(a) Short title.—This title may be cited as the “Prescription Drug User Fee Amendments of 2022”.

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

Section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) is amended—

(1) in paragraph (1), in the matter following subparagraph (B), by striking “an allergenic extract product, or” and inserting “does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to”;

(2) in paragraph (3), in the matter following subparagraph (C)—

(A) by inserting “licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022,” after “an allergenic extract product”;

(B) by adding at the end the following: “If a written request to place a product in the discontinued section of either of the lists described in subparagraph (C) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then, for purposes of assessing the prescription drug program fee under section 736(a)(2), the Secretary shall consider such product to have been included in the discontinued section on the later of (i) the date such request was received, or (ii) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale. For purposes of subparagraph (C), a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.”; and

(C) by adding at the end the following:

“(12) The term ‘skin-test diagnostic product’—

“(A) means a product—

“(i) for prick, scratch, intradermal, or subcutaneous administration;

“(ii) expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect;

“(iii) not intended to be a preventive or therapeutic intervention; and

“(iv) intended to detect an immediate or delayed-type skin hypersensitivity reaction to aid in the diagnosis of—

“(I) an allergy to an antimicrobial agent;

“(II) an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or

“(III) infection with fungal or mycobacterial pathogens; and

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

(a) Types of fees.—Section 736(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is amended—

(1) in the matter preceding paragraph (1), by striking “2018” and inserting “2023”;

(2) in paragraph (1)—

(A) in subparagraph (A), by striking “subsection (c)(5)” each place it appears and inserting “subsection (c)(6)”;

(B) in subparagraph (C), by inserting “prior to approval” after “or was withdrawn”; and

(C) by adding at the end the following:

“(H) EXCEPTION FOR SKIN-TEST DIAGNOSTIC PRODUCTS.—A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A).”; and

(3) in paragraph (2)—

(A) in subparagraph (A)—

(i) by striking “subsection (c)(5)” and inserting “subsection (c)(6)”;

(ii) by striking “Except as provided” and inserting the following:

“(i) PAYMENT OF FEES.—Except as provided”; and

(iii) by adding at the end the following:

“(ii) PREVIOUSLY DISCONTINUED DRUG PRODUCTS.—If a drug product that is identified in a human drug application approved as of October 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list identified in section 735(3), and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each product for a fiscal year in which the fee is payable.”; and

(B) by amending subparagraph (B) to read as follows:

“(B) EXCEPTION FOR CERTAIN PRESCRIPTION DRUG PRODUCTS.—A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—

“(i) a large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to 100 mL, not including powders for reconstitution or pharmacy bulk packages) identified on the list compiled under section 505(j)(7);

“(ii) pharmaceutically equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)), to another product on the list of products compiled under section 505(j)(7) (not including the discontinued section of such list); or

“(iii) a skin-test diagnostic product.”.

(b) Fee revenue amounts.—Section 736(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is amended—

(1) in paragraph (1)—

(A) in the matter preceding subparagraph (A), by striking “2018 through 2022” and inserting “2023 through 2027”;

(B) by redesignating subparagraphs (C) through (F) as subparagraphs (D) through (G), respectively;

(C) by inserting after subparagraph (B) the following:

“(C) The dollar amount equal to the strategic hiring and retention adjustment for the fiscal year (as determined under subsection (c)(2));”;

(D) in subparagraph (D), as so redesignated, by striking “(c)(2)” and inserting “(c)(3)”;

(E) in subparagraph (E), as so redesignated, by striking “(c)(3)” and inserting “(c)(4)”;

(F) in subparagraph (F), as so redesignated, by striking “(c)(4)” and inserting “(c)(5)”; and

(G) in subparagraph (G), as so redesignated, by striking clauses (i) through (v) and inserting the following:

“(i) $65,773,693 for fiscal year 2023.

“(ii) $25,097,671 for fiscal year 2024.

“(iii) $14,154,169 for fiscal year 2025.

“(iv) $4,864,860 for fiscal year 2026.

“(v) $1,314,620 for fiscal year 2027.”; and

(2) in paragraph (3)—

(A) in subparagraph (A), by striking “2018, $878,590,000” and inserting “2023, $1,151,522,958”; and

(B) in subparagraph (B)—

(i) by striking “2019 through 2022” and inserting “2024 through 2027”; and

(ii) by striking “subsection (c)(3) or (c)(4)” and inserting “subsection (c)(4) or (c)(5)”.

(c) Adjustments; annual fee setting.—Section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended—

(1) in paragraph (1)(B)(ii), by striking “Washington-Baltimore, DC–MD–VA–WV” and inserting “Washington–Arlington–Alexandria, DC–VA–MD–WV”;

(2) by redesignating paragraphs (2) through (6) as paragraphs (3) through (7), respectively;

(3) by inserting after paragraph (1) the following:

“(2) STRATEGIC HIRING AND RETENTION ADJUSTMENT.—For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees—

“(A) for fiscal year 2023, by $9,000,000; and

“(B) for fiscal year 2024 and each subsequent fiscal year, by $4,000,000.”;

(4) in paragraph (3), as so redesignated—

(A) in subparagraph (A)—

(i) by striking “for inflation”; and

(ii) by striking “paragraph (1)” and inserting “paragraphs (1) and (2)”;

(B) by amending subparagraph (B) to read as follows:

“(B) METHODOLOGY.—For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled ‘Prescription Drug User Fee Rates for Fiscal Year 2021’ (85 Fed. Reg. 46651; August 3, 2020). The workload categories used in forecasting shall include only the activities described in such notice and, as feasible, additional activities that are directly related to the direct review of applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved prescription drug products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in forecasting any non-core review activities, including any activities that the Secretary referenced for potential future use in such notice but did not utilize in the setting fees for fiscal year 2021.”;

(C) by striking subparagraph (C);

(D) by redesignating subparagraphs (D) and (E) as subparagraphs (C) and (D), respectively;

(E) in subparagraph (C), as so redesignated—

(i) by striking “year) and” and inserting “year),”; and

(ii) by inserting “, and subsection (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment).”; and

(F) in subparagraph (D), as so redesignated, by striking “paragraph (5)” and inserting “paragraph (6)”;

(5) in paragraph (4), as so redesignated—

(A) by amending subparagraph (A) to read as follows:

“(A) INCREASE.—For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for at least the following amounts of operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year, as follows:

“(i) For fiscal year 2023, at least 8 weeks of operating reserves.

“(ii) For fiscal year 2024, at least 9 weeks of operating reserves.

“(iii) For fiscal year 2025 and subsequent fiscal years, at least 10 weeks of operating reserves.”; and

(B) in subparagraph (C), by striking “paragraph (5)” and inserting “paragraph (6)”;

(6) by amending paragraph (5), as so redesignated, to read as follows:

“(5) ADDITIONAL DIRECT COST ADJUSTMENT.—The Secretary shall, in addition to adjustments under paragraphs (1), (2), (3), and (4), further increase the fee revenue and fees—

“(A) for fiscal year 2023, by $44,386,150; and

“(B) for fiscal years 2024 through 2027, by the amount set forth in clauses (i) through (iv), as applicable, multiplied by the Consumer Price Index for urban consumers (Washington–Arlington–Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2021—

“(i) for fiscal year 2024, $60,967,993;

“(ii) for fiscal year 2025, $35,799,314;

“(iii) for fiscal year 2026, $35,799,314; and

“(iv) for fiscal year 2027, $35,799,314.”; and

(7) in paragraph (6), as so redesignated, by striking “2017” and inserting “2022”.

(d) Crediting and availability of fees.—Section 736(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended by striking “2018 through 2022” and inserting “2023 through 2027”.

(e) Written requests for waivers, reductions, and refunds.—Section 736(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is amended to read as follows:

“(i) Written requests for waivers, reductions, exemptions, and returns; disputes concerning fees.—To qualify for consideration for a waiver or reduction under subsection (d), an exemption under subsection (k), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall submit to the Secretary a written request justifying such waiver, reduction, exemption, or return not later than 180 days after such fee is due. A request submitted under this paragraph shall include any legal authorities under which the request is made.”.

(f) Orphan drugs.—Section 736(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is amended—

(1) in paragraph (1)(B), by striking “during the previous year” and inserting “, as determined under paragraph (2)”; and

(2) in paragraph (2), by striking “that its gross annual revenues” and all that follows through the period at the end and inserting “supported by tax returns submitted to the Internal Revenue Service, or, as necessary, by other appropriate financial information, that its gross annual revenues did not exceed $50,000,000 for the last calendar year ending prior to the fiscal year for which the exemption is requested.”.

Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) is amended—

(1) by striking “2018” each place it appears and inserting “2023”;

(2) by striking “Prescription Drug User Fee Amendments of 2017” each place it appears and inserting “Prescription Drug User Fee Amendments of 2022”;

(3) in subsection (a)(4), by striking “2020” and inserting “2023”; and

(4) in subsection (f), by striking “2022” each place it appears and inserting “2027”.

(a) Authorization.—Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective October 1, 2027.

(b) Reporting requirements.—Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to be effective January 31, 2028.

(c) Previous sunset provision.—Effective October 1, 2022, subsections (a) and (b) of section 104 of the FDA Reauthorization Act of 2017 (Public Law 115–52) are repealed.

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

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

(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.

Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i) is amended—

(1) in paragraph (9)—

(A) in the matter preceding subparagraph (A), by striking “and premarket notification submissions” and inserting “premarket notification submissions, and de novo classification requests”;

(B) in subparagraph (D), by striking “and submissions” and inserting “submissions, and de novo classification requests”;

(C) in subparagraph (F), by striking “and premarket notification submissions” and inserting “premarket notification submissions, and de novo classification requests”;

(D) in subparagraphs (G) and (H), by striking “or submissions” each place it appears and inserting “submissions, or requests”; and

(E) in subparagraph (K), by striking “or premarket notification submissions” and inserting “premarket notification submissions, or de novo classification requests”; and

(2) in paragraph (11), by striking “2016” and inserting “2021”.

(a) Types of fees.—Section 738(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is amended—

(1) in paragraph (1), by striking “2018” and inserting “2023”; and

(2) in paragraph (2)—

(A) in subparagraph (A)—

(i) in the matter preceding clause (i), by striking “2017” and inserting “2022”;

(ii) in clause (iii), by striking “75 percent” and inserting “80 percent”; and

(iii) in clause (viii), by striking “3.4 percent” and inserting “4.5 percent”;

(B) in subparagraph (B)(iii), by striking “or premarket notification submission” and inserting “premarket notification submission, or de novo classification request”; and

(C) in subparagraph (C), by striking “or periodic reporting concerning a class III device” and inserting “periodic reporting concerning a class III device, or de novo classification request”.

(b) Fee amounts.—Section 738(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is amended—

(1) in paragraph (1), by striking “2018 through 2022” and inserting “2023 through 2027”;

(2) by amending the table in paragraph (2) to read as follows:

and

(3) in paragraph (3), by amending subparagraphs (A) through (E) to read as follows:

“(A) $312,606,000 for fiscal year 2023.

“(B) $335,750,000 for fiscal year 2024.

“(C) $350,746,400 for fiscal year 2025.

“(D) $366,486,300 for fiscal year 2026.

“(E) $418,343,000 for fiscal year 2027.”.

(c) Annual fee setting; adjustments.—Section 738(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended—

(1) in paragraph (1), by striking “2017” and inserting “2022”;

(2) in paragraph (2)—

(A) by striking “2018” each place it appears and inserting “2023”;

(B) in subparagraph (B)(ii), by striking “2016” and inserting “2022”;

(C) in subparagraph (C)(i)(II), by striking “Washington-Baltimore, DC–MD–VA–WV” and inserting “Washington–Arlington–Alexandria, DC–VA–MD–WV”; and

(D) in subparagraph (D), by striking “2022” and inserting “2027”;

(3) in paragraph (3), by striking “2018 through 2022” and inserting “2023 through 2027”;

(4) by redesignating paragraphs (4) and (5) as paragraphs (7) and (8), respectively; and

(5) by inserting after paragraph (3) the following:

“(4) PERFORMANCE IMPROVEMENT ADJUSTMENT.—

“(A) IN GENERAL.—For each of fiscal years 2025 through 2027, after the adjustment under paragraph (3), the base establishment registration fee amounts for such fiscal year shall be increased to reflect changes in the resource needs of the Secretary due to improved review performance goals for the process for the review of device applications identified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022, as the Secretary determines necessary to achieve an increase in total fee collections for such fiscal year, equal to the following amounts, as applicable:

“(i) For fiscal year 2025, the product of—

“(I) the amount determined under subparagraph (B)(i)(I); and

“(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.

“(ii) For fiscal year 2026, the product of—

“(I) the sum of the amounts determined under subparagraphs (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); and

“(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.

“(iii) For fiscal year 2027, the product of—

“(I) the sum of the amounts determined under subparagraphs (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); and

“(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.

“(B) AMOUNTS.—

“(i) PRESUBMISSION AMOUNT.—For purposes of subparagraph (A), with respect to the presubmission written feedback goal, the amounts determined under this subparagraph are as follows:

“(I) For fiscal year 2025, $15,396,600 if the goal for fiscal year 2023 is met.

“(II) For fiscal year 2026—

“(aa) $15,396,600 if the goal for fiscal year 2023 is met and the goal for fiscal year 2024 is missed; or

“(bb) $36,792,200 if the goal for fiscal year 2024 is met.

“(III) For fiscal year 2027—

“(aa) $15,396,600 if the goal for fiscal year 2023 is met and the goal for each of fiscal years 2024 and 2025 is missed;

“(bb) $36,792,200 if the goal for fiscal year 2024 is met and the goal for fiscal year 2025 is missed; or

“(cc) $40,572,600 if the goal for fiscal year 2025 is met.

“(ii) DE NOVO CLASSIFICATION REQUEST AMOUNT.—For purposes of subparagraph (A), with respect to the de novo decision goal, the amounts determined under this subparagraph are as follows:

“(I) For fiscal year 2026, $6,323,500 if the goal for fiscal year 2023 is met.

“(II) For fiscal year 2027—

“(aa) $6,323,500 if the goal for fiscal year 2023 is met and the goal for fiscal year 2024 is missed; or

“(bb) $11,765,400 if the goal for fiscal year 2024 is met.

“(iii) PREMARKET NOTIFICATION AND PREMARKET APPROVAL AMOUNT.—For purposes of subparagraph (A), with respect to the 510(k) decision goal, 510(k) shared outcome total time to decision goal, PMA decision goal, and PMA shared outcome total time to decision goal, the amounts determined under this subparagraph are as follows:

“(I) For fiscal year 2026, $1,020,000 if the 4 goals for fiscal year 2023 are met.

“(II) For fiscal year 2027—

“(aa) $1,020,000 if the 4 goals for fiscal year 2023 are met and one or more of the 4 goals for fiscal year 2024 is missed; or

“(bb) $3,906,000 if the 4 goals for fiscal year 2024 are met.

“(C) PERFORMANCE CALCULATION.—For purposes of this paragraph, performance of the following goals shall be determined as specified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022 and based on data available as of the applicable dates as follows:

“(i) The performance of the presubmission written feedback goal—

“(I) for fiscal year 2023, shall be based on data available as of March 31, 2024;

“(II) for fiscal year 2024, shall be based on data available as of March 31, 2025; and

“(III) for fiscal year 2025, shall be based on data available as of March 31, 2026.

“(ii) The performance of the de novo decision goal, 510(k) decision goal, 510(k) shared outcome total time to decision goal, PMA decision goal, and PMA shared outcome total time to decision goal—

“(I) for fiscal year 2023, shall be based on data available as of March 31, 2025; and

“(II) for fiscal year 2024, shall be based on data available as of March 31, 2026.

“(D) DEFINITIONS.—For purposes of this paragraph, the terms ‘presubmission written feedback goal’, ‘de novo decision goal’, ‘510(k) decision goal’, ‘510(k) shared outcome total time to decision goal’, ‘PMA decision goal’, and ‘PMA shared outcome total time to decision goal’ have the meanings given such terms in the goals identified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022.

“(5) HIRING ADJUSTMENT.—

“(A) IN GENERAL.—For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (3) and (4), if applicable, the base establishment registration fee amounts shall be decreased as the Secretary determines necessary to achieve a reduction in total fee collections equal to the hiring adjustment amount under subparagraph (B), if the number of hires to support the process for the review of device applications falls below the following thresholds for the applicable fiscal years:

“(i) For fiscal year 2025, 85 percent of the hiring goal specified in subparagraph (C) for fiscal year 2023.

“(ii) For fiscal year 2026, 90 percent of the hiring goal specified in subparagraph (C) for fiscal year 2024.

“(iii) For fiscal year 2027, 90 percent of the hiring goal specified in subparagraph (C) for fiscal year 2025.

“(B) HIRING ADJUSTMENT AMOUNT.—The hiring adjustment amount for fiscal year 2025 and each subsequent fiscal year is the product of—

“(i) the number of hires by which the hiring goal specified in subparagraph (C) for the fiscal year before the prior fiscal year was missed;

“(ii) $72,877; and

“(iii) the applicable inflation adjustment under paragraph (2)(B) for the fiscal year for which the hiring goal was missed.

“(C) HIRING GOALS.—

“(i) IN GENERAL.—For purposes of subparagraph (B), the hiring goals for each of fiscal years 2023 through 2025 are as follows:

“(I) For fiscal year 2023, 144 hires.

“(II) For fiscal year 2024, 42 hires.

“(III) For fiscal year 2025—

“(aa) 24 hires if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i); or

“(bb) 83 hires if the base establishment registration fees are increased by the amount determined under paragraph (4)(A)(i).

“(ii) NUMBER OF HIRES.—For purposes of this paragraph, the number of hires for a fiscal year shall be determined by the Secretary, as set forth in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022.

“(6) OPERATING RESERVE ADJUSTMENT.—

“(A) IN GENERAL.—For each of fiscal years 2023 through 2027, after the adjustments under paragraphs (3), (4), and (5), if applicable, if the Secretary has operating reserves of carryover user fees for the process for the review of device applications in excess of the designated amount in subparagraph (B), the Secretary shall decrease the base establishment registration fee amounts to provide for not more than such designated amount of operating reserves.

“(B) DESIGNATED AMOUNT.—Subject to subparagraph (C), for each fiscal year, the designated amount in this subparagraph is equal to the sum of—

“(i) 13 weeks of operating reserves of carryover user fees; and

“(ii) the 1 month of operating reserves described in paragraph (8).

“(C) EXCLUDED AMOUNT.—For the period of fiscal years 2023 through 2026, a total amount equal to $118,000,000 shall not be considered part of the designated amount under subparagraph (B) and shall not be subject to the decrease under subparagraph (A).”.

(d) Small businesses.—Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended—

(1) in subsection (d)(2)(B)(iii), by inserting “, if extant,” after “national taxing authority”; and

(2) in subsection (e)(2)(B)(iii), by inserting “, if extant,” after “national taxing authority”.

(e) Conditions.—Section 738(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(g)) is amended—

(1) in paragraph (1)(A), by striking “$320,825,000” and inserting “$398,566,000”; and

(2) in paragraph (2), by inserting “de novo classification requests,” after “class III device,”.

(f) Authorization of appropriations.—Section 738(h)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)(3)) is amended to read as follows:

“(3) AUTHORIZATION OF APPROPRIATIONS.—

“(A) IN GENERAL.—For each of the fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined in subparagraph (B), less the amount of reductions determined in subparagraph (C).

“(B) REVENUE AMOUNT.—For purposes of this paragraph, the revenue amount for each fiscal year is the sum of—

“(i) the total revenue amount under subsection (b)(3) for the fiscal year, as adjusted under subsection (c)(2); and

“(ii) the performance improvement adjustment amount for the fiscal year under subsection (c)(4)(A), if applicable.

“(C) AMOUNT OF REDUCTIONS.—For purposes of this paragraph, the amount of reductions for each fiscal year is the sum of—

“(i) the hiring adjustment amount for the fiscal year under subsection (c)(5), if applicable; and

“(ii) the operating reserve adjustment amount for the fiscal year under subsection (c)(6), if applicable.”.

(a) Accreditation scheme for conformity assessment.—Section 514(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(d)) is amended—

(1) in the subsection heading, by striking “Pilot”;

(2) in paragraph (1)—

(A) in the matter preceding subparagraph (A), by striking “pilot”;

(B) in subparagraph (A)—

(i) by inserting “meeting criteria specified by the Secretary in guidance” after “testing laboratories”;

(ii) by inserting “in guidance” after “by the Secretary”; and

(iii) by striking “assess the conformance of a device with” and inserting “conduct testing to support the assessment of the conformance of a device to”; and

(C) in subparagraph (B)—

(i) by striking “determinations” and inserting “results”;

(ii) by inserting “to support” after “so accredited”; and

(iii) by striking “a particular such determination” and inserting “particular such results”;

(3) in paragraph (2)—

(A) in the paragraph heading, by striking “determinations” and inserting “results”;

(B) in subparagraph (A)—

(i) by striking “determinations by testing laboratories” and all that follows through “such determinations or” and inserting “results by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such results or of the”;

(ii) by inserting a comma after “or testing laboratories”;

(iii) by inserting “or recognition of an accreditation body” after “accreditation of such testing laboratory”; and

(iv) by striking “such device” and inserting “a device”; and

(C) in subparagraph (B)—

(i) by striking “by a testing laboratory so accredited” and inserting “under this subsection”; and

(ii) by inserting “or recognition of an accreditation body” before “under paragraph (1)(A)”;

(4) in paragraph (3)(C)—

(A) in the subparagraph heading, by inserting “and transition” after “initiation”; and

(B) by adding at the end the following: “After September 30, 2023, such pilot program will be considered to be completed, and the Secretary shall have the authority to continue operating a program consistent with this subsection.”; and

(5) by striking paragraph (4).

(b) Accredited persons.—Section 523(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m(c)) is amended by striking “2022” and inserting “2027”.

(a) Authorization.—Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 379fj) shall cease to be effective October 1, 2027.

(b) Reporting requirements.—Section 738A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1) shall cease to be effective January 31, 2028.

(c) Previous sunset provision.—Effective October 1, 2022, subsections (a) and (b) of section 210 of the FDA Reauthorization Act of 2017 (Public Law 115–52) are repealed.

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

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

(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.

(a) Types of fees.—Section 744B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(a)) is amended—

(1) in the matter preceding paragraph (1), by striking “2018” and inserting “2023”;

(2) in paragraph (2)(C), by striking “fiscal years 2018 through 2022” and inserting “fiscal years 2023 through 2027”;

(3) in paragraph (3)(B), by striking “fiscal years 2018 through 2022” and inserting “fiscal years 2023 through 2027”;

(4) in paragraph (4)(D), by striking “fiscal years 2018 through 2022” and inserting “fiscal years 2023 through 2027”; and

(5) in paragraph (5)(D), by striking “fiscal years 2018 through 2022” and inserting “fiscal years 2023 through 2027”.

(b) Fee revenue amounts.—Section 744B(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(b)) is amended—

(1) in paragraph (1)—

(A) in subparagraph (A)—

(i) in the heading, by striking “2018” and inserting “2023”;

(ii) by striking “2018” and inserting “2023”; and

(iii) by striking “$493,600,000” and inserting “$582,500,000”; and

(B) in subparagraph (B)—

(i) in the heading, by striking “2019 through 2022” and inserting “2024 through 2027”;

(ii) by striking “For each” and inserting the following:

“(i) IN GENERAL.—For each”;

(iii) by striking “2019 through 2022” and inserting “2024 through 2027”;

(iv) by striking “$493,600,000” and inserting “the base revenue amount under clause (ii)”; and

(v) by adding at the end the following:

“(ii) BASE REVENUE AMOUNT.—The base revenue amount for a fiscal year is the total revenue amount established under this paragraph for the previous fiscal year, not including any adjustments made for such previous fiscal year under subsection (c)(3).”; and

(2) in paragraph (2)—

(A) in subparagraph (C), by striking “one-third the amount” and inserting “24 percent”;

(B) in subparagraph (D), by striking “Seven” and inserting “Six”; and

(C) in subparagraph (E)(i), by striking “Thirty-five” and inserting “Thirty-six”.

(c) Adjustments.—Section 744B(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(c)) is amended—

(1) in paragraph (1)—

(A) in the matter preceding subparagraph (A)—

(i) by striking “2019” and inserting “2024”; and

(ii) by striking “the product of the total revenues established in such notice for the prior fiscal year” and inserting “the base revenue amount for the fiscal year determined under subsection (b)(1)(B)(ii)”; and

(B) in subparagraph (C), by striking “Washington-Baltimore, DC–MD–VA–WV” and inserting “Washington-Arlington-Alexandria, DC–VA–MD–WV”; and

(2) by striking paragraph (2) and inserting the following:

“(2) CAPACITY PLANNING ADJUSTMENT.—

“(A) IN GENERAL.—Beginning with fiscal year 2024, the Secretary shall, in addition to the adjustment under paragraph (1), further increase the fee revenue and fees under this section for a fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for human generic drug activities.

“(B) CAPACITY PLANNING METHODOLOGY.—The Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—

“(i) be derived from the methodology and recommendations made in the report titled ‘Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations’ as announced in the Federal Register on August 3, 2020 (85 Fed. Reg. 46658); and

“(ii) incorporate approaches and attributes determined appropriate by the Secretary, including those made in such report recommendations, except the workload categories used in forecasting resources shall only be those specified in section VIII.B.2.e. of the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2022.

“(C) LIMITATIONS.—

“(i) IN GENERAL.—Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsection (b)(1)(B)(ii) (the base revenue amount for the fiscal year) and paragraph (1) (the dollar amount of the inflation adjustment for the fiscal year).

“(ii) ADDITIONAL LIMITATION.—An adjustment under this paragraph shall not exceed 3 percent of the sum described in clause (i) for the fiscal year, except that such limitation shall be 4 percent if—

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

“(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,000; or

“(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as that term is defined in section XI of the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2022);

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

“(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or

“(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined);

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

“(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or

“(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); and

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

“(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or

“(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined).

“(D) PUBLICATION IN FEDERAL REGISTER.—The Secretary shall publish in the Federal Register notice under subsection (a), the fee revenue and fees resulting from the adjustment and the methodology under this paragraph.

“(3) OPERATING RESERVE ADJUSTMENT.—

“(A) IN GENERAL.—For fiscal year 2024 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees under this section if such an adjustment is necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in subparagraph (B).

“(B) NUMBER OF WEEKS.—The number of weeks specified in this subparagraph is—

“(i) 8 weeks for fiscal year 2024;

“(ii) 9 weeks for fiscal year 2025; and

“(iii) 10 weeks for each of fiscal year 2026 and 2027.

“(C) DECREASE.—If the Secretary has carryover balances for human generic drug activities in excess of 12 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 12 weeks of such operating reserves.

“(D) RATIONALE FOR ADJUSTMENT.—If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under subsection (a) publishing the fee revenue and fees for the fiscal year involved.”.

(d) Annual fee setting.—Section 744B(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(d)(1)) is amended—

(1) in the heading, by striking “2018 through 2022” and inserting “2023 through 2027”;

(2) by striking “more” and inserting “later”; and

(3) by striking “2018 through 2022” and inserting “2023 through 2027”.

(e) Effect of failure To pay fees.—The heading of paragraph (3) of section 744B(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(g)) is amended by striking “and prior approval supplement fee”.

(f) Crediting and availability of fees.—Section 744B(i)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(i)(3)) is amended by striking “2018 through 2022” and inserting “2023 through 2027”.

Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) is amended—

(1) in subsection (a)—

(A) by striking “2018” each place it appears and inserting “2023”; and

(B) by striking “Generic Drug User Fee Amendments of 2017” each place it appears and inserting “Generic Drug User Fee Amendments of 2022”;

(2) in subsection (b), by striking “2018” and inserting “2023”;

(3) in subsection (c)—

(A) by striking “2018” and inserting “2023”; and

(B) by striking “Generic Drug User Fee Amendments of 2017” each place it appears and inserting “Generic Drug User Fee Amendments of 2022”; and

(4) in subsection (f)—

(A) in paragraph (1), by striking “2022” and inserting “2027”; and

(B) in paragraph (5), by striking “January 15, 2022” and inserting “January 15, 2027”.

(a) Authorization.—Sections 744A and 744B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41; 379j–42) shall cease to be effective October 1, 2027.

(b) Reporting requirements.—Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) shall cease to be effective January 31, 2028.

(c) Previous sunset provision.—Effective October 1, 2022, subsections (a) and (b) of section 305 of the FDA Reauthorization Act of 2017 (Public Law 115–52) are repealed.

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.

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

(a) Short title.—This title may be cited as the “Biosimilar User Fee Amendments of 2022”.

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

Section 744G of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51) is amended—

(1) in paragraph (1)—

(A) by striking “Washington-Baltimore, DC–MD–VA–WV” and inserting “Washington–Arlington–Alexandria, DC–VA–MD–WV”;

(B) by striking “October of” and inserting “September of”; and

(C) by striking “October 2011” and inserting “September 2011”; and

(2) in paragraph (4)(B)(iii)—

(A) by striking subclause (II); and

(B) by redesignating subclauses (III) and (IV) as subclauses (II) and (III), respectively.

(a) Types of fees.—Section 744H(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)) is amended—

(1) in the matter preceding paragraph (1), by striking “2018” and inserting “2023”;

(2) in paragraph (1)—

(A) in subparagraph (A)—

(i) in clause (iv)(I), by striking “5 days” and inserting “7 days”; and

(ii) in clause (v)(II), by striking “5 days” and inserting “7 days”;

(B) in subparagraph (B)—

(i) in clause (i), by inserting “except that, in the case that such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, such licensee, assignee or successor shall pay the annual biosimilar biological product development fee” before the period;

(ii) in clause (iii)—

(I) in subclause (I), by striking “; or” and inserting a semicolon;

(II) in subclause (II), by striking the period and inserting “; or”; and

(III) by adding at the end the following:

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

(iii) in clause (iv), by striking “accepted for filing on or after October 1 of such fiscal year” and inserting “subsequently accepted for filing”;

(C) in subparagraph (D)—

(i) in clause (i)—

(I) in the matter preceding subclause (I), by striking “shall, if the person seeks to resume participation in such program, pay” and inserting “or who has been administratively removed from such program for a product under subparagraph (E)(v) shall, if the person seeks to resume participation in such program, pay all annual biosimilar biological product development fees previously assessed for such product and still owed and”;

(II) in subclause (I)—

(aa) by striking “5 days” and inserting “7 days”; and

(bb) by inserting “or the date of administrative removal, as applicable” after “discontinued”; and

(III) in subclause (II), by inserting “or the date of administrative removal, as applicable” after “discontinued”; and

(ii) in clause (ii), by inserting “except that, in the case that such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, such licensee, assignee or successor shall pay the annual biosimilar biological product development fee” before the period at the end; and

(D) in subparagraph (E), by adding at the end the following:

“(v) ADMINISTRATIVE REMOVAL FROM THE BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT PROGRAM.—If a person has failed to pay an annual biosimilar biological product development fee for a product as required under subparagraph (B) for a period of 2 consecutive fiscal years, the Secretary may administratively remove such person from the biosimilar biological product development program for the product. At least 30 days prior to administratively removing a person from the biosimilar biological product development program for a product under this clause, the Secretary shall provide written notice to such person of the intended administrative removal.”;

(3) in paragraph (2)(D), by inserting “prior to approval” after “withdrawn”;

(4) in paragraph (3)—

(A) in subparagraph (A)—

(i) in clause (i), by striking “; and” and inserting a semicolon;

(ii) by redesignating clause (ii) as clause (iii); and

(iii) by inserting the following after clause (i):

“(ii) may be dispensed only under prescription pursuant to section 503(b); and”; and

(B) by adding at the end the following:

“(E) MOVEMENT TO DISCONTINUED LIST.—

“(i) WRITTEN REQUEST TO PLACE ON DISCONTINUED LIST.—

“(I) IN GENERAL.—If a written request to place a product on the list of discontinued biosimilar biological products referred to in subparagraph (A)(iii) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the biosimilar biological product program fee, the Secretary shall consider such product to have been included on such list on the later of—

“(aa) the date such request was received; or

“(bb) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.

“(II) WITHDRAWN FROM SALE DEFINED.—For purposes of this clause, a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.

“(ii) PRODUCTS REMOVED FROM DISCONTINUED LIST.—If a biosimilar biological product that is identified in a biosimilar biological product application approved as of October 1 of a fiscal year appears, as of October 1 of such fiscal year, on the list of discontinued biosimilar biological products referred to in subparagraph (A)(iii), and on any subsequent day during such fiscal year the biosimilar biological product does not appear on such list, except as provided in subparagraph (D), each person who is named as the applicant in the biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for such biosimilar biological product. Notwithstanding subparagraph (B), such fee shall be due on the last business day of such fiscal year and shall be paid only once for each product for each fiscal year.”; and

(5) by striking paragraph (4).

(b) Fee revenue amounts.—Section 744H(b) of the Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 379j–52(b)) is amended—

(1) by striking paragraph (1);

(2) by redesignating paragraphs (2) through (4) as paragraphs (1) through (3), respectively;

(3) in paragraph (1), as so redesignated—

(A) in the paragraph heading, by striking “Subsequent fiscal years” and inserting “In general”;

(B) in the matter preceding subparagraph (A), by striking “2019 through 2022” and inserting “2023 through 2027”;

(C) in subparagraph (A), by striking “paragraph (4)” and inserting “paragraph (3)”;

(D) by redesignating subparagraphs (C) and (D) as subparagraphs (D) and (E), respectively;

(E) by inserting after subparagraph (B) the following:

“(C) the dollar amount equal to the strategic hiring and retention adjustment (as determined under subsection (c)(2));”;

(F) in subparagraph (D), as so redesignated, by striking “subsection (c)(2)); and” and inserting “subsection (c)(3));”;

(G) in subparagraph (E), as so redesignated, by striking “subsection (c)(3)).” and inserting “subsection (c)(4)); and”; and

(H) by adding at the end the following:

“(F) for fiscal years 2023 and 2024, additional dollar amounts equal to—

“(i) $4,428, 886 for fiscal year 2023; and

“(ii) $320,569 for fiscal year 2024.”;

(4) in paragraph (2), as so redesignated—

(A) in the paragraph heading, by striking “; limitations on fee amounts”;

(B) by striking subparagraph (B); and

(C) by redesignating subaparagraphs (C) and (D) as subparagraphs (B) and (C), respectively; and

(5) by amending paragraph (3), as so redesignated, to read as follows:

“(3) ANNUAL BASE REVENUE.—For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—

“(A) for fiscal year 2023, $43,376,922; and

“(B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(4).”.

(c) Adjustments; annual fee setting.—Section 744H(c) of the Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 379j–52(c)) is amended—

(1) in paragraph (1)—

(A) in subparagraph (A)—

(i) in the matter preceding clause (i), by striking “subsection (b)(2)(B)” and inserting “subsection (b)(1)(B)”; and

(ii) in clause (i), by striking “subsection (b)” and inserting “subsection (b)(1)(A)”; and

(B) in subparagraph (B)(ii), by striking “Washington-Baltimore, DC–MD–VA–WV” and inserting “Washington–Arlington–Alexandria, DC–VA–MD–WV”;

(2) by striking paragraph (4);

(3) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively;

(4) by inserting after paragraph (1) the following:

“(2) STRATEGIC HIRING AND RETENTION ADJUSTMENT.—For each fiscal year beginning in fiscal year 2023, after the annual base revenue under subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by $150,000.”;

(5) in paragraph (3), as so redesignated—

(A) in subparagraph (A)—

(i) by striking “Beginning with the fiscal year described in subparagraph (B)(ii)(II)” and inserting “For each fiscal year”; and

(ii) by striking “adjustment under paragraph (1), further increase” and inserting “adjustments under paragraphs (1) and (2), further adjust”; and

(B) by amending subparagraph (B) to read as follows:

“(B) METHODOLOGY.—For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled ‘Biosimilar User Fee Rates for Fiscal Year 2021’ (85 Fed. Reg. 47220; August 4, 2020). The workload categories used in forecasting shall include only the activities described in such notice and, as feasible, additional activities that are also directly related to the direct review of biosimilar biological product applications and supplements, including additional formal meeting types and the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved biosimilar biological products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in forecasting any non-core review activities, including any activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.”; and

(C) in subparagraph (C)—

(i) by striking “subsections (b)(2)(A)” and inserting “subsections (b)(1)(A)”;

(ii) by striking “and (b)(2)(B)” and inserting “, (b)(1)(B)”; and

(iii) by inserting “, and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment)” before the period at the end;

(6) by amending paragraph (4), as so redesignated, to read as follows:

“(4) OPERATING RESERVE ADJUSTMENT.—

“(A) INCREASE.—For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for at least 10 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications.

“(B) DECREASE.—

“(i) FISCAL YEAR 2023.—For fiscal year 2023, if the Secretary has carryover balances for the process for the review of biosimilar biological product applications in excess of 33 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 33 weeks of such operating reserves.

“(ii) FISCAL YEAR 2024.—For fiscal year 2024, if the Secretary has carryover balances for the process for the review of biosimilar biological product applications in excess of 27 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 27 weeks of such operating reserves.

“(iii) FISCAL YEAR 2025 AND SUBSEQUENT FISCAL YEARS.—For fiscal year 2025 and subsequent fiscal years, if the Secretary has carryover balances for the process for the review of biosimilar biological product applications in excess of 21 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 21 weeks of such operating reserves.

“(C) FEDERAL REGISTER NOTICE.—If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5)(B) establishing fee revenue and fees for the fiscal year involved.”; and

(7) in paragraph (5), in the matter preceding subparagraph (A), by striking “2018” and inserting “2023”.

(d) Crediting and availability of fees.—Section 744H(f)(3) of the Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 379j–52(f)(3)) is amended by striking “2018 through 2022” and inserting “2023 through 2027”.

(e) Written requests for waivers and refunds.—Subsection (h) of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52) is amended to read as follows:

“(h) Written requests for waivers and returns; disputes concerning fees.—To qualify for consideration for a waiver under subsection (d), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall submit to the Secretary a written request justifying such waiver or return and, except as otherwise specified in this section, such written request shall be submitted to the Secretary not later than 180 days after such fee is due. A request submitted under this paragraph shall include any legal authorities under which the request is made.”.

Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53) is amended—

(1) by striking “2018” each place it appears and inserting “2023”;

(2) by striking “Biosimilar User Fee Amendments of 2017” each place it appears and inserting “Biosimilar User Fee Amendments of 2022”;

(3) in subsection (a)(4), by striking “2020” and inserting “2023”; and

(4) in subsection (f), by striking “2022” each place it appears and inserting “2027”.

(a) Authorization.—Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51, 379j–52 ) shall cease to be effective October 1, 2027.

(b) Reporting requirements.—Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53) shall cease to be effective January 31, 2028.

(c) Previous sunset provision.—Effective October 1, 2022, subsections (a) and (b) of section 405 of the FDA Reauthorization Act of 2017 (Public Law 115–52) are repealed.

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

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

(a) In general.—Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended—

(1) in subsection (i)—

(A) in paragraph (1)(A), by striking “preclinical tests (including tests on animals)” and inserting “nonclinical tests”; and

(B) in paragraph (2)(B), by striking “animal” and inserting “nonclinical tests”; and

(2) after subsection (y), by inserting the following:

“(z) Nonclinical test defined.—For purposes of this section, the term ‘nonclinical test’ means a test conducted in vitro, in silico, or in chemico, or a non-human in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug, and may include animal tests, or non-animal or human biology-based test methods, such as cell-based assays, microphysiological systems, or computer models.”.

(b) Biosimilar biological product applications.—Item (bb) of section 351(k)(2)(A)(i)(I) of the Public Health Service Act (42 U.S.C. 262(k)(2)(A)(i)(I)) is amended to read as follows:

“(bb) an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)); and”.

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

Section 351(k)(6) of the Public Health Service Act (42 U.S.C. 262(k)(6)) is amended—

(1) in the matter preceding subparagraph (A)—

(A) by striking “Upon review of” and inserting “The Secretary shall not make licensure as an interchangeable biological product effective with respect to”;

(B) by striking “relying on” and inserting “that relies on”; and

(C) by striking “the Secretary shall not make a determination under paragraph (4) that the second or subsequent biological product is interchangeable for any condition of use”; and

(2) in the flush text that follows subparagraph (C), by striking the period and inserting “, and the term ‘first interchangeable biosimilar biological product’ means any interchangeable biosimilar biological product that is approved on the first day on which such a product is approved as interchangeable with the reference product.”.

(a) In general.—Section 506I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amended—

(1) in subsection (a)—

(A) by striking “The holder of an application approved under subsection (c) or (j) of section 505” and inserting “The holder of an application approved under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act”;

(B) in paragraph (2), by inserting “(in the case of a biological product, the proper name)” after “established name”; and

(C) in paragraph (3), by striking “or abbreviated application number” and inserting “, abbreviated application number, or biologics license application number”; and

(2) in subsection (b)—

(A) in the matter preceding paragraph (1), by striking “The holder of an application approved under subsection (c) or (j)” and inserting “The holder of an application approved under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act”;

(B) in paragraph (1), by inserting “(in the case of a biological product, the proper name)” after “established name”; and

(C) in paragraph (2), by striking “or abbreviated application number” and inserting “, abbreviated application number, or biologics license application number”.

(b) Additional one-Time report.—Subsection (c) of section 506I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amended to read as follows:

“(c) Additional one-Time report.—Within 180 days of the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022, all holders of applications approved under subsection (a) or (k) of section 351 of the Public Health Service Act shall review the information in the list published under section 351(k)(9)(A) and shall submit a written notice to the Secretary—

“(1) stating that all of the application holder’s biological products in the list published under section 351(k)(9)(A) that are not listed as discontinued are available for sale; or

“(2) including the information required pursuant to subsection (a) or (b), as applicable, for each of the application holder’s biological products that are in the list published under section 351(k)(9)(A) and not listed as discontinued, but have been discontinued from sale or never have been available for sale.”.

(c) Purple book.—Section 506I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amended—

(1) in subsection (d)—

(A) by striking “or (c), the Secretary” and inserting “or (c)—

“(1) the Secretary”;

(B) by striking the period at the end, and inserting “; and”; and

(C) by adding at the end the following:

“(2) the Secretary may identify the application holder’s biological products as discontinued in the list published under section 351(k)(9)(A) of the Public Health Service Act, except that the Secretary shall remove from the list in accordance with section 351(k)(9)(B) of such Act any biological product for which a license has been revoked or suspended for reasons of safety, purity, or potency.”; and

(2) in subsection (e)—

(A) by inserting after the first sentence the following: “The Secretary shall update the list published under section 351(k)(9)(A) of the Public Health Service Act based on information provided under subsections (a), (b), and (c) by identifying as discontinued biological products that are not available for sale, except that any biological product for which the license has been revoked or suspended for reasons of safety, purity, or potency shall be removed from the list in accordance with section 351(k)(9)(B) of the Public Health Service Act.”; and

(B) in the last sentence—

(i) by striking “updates to the list” and inserting “updates to the lists published under section 505(j)(7)(A) of this Act and section 351(k)(9)(A) of the Public Health Service Act”; and

(ii) by striking “update the list” and inserting “update such lists”.

Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)(A)) is amended by adding at the end the following:

“(v) (I) With respect to an application submitted pursuant to subsection (b)(2) for a drug that is subject to section 503(b) for which the sole difference from a listed drug relied upon in the application is a difference in inactive ingredients not permitted under clause (iii) or (iv) of section 314.94(a)(9) of title 21, Code of Federal Regulations (or successor regulations), the Secretary shall make an evaluation with respect to whether such drug is a therapeutic equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to another approved drug product in the prescription drug product section of the list under this paragraph as follows:

“(aa) With respect to such an application submitted after the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022, the evaluation shall be made with respect to a listed drug relied upon in the application under subsection (b)(2) that is a pharmaceutical equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to the drug in the application under subsection (b)(2) at the time of approval of such application or not later than 180 days after the date of such approval, provided that the request for such a determination is made in the original application (or in a resubmission to a complete response letter), and all necessary data and information are submitted in the original application (or in a resubmission in response to a complete response letter) for the therapeutic equivalence evaluation, including information to demonstrate bioequivalence, in a form and manner prescribed by the Secretary.

“(bb) With respect to such an application submitted prior to the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022, with respect to an application approved on or after the date of enactment of such Act, the evaluation shall be made not later than 180 days after receipt of a request for a therapeutic equivalence evaluation submitted as part of a supplement to such application; or with respect to an application that was not approved as of the date of enactment of such Act, the evaluation shall be made not later than 180 days after the date of approval of such application if a request for such evaluation is submitted to the application, provided that—

“(AA) such request for a therapeutic equivalent evaluation is being sought with respect to a listed drug relied upon in the application, and the relied upon listed drug is in the prescription drug product section of the list under this paragraph and is a pharmaceutical equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to the drug for which a therapeutic equivalence evaluation is sought; and

“(BB) the initial submission containing such request, or the relevant application, includes all necessary data and information for the therapeutic equivalence evaluation, including information to demonstrate bioequivalence, in a form and manner prescribed by the Secretary.

“(II) When the Secretary makes an evaluation under subclause (I), the Secretary shall, in revisions made to the list pursuant to clause (ii), include such information for such drug.”.

(a) In general.—Section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) is amended—

(1) in paragraph (2)—

(A) by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and adjusting the margins accordingly;

(B) by striking “Approval of a product” and inserting the following:

“(A) IN GENERAL.—Approval of a product”;

(C) in clause (i) of such subparagraph (A), as so redesignated, by striking “appropriate postapproval studies” and inserting “an appropriate postapproval study or studies (which may be augmented or supported by real world evidence)”; and

(D) by adding at the end the following:

“(B) STUDIES NOT REQUIRED.—If the Secretary does not require that the sponsor of a product approved under accelerated approval conduct a postapproval study under this paragraph, the Secretary shall publish on the website of the Food and Drug Administration the rationale for why such study is not appropriate or necessary.

“(C) POSTAPPROVAL STUDY CONDITIONS.—Not later than the time of approval of a product under accelerated approval, the Secretary shall specify the conditions for a postapproval study or studies required to be conducted under this paragraph with respect to such product, which may include enrollment targets, the study protocol, and milestones, including the target date of study completion.

“(D) STUDIES BEGUN BEFORE APPROVAL.—The Secretary may require such study or studies to be underway prior to approval.”; and

(2) in paragraph (3)—

(A) by redesignating subparagraphs (A) through (D) as clauses (i) through (iv), respectively and adjusting the margins accordingly;

(B) by striking “The Secretary may” and inserting the following:

“(A) IN GENERAL.—The Secretary may”;

(C) in clause (i) of such subparagraph (A), as so redesignated, by striking “drug with due diligence” and inserting “product with due diligence, including with respect to conditions specified by the Secretary under paragraph (2)(C)”;

(D) in clause (iii) of such subparagraph (A), as so redesignated, by inserting “shown to be” after “product is not”; and

(E) by adding at the end the following:

“(B) EXPEDITED PROCEDURES DESCRIBED.—Expedited procedures described in this subparagraph shall consist of, prior to the withdrawal of accelerated approval—

“(i) providing the sponsor with—

“(I) due notice;

“(II) an explanation for the proposed withdrawal;

“(III) an opportunity for a meeting with the Commissioner or the Commissioner’s designee; and

“(IV) an opportunity for written appeal to—

“(aa) the Commissioner; or

“(bb) a designee of the Commissioner who has not participated in the proposal withdrawal of approval (other than a meeting pursuant to subclause (III)) and is not subordinate of an individual (other than the Commissioner) who participated in such proposed withdrawal;

“(ii) providing an opportunity for public comment on the proposing to withdrawal approval;

“(iii) the publication of a summary of the public comments received, and the Secretary’s response to such comments, on the website of the Food and Drug Administration; and

“(iv) convening and consulting an advisory committee on issues related to the proposed withdrawal, if requested by the sponsor and if no such advisory committee has previously advised the Secretary on such issues with respect to the withdrawal of the product prior to the sponsor’s request.”.

(b) Reports of postmarketing studies.—Section 506B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356b(a)) is amended—

(1) by redesignating paragraph (2) as paragraph (3); and

(2) by inserting after paragraph (1) the following:

“(2) ACCELERATED APPROVAL.—Notwithstanding paragraph (1), a sponsor of a drug approved under accelerated approval shall submit to the Secretary a report of the progress of any study required under section 506(c), including progress toward enrollment targets, milestones, and other information as required by the Secretary, not later than 180 days after the approval of such drug and not less frequently than every 180 days thereafter, until the study is completed or terminated.”.

(c) Enforcement.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 824, is further amended by adding at the end the following:

“(ll) The failure of a sponsor of a product approved under accelerated approval pursuant to section 506(c)—

“(1) to conduct with due diligence any postapproval study required under section 506(c) with respect to such product; or

“(2) to submit timely reports with respect to such product in accordance with section 506B(a)(2).”.

(d) Guidance.—

(1) IN GENERAL.—The Secretary of Health and Human Services shall issue guidance describing—

(A) how sponsor questions related to the identification of novel surrogate or intermediate clinical endpoints may be addressed in early-stage development meetings with the Food and Drug Administration;

(B) the use of novel clinical trial designs that may be used to conduct appropriate post-approval studies as may be required under section 506(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a);

(C) the expedited procedures described in section 506(c)(3)(B) of the Federal Food, Drug, and Cosmetic Act; and

(D) considerations related to the use of surrogate or intermediate clinical endpoints that may support the accelerated approval of an application under 506(c)(1)(A), including considerations in evaluating the evidence related to any such endpoints.

(2) FINAL GUIDANCE.—The Secretary shall issue—

(A) a draft guidance under paragraph (1) not later than 18 months after the date of enactment of this Act; and

(B) final guidance not later than 1 year after the close of the public comment period on such draft guidance.

(e) Rare disease endpoint advancement pilot.—

(1) IN GENERAL.—The Secretary of Health and Human Services shall establish a pilot program under which the Secretary will establish procedures to provide increased interaction with sponsors of rare disease drug development programs for purposes of advancing the development of efficacy endpoints, including surrogate and intermediate endpoints, for drugs intended to treat rare diseases, including through—

(A) determining eligibility of participants for such program; and

(B) developing and implementing a process for applying to, and participating in, such a program.

(2) PUBLIC WORKSHOPS.—The Secretary shall conduct up to 3 public workshops, which shall be completed not later than September 30, 2026, to discuss topics relevant to the development of endpoints for rare diseases, which may include discussions about—

(A) novel endpoints developed through the pilot program established under this subsection; and

(B) as appropriate, the use of real world evidence and real work data to support the validation of efficacy endpoints, including surrogate and intermediate endpoints, for rare diseases.

(3) REPORT.—Not later than September 30, 2027, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report describing the outcomes of the pilot program established under this subsection.

(4) GUIDANCE.—Not later than September 30, 2027, the Secretary shall issue guidance describing best practices and strategies for development of efficacy endpoints, including surrogate and intermediate endpoints, for rare diseases.

(5) SUNSET.—The Secretary may not accept any new application or request to participate in the program established by this subsection on or after October 1, 2027.

(f) Accelerated approval council.—

(1) GENERAL.—Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall establish an intra-agency coordinating council within the Food and Drug Administration to ensure the consistent and appropriate use of accelerated approval across the Food and Drug Administration, pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)).

(2) MEMBERSHIP.—The members of the Council shall consist of the following senior officials, or a designee of such official, from the Food and Drug Administration and relevant Centers:

(A) The Director of the Center for Drug Evaluation and Research.

(B) The Director of the Center for Biologics Evaluation and Research.

(C) The Director of the Oncology Center of Excellence.

(D) The Director of the Office of New Drugs.

(E) The Director of the Office of Orphan Products Development.

(F) The Director of the Office of Tissues and Advanced Therapies.

(G) The Director of the Office of Medical Policy.

(H) At least 3 directors of review division overseeing products approved under accelerated approval, including at least one director of a review division within the Office of Neuroscience.

(3) DUTIES OF THE COUNCIL.—

(A) MEETINGS.—The Council shall convene not fewer than 3 times per calendar year to discuss issues related to accelerated approval, including any relevant cross-disciplinary approaches related to product review with respect to accelerated approval.

(B) POLICY DEVELOPMENT.—The Council shall directly engage with product review teams to support the consistent and appropriate use of accelerated approval across the Food and Drug Administration. Such activities may include—

(i) developing guidance for Food and Drug Administration staff and best practices for, and across, product review teams, including with respect to communication between sponsors and the Food and Drug Administration and the review of products under accelerated approval;

(ii) providing training for product review teams; and

(iii) advising review divisions on product-specific development, review, and withdrawal of products under accelerated approval.

(4) PUBLICATION OF A REPORT.—Not later than 1 year after the date of enactment of this Act, and annually thereafter, the council shall publish on the public website of the Food and Drug Administration a report on the activities of the council.

(g) Rule of construction.—Nothing in this section (including the amendments made by this section) shall be construed to affect products approved under 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) prior to the date of enactment of this Act.

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

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

Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking “2022” and inserting “2027”.

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

Section 505(u) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(u)) is amended by—

(1) in paragraph (1)(A)(ii)(II), by adding “(other than bioavailability studies)” after “any clinical investigations”; and

(2) in paragraph (4), by striking “October 1, 2022” and inserting “October 1, 2027”.

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

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

Section 714A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d–3a) is amended—

(1) in subsection (a)—

(A) by inserting “, including cross-cutting operational positions,” after “professional positions”; and

(B) by inserting “and the regulation of food” after “medical products”; and

(2) in subsection (d)(1)—

(A) in the matter preceding subparagraph (A)—

(i) by striking “the 21st Century Cures Act” and inserting “the Food and Drug Administration Safety and Landmark Advancements Act of 2022”; and

(ii) by striking “that examines the extent” and all that follows through “, including” and inserting “that addresses”;

(B) in subparagraph (A)—

(i) by inserting “updated” before “analysis”; and

(ii) by striking “; and” and inserting a semicolon;

(C) by redesignating subparagraph (B) as subparagraph (C);

(D) by inserting after subparagraph (A) the following:

“(B) an analysis of how the Secretary has used the authorities provided under this section, and a plan for how the Secretary will use the authority under this section, and other applicable hiring authorities, for employees of the Food and Drug Administration; and”; and

(E) in subparagraph (C), as so redesignated, by striking “a recruitment” and inserting “an updated recruitment”.

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

This subtitle may be cited as the “Modernization of Cosmetics Regulation Act of 2022”.

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

(a) In general.—

(1) PROHIBITED ACTS.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended—

(A) by adding at the end the following:

“(fff) The failure to register or submit listing information in accordance with section 607.

“(ggg) The refusal or failure to follow an order under section 611.”; and

(B) in paragraph (d), by striking “or 564” and inserting “, 564, or 607”.

(2) ADULTERATED PRODUCTS.—Section 601 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amended by adding at the end the following:

“(f) If it has been manufactured or processed under conditions that do not meet good manufacturing practice regulations, as prescribed by the Food and Drug Administration in accordance with section 606.

“(g) If it is a cosmetic product, and the cosmetic product, including each ingredient in the cosmetic product, does not have adequate substantiation for safety, as defined in section 608(c).”.

(3) MISBRANDED COSMETICS.—Section 602(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 362(b)) is amended—

(A) by striking “and (2)” and inserting “(2)”; and

(B) by inserting after “numerical count” the following: “; and (3) the information required under section 609”.

(4) ADVERSE EVENT REPORTING.—The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended—

(A) in section 301(e) (21 U.S.C. 331(e))—

(i) by striking “564, 703” and inserting “564, 605, 703”; and

(ii) by striking “564, 760” and inserting “564, 605, 611, 760”;

(B) in section 301(ii) (21 U.S.C. 331(ii))—

(i) by striking “760 or 761) or” and inserting “604, 760, or 761) or”; and

(ii) by inserting “or required under section 605(a)” after “report (as defined under section 760 or 761”;

(C) in section 801(a) (21 U.S.C. 381(a))—

(i) by striking “under section 760 or 761” and inserting “under section 605, 760, or 761”;

(ii) by striking “defined in such section 760 or 761” and inserting “defined in section 604, 760, or 761”;

(iii) by striking “of such section 760 or 761” and inserting “of such section 605, 760, or 761”; and

(iv) by striking “described in such section 760 or 761” and inserting “described in such section 605, 760, or 761”; and

(D) in section 801(b) (21 U.S.C. 381(b))—

(i) by striking “requirements of sections 760 or 761,” and inserting “requirements of section 605, 760, or 761”;

(ii) by striking “as defined in section 760 or 761” and inserting “as defined in section 604, 760, or 761”; and

(iii) by striking “with section 760 or 761” and inserting “with section 605, 760, or 761”.

(b) Effective date.—The amendments made by subsection (a) shall take effect on the date that is 1 year after the date of enactment of this Act.

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

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.

(a) In general.—The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall assess the use of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products and the scientific evidence regarding the safety of such use in cosmetic products, including any risks associated with such use. In conducting such assessment, the Secretary may, as appropriate, consult with the National Center for Toxicological Research.

(b) Report.—Not later than 2 years after enactment of this Act, the Secretary shall publish on the website of the Food and Drug Administration a report summarizing the results of the assessment conducted under subsection (a).

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).

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

(b) Guidance.—Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall publish final guidance related to the draft guidance titled, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Availability” (81 Fed. Reg. 53486; August 12, 2016), consistent with section 403D of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).

(c) Inspections for certain dietary supplements.—The Secretary of Health and Human Services shall direct resources to inspections of facilities, suppliers, and dietary supplement types that present a high risk to public health (as identified by the Secretary).

(d) Misbranding.—Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following:

“(z) If it is a dietary supplement for which a responsible person is required under section 403D to file a listing, file a change to an existing listing, or provide additional information to the Secretary, and such person has failed to comply with any such requirements under section 403D with respect to such dietary supplement.”.

(e) New prohibited act.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 803(a), is further amended by adding at the end the following:

“(hhh) The introduction or delivery for introduction into interstate commerce of any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under section 201(ff).

“(iii) The introduction or delivery for introduction into interstate commerce of a dietary supplement that has been prepared, packed, or held using the assistance of, or at the direction of, a person debarred under section 306.”.

(a) Short title.—This subtitle may be cited as the “Food and Drug Administration Safety and Landmark Advancements Act of 2022” or the “VALID Act of 2022”.

(b) Table of contents.—The table of contents of this subtitle is as follows:

(a) In general.—Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended—

(1) by adding at the end the following:

“(ss) (1) The term ‘in vitro clinical test’ means an article specified in subparagraph (2) that is intended by its developer (as defined in section 587) to be used in the collection, preparation, analysis, or in vitro clinical examination of specimens taken or derived from the human body for the purpose of—

“(A) identifying or diagnosing a disease or condition;

“(B) providing information for diagnosing, screening, measuring, detecting, predicting, prognosing, analyzing, or monitoring a disease or condition, including by making a determination of an individual’s state of health; or

“(C) selecting, monitoring, or informing therapy or treatment for a disease or condition.

“(2) An article specified in this subparagraph is—

“(A) a test kit;

“(B) a test system;

“(C) a test protocol or laboratory test protocol;

“(D) an instrument (as defined in section 587(11));

“(E) a specimen receptacle (as defined in section 587(17));

“(F) software, excluding software that is excluded by section 520(o) from the definition of a device under section 201(h), that—

“(i) is a component or part of another in vitro clinical test or analyzes, processes, or interprets a signal or pattern from another in vitro clinical test; and

“(ii) does not analyze, process, or interpret a signal, pattern, or medical image from a device; and

“(G) subject to subparagraph (3), a component or part of a test, a test protocol, an instrument, an article, or software described in any of clauses (A) through (D) of such subparagraph, whether alone or in combination, including reagents, calibrators, and controls.

“(3) Notwithstanding subparagraph (2)(G), an article intended to be used as a component or part of an in vitro clinical test described in subparagraph (1) is excluded from the definition in subparagraph (1) if the article consists of any of the following:

“(A) Blood, blood components, or human cells or tissues, from the time of acquisition, donation, or recovery of such article, including determination of donor eligibility, as applicable, until such time as the article is released as a component or part of an in vitro clinical test by the establishment that collected such article.

“(B) An article used for invasive sampling, a needle, or a lancet, except to the extent such article, needle, or lancet is an integral component of an article for holding, storing, or transporting a specimen.

“(C) General purpose laboratory equipment, including certain pre-analytical equipment, as determined by the Secretary.

“(D) An article used solely for personal protection during the administering, conducting, or otherwise performing of test activities.”;

(2) by adding at the end of section 201(g) the following:

“(3) The term ‘drug’ does not include an in vitro clinical test.”; and

(3) in section 201(h)(1), in the matter following clause (C), by striking “section 520(o)” and inserting “section 520(o) or an in vitro clinical test”.

(b) Exclusion from definition of biological product.—Section 351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)) is amended—

(1) by striking “(1) The term ‘biological product’ means” and inserting “(1)(A) The term ‘biological product’ means”; and

(2) by adding at the end the following:

“(B) The term ‘biological product’ does not include an in vitro clinical test as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act.”.

(c) In vitro clinical test definition.—In this Act, the term “in vitro clinical test” has the meaning given such term in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).

The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended—

(1) by amending the heading of chapter V to read as follows: “Drugs, Devices, and In Vitro Clinical Tests”; and

(2) by adding at the end of chapter V the following: