed drug has been approved by the Secretary within 90 days of when the application is otherwise eligible for approval under this subsection; (ii) the sponsor of the application agrees to submit revised labeling for the drug that is the subject of the application not later than 60 days after approval under this subsection of the application; (iii) the labeling revision described under clause (i) does not include a change to the Warnings . 510. Limitations on exclusive approval or licensure of orphan drugs (a) In general Section 527 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc (1) in subsection (a), in the matter following paragraph (2), by striking same disease or condition same approved use or indication within such rare disease or condition (2) in subsection (b)— (A) in the matter preceding paragraph (1), by striking same rare disease or condition same approved use or indication for which such 7-year period applies to such already approved drug (B) in paragraph (1), by inserting , relating to the approved use or indication, the needs (3) in subsection (c)(1), by striking same rare disease or condition as the already approved drug same use or indication for which the already approved or licensed drug was approved or licensed (4) by adding at the end the following: (f) Approved use or indication defined In this section, the term approved use or indication . (b) Application of amendments The amendments made by subsection (a) shall apply with respect to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb 21 U.S.C. 355 42 U.S.C. 262 511. Ensuring timely access to generics Section 505(q) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(q) (1) in paragraph (1)— (A) in subparagraph (A)(i), by inserting , 10.31, 10.30 (B) in subparagraph (E)— (i) by striking application and application or (ii) by striking If the Secretary (i) In general If the Secretary ; and (iii) by striking the second sentence and inserting the following: (ii) Primary purpose of delaying (I) In general In determining whether a petition was submitted with the primary purpose of delaying an application, the Secretary may consider the following factors: (aa) Whether the petition was submitted in accordance with paragraph (2)(B), based on when the petitioner knew or reasonably should have known the relevant information relied upon to form the basis of such petition. (bb) Whether the petitioner has submitted multiple or serial petitions or supplements to petitions raising issues that reasonably could have been known to the petitioner at the time of submission of the earlier petition or petitions. (cc) Whether the petition was submitted close in time to a known, first date upon which an application under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act could be approved. (dd) Whether the petition was submitted without relevant data or information in support of the scientific positions forming the basis of such petition. (ee) Whether the petition raises the same or substantially similar issues as a prior petition to which the Secretary has responded substantively already, including if the subsequent submission follows such response from the Secretary closely in time. (ff) Whether the petition requests changing the applicable standards that other applicants are required to meet, including requesting testing, data, or labeling standards that are more onerous or rigorous than the standards the Secretary has determined to be applicable to the listed drug, reference product, or petitioner’s version of the same drug. (gg) The petitioner's record of submitting petitions to the Food and Drug Administration that have been determined by the Secretary to have been submitted with the primary purpose of delay. (hh) Other relevant and appropriate factors, which the Secretary shall describe in guidance. (II) Guidance The Secretary may issue or update guidance, as appropriate, to describe factors the Secretary considers in accordance with subclause (I). ; (C) by adding at the end the following: (iii) Referral to the Federal Trade Commission The Secretary shall establish procedures for referring to the Federal Trade Commission any petition or supplement to a petition that the Secretary determines was submitted with the primary purpose of delaying approval of an application. Such procedures shall include notification to the petitioner by the Secretary. ; (D) by striking subparagraph (F); (E) by redesignating subparagraphs (G) through (I) as subparagraphs (F) through (H), respectively; and (F) in subparagraph (H), as so redesignated, by striking submission of this petition submission of this document (2) in paragraph (2)— (A) by redesignating subparagraphs (A) through (C) as subparagraphs (C) through (E), respectively; (B) by inserting before subparagraph (C), as so redesignated, the following: (A) In general A person shall submit a petition to the Secretary under paragraph (1) before filing a civil action in which the person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act. Such petition and any supplement to such a petition shall describe all information and arguments that form the basis of the relief requested in any civil action described in the previous sentence. (B) Timely submission of citizen petition A petition and any supplement to a petition shall be submitted within 60 days after the person knew, or reasonably should have known, the information that forms the basis of the request made in the petition or supplement. ; (C) in subparagraph (C), as so redesignated— (i) in the heading, by striking within 150 days (ii) in clause (i), by striking during the 150-day period referred to in paragraph (1)(F), (iii) by amending clause (ii) to read as follows: (ii) on or after the date that is 151 days after the date of submission of the petition, the Secretary approves or has approved the application that is the subject of the petition without having made such a final decision. ; (D) by amending subparagraph (D), as so redesignated, to read as follows: (D) Dismissal of certain civil actions (i) Petition If a person files a civil action against the Secretary in which a person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act without complying with the requirements of subparagraph (A), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies. (ii) Timeliness If a person files a civil action against the Secretary in which a person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act without complying with the requirements of subparagraph (B), the court shall dismiss with prejudice the action for failure to timely file a petition. (iii) Final response If a civil action is filed against the Secretary with respect to any issue raised in a petition timely filed under paragraph (1) in which the petitioner requests that the Secretary take any form of action that could, if taken, set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act before the Secretary has taken final agency action on the petition within the meaning of subparagraph (C), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies. ; and (E) in clause (iii) of subparagraph (E), as so redesignated, by striking as defined under subparagraph (2)(A) within the meaning of subparagraph (C) (3) in paragraph (4)— (A) by striking Exceptions This subsection does Exceptions.— (B) by striking subparagraph (B); and (C) by redesignating clauses (i) and (ii) as subparagraphs (A) and (B), respectively, and adjusting the margins accordingly. 512. Increasing transparency in generic drug applications (a) In general Section 505(j)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(3) (H) (i) Upon request (in controlled correspondence or otherwise) by a person that has submitted or intends to submit an abbreviated application under this subsection for a drug that is generally required by regulation or recommended in guidance to contain the same inactive ingredients in the same concentration as the listed drug referred to or for which there is a scientific justification that an in vitro approach can be used to demonstrate bioequivalence based on certain qualitative or quantitative criteria with respect to an inactive ingredient, or on the Secretary’s own initiative during the review of an application under this subsection for such a drug, the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug. (ii) If the Secretary determines that such drug is not qualitatively or quantitatively the same as the listed drug, the Secretary shall identify and disclose to the person— (I) the ingredient or ingredients that cause the drug not to be qualitatively or quantitatively the same as the listed drug; and (II) for any ingredient for which there is an identified quantitative deviation, the amount of such deviation. (iii) If the Secretary determines that such drug is qualitatively and quantitatively the same as the listed drug, the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless— (I) the formulation of the listed drug has been changed and the Secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness; or (II) the Secretary makes a written determination that the prior determination must be changed because an error has been identified. (iv) If the Secretary makes a written determination described in clause (iii)(II), the Secretary shall provide notice and a copy of the written determination to the person making the request under clause (i). (v) The disclosures required by this subparagraph are disclosures authorized by law, including for purposes of section 1905 of title 18, United States Code. . (b) Guidance (1) In general Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance, or update guidance, describing how the Secretary will determine whether a drug is qualitatively and quantitatively the same as the listed drug (as such terms are used in section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)), including with respect to assessing pH adjusters. (2) Process In issuing guidance under this subsection, the Secretary of Health and Human Services shall— (A) publish draft guidance; (B) provide a period of at least 60 days for comment on the draft guidance; and (C) after considering any comments received and not later than one year after the close of the comment period on the draft guidance, publish final guidance. (c) Applicability Section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies beginning on the date of enactment of this Act, irrespective of the date on which the guidance required by subsection (b) is finalized. 513. GAO report on nonprofit pharmaceutical organizations (a) GAO review The Comptroller General of the United States (referred to in this section as the Comptroller General (1) what is known about nonprofit pharmaceutical manufacturing organizations, including the impact of such organizations on the development, availability, and cost of prescription drugs in the United States, which may include information with respect to the capacity and capability to help prevent or mitigate shortages of such drugs, and any challenges to manufacturing or other operations; and (2) recommendations to address such challenges. (b) Report Not later than 2 years after the date of enactment of this Act, the Comptroller General shall submit the report described in subsection (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. 514. FDA public meeting on nonprofit prescription drug manufacturers (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall— (1) hold a public meeting on nonprofit manufacturers of prescription drugs, which shall include public testimony from relevant stakeholders and academics; and (2) open a docket for public comment related to such meeting. (b) Topics The public meeting under subsection (a) shall focus on the following topics: (1) The extent to which growth in the nonprofit prescription drug sector can help address patient access challenges in the current prescription drug marketplace, such as drug shortages, limited medication alternatives and competition, supply chain resiliency, and specific products where there is insufficient market demand to induce manufacturers to continue to offer certain prescription drugs. (2) Whether, and to what extent, the Secretary of Health and Human Services should consider changes to future user fee structures and processes for nonprofit manufacturers of prescription drugs. 515. 180-day exclusivity period (a) In general Section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(B)(iv) (1) in subclause (I)— (A) by inserting and subclause (III) subparagraph (D) (B) by inserting before the period at the end the following: or an applicant whose application was approved pursuant to subclause (III). If an applicant described in subclause (III) is eligible for effective approval on the same day a tentatively approved first applicant who has requested final approval is determined by the Secretary to be eligible for effective approval by meeting all the approval requirements of this subsection, such applicant may not receive effective approval until 180 days after the first applicant begins commercial marketing of the drug. (2) by adding at the end the following new subclause: (III) Applicant approval The Secretary may approve an application containing a certification described in paragraph (2)(A)(vii)(IV) that is for a drug for which a first applicant has submitted an application containing such a certification, notwithstanding the eligibility of a first applicant for the 180-day exclusivity period described in subclause (II)(aa), if each of the following conditions is met: (aa) The approval of such application could be made effective, but for the eligibility of a first applicant for 180-day exclusivity under this clause. (bb) The applicant of such application has submitted a certification to the abbreviated new drug application that there are no conditions that would prevent the applicant from commercial marketing within 75 days after the date of approval and that the applicant intends to so market the drug. (cc) At least 33 months have passed since the date of submission of an application for the drug by at least one first applicant. (dd) Approval of an application for the drug submitted by at least one first applicant is not precluded under clause (iii). (ee) No application for the drug submitted by any first applicant is effectively approved on the date that the conditions under items (aa), (bb), (cc), and (dd) are all met and maintained. . (b) Special approval status rule for certain subsequent applicants Section 505(j)(5)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355 (j)(5)(D)) is amended at the end by adding the following: (v) Special approval status rule for certain subsequent applicants An application that is approved pursuant to subclause (III) of subparagraph (B)(iv) is deemed to be tentatively approved and to no longer have an effective approval pursuant to such subclause (III) on the date that is 76 days after the date on which the approval has been made effective pursuant to such subclause (III) if the applicant fails to commercially market such drug within the 75-day period after the date on which the approval is made effective. If the applicant of an application approved pursuant to such subclause (III) submits a notification that it can no longer commence commercial marketing within 75 days after the date of approval, as required under subparagraph (B)(iv)(III)(bb), its application is deemed to be tentatively approved and to no longer be effectively approved on the date that such a notification is received. If an applicant does not commence commercial marketing within the 75-day period, it shall not be eligible for a subsequent effective approval for the application under subclause (III) of subparagraph (B)(iv) unless, in addition to meeting each of the conditions in such subclause (III), it submits a certification to its abbreviated new drug application that an event that could not have been reasonably foreseen by the applicant prevented it from commencing commercial marketing and that it has fully resolved this issue. The applicant shall submit notification to the abbreviated new drug application confirming that such applicant has commenced commercial marketing of the drug not later than one business day after commencing such marketing. . (c) Applicability The amendments made by subsections (a) and (b) shall apply only with respect to an application filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) VI Other reauthorizations 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) 2018 through 2022 2023 through 2027 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) 2018 through 2022 2023 through 2027 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) 2022 2027 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 $5,250,000 for each of fiscal years 2018 through 2022 $7,000,000 for each of fiscal years 2023 through 2027 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) (1) in paragraph (1)(A)(ii)(II), by adding (other than bioavailability studies) any clinical investigations (2) in paragraph (4), by striking October 1, 2022 October 1, 2027 606. Reauthorization of orphan drug grants Section 5(c) of the Orphan Drug Act ( 21 U.S.C. 360ee(c) 2018 through 2022 2023 through 2027 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) 2022 2027 VII Enhancing FDA hiring authorities 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 (1) in subsection (a)— (A) by inserting , including cross-cutting operational positions, professional positions (B) by inserting and the regulation of food medical products (2) in subsection (d)(1)— (A) in the matter preceding subparagraph (A)— (i) by striking the 21st Century Cures Act the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (ii) by striking that examines the extent , including that addresses (B) in subparagraph (A)— (i) by inserting updated analysis (ii) by striking ; and (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 the matter preceding clause (i) of subparagraph (C), as so redesignated, by striking a recruitment an updated recruitment 702. Strategic workforce plan and report Chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 371 et seq. 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. . VIII Advancing regulation of cosmetics, dietary supplements, and in vitro clinical tests A Cosmetics 801. Short title This subtitle may be cited as the Modernization of Cosmetics Regulation Act of 2022 802. Amendments to cosmetic requirements Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. 604. Definitions In this chapter: (1) Adverse event The term adverse event (2) Cosmetic product The term cosmetic product (3) Facility (A) In general The term facility (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 (as defined in section 3508(b)(2) (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 repackaging (4) Responsible person The term responsible person (5) Serious adverse event The term serious adverse event (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). 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 (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 list of ingredients or categories 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. In response to a request under section 552 of title 5, United States Code, information submitted to the Secretary under this subsection shall be withheld under section 552(b)(3) 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 (b)(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 Freedom of Information Act (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. 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 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 (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 (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 to the Secretary a cosmetic product listing, or ensure that such submission is made, 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 Modernization of Cosmetics Regulation Act of 2022 (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, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), 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 In response to a request under section 552 of title 5, United States Code, information described in subsection (b)(2)(D) or (c)(4)(A)(i) that is derived from a registration or listing under this section shall be withheld under section 552(b)(3) of title 5, United States Code. (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 registration 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. 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 (2) Safe The term safe 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 (c) Cosmetic products for professional use (1) Definition of professional For purposes of this subsection, the term professional (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. 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) 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. 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 determines 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. 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. 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. 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 Modernization of Cosmetics Regulation Act of 2022 (c) Savings Nothing in the amendments to this Act made by the Modernization of Cosmetics Regulation Act of 2022 (d) Rule of construction Nothing in this section shall be construed to amend, expand, or limit the provisions under section 752. . 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 (A) by adding at the end the following: (ggg) The failure to register or submit listing information in accordance with section 607. (hhh) The refusal or failure to follow an order under section 611. ; and (B) in paragraph (d), by striking or 564 , 564, or 607 (2) Adulterated products Section 601 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 (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) (A) by striking and (2) (2) (B) by inserting after numerical count ; 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. (A) in section 301(e) ( 21 U.S.C. 331(e) (i) by striking 564, 703 564, 605, 703 (ii) by striking 564, 760 564, 605, 611, 760 (B) in section 301(ii) ( 21 U.S.C. 331(ii) (i) by striking 760 or 761) or 604, 760, or 761) or (ii) by inserting or required under section 605(a) 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 under section 605, 760, or 761 (ii) by striking defined in such section 760 or 761 defined in section 604, 760, or 761 (iii) by striking of such section 760 or 761 of such section 605, 760, or 761 (iv) by striking described in such section 760 or 761 described in such section 605, 760, or 761 (D) in section 801(b) ( 21 U.S.C. 381(b) (i) by striking requirements of sections 760 or 761, requirements of section 605, 760, or 761 (ii) by striking as defined in section 760 or 761 as defined in section 604, 760, or 761 (iii) by striking with section 760 or 761 with section 605, 760, or 761 (b) Effective dates (1) In general The amendments made by subsection (a) shall take effect on the date that is 1 year after the date of enactment of this Act. (2) Labeling requirement Section 609(a) of the Federal Food, Drug, and Cosmetic Act, as added by section 802, shall take effect on the date that is 2 years after the date of enactment of this Act. (c) Confidentiality (1) In general 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 commercial information that is obtained by the Secretary of Health and Human Services pursuant to this subtitle, including the amendments made by this subtitle. (2) Clarification Nothing in this subtitle, including the amendments made by this subtitle, shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 301(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331(j) 804. Records inspection Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(a)(1) 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. 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. 806. PFAS in cosmetics (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary (b) Report Not later than 3 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). 807. Sense of the Senate on animal testing It is the sense of the Senate that animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances. 808. 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 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). B Dietary supplements 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. 21 U.S.C. 343–3 403D. Dietary supplement listing requirement (a) In general Beginning on the date specified in subsection (b)(4), each dietary supplement marketed in the United States 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 (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 full 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. (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, powders, liquids, softgels, and gummies). (K) Any health claims or structure or function claims. (L) The dietary supplement product listing number for the dietary supplement provided by the Secretary in accordance with subsection (c). (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 and forms, or formulations of the same form, that differ only with respect to color, excipients, 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, excipients, 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 (3) Confidential information In response to a request under section 552 of title 5, United States Code, information described in subparagraph (D) or (E)(iv) of subsection (b)(1) that is derived from a listing under this section shall be withheld under section 552(b)(3) of title 5, United States Code. (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; (2) to authorize the disclosure of information that is prohibited from disclosure under section 301(j) of this Act or section 1905 of title 18, United States Code, or that is subject to withholding under section 552(b)(4) of title 5, United States Code; or (3) to grant the Secretary authority to require the approval of a dietary supplement prior to marketing. (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 (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 (z) If it is a dietary supplement for which a responsible person or the United States agent of such a 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 or agent 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 (iii) 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). (jjj) 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. . C In vitro clinical tests 821. Short title (a) Short title This subtitle may be cited as the Verifying Accurate Leading-edge IVCT Development Act of 2022 VALID Act of 2022 822. Definitions (a) In general Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 (1) by adding at the end the following: (ss) (1) The term in vitro clinical test (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(16)); (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. ; (2) by adding at the end of section 201(g) the following: (3) The term drug ; and (3) in section 201(h)(1), in the matter following clause (C), by striking section 520(o) 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) (1) by striking (1) The term biological product (1)(A) The term biological product (2) by adding at the end the following: (B) The term biological product . (c) In vitro clinical test definition In this subtitle, the term in vitro clinical test 823. Regulation of in vitro clinical tests The Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. (1) by amending the heading of chapter V to read as follows: Drugs, Devices, and In Vitro Clinical Tests (2) by adding at the end of chapter V the following: J In Vitro Clinical Tests 587. Definitions In this subchapter: (1) Analytical validity The term analytical validity (2) Applicable standard The term applicable standard (3) Clinical use The term clinical use (4) Clinical validity The term clinical validity (5) Component or part The term component or part (6) Develop The term develop (A) designing, validating, producing, manufacturing, remanufacturing, labeling, advertising, propagating, importing, 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 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 (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 (9) High-risk The term high-risk (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 (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 (B) Analytic instrument The term analytic instrument (C) Pre-analytical instrument The term pre-analytical instrument (12) Instrument family The term instrument family (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) Laboratory operations The term laboratory operations (A) means the conduct of a laboratory examination or other laboratory procedure on materials derived from the human body, including the conduct of an in vitro clinical test and associated activities within or under the oversight of a laboratory and not related to the design of an in vitro clinical test; and (B) includes— (i) performing pre-analytical and post-analytical processes for an in vitro clinical test; (ii) standard operating procedures and the conduct thereof; and (iii) preparing reagents or other test materials that do not meet the definition of an in vitro clinical test for clinical use under section 201(ss). (14) Low-risk The term low-risk (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). (15) 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, the role of a health professional in the testing process, or testing. (16) Moderate-risk The term moderate-risk (A) that, when used as intended, meets the criteria specified in paragraph (9)(A) 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 under the criteria in paragraph (13); or (B) for which, when used as intended— (i) an undetected inaccurate result 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 under the criteria in paragraph (13). (17) Specimen receptacle The term specimen receptacle (18) 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. (19) Test The term test (20) 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. 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) the in vitro clinical test is offered under a technology certification order in effect under section 587D(b)(1); 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. 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 (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) raw data for each study, which may include, as applicable, tabulations of data and results; 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 (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 45 calendar days of receipt of such application submitted under this subsection or within 30 calendar days of receipt of an application submitted under subsection (b), 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)(3), 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)(3)(B)(iii)) 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) 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)(3)(J) 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. In making the order and summary publicly available, the Secretary shall not disclose any information that— (i) is confidential commercial information or trade secret information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code; or (ii) could compromise 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 (e) 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(a)(6). (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)(3)(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 (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 modification, 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 provided that doing so does not disclose any information that— (A) is trade secret or confidential commercial or financial information; or (B) could compromise national security. (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 provided that doing so does not disclose— (i) any information that is trade secret or confidential commercial or financial information; or (ii) any other information that the Secretary determines, if published, could compromise 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. 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) (aa) was offered for clinical use prior to the date of enactment of the VALID Act of 2022 (bb) 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 (II) (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 (D) Near-patient testing Not later than 1 year after the date of enactment of the VALID Act of 2022 (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), 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 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— (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 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 paragraph (1) or this paragraph; and (II) all in vitro clinical tests and categories of in vitro clinical tests that are designated by the Secretary pursuant to subparagraph (D) as low-risk for purposes of this paragraph. (D) Designation of tests and categories Without regard to subchapter II of chapter 5 (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; (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 adverse 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 section 587F(e) 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) the modification is made by— (I) the developer that obtained premarket approval for the unmodified version of the test under section 587B; or (II) 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; and (ii) the modification does not— (I) constitute a significant change to the indications for use; (II) cause the test to no longer comply with applicable mitigating measures under section 587E or restrictions under section 587O; (III) significantly and adversely change performance claims or significantly and adversely change performance, unless provided for under an approved change protocol under section 587B(a)(3)(H); or (IV) 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; (iii) the test meets the applicable standard as described in section 587(2); (iv) the labeling and advertising are not false or misleading; and (v) 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 (ii) through (iv) 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 (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 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 components or parts of such test, including any reagent, is introduced into interstate commerce under the exemption under subsection (e), 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 587K. (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)(G) 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 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 under this section 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 (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. 587D. Technology certification (a) Definitions In this section: (1) Eligible in vitro clinical test The term eligible in vitro clinical test (A) a component or part of an in vitro clinical test as described in section 201(ss)(2)(G) unless it is a component or part and is regulated based on its own risk under section 587C(e)(1)(B) or as part of an otherwise eligible in vitro clinical test; (B) an instrument under section 201(ss)(2)(D) or an in vitro clinical test that includes an instrument that is subject to section 587B, but is not approved under, or exempt from, section 587B; (C) a specimen receptacle under section 201(ss)(2)(E) or an in vitro clinical test that includes a specimen receptacle that is subject to section 587B, but 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 (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 one or more technologies with multiple in vitro clinical tests utilizing a technology that does 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 that eligible in vitro clinical tests within the proposed scope of the technology certification order are 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; (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 (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, issued, 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 issued 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 (2) Public meeting Not later than 180 days after the date of enactment of the VALID Act of 2022 technology (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 any of subparagraphs (A) through (E) of subsection (a)(1); or (iii) is not eligible to be introduced into interstate commerce under the referenced technology certification order issued by the Secretary because it is not within the scope of the technology certification order 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). 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 (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). (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 VALID Act of 2022 (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. 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(b) or technology certification under section 587D(a)(1); 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) Abbreviated 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 Not later than 30 days 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 (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 (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 (5) No effect on grandfathering determinations A determination under paragraph (1) shall have no effect on the applicability of section 587G to an in vitro clinical tests. (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. 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, and was not intended solely for investigational use, before the date of enactment of the VALID Act of 2022 (2) the test 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 in 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 (6) when used as an investigational in vitro clinical test, such test complies with section 587S, as applicable; (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) the test is not a specimen receptacle or instrument; (10) each test report for the test bears a statement that reads as follows: This in vitro clinical test was introduced into commerce prior to the application of the VALID Act and is exempt from FDA premarket review. (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 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 a lack of valid scientific evidence to support that the in vitro clinical 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 test. 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 subclause (II) to discuss the Secretary's request; and (II) shall submit the information requested pursuant to subparagraph (A), and may include in such submission a request for a teleconference; and (ii) the Secretary shall— (I) schedule a teleconference requested under clause (i)(I); and (II) hold a teleconference if requested within 10 days of the Secretary's receipt of the information submitted 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, or, upon a determination by the Secretary pursuant to section 587F, offered under a technology certification order under section 587D or offered as a low-risk test. (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, or upon a determination by the Secretary pursuant to section 587F, offered under a technology certification order under section 587D or offered as a low-risk test. 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 (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). 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 in vitro clinical tests, 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 existing alternative in vitro clinical tests that are approved or cleared (including in vitro clinical tests 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 (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(20) 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 587S; (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 section 587X. 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 the least burdensome requirements under section 587AA(c): (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 587C of 587G. (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 or financial 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. 587K. Test design and quality requirements (a) Applicability (1) In general Each developer and each other person required to register under section 587J(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 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 and guidance under section 353 of the Public Health Service Act; (B) not apply to laboratory operations; and (C) include the following, as applicable, subject to subparagraphs (A) and (B) 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)(C) except for the requirements described in clauses (iv), (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), (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. 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 for 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 or financial information; or (B) if posted, could compromise 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 (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. 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 (2) the term serious injury (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. 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 reporting of a correction or removal by the developer— (1) the Secretary shall classify such correction or removal under this section within 45 calendar days; and (2) not later than 70 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. 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 this subchapter takes effect; and (2) except for in vitro clinical tests required to meet the requirements of 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 587P. Appeals (a) Significant decision (1) In general The Secretary shall— (A) 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— (i) the submission of an application for, or a review of, an in vitro clinical test under section 587B or section 587D; (ii) an exemption under section 587C; or (iii) any requirements for mitigation measures to an in vitro clinical test or category of in vitro clinical tests; and (B) include in such summaries 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. 587Q. Accredited persons (a) In general (1) Authorization Beginning on the date of enactment of the VALID Act of 2022 (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 587J. (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(e)(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(e)(2)(A) are met; and (II) any proposed restrictions, mitigating measures, or conditions of approval under section 587B(e)(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(e)(2)(A) are met and the reasons for such decision. (B) Requesting missing or clarifying information After receipt of an application from a developer under this section, the Secretary may request missing or clarifying information from the applicant concerning the application, which the developer shall promptly provide. (C) Secretary action on finding that approval criteria are met If the accredited person transmits a finding to the Secretary under subparagraph (A)(i), 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(e)(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(e)(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(d)(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(d)(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(d)(3) are met and the reasons for such decision. (B) Requesting missing or clarifying information After receipt of an application under this section, the accredited person 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(d)(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(d)(3) have not been met. (c) Requirements for inspections (1) In general When conducting inspection, persons accredited under subsection (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 subsection (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 subsection (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 587J 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 587J, 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 587J; (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 (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 5-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 587J. (h) Reports Not later than 2 years after the effective date of the VALID Act of 2022 (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). 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. 587S. Investigational use (a) In general Subject to the conditions prescribed in subsections (c), (d), (e), (f), and (g), 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 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 (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)(6); 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 or involves an exception from informed consent for emergency research, 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). (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 (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 required by the Secretary pursuant to regulations issued under subsection (b); and (v) ensure that investigators monitor investigations, maintain records and make reports as required by the Secretary pursuant to regulations issued under subsection (b); and (B) the sponsor may rely on any exception or exemption described in paragraph (4) 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)(B) and (6)(C). (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 under 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) ensure 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 in vitro clinical test is required to save the life of the human subject of such testing and there is not sufficient time to obtain such concurrence. (8) Significant risk For purposes of this subsection, the term significant risk (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. (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 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. 587T. Comprehensive test information system (a) Establishment Not later than 2 years after the date of enactment of the VALID Act of 2022 (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 confidential commercial or financial information; and (B) information that could compromise national security. (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. 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— (1) that 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. (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 shall exempt such test for 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. 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)(1); (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. 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 paragraph 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. 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 requirements under section 587AA(c). (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. 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 587T. (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. 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 that 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). 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. Laboratory operations shall not be subject to the requirements of 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), the term necessary (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) Sale, distribution, labeling Nothing in this section 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. (i) Promotion of unapproved uses Nothing in this section shall be construed to alter any prohibition on the promotion of unapproved uses of legally marketed in vitro clinical tests. 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. . 824. Enforcement and other provisions (a) Prohibited acts Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 (1) in paragraphs (a), (b), (c), (g), (h), (k), (q), (r), and (y), by inserting in vitro clinical test, device, (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 section 523 (4) in paragraph (ff), by striking or device , device, or in vitro clinical test (5) by adding at the end, the following: (kkk) (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. (lll) (1) The introduction or delivery for introduction into interstate commerce of an in vitro clinical test in violation of section 587A(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 (1) in subsection (b)(8), by inserting or counterfeit in vitro clinical test counterfeit drug (2) in subsection (c)— (A) by striking ; or (5) ; (5) (B) by inserting before the period at the end the following: ; or (6) for having violated section 301(kkk)(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(kkk)(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 (3) in subsection (f)(1)— (A) in subparagraph (A)— (i) by inserting or in vitro clinical tests which relates to devices (ii) by inserting or section 587Q(a)(1) section 704(g) (iii) by inserting or in vitro clinical tests, as applicable (B) in subparagraph (B)(i), by striking or 520(f) , 520(f), 587K, or 587M, (c) Seizure Section 304 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 334 (1) in subsection (a)(2)— (A) by striking , and (E) , (E) (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, device, (3) in subsection (g)— (A) in paragraph (1), by inserting , in vitro clinical test, device (B) in paragraph (2)— (i) in subparagraph (A), by inserting , in vitro clinical test, device (ii) in subparagraph (B), by inserting or in vitro clinical test device (d) Debarment, temporary denial of approval, and suspension Section 306 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 335a (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(kkk)(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 (1) in subsections (a) through (d)— (A) by striking or investigational devices , investigational devices, or investigational in vitro clinical tests (B) by striking or investigational device , investigational device, or investigational in vitro clinical test (2) in subsection (b)(4) by striking or 520(g) , 520(g), or 587S (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) , 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 , treatment investigational device exemption, or treatment investigational in vitro clinical test exemption (D) in paragraph (5), by striking or 520(g) , 520(g), or 587S (E) in the matter following paragraph (7) by striking or 520(g) , 520(g), or 587S (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 treatment investigational in vitro clinical test exemption . (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— (1) by striking subsection paragraph (2) by inserting an in vitro clinical test, as defined in paragraph (ss) of such section, 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 drugs and devices drugs, devices, and in vitro clinical tests (h) Regulations and hearings Clause (ii) of section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 371(h)(1)(C) (1) by inserting and in vitro clinical tests devices (2) by moving the margin of such clause 2 ems to the left. (i) Records Section 703 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 373 (1) by inserting in vitro clinical tests, devices, (2) by inserting in vitro clinical test, device, (j) Factory inspection Section 704 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374 (1) by striking drugs or devices drugs, devices, or in vitro clinical tests (2) in subsection (a)(1), in the fourth sentence, by striking or chapter IX 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, devices, (4) in subsection (a)(2)(B)— (A) by inserting or in vitro clinical tests prescribe or use devices (B) by inserting or in vitro clinical tests process devices (5) by inserting in vitro clinical test, device, (6) in subsection (e), by inserting , or section 587M, 587N, or 587S, section 519 or 520(g) (7) in subsection (f)(3)— (A) in subparagraph (A), by striking or (B) in subparagraph (B), by striking the period at the end and inserting ; or (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 . (k) Publicity Section 705(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 375(b) in vitro clinical tests, devices, (l) Presumption Section 709 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379a in vitro clinical test, 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) (1) in the matter preceding paragraph (1), by inserting or in vitro clinical tests or devices (2) in the flush text following paragraph (2)— (A) by inserting or an in vitro clinical test a device (B) by inserting or in vitro clinical tests devices (n) Imports and exports Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 (1) in subsection (a)— (A) by inserting in vitro clinical tests, devices, (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 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, health-related purposes (ii) in clause (i), by striking drug or device drug, device, or in vitro clinical test (iii) in clause (i)(I), by inserting in vitro clinical test, device, (B) in subparagraph (B), by inserting in vitro clinical test, device, (3) in subsection (e)(1), by inserting in vitro clinical test, device, (4) in subsection (o)— (A) by inserting or in vitro clinical test device (B) by inserting , or under section 587J of each foreign establishment, 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 (1) in subsection (b)— (A) in the matter preceding paragraph (1), by inserting and in vitro clinical tests devices (B) in paragraph (1), by striking , and and quality requirements established under section 587K; and (2) in subsection (c)— (A) in paragraph (2), by inserting in vitro clinical tests, devices, (B) in paragraph (4), by inserting or in vitro clinical tests 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) , or of foreign establishments registered under section 587J 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) (1) in subparagraph (D), by striking and (2) in subparagraph (E), by striking the semicolon at the end and inserting ; 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) (1) in paragraph (1), by inserting in vitro clinical tests, devices, (2) in paragraph (4), by striking and device manufacturers 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 device (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) Act ( 21 U.S.C. 321(h) (B) in each of clauses (ii) and (iii), by striking or device 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 device (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) Act ( 21 U.S.C. 321(h) (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 device (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) 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 device, or in vitro clinical test (C) in subparagraph (B)— (i) in clause (i), by inserting or offered under a technology certification order approved or cleared (ii) in clause (ii), by striking or 520(g) , 520(g), or 587S 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 (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 823) 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, registers under such section 587J 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 the Federal Food, Drug, and Cosmetic 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(i) of the Federal Food, Drug, and Cosmetic Act (as added by section 823); (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, including— (i) establishment of mitigating measures for an in vitro clinical test or category of in vitro clinical tests, which may not take effect until after the effective date described in paragraph (1)(A); and (ii) establishment of the comprehensive test information system under section 587T of the Federal Food, Drug, and Cosmetic Act, as added by section 823. (3) Applicability of guidance and regulations Notwithstanding the date on which guidance or regulations are issued under paragraph (2) and section 587K of the Federal Food, Drug, and Cosmetic Act, as added by section 823, 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, 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 for which a submission for approval under section 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e 21 U.S.C. 360(k) 21 U.S.C. 360c(f)(2) 42 U.S.C. 262 (c) Application of authorities to transitional In vitro clinical tests (1) Definition For purposes of this section, the term transitional in vitro clinical test (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 (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 in 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 such section 353 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) 21 U.S.C. 360j(g) 21 U.S.C. 360bbb–3 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 without marketing authorization 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 section 587B of the Federal Food, Drug, and Cosmetic Act, as added by section 823, and design control provisions of section 587K of such Act; (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 (C) a premarket application under section 587B of the Federal Food, Drug, and Cosmetic Act, as added by section 823, or technology certification application under section 587D of such Act, as added by section 823, 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 may continue to be offered, sold, or distributed until the completion of the Secretary’s review of the premarket application or technology certification application described in subparagraph (C). (d) Conversion (1) Deemed premarket approval Beginning on the effective date of this Act— (A) any in vitro clinical test with a premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e 42 U.S.C. 262 (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) 21 U.S.C. 360c(f)(2) (2) Deemed investigational use exemption Any in vitro clinical test 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) (3) Deemed humanitarian device exemption Any in vitro clinical test 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 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) (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 (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 (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 (3) In the case of an in vitro clinical test type that has been classified by the Secretary as a class III device pursuant to section 513 of such Act ( 21 U.S.C. 360c 42 U.S.C. 262 826. Emergency use authorization (a) In general Section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 (1) by inserting or developer manufacturer (2) in subsection (a)— (A) in paragraphs (1) and (4)(C), by inserting in vitro clinical test, or biological product (B) in paragraph (2)(A), by striking or 515 515, or 587B (C) by adding at the end the following: (F) The terms develop developer ; (3) in subsection (b), by inserting or developer manufacturer (4) in subsection (e)— (A) by inserting or developers manufacturers (B) in paragraph (2)(B)(ii), by inserting or develop not manufacture (C) in paragraph (3)— (i) in subparagraph (A), by striking or 520(f)(1) , 520(f)(1), or 587V (ii) in subparagraph (B), by striking and (iii) in subparagraph (C), by striking the period and inserting or 587O; and (iv) by adding at the end the following: (D) quality requirements (with respect to in vitro clinical tests) under section 587K. ; and (D) in paragraph (4)— (i) in subparagraph (A), by striking ; or (ii) in subparagraph (B), by striking the period and inserting ; or (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. ; (5) in subsection (k), by striking or 520(g) 520(g), or 587S (6) in subsection (m)— (A) in the subsection heading, by striking Laboratory tests associated with devices in vitro clinical tests devices (B) in paragraph (1)— (i) by striking to a device to an in vitro clinical test (ii) by striking such device such in vitro clinical test (b) Emergency use of medical products Section 564A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3a (1) in subsection (a)— (A) in paragraph (2), by inserting in vitro clinical test, device, (B) by adding at the end the following: (3) Developer The term developer ; (2) by inserting or developer manufacturer (3) in subsection (c)(1)— (A) by inserting or quality requirements good manufacturing practice requirements (B) by striking or 520(f)(1) , 520(f)(1), or 587K (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 515 515, or 587B (2) in subparagraph (B), by striking or 520 827. Antimicrobial susceptibility tests Section 511A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360a–2 (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 approve under section 587B, exempt from premarket review under section 587C, or grant a technology certification order under section 587D (B) by striking testing devices in vitro clinical tests (2) in subsection (c)(5)— (A) by striking drug or device drug, device, or in vitro clinical test (B) by striking the drug or the device the drug, device, or in vitro clinical test (3) in subsection (e)— (A) in the heading, by striking testing devices In vitro clinical tests (B) in paragraph (1)— (i) by striking 510, 513, and 515, 587B, and 587D (ii) by striking antimicrobial susceptibility testing device antimicrobial susceptibility in vitro clinical test (iii) by striking such device such in vitro clinical test (C) in paragraph (2)— (i) in the heading, by striking testing devices in vitro clinical tests (ii) in subparagraphs (A) and (B) (other than clause (iii) of such subparagraph (B)), by striking device in vitro clinical test (iii) in subparagraph (B)(iii), by striking a device an in vitro clinical test (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, to be exempted from premarket review under section 587C, or to be 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 ; 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 in vitro clinical test (ii) by striking antimicrobial susceptibility testing device antimicrobial susceptibility in vitro clinical test 828. Combination products (a) In general Section 503(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(g) (1) in paragraph (1)— (A) in subparagraph (A), by striking or biological product 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 device and an in vitro clinical test is not a combination product within the meaning of this subsection. (C) in subparagraph (D)(ii)— (i) by inserting or in vitro clinical test device (ii) by inserting and in vitro clinical tests shall (2) in paragraph (3), by striking safety and effectiveness or substantial equivalence safety and effectiveness, substantial equivalence, or analytical validity and clinical validity 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)) 513(f)(2) (submitted in accordance with paragraph (5)), 587B, or 587D, or an exempt test under section 587C, as applicable (B) in subparagraph (B), by inserting , 587B, or 587D section 515 (4) in paragraph (5)(A), by striking or 510(k) , 510(k), 587B, or 587D (5) in paragraph (7), by striking or substantial equivalence , 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) 520(g), 587B, or 587D (B) in subparagraph (D), by striking or 520 520, 587B, or 587D (b) Classification of products Section 563 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–2 (d) Exemption This section shall not apply to a product constituted of a device and an in vitro clinical test. . 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) Establishment of user fee program (1) Development of user fees for in vitro clinical tests (A) In general Beginning not later than October 1, 2025, the Secretary of Health and Human Services (in this section referred to as the Secretary (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 the In Vitro Clinical Test User Fee Program, as described in this section, 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 the authorization of the In Vitro Clinical Test User Fee Program, as described in this section; 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 of the In Vitro Clinical Test User Fee Program 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 submitted 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 (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 (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) 21 U.S.C. 379i(9)(C) (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 (c) Reports (1) Performance report (A) In general (i) General requirements Beginning with fiscal year 2028, 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 2028, 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 2028, 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 regulations 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 (b)(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 (b)(1)(E). (iv) Rationale for IVCT user fee program changes Beginning with fiscal year 2028, 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 (A) In general For fiscal years 2028 and annually thereafter, not later than 120 days after the end of each fiscal year during 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, 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. (B) 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. (C) Operating reserve Such report shall provide the amount of operating reserves of carryover user fees available each year, and any planned allocations or obligations of such balance of operating reserves 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. 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 $480,000,000, to remain available through the end of fiscal year 2028. 831. Guidance on Diagnostic Innovation Not later than January 1, 2025, the Secretary shall issue guidance to assist developers of in vitro clinical tests intended to identify or diagnose rare diseases and in vitro clinical tests intended to address an unmet medical need. Such guidance shall include considerations for addressing barriers to developing sufficient data to demonstrate clinical validity for such tests, such as challenges associated with data collection and obstacles to the timely generation of evidence. 832. GAO report on unique considerations Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States 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 a report— (1) evaluating the unique considerations for hospital-based laboratories, laboratories serving academic medical centers, and other health care practitioners, as appropriate, in implementing this subtitle, including the amendments made by this subtitle; and (2) including recommendations based on the findings of the report. IX Other provisions 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 (I) for fiscal year 2023, to defray ; (B) by striking the period and inserting ; 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 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) (1) in subparagraph (B)(i)— (A) by striking available for a fiscal year beginning after fiscal year 2012 (I) for fiscal year 2023 ; (B) by striking the fiscal year involved. such fiscal year; 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 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 (1) in subsection (e)(2), by striking 744A(11)(C) 744A(12)(C) (2) in subsection (i)(2)— (A) in subparagraph (A)(ii)— (i) by striking available for a fiscal year beginning after fiscal year 2012 (I) for fiscal year 2023 ; (ii) by striking the fiscal year involved. such fiscal year; 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 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 (1) in subsection (h)(2)— (A) in subparagraph (A)(ii)— (i) by striking shall be available to defray (I) for fiscal year 2023, to defray ; (ii) by striking the period and inserting ; 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 as described in subclause (I) or (II) of such subparagraph, as applicable (2) in subsection (g)(3), by striking 737(9)(C) 737(10)(C) (e) Technical correction (1) In general Section 905(b)(2) of the FDA Reauthorization Act of 2017 ( Public Law 115–52 Section 738(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(h) Subsection (g) of section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j (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 115–52 902. User fee program transparency and accountability (a) PDUFA (1) Reauthorization; reporting requirements Section 736B(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2(a) (A) in paragraph (1)— (i) in subparagraph (B)— (I) in clause (vii), by striking ; and (II) in clause (viii), by striking the period and inserting ; and (III) 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 information that is prohibited from disclosure under section 301(j) of this Act or section 1905 of title 18, United States Code, or that is subject to withholding under section 552(b)(4) of title 5, United States Code. ; and (B) 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 ; (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 (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) (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 The (II) by inserting , not later than 30 days after each such negotiation meeting (ii) in subparagraph (B), by inserting , in sufficient detail, shall summarize (b) MDUFA (1) Reauthorization; reporting requirements Section 738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1(a)(1)(A) (A) in clause (ii)— (i) in subclause (II), by striking ; and (ii) in subclause (III), by striking the period and inserting a semicolon; and (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. Nothing in this clause shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 301(j) of this Act or section 1905 of title 18, United States Code, or that is subject to withholding under section 552(b)(4) of title 5, United States Code. ; and (B) in 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 ; (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 (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. . (2) Reauthorization Section 738A(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1(b) (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 The (II) by inserting , not later than 30 days after each such negotiation meeting (ii) in subparagraph (B), by inserting , in sufficient detail, shall summarize (c) GDUFA (1) Reauthorization; reporting requirements Section 744C(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–43(a)(3) (A) in the matter preceding subparagraph (A), by striking fiscal year 2020 fiscal year 2023 (B) 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 ; (C) 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; ; (D) in subparagraph (C), by striking the period at the end and inserting ; and (E) 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) (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 The (II) by inserting , not later than 30 days after each such negotiation meeting (ii) in subparagraph (B), by inserting , in sufficient detail, 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) (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 ; (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 (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) (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. . 903. 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 Public Law 115–52 904. Enhancing coordination and transparency on inspections (a) Coordination Section 506D of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356d (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 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) (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 (4)(A), as so redesignated, by striking paragraph (7) 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) (1) in paragraph (6)— (A) in subparagraph (A), by striking clauses (i) and (ii) and inserting the following: (i) the number of domestic and foreign establishments registered pursuant to this section in the previous fiscal year; (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 fiscal 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, including in each region of interest; (vi) the number of for-cause inspections the Secretary conducted in the previous fiscal year, not including inspections described in clause (iv), including in each region of interest; 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), including for inspections of establishments in each region of interest. ; (B) in subparagraph (B), by striking ; and (C) in subparagraph (C), by striking the period and inserting ; 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 . (e) Enhancing transparency of drug facility inspection timelines Section 902 of the FDA Reauthorization Act of 2017 ( 21 U.S.C. 355 902. Annual report on inspections Not later than 120 days after the end of each fiscal year, the Secretary of Health and Human Services shall post on the 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 21 U.S.C. 360e (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 for which a notification has been submitted in accordance with section 506C(a) of such Act ( 21 U.S.C. 356c(a) (C) the median time for drugs on the drug shortage list in effect under section 506E of such Act ( 21 U.S.C. 356e (2) The median time from the issuance of a report pursuant to section 704(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(b) (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) (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 adequate corrective or preventive actions following a report issued pursuant to such section 704(b), resulting in a withhold recommendation for an application under review, including the number of such facilities manufacturing each category of drugs listed in subparagraphs (A) through (C) of paragraph (1). . 905. Certificates to foreign governments Section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(e)(4) (1) in subparagraph (E), by striking clause (iii); and (2) by adding at the end the following: (F) (i) This paragraph applies to requests for certification under this subparagraph of a device manufactured by a device establishment located outside of the United States that is registered under section 510, if the device is listed pursuant to section 510(j), the device has been cleared, approved, or is not required to submit a premarket report pursuant to subsection (l) or (m) of section 510, and the device is imported or offered for import into the United States. (ii) The Secretary shall issue the certification as described in clause (iii) if the device or devices for which certification is requested under this subparagraph meet the applicable requirements of this Act. (iii) (I) A certification for a device described in clause (i) shall be subject to the fee described in subparagraph (B). (II) Notwithstanding subparagraph (C), a certification for a device described in clause (i) shall address and include the same material information as a Certificate to Foreign Government Certificate to Foreign Government (iv) The requirements and procedures of subparagraph (E) shall apply to a denial of a certification under this subparagraph. . 906. Importation of drugs (a) In general Section 804 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384 804. Importation of prescription drugs (a) Definitions In this section: (1) Foreign seller The term foreign seller (A) has an active Drug Establishment License to wholesale drugs by the appropriate Canadian regulatory authority; (B) is registered with the applicable regulatory authorities to distribute drugs approved by the appropriate Canadian regulatory authority; (C) is not licensed by a regulatory authority with an international pharmacy license that allows it to distribute drugs that are approved by countries other than Canada and that are not approved by the appropriate Canadian regulatory authority for distribution in Canada; and (D) is registered with the Secretary under this section. (2) Importer The term importer (3) Pharmacist The term pharmacist (4) Prescription drug The term prescription drug (A) a controlled substance (as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 (B) a biological product (as defined in section 351 of the Public Health Service Act ( 42 U.S.C. 262 (C) an infused drug (including a peritoneal dialysis solution); (D) an intravenously injected drug; (E) a drug that is inhaled during surgery; (F) an intrathecally or intraocularly injected drug; (G) a drug that is subject to a risk evaluation and mitigation strategy under section 505-1; (H) a drug that is not a product (I) a compounded drug; or (J) a drug the importation of which pursuant to subsection (b) is determined by the Secretary to pose a threat to the public health. (5) Qualifying laboratory The term qualifying laboratory (6) Section 804 importation program sponsor The term section 804 importation program sponsor (7) Wholesaler The term wholesaler (A) means a person licensed (as defined in section 581(9)(A)) as a wholesale distributor (as defined in section 581(29)); and (B) excludes a person authorized to import drugs under section 801(d)(1). (b) Regulations The Secretary, after consultation with the United States Trade Representative and the Commissioner of Customs, shall promulgate regulations permitting time-limited section 804 importation programs, which shall be authorized by the Secretary and managed by States or Indian Tribes, or in certain circumstances by pharmacists and wholesalers, to import prescription drugs from Canada into the United States. The time limit for a section 804 importation program authorized by the Secretary may be extended for a period not to exceed the initial time limit authorized by the Secretary. (c) Limitation The regulations under subsection (b) shall— (1) require that safeguards be in place to ensure that each prescription drug imported under the regulations complies with section 505 (including with respect to being safe and effective for the intended use of the prescription drug), with sections 501 and 502, and with other applicable requirements of this Act; (2) require that a section 804 importation program sponsor and an importer of a prescription drug under the regulations comply with subsections (d)(1), (d)(2), (d)(3), and (e); (3) require that the section 804 importation program sponsor demonstrates that the importation program meets the certification requirements under subsection (l)(1); and (4) contain any additional provisions determined by the Secretary to be appropriate as a safeguard to protect the public health or as a means to facilitate the importation of prescription drugs. (d) Information and records (1) In general The regulations under subsection (b) shall require an importer of a prescription drug under subsection (b) to submit to the Secretary the following information and documentation: (A) The name and quantity of the active ingredient of the prescription drug. (B) A description of the dosage form of the prescription drug. (C) The date on which the prescription drug is shipped. (D) The quantity of the prescription drug that is shipped. (E) The point of origin and destination of the prescription drug. (F) The price paid by the importer for the prescription drug. (G) Documentation from the foreign seller specifying— (i) the original source of the prescription drug; and (ii) the quantity of each lot of the prescription drug originally received by the seller from that source. (H) The lot or control number assigned to the prescription drug by the manufacturer of the prescription drug. (I) The name, address, telephone number, and professional license number (if any) of the importer. (J) Documentation demonstrating that the prescription drug was received by the foreign seller from the manufacturer and subsequently shipped by the foreign seller to the importer. (K) Documentation of the quantity of each lot of the prescription drug received by the foreign seller demonstrating that the quantity being imported into the United States is not more than the quantity that was received by the foreign seller. (L) (i) In the case of an initial imported shipment, documentation demonstrating that each batch of the prescription drug in the shipment was statistically sampled and tested for authenticity and degradation. (ii) In the case of any subsequent shipment, documentation demonstrating that a statistically valid sample of the shipment was tested for authenticity and degradation. (M) Documentation that each supply chain under a section 804 importation program proposal is limited to one manufacturer, one foreign seller, and one importer. (N) For each prescription drug imported under a section 804 importation program, documentation that the prescription drug was purchased directly from the manufacturer by the foreign seller and that the foreign seller sold the prescription drug directly to the importer. (O) Certification from the importer that the prescription drug— (i) is approved for marketing in the United States and is not adulterated or misbranded; and (ii) is relabeled after the Secretary has accepted the results of testing required by subparagraphs (J) through (P)) and meets all labeling requirements under this Act. (P) Laboratory records, including complete data derived from all tests necessary to ensure that the prescription drug is in compliance with established specifications and standards. (Q) Documentation demonstrating that the testing required by subparagraphs (J) through (P) was conducted at a qualifying laboratory in the United States. (R) Any other information that the Secretary determines is necessary to ensure the protection of the public health. (2) Section 804 importation program proposal The regulations under subsection (b) shall require a sponsor of a time-limited section 804 importation program authorized under such subsection to submit to the Secretary the following information and documentation in its proposal to the Secretary: (A) The names of all participants in the supply chain, including— (i) the foreign seller; (ii) the importer; (iii) the repackager or relabeler, if different from the importer, that will relabel the eligible prescription drugs; and (iv) the qualifying laboratory that will conduct testing for the importer. (B) Information about how the section 804 importation program sponsor will ensure that— (i) the prescription drug meets the testing requirements in subparagraphs (J) through (P) of paragraph (1); (ii) the supply chain is secure; (iii) the prescription drug will meet the labeling requirements of this Act; (iv) the adverse event-related requirements of this Act are met; and (v) the section 804 importation program will result in a significant reduction in the cost to the American consumer of the prescription drug. (C) A compliance plan. (D) Information about how the section 804 importation sponsor will ensure that any trade secrets or commercial or financial information that is privileged or confidential that the manufacturer supplies are kept in strict confidence and used only for the purposes of testing or otherwise complying with Federal law. (3) Pre -import request The regulations under subsection (b) shall require an importer under a program authorized under such subsection to submit a pre-import request to the Secretary at least 30 calendar days before the scheduled date of arrival or entry for consumption of a shipment containing a prescription drug covered by the section 804 importation program, whichever is earlier. (4) Maintenance by the secretary The Secretary shall maintain information and documentation submitted under paragraphs (1), (2), and (3) for such period of time as the Secretary determines to be necessary. (e) Testing The regulations under subsection (b) shall require— (1) that testing described in subparagraphs (J) through (P) of subsection (d)(1) be conducted by the importer or by the manufacturer of the prescription drug at a qualified laboratory; (2) if the tests are conducted by the importer— (A) that information needed to— (i) authenticate the prescription drug being tested; and (ii) confirm that the labeling of the prescription drug complies with labeling requirements under this Act, be supplied by the manufacturer of the prescription drug to the pharmacist or wholesaler; and (B) that the information supplied under subparagraph (A) be kept in strict confidence and used only for purposes of testing or otherwise complying with this Act; and (3) such additional provisions as the Secretary determines to be appropriate to provide for the protection of trade secrets and commercial or financial information that is privileged or confidential. (f) Registration of foreign sellers Any establishment within Canada engaged in the distribution of a prescription drug that is imported or offered for importation into the United States shall register with the Secretary the name and place of business of the establishment and the name of the United States agent for the establishment. (g) Suspension of importation The Secretary shall require that importations of a specific prescription drug or importations by a specific importer under subsection (b) be immediately suspended on discovery of a pattern of importation of that specific prescription drug or by that specific importer of drugs that are counterfeit or in violation of any requirement under this section, until an investigation is completed and the Secretary determines that the public is adequately protected from counterfeit and violative prescription drugs being imported under subsection (b). (h) Approved labeling The manufacturer of a prescription drug shall provide an importer written authorization for the importer to use, at no cost, the approved labeling for the prescription drug. (i) Charitable contributions Notwithstanding any other provision of this section, section 801(d)(1) continues to apply to a prescription drug that is donated or otherwise supplied at no charge by the manufacturer of the drug to a charitable or humanitarian organization (including the United Nations and affiliates) or to a government of a foreign country. (j) Importation for personal use (1) Declarations Congress declares that, in implementing the provisions under this section, the Secretary may— (A) focus enforcement on cases in which the importation by an individual poses a significant threat to public health; and (B) exercise discretion to permit individuals to make such importations in circumstances in which— (i) the importation is clearly for personal use; and (ii) the prescription drug or device imported does not appear to present an unreasonable risk to the individual. (2) Regulations (A) In general The Secretary may, by regulation, permit importation of a prescription drug, or class of prescription drugs, for personal use, provided that such importation— (i) does not increase the public’s exposure to counterfeit prescription drug products; (ii) does not pose a risk of creating, exacerbating, or prolonging an opioid epidemic, including by increasing the public’s exposure to counterfeit prescription opioid drug products, such as counterfeit fentanyl, or increasing the public’s misuse of prescription opioid drug products; (iii) meets the certification requirements under subsection (l)(1); and (iv) meets such other conditions as the Secretary determines to be appropriate. (B) Requirements Regulations described in subparagraph (A) may permit importation into the United States of a prescription drug that— (i) is imported in a quantity that does not exceed a 90-day supply; (ii) is for personal use by an individual, not for resale; (iii) is accompanied by a copy of a valid prescription issued by a health care practitioner licensed by a State to practice in the United States to administer the drug, and is not distributed to anyone other than the individual for whom such prescription is written; (iv) is imported from Canada, from a licensed pharmacy physically located in Canada and registered with the Secretary; (v) is a prescription drug that complies with section 505 (including with respect to being safe and effective for the intended use of the prescription drug), with sections 501 and 502, and with other applicable requirements of this Act; (vi) is accompanied by an electronic import entry for such prescription drug regardless of its values, submitted using an authorized electronic data interchange system; (vii) is in the form of a final finished dosage that was manufactured in an establishment registered under section 510; and (viii) is imported under such other conditions as the Secretary determines to be necessary to ensure public safety. (C) Procedure The Secretary shall— (i) proceed in accordance with section 553 of title 5 (without regard to any reference in such section to sections 556 and 557 of such title) when promulgating a regulation under subparagraph (A), and shall— (I) publish a notice of proposed rulemaking stating with particularity the reason for the proposed rule; (II) allow interested persons to submit written data, views, and arguments, and make all such submissions publicly available; (III) hold a public meeting; and (IV) promulgate a final rule based on the matter in the rulemaking record; (ii) consult with the United States Trade Representative, the Commissioner of the U.S. Customs and Border Protection, and the Administrator of the Drug Enforcement Administration prior to proposing and finalizing a rule under subparagraph (A); (iii) include in the preamble to the proposed rule under subparagraph (A) a clear and complete description of how the Secretary made each of the determinations in subparagraph (A), including associated analyses, assumptions, and information sources used to make each such determination, and a description of any key limitations or uncertainties that could affect each determination; and (iv) publish the proposed rule and final rule under subparagraph (A) in the Federal Register and concurrently publish the record of the consultations described in clause (ii) and the descriptions described in clause (iii). (k) Construction Nothing in this section limits the authority of the Secretary relating to the importation of prescription drugs, including the Secretary’s authority to refuse admission of a drug under section 801(a), other than with respect to section 801(d)(1) as provided in this section. (l) Effectiveness of section (1) Commencement of program This section shall become effective only if the Secretary certifies to Congress that the implementation of this section will— (A) pose no additional risk to the public’s health and safety; (B) result in a significant reduction in the cost of covered products to the American consumer; and (C) be subject to adequate and consistent oversight by the Secretary. (m) Termination of program If, after the date that is 1 year after the effective date of the regulations under subsection (b) or (j), the Secretary submits to Congress a certification that, in the option of the Secretary, the benefits of implementation of either or both such subsections do not outweigh any detriment of implementation of such subsection or subsections and any regulations promulgated thereunder, such subsection or subsections shall cease to be effective as of the date that is 30 days after the date on which the Secretary submits the certification. (n) Authorization of appropriations There are authorized to be appropriated such sums as are necessary to carry out this section. . (b) Requirement The Secretary of Health and Human Services shall reissue, or amend, as appropriate, the regulations published at part 251 of title 21 of the Code of Federal Regulations pursuant to section 804(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384(b) 907. Improving information technology systems of the Food and Drug Administration (a) FDA strategic information technology plan (1) In general Not later than September 30, 2023, and at least every 4 years thereafter, the Secretary of Health and Human Services shall develop and submit to the appropriate committees of Congress and post on the website of the Food and Drug Administration, a coordinated information technology strategic plan to modernize the information technology systems of the Food and Drug Administration. Each such report shall be known as the Food and Drug Administration Strategic Information Technology Plan. (2) Content of strategic plan The Food and Drug Administration Strategic Information Technology Plan under paragraph (1) shall include— (A) agency-wide strategic goals and priorities for modernizing the information technology systems of the Food and Drug Administration to maximize the efficiency and effectiveness of such systems for enabling the Food and Drug Administration to fulfill its public health mission; (B) specific activities and strategies for achieving the goals and priorities identified under subparagraph (A), and specific milestones, metrics, and performance measures for assessing progress against the strategic goals and priorities in subparagraph (A); (C) specific activities and strategies for improving and streamlining internal coordination and communication within the Food and Drug Administration, including for activities and communications related to signals of potential public health concerns; (D) challenges and risks the Food and Drug Administration will face in meeting its strategic goals and priorities, and the activities the Food and Drug Administration will undertake to overcome those challenges and mitigate those risks; (E) the ways in which the Food and Drug Administration will use the plan to guide and coordinate the projects and activities of the Food and Drug Administration across its offices and centers; and (F) a skills inventory, needs assessment, gap analysis, and initiatives to address skills gaps as part of a strategic approach to information technology human capital planning. (3) Evaluation of progress Each Food and Drug Administration Strategic Information Technology Plan issued pursuant to this subsection, with the exception of the first such Food and Drug Administration Strategic Information Technology Plan, shall include an evaluation of— (A) the progress the Secretary has made, based on the metrics, benchmarks, and other milestones that measure successful development and implementation of information technology systems; and (B) 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 Information Technology Plan. (b) GAO report (1) In general Not later than September 30, 2026, the Comptroller General of the United States 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 a report assessing the implementation of the Food and Drug Administration Strategic Information Technology Plan adopted pursuant to subsection (a). (2) Content of report The report required under paragraph (1) shall include an assessment of— (A) the development and implementation of the Food and Drug Administration Strategic Information Technology Plan, including the sufficiency of the plan, progress of the Food and Drug Administration in meeting the results-oriented goals, milestones, and performance measures identified in such plan and any gaps in such implementation; (B) the efficiency and effectiveness of the Food and Drug Administration’s expenditures on information technology systems over the preceding 10 fiscal years, including the implementation by the Food and Drug Administration of the Technology Modernization Action Plan and Data Modernization Action Plan; (C) challenges posed by the information technology systems of the Food and Drug Administration for carrying out the Food and Drug Administration’s public health mission, including on meeting user fee agreement performance goals, conducting inspections, responding to identified safety concerns, and keeping pace with new scientific and medical advances; and (D) recommendations for the Food and Drug Administration to address the identified challenges, improve its implementation of the Food and Drug Administration Strategic Information Technology Plan, and to otherwise improve the Food and Drug Administration’s information technology systems. 908. Regulation of certain products as drugs Section 503 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353 (h) Deeming certain products as drugs (1) In general Any contrast agent, radioactive drug, OTC monograph drug, or ophthalmic drug article shall be deemed to be a drug under section 201(g) and not a device under section 201(h). (2) Definitions For purposes of this subsection— (A) the term contrast agent (i) is a diagnostic radiopharmaceutical, as defined in section 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations), including PET drugs, as defined in section 212.1 of title 21, Code of Federal Regulations (or any successor regulations) and positron emission tomography radiotracers; or (ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid; (B) the term ophthalmic drug article (C) the term OTC monograph drug (D) the term radioactive drug (i) implants or articles similar to an implant; (ii) articles that apply radiation from outside of the body; or (iii) the radiation source of an article described in clause (i) or (ii). (3) Rule of construction Nothing in this subsection shall be construed as allowing for the classification of a product as a drug (as defined in section 201(g)) if such product— (A) is not described in paragraph (1); and (B) meets the definition of a device under section 201(h), unless another provision of this Act otherwise indicates a different classification. (4) Fees The Secretary shall waive the application fee under sections 736 and 744B for applications for products that are, on the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022 . 909. Reporting on mailroom and Office of the Executive Secretariat of the Food and Drug Administration (a) Report Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary (1) information related to policies, procedures, and activities of the mailroom and the Office of the Executive Secretariat of the Food and Drug Administration, including— (A) taking receipt, tracking, managing, and prioritizing confidential informant complaints; (B) taking receipt of common carrier packages to the Food and Drug Administration; (C) the organizational structure and management of the mailroom; (D) the organizational structure and management of the Office of the Executive Secretariat; (E) the total number of employees and contractors in the mailroom including those working remotely and those working in person; (F) the total number of employees and contractors in the Office of the Executive Secretariat; (G) the number of vacant positions in the mailroom; (H) the number of vacant positions in the Office of the Executive Secretariat; (I) the average number of days for response to correspondence received by the Office of the Secretariat; (J) the extent to which there is a backlog of common carrier packages received by the mailroom and the number of common carrier packages in any backlog; (K) the extent to which there is a backlog of correspondence in the Office of the Executive Secretariat that has not been appropriately responded to by the Food and Drug Administration and the number of correspondence or common carrier packages in any backlog; (L) a rationale for the failure of the Office of the Executive Secretariat to respond to correspondence in any backlog and the position of the decision-making official who determined not to respond to such correspondence; (M) the number of whistleblower correspondence received, including within each agency center; (N) the amount of resources expended for the mailroom, including a breakdown of budget authority and user fee dollars; (O) the amount of resources expended for the Office of the Executive Secretariat and correspondence-related activities, including a breakdown of budget authority and user fee dollars; and (P) the performance of third-party contractors responsible for correspondence-related activities with respect to the receipt and tracking of correspondence, and efforts by the Food and Drug Administration to improve performance by such contractors; and (2) the development and implementation of new or revised policies and procedures of the Food and Drug Administration to monitor and ensure— (A) the effective receipt, tracking, managing, and prioritization of such complaints; and (B) the effective receipt of common carrier packages to the Food and Drug Administration. (b) Quarterly reporting Beginning on the date of enactment of this Act, the Secretary shall issue a report each quarter through September 30, 2024, to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the implementation of the new or revised policies of the Food and Drug Administration reported under subsection (a)(2), and since such implementation— (1) the volume of incoming common carrier packages to the mailroom; (2) the volume of incoming correspondence to the Office of the Executive Secretariat; (3) the extent to which new backlogs occur in the processing of common carrier packages received by the mailroom; (4) the extent to which new backlogs occur in the processing of correspondence received by the Office of the Executive Secretariat; (5) the length of time required to resolve each such backlog; (6) any known issues of unreasonable delays in correspondence being provided to the intended recipient, or in correspondence being lost, and the measures taken to remedy such delays or lost items; (7) the average number of days it takes to respond to correspondence received by the Office of the Executive Secretariat; (8) the resources expended by the mailroom, including a breakdown of budget authority and user fee dollars; and (9) the resources expended by the Office of the Executive Secretariat on correspondence-related activities, including a breakdown of budget authority and user fee dollars. (c) GAO report Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States 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 a report assessing the policies and practices of the Division of Executive Operations of the Office of the Executive Secretariat of the Food and Drug Administration with respect to the receipt, tracking, managing, and prioritization of correspondence. 910. Protecting infants and improving formula supply (a) Definitions (1) In general In this section— (A) the term infant formula 21 U.S.C. 321 (B) the term Secretary (2) Critical food Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 (tt) The term critical food (1) is an infant formula; (2) is a medical food, as defined in section 5(b)(3) of the Orphan Drug Act; or (3) is intended for use by individuals with certain inborn errors of metabolism or other conditions requiring a medical food. . (b) Office of critical foods (1) In general The Secretary shall establish within the Center for Food Safety and Applied Nutrition an office to be known as the Office of Critical Foods. The Secretary shall appoint a Director to lead such Office. (2) Duties The Office of Critical Foods shall be responsible for oversight, coordination, and facilitation of activities related to critical foods, as defined in section 201(tt) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)(2), and any other food determined by the Secretary to be critical. (c) Premarket submissions of infant formula to address shortages Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a (j) Premarket submissions to address shortages (1) In general The Secretary shall waive the 90 day premarket submission requirement under section 412(c) and apply a 30-day premarket submission requirement, for any person who intends to introduce or deliver for introduction into interstate commerce any new infant formula. (2) Effective period The waiver authority under this subsection shall remain in effect for 90 days beginning on the date that the Secretary distributes information under section 424(a)(2), or such longer period as the Secretary determines appropriate to prevent or mitigate a shortage of infant formula. (3) Report Not later than one year after the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (A) the number of premarket submissions for new infant formula the Secretary has received under subsection (d) each year since 2012; (B) how many of such submissions received requests from the Secretary for additional information; (C) how long after receiving such submissions the Secretary sent such requests for additional information; (D) what additional information the Secretary requested of the persons submitting such submissions; and (E) the date each new infant formula product described in subparagraph (A) was first marketed, if available. . (d) Infant formula flexibilities The Secretary shall publish a list on the website of the Food and Drug Administration detailing which infant formula products may be appropriate substitutes for infant formula products in shortage that are relied upon by infants and other individuals with amino-acid and metabolic conditions. (e) International harmonization of infant formula requirements (1) In general The Secretary— (A) shall participate in meetings with representatives from other countries to discuss methods and approaches to harmonizing regulatory requirements for infant formula, including with respect to inspections, labeling, and nutritional requirements; and (B) may enter into agreements regarding such requirements with other countries, as appropriate. (2) Study on infant formula (A) In general Not later than 60 days after the date of enactment of this Act, the Secretary shall seek to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this paragraph as the National Academies (B) Requirements of foreign countries The report developed pursuant to the agreement under subparagraph (A) shall assess and evaluate infant formula marketed in the United States, any challenges in supply, market competition, and any differences in infant formula marketed in the European Union, including with respect to nutritional content and applicable labeling and other regulatory requirements. (C) Final report The agreement under subparagraph (A) shall specify that the National Academies shall, not later than 1 year after the date of enactment of this Act, complete such study and submit a report on the results of such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. (f) Transparency and accountability to support infant formula innovation (1) Congressional notification of recall (A) In general Not later than 24 hours after the initiation of a recall of infant formula as described in section 412(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350e(e) (B) Contents A notification under subparagraph (A) shall include the following: (i) If the recall is required by the Food and Drug Administration, a summary of the determination of a case of adulterated or misbranded infant formula that presents a risk to human health. (ii) If the recall is voluntarily initiated by the manufacturer, a summary of the information provided to the Food and Drug Administration by the manufacturer regarding infant formula that has left the control of the manufacturer that may be adulterated or misbranded. (iii) Specification of when the Food and Drug Administration was first made aware of the instance or circumstances surrounding the recall. (iv) An initial estimate of the disruption in domestic production that may result from the recall. (2) Annual report to Congress Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a (k) Annual report to congress (1) In general Not later than March 30 of each year, the Secretary shall submit a report to Congress containing, with respect to the preceding calendar year, the following information: (A) The number of submissions received by the Secretary under subsection (d). (B) The number of submissions that included any new ingredients that were not included in any infant formula already on the market. (C) The number of inspections conducted by the Food and Drug Administration or any agent thereof to evaluate compliance with the requirements for infant formulas under subsection (b)(2). (D) The time between any inspection referred to in subparagraph (C) and any necessary reinspection to evaluate compliance with the requirements for infant formulas under subsection (b)(2). (E) A breakdown of the information described in subparagraphs (A) through (D) between foreign and domestic manufacturers and facilities. (2) Confidentiality The Secretary shall ensure that the reports under paragraph (1) do not include any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code. . (3) Marketing submissions Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a (l) Marketing submissions (1) In general Subject to paragraph (2), the Secretary shall respond to a submission under subsection (d) for infant formula not later than 65 days after receiving such submission. (2) Expedited response The Secretary shall respond to a submission under subsection (d) for infant formula not later than 45 days after receiving such notification if it— (A) is submitted by a manufacturer that is not already marketing infant formula in the United States; or (B) is a new infant formula, as defined in subsection (c)(2). . (4) List of nutrients Section 412(i)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a(i) or, if revised by the Secretary under paragraph (3), as so revised , which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table (5) Technical correction Section 412(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a(c)(1)(B) subsection (c)(1) subsection (d)(1) (g) Response to recall (1) Manufacturer submission (A) In general Promptly after the initiation of a recall of infant formula, the manufacturer of the recalled infant formula shall submit information to the Secretary regarding such recall. (B) Contents A submission under subparagraph (A) shall include the following: (i) A plan (including an estimated timeline, as applicable) of actions the manufacturer will take, suited to the individual circumstances of the particular recall, including— (I) to identify and address any cause of adulteration or misbranding; and (II) if appropriate, to restore operation of the impacted facilities. (ii) In the case that a recall of the manufacturer’s infant formula products, and subsequent actions to respond to such recall, impacts over 10 percent of the production of the infant formula intended for sale in the United States, a plan to backfill the supply of the manufacturer’s infant formula supply if the current domestic supply of such infant formula has fallen, or is expected to fall, below the expected demand for the formula. (2) Report to Congress (A) In general Promptly after a submission under paragraph (1) is received, the Secretary shall provide such submission, together with the information specified in subparagraph (B), in a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. (B) Contents A submission under subparagraph (A) shall include the following: (i) Information concerning the current domestic supply of infant formula, including— (I) a breakdown of the specific types of formula involved; and (II) an estimate of how long current supplies will last. (ii) In the case that a submission or submissions under paragraph (1) show that the recall and subsequent actions to respond to the recall impact over 10 percent of the domestic production of infant formula intended for sale in the United States— (I) actions to work with the impacted manufacturer or other manufacturers to increase production; and (II) specification of— (aa) any additional authorities needed regarding production or importation to fill a supply gap; and (bb) any supplemental funding necessary to address the shortage. (3) Sunset This subsection shall cease to have force or effect on of September 30, 2026. (h) Coordination with manufacturer (1) In general (A) Communication following inspection Upon completing an inspection of an infant formula manufacturing facility impacted by a recall, the Secretary, acting through the Commissioner of Food and Drugs, shall provide the manufacturer involved a list of any actions necessary to— (i) address deficiencies contributing to the potential adulteration or misbranding of product at the facility; and (ii) safely restart production at the facility. (B) Response to Manufacturer Not later than 7 days after receiving a written communication from a manufacturer of infant formula regarding safely restoring production following a recall of such product, the Secretary, acting through the Commissioner of Food and Drugs, shall provide a substantive response to such communication, including any necessary next steps. (2) Inspections The Secretary shall ensure timely communication with a manufacturer of infant formula following an inspection of a facility engaged in the manufacturing of infant formula for consumption in the United States. If a reinspection of a manufacturer of an infant formula is required to ensure that such manufacturer completed any remediation actions or addressed any deficiencies, the Secretary shall reinspect such facility in a timely manner. The Secretary shall prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent a shortage of an infant formula. (3) Annual inspections Not later than 6 months after the date of enactment of this Act, and not less than once per calendar year thereafter, the Secretary shall conduct inspections, including unannounced inspections, of the facilities (including foreign facilities) of each manufacturer of an infant formula required to be registered under section 412(c)(1)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a(c)(1)(A) (i) National strategy on infant formula (1) In general The Secretary, in consultation with the Secretary of Agriculture and other heads of relevant departments and agencies, shall develop and issue, not later than 90 days after the date of enactment of this Act, a national strategy on infant formula to increase the resiliency of the infant formula supply chain, protect against future contamination and other potential causes of shortages, and ensure parents and caregivers have access to formula and information they need. (2) National strategy The national strategy under paragraph (1) shall— (A) increase the resiliency of the infant formula supply chain in the short-term by— (i) assessing causes of the current shortage and potential causes of future shortages, (ii) assessing and addressing immediate infant formula needs associated with the shortage, and (iii) developing a plan to increase infant formula supply, including through increased competition; (B) improve preparedness against infant formula shortages in the long-term by— (i) outlining methods to improve information-sharing between the Federal Government and State and local governments, and other entities as appropriate, regarding shortages; (ii) recommending measures for protecting the integrity of infant formula supply and preventing contamination; (iii) outlining methods to incentivize new infant formula manufacturers to increase supply and mitigate future shortages; and (iv) recommending other necessary authorities to gain insight into the supply chain and risk for shortages, and to incentivize new infant formula manufacturers; and (C) ensure the development and updating of education and communication materials for parents and caregivers that cover— (i) where and how to find infant formula; (ii) comparable infant formulas on the market, (iii) what to do if a medical or specialty infant formula is unavailable; (iv) safe practices for handling infant formula; and (v) other topics, as appropriate. (j) Meaningful disruption in the production of critical food Chapter IV of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 341 et seq. 424. Requirements for critical food (a) Notification of meaningful disruption for critical food (1) In general A manufacturer of a critical food (as defined in section 201(tt)) shall notify the Secretary of a permanent discontinuance in the manufacture or an interruption of the manufacture of such food that is likely to lead to a meaningful disruption in the supply of such food in the United States, and the reasons for such discontinuance or interruption, as soon as practicable, but not later than 5 business days after such discontinuance or such interruption. (2) Distribution of information Not later than 5 calendar days after receiving a notification under paragraph (1), the Secretary shall distribute, to the Secretary of Agriculture and to the maximum extent practicable to the appropriate entities, as determined by the Secretary through such means as the Secretary determines appropriate, information on the meaningful disruption of a critical food reported under this subsection. (3) Confidentiality Nothing in this subsection authorizes the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code. (4) Meaningful disruption In this subsection, the term meaningful disruption (A) means a change in production that is reasonably likely to lead to a significant reduction in the supply of a critical food by a manufacturer that affects the ability of the manufacturer to meet expected demand for its product; and (B) does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time. (b) Risk management plans Each manufacturer of a critical food shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the food, as applicable, for each establishment in which such food is manufactured. A risk management plan under this subsection— (1) may identify and evaluate risks to the supply of more than one critical food, or critical food category, manufactured at the same establishment; and (2) shall be subject to inspection and copying by the Secretary pursuant to an inspection under section 704. (c) Failure to meet requirements (1) In general If a person fails to submit information required under, and in accordance with, subsection (a)— (A) the Secretary shall issue a letter to such person informing such person of such failure; and (B) not later than 45 calendar days after the issuance of a letter under subparagraph (A), subject to paragraph (2), the Secretary shall make available to the public on the website of the Food and Drug Administration, with appropriate redactions made to protect the information described in subsection (a)(3)— (i) the letter issued under subparagraph (A); and (ii) at the request of such person, any response to such letter such person submitted to the Secretary. (2) Exception If the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person had a reasonable basis for not submitting a notification as required under subsection (m), the requirements of paragraph (1)(B) shall not apply. . (k) Specialty infant formula for importation Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a (m) Waiver of requirements for importation of specialty infant formula (1) In general The Secretary may, during a shortage of specialty infant formula as determined by the Secretary, waive any requirement under this Act applicable to facilitate the importation of specialty infant formula. Such a waiver may be applicable to— (A) the importation of specialty infant formula from any country that is determined by the Secretary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety as the regulatory requirements of this Act; or (B) the distribution and sale of such imported specialty infant formula. (2) Rule of construction Nothing in paragraph (1) shall be construed to limit the authority of the Secretary to require a recall of, or otherwise impose restrictions and requirements under this Act with respect to, specialty infant formula that is subject to a waiver under paragraph (1). (3) Definition of specialty infant formula In this subsection, the term specialty infant formula . (l) Importation for personal use (1) In general Notwithstanding any other provision of law, during the 90-day period beginning on the date of enactment of this Act, a person may, without prior notice to the Food and Drug Administration, import up to a 3-month supply of infant formula for personal use from— (A) Canada; (B) any country in the European Union; or (C) any other country that is determined by the Secretary, acting through the Commissioner of Food and Drugs, to have safety standards for infant formula similar to such standards applicable under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. (2) Limitations Infant formula may be imported pursuant to paragraph (1) only if the infant formula— (A) is exclusively for personal use and will not be commercialized or promoted; and (B) does not present an unreasonable risk to human health. (3) Reporting of adverse events If a health care provider becomes aware of any adverse event which the health care provider reasonably suspects to be associated with infant formula imported pursuant to paragraph (1), the health care provider shall report such adverse event to the Commissioner of Food and Drugs. (4) Public notice The Secretary, acting through the Commissioner of Food and Drugs, shall post on the public website of the Food and Drug Administration notice that— (A) infant formula imported pursuant to paragraph (1) may not have been manufactured in a facility that has been inspected by the Food and Drug Administration; (B) the labeling of such infant formula may not meet the standards and other requirements applicable with respect to infant formula under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. (C) the nutritional content of the infant formula may vary from that of infant formula meeting such standards and other requirements. (5) Sense of Congress It is the sense of Congress that persons considering the personal importation of infant formula should consult with their pediatrician about such importation. 911. Predetermined change control plans for devices (a) In general Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. 21 U.S.C. 360e–3 515C. Predetermined change control plans for devices (a) Approved devices (1) In general Notwithstanding section 515(d)(5)(A), a supplemental application shall not be required for a change to a device approved under section 515, if such change is consistent with a predetermined change control plan that is approved pursuant to paragraph (2). (2) Predetermined change control plan The Secretary may approve a predetermined change control plan submitted in an application, including a supplemental application, under section 515 that describes planned changes that may be made to the device (and that would otherwise require a supplemental application under section 515), if the device remains safe and effective without any change. (3) Scope The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan. (b) Cleared devices (1) In general Notwithstanding section 510(k), a premarket notification shall not be required for a change to a device cleared under section 510(k), if such change is consistent with an established predetermined change control plan granted pursuant to paragraph (2). (2) Predetermined change control plan The Secretary may clear a predetermined change control plan submitted in a notification submitted under section 510(k) that describes planned changes that may be made to the device (and that would otherwise require a new notification), if— (A) the device remains safe and effective without any such change; and (B) the device would remain substantially equivalent to the predicate. (3) Scope The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan. (c) Predicate devices In making a determination of substantial equivalence pursuant to section 513(i), the Secretary shall not compare a device to changed versions of a device implemented in accordance with an established predetermined change control plan as a predicate device. Only the version of the device cleared or approved, prior to changes made under the predetermined change control plan, may be used by a sponsor as a predicate device. . (b) Conforming amendments (1) Cleared devices Section 510(l)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(l)(1) , or with respect to a change that is consistent with a predetermined change control plan cleared under section 515C (2) Approved devices Section 515(d)(5)(A)(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e(d)(5)(A)(i) A supplemental Unless the change is consistent with a predetermined change control plan approved under section 515C, a supplemental (3) Documentation of rationale for significant decisions Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360g–1(a)(1) (1) In general The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 510(k), a petition for classification under section 513(f), an application under section 515, or an application for an exemption under section 520(g), including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion. . 912. Prohibition against food packaging containing intentionally added PFAS (a) In general Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 (mmm) (1) The introduction or delivery for introduction into interstate commerce of food packaging containing intentionally added PFAS. (2) The term PFAS . (b) Applicability The amendment made by subsection (a) applies beginning on January 1, 2024. 913. Requirements regarding conflicts of interest (a) Ongoing reporting of contractor conflicts of interest (1) In general The Secretary of Health and Human Services (referred to in this section as the Secretary (A) to disclose, on an ongoing basis during the term of the contract, any information related to potential and actual conflicts of interest, including conflicts of interest concerning the contractor’s personnel, consultants, and subcontractors; and (B) during the term of the contract, to refrain from entering into consulting or other contractual arrangements with any person to perform work that may reasonably create a potential or actual conflict of interest, without receiving the written approval of the contracting officer before the execution of the contractual arrangement. (2) Regulations Not later than 18 months after the date of enactment of this Act, the Secretary, in consultation with the Federal Acquisition Regulatory Council, shall issue regulations to carry out paragraph (1). (b) Restrictions on FDA contractors (1) Prohibition against certain contracts (A) In general Subject to subparagraph (B), the Secretary shall not award a contract relating to the duties of the Food and Drug Administration to any person providing consulting services (referred to in this subsection as a consulting firm (i) the Food and Drug and Administration under the consulting firm’s contract; and (ii) (I) a person engaged in the development or manufacturing of a device, drug, or biological product; or (II) any other private entity engaged in activities regulated by the Food and Drug Administration. (B) Exception (i) In general The Secretary may issue an exception to the requirement under subparagraph (A) with respect to an employee or subcontractor of a consulting firm only if the Secretary or designee determines in writing that there is a compelling reason to award a contract with such consulting firm with such exception. The Secretary shall not delegate the authority to issue exceptions under this clause below the level of head of a contracting activity. (ii) Reporting Not later than 14 days after issuing an exception under clause (i), the Secretary shall publish, on the website of the Food and Drug Administration, a notification of the exception. Such notification shall be made publicly available in an easily accessible format, and shall include— (I) the name of the contract; (II) the consulting firm receiving the exception, and the employee or subcontractor to whom the exception applies; (III) the other contracts or clients that would, in the absence of the exception, cause the consulting firm to be in violation of subparagraph (A); and (IV) the efforts that the consulting firm plans to take to mitigate any potential or actual conflict of interest arising from the other work of its employees or subcontractors. (C) Restricted period (i) In general For purposes of subparagraph (A), the restricted period is the period that— (I) begins when the applicable employee or subcontractor of the consulting firm first provides services under the consulting firm’s contract; and (II) ends not less than the applicable period specified in clause (ii) after the last date on which such employee or subcontractor provides services under the consulting firm’s contract. (ii) Applicable period specified For purposes of clause (i)(II), the applicable period specified in this clause is— (I) 30 days; or (II) such longer period of time as the Secretary may specify after consultation with the Federal Acquisition Regulatory Council, which shall apply with respect to all exceptions issued under subparagraph (B). (2) Regulations Not later than 18 months after the date of enactment of this Act, the Secretary, in consultation with the Federal Acquisition Regulatory Council, shall issue regulations to carry out paragraph (1). (c) Requirements regarding waivers relating to organizational conflicts of interest (1) In general The Secretary shall, not later than 14 days after awarding a contract relating to the Food and Drug Administration, publish, on the website of the Food and Drug Administration, a notification of any waiver of any requirements regarding a potential or actual organizational conflict of interest granted to the contractor. Such notification shall be made publicly available in an easily accessible format, and shall include the name of the contract, the contractor receiving the waiver, the other contracts or clients that created the potential or actual organizational conflict of interest, and the efforts that the contractor plans to take to mitigate the potential or actual organizational conflict of interest. (2) Regulations Not later than 18 months after the date of enactment of this Act, the Secretary, in consultation with the Federal Acquisition Regulatory Council, shall issue regulations to carry out paragraph (1). 914. Third party data transparency (a) In general To the extent the Secretary of Health and Human Services (referred to in this section as the Secretary (1) request access to the datasets, inputs, clinical or other assumptions, methods, analytical code, results, and other components underlying or comprising the analysis, conclusions, or other findings upon which the Secretary seeks to rely; and (2) in the event that information described in paragraph (1) is used to support regulatory decision-making, and as otherwise appropriate, to the extent practicable, provide the manufacturer or manufacturers subject to such decision a summary of such information, subject to protection of confidential commercial information or trade secret information or personally identifiable information. (b) Report Not later than September 30, 2023, and biennially thereafter, 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 publish on the website of the Food and Drug Administration, a report on the number of postmarket device signals communications issued by the Secretary, the sources of data for such signals, and how such signals were revised or resolved. 915. Banned devices (a) In general Section 516 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360f (1) in subsection (a)— (A) in paragraph (1), by inserting for one or more of its intended uses (B) in the flush text following paragraph (2), by inserting for any such intended use or uses (2) by adding at the end the following: (c) Specific devices Adverse conditioning devices, including electrical stimulation devices, that apply a noxious electrical stimulation to an individual’s skin intended to reduce or cease self-injurious or aggressive behavior are deemed to be banned devices, as described in subsection (a), without the need for the Secretary to promulgate a regulation with respect to such devices as described in such subsection. . (b) Rule of construction Nothing in this section shall be construed to limit the authority of the Secretary of Health and Human Services to amend, in accordance with section 516 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360f chapter 5 916. Device cybersecurity (a) Guidance for industry and FDA staff on device cybersecurity Not later than 2 years after the date of enactment of this Act, and periodically thereafter as appropriate, the Secretary of Health and Human Services (referred to in this section as the Secretary Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (b) Resources regarding cybersecurity of devices Not later than 180 days after the date of enactment of this Act, and not less than annually thereafter, the Secretary shall update public information provided by the Food and Drug Administration, including on the website of the Food and Drug Administration, with information regarding improving cybersecurity of devices. Such information shall include information on identifying and addressing cyber vulnerabilities for health care providers, health systems, and device manufacturers, and how such entities may access support through the Cybersecurity and Infrastructure Security Agency and other Federal entities, including the Department of Health and Human Services, to improve cybersecurity of devices. (c) GAO report Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall publish a report identifying challenges in cybersecurity for devices, including legacy devices that may not support certain software security updates. Through such report, the Comptroller General shall examine— (1) challenges for device manufacturers, health care providers, health systems, and patients in accessing Federal support to address vulnerabilities across Federal agencies; (2) how Federal agencies can strengthen coordination to better support cybersecurity for devices; and (3) statutory limitations and opportunities for improving cybersecurity for devices. (d) Definition In this section, the term device 21 U.S.C. 321(h) 917. Women's Health Research Roadmap Not later than 2 years after the date of enactment of this Act, the Office of Women's Health of the Food and Drug Administration, established under section 1011 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399b (1) review and, as appropriate, update the Women's Health Research Roadmap issued in December 2015; and (2) brief the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the review and, as appropriate, any resulting update. 918. GAO report on deaths due to the cost of drugs in the United States Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall publish a study on the number of individuals in the United States who die each year because they cannot afford to purchase the medicine prescribed by their health care providers. July 13, 2022 Reported with an amendment

Summary: Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022 This bill modifies Food and Drug Administration (FDA) authority to collect certain fees. It also expands FDA authority to regulate certain products, including cosmetics. Among other provisions, the bill reauthorizes FDA authority to collect certain fees related to drugs, medical devices, and biosimilar biological products and modifies such fees, including the base fee amounts; establishes that certain requirements related to obtaining market approval for a new drug or a biosimilar may be satisfied using alternatives to animal testing, such as in vitro tests; authorizes the FDA to require that certain drugs be dispensed with a safe disposal system even if the system does not render a drug nonretrievable (current law requires such a system to render the drug nonretrievable); establishes time lines for the FDA to respond to requests to determine whether a drug is a therapeutic equivalent to an approved drug; modifies the accelerated process for approving products for a serious or life-threatening disease or condition and establishes an intra-agency coordinating council to ensure consistent and appropriate use of the process; requires additional regulation of cosmetics, including by requiring manufacturers to register manufacturing facilities and each cosmetic product with the FDA; requires dietary supplement manufacturers to provide to the FDA certain information, including a list of all ingredients, about each dietary supplement that it markets; requires an in vitro clinical test to receive FDA premarket approval or a technology certification (or be otherwise exempted) before being introduced into interstate commerce; and requires the FDA to temporarily relax certain premarket requirements for a manufacturer that intends to market a new infant formula.