SEC. 1. Short Title.
This division may be cited as the “FDA User Fee Reauthorization Act of 2022”.
Division F — Fda User Fee Reauthorization Act of 2022
DIVISION F Fda User Fee Reauthorization Act of 2022
SEC. 2. Table of Contents.
The table of contents for this division is as follows:
DIVISION F— FDA USER FEE REAUTHORIZATION ACT OF 2022
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I— FEES RELATING TO DRUGS
Sec. 1001. Short title; finding.
Sec. 1002. Definitions.
Sec. 1003. Authority to assess and use drug fees.
Sec. 1004. Reauthorization; reporting requirements.
Sec. 1005. Sunset dates.
Sec. 1006. Effective date.
Sec. 1007. Savings clause.
TITLE II— FEES RELATING TO DEVICES
Sec. 2001. Short title; finding.
Sec. 2002. Definitions.
Sec. 2003. Authority to assess and use device fees.
Sec. 2004. Reauthorization; reporting requirements.
Sec. 2005. Conformity assessment pilot program.
Sec. 2006. Reauthorization of third-party review program.
Sec. 2007. Sunset dates.
Sec. 2008. Effective date.
Sec. 2009. Savings clause.
TITLE III— FEES RELATING TO GENERIC DRUGS
Sec. 3001. Short title; finding.
Sec. 3002. Authority to assess and use human generic drug fees.
Sec. 3003. Reauthorization; reporting requirements.
Sec. 3004. Sunset dates.
Sec. 3005. Effective date.
Sec. 3006. Savings clause.
TITLE IV— FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 4001. Short title; finding.
Sec. 4002. Definitions.
Sec. 4003. Authority to assess and use biosimilar biological product fees.
Sec. 4004. Reauthorization; reporting requirements.
Sec. 4005. Sunset dates.
Sec. 4006. Effective date.
Sec. 4007. Savings clause.
TITLE V— REAUTHORIZATION OF OTHER PROVISIONS
Sec. 5001. Reauthorization of the best pharmaceuticals for children program.
Sec. 5002. Reauthorization of the humanitarian device exemption incentive.
Sec. 5003. Reauthorization of the pediatric device consortia program.
Sec. 5004. Reauthorization of provision pertaining to drugs containing single enantiomers.
Sec. 5005. Reauthorization of the critical path public-private partnership.
Sec. 5006. Reauthorization of orphan drug grants.
Sec. 5007. Reauthorization of certain device inspections.
Sec. 5008. Reauthorization of reporting requirements related to pending generic drug applications and priority review applications.
TITLE I Fees Relating to Drugs
SEC. 1001. Short Title; Finding.
Short Title.— This title may be cited as the “Prescription Drug User Fee Amendments of 2022”.
Finding.— Congress finds that the fees authorized by the amendments made by this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.
SEC. 1002. Definitions.
Human Drug Application.— Section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended, 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”.
Prescription Drug Product.— Section 735(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(3)) is amended—
by redesignating subparagraphs (A), (B), and (C) as clauses (i), (ii), and (iii), respectively;
by striking “ (3) The term” and inserting “ (3)(A) The term”;
by striking “ Such term does not include whole blood” and inserting the following:
“(B) Such term does not include whole blood”
by striking “ an allergenic extract product,” and inserting “ an allergenic extract product licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022,” ; and
by adding at the end the following:
“(C)
(i) If a written request to place a product in the discontinued section of either of the lists referenced in subparagraph (A)(iii) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, 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.
“(ii) For purposes of this subparagraph, a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.”
Skin-Test Diagnostic Product.— Section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) is amended by adding at the end the following:
“(12) The term ‘skin-test diagnostic product’—
“(A) means a product—
“(i) for prick, scratch, intradermal, or subcutaneous administration;
“(ii) expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect;
“(iii) not intended to be a preventive or therapeutic intervention; and
“(iv) intended to detect an immediate- or delayed-type skin hypersensitivity reaction to aid in the diagnosis of—
“(I) an allergy to an antimicrobial agent;
“(II) an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or
“(III) infection with fungal or mycobacterial pathogens; and
“(B) includes positive and negative controls required to interpret the results of a product described in subparagraph (A).”
SEC. 1003. Authority to Assess and Use Drug Fees.
Types of Fees.—
Human drug application fee.— Section 736(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is amended—
in the matter preceding paragraph (1), by striking “ fiscal year 2018” and inserting “ fiscal year 2023”;
in paragraph (1)(A), by striking “ (c)(5)” each place it appears and inserting “ (c)(6)”;
in paragraph (1)(C), by inserting “ prior to approval” after “ or was withdrawn”; and
in paragraph (1), by adding at the end the following:
“(H) Exception for skin-test diagnostic products.—A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A).”
Prescription drug program fee.— Section 736(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(2)) is amended—
in subparagraph (A)—
by striking “ Except as provided in subparagraphs (B) and (C)” and inserting the following:
“(i) Payment of fees.—Except as provided in subparagraphs (B) and (C)”
by striking “ subsection (c)(5)” and inserting “ subsection (c)(6)”; and
by adding at the end the following:
“(ii) Special rule for 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 referenced in section 735(3)(A)(iii), and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for a fiscal year in which the fee is payable.”
; and
by amending subparagraph (B) to read as follows:
“(B) Exception for certain prescription drug products.—A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—
“(i) a large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to 100 mL, not including powders for reconstitution or pharmacy bulk packages) identified on the list compiled under section 505(j)(7);
“(ii) pharmaceutically equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulation)) to another product on the list of products compiled under section 505(j)(7) (not including the discontinued section of such list); or
“(iii) a skin-test diagnostic product.”
Fee Revenue Amounts.—
In general.— Paragraph (1) of section 736(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows:
“(1) In general.—For each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of—
“(A) the annual base revenue for the fiscal year (as determined under paragraph (3));
“(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));
“(C) the dollar amount equal to the strategic hiring and retention adjustment for the fiscal year (as determined under subsection (c)(2));
“(D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3));
“(E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4));
“(F) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(5)); and
“(G) additional dollar amounts for each fiscal year as follows:
“(i) $65,773,693 for fiscal year 2023.
“(ii) $25,097,671 for fiscal year 2024.
“(iii) $14,154,169 for fiscal year 2025.
“(iv) $4,864,860 for fiscal year 2026.
“(v) $1,314,620 for fiscal year 2027.”
Annual base revenue.— Paragraph (3) of section 736(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows:
“(3) Annual base revenue.—For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—
“(A) for fiscal year 2023, $1,151,522,958; and
“(B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(4) or (c)(5).”
Adjustments; Annual Fee Setting.—
Inflation adjustment.— Section 736(c)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)(1)(B)(ii)) is amended by striking “ Washington-Baltimore, DC–MD–VA–WV” and inserting “ Washington-Arlington-Alexandria, DC–VA–MD–WV”.
Strategic hiring and retention adjustment.— Section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended—
by redesignating paragraphs (2) through (6) as paragraphs (3) through (7), respectively; and
by inserting after paragraph (1) the following:
“(2) Strategic hiring and retention adjustment.—For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by the following amounts:
“(A) For fiscal year 2023, $9,000,000.
“(B) For each of fiscal years 2024 through 2027, $4,000,000.”
Capacity planning adjustment.— Paragraph (3), as redesignated, of section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
“(3) Capacity planning adjustment.—
“(A) In general.—For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted in accordance with paragraphs (1) and (2), such revenue shall be adjusted further for such fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for the process for the review of human drug applications.
“(B) Methodology.—For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled ‘Prescription Drug User Fee Rates for Fiscal Year 2021’ published in the Federal Register on August 3, 2020 (85 Fed. Reg. 46651). The workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and, as feasible, additional activities that are directly related to the direct review of applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved prescription drug products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.
“(C) Limitation.—Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year), (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year), and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment for the fiscal year).
“(D) Publication in federal register.—The Secretary shall publish in the Federal Register notice under paragraph (6) of the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.”
Operating reserve adjustment.— Paragraph (4), as redesignated, of section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended—
by amending subparagraph (A) to read as follows:
“(A) Increase.—For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year in at least the following amounts:
“(i) For fiscal year 2023, at least 8 weeks of operating reserves.
“(ii) For fiscal year 2024, at least 9 weeks of operating reserves.
“(iii) For fiscal year 2025 and subsequent fiscal years, at least 10 weeks of operating reserves.”
; and
in subparagraph (C), by striking “ paragraph (5)” and inserting “ paragraph (6)”.
Additional direct cost adjustment.— Paragraph (5), as redesignated, of section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
“(5) Additional direct cost adjustment.—
“(A) Increase.—The Secretary shall, in addition to adjustments under paragraphs (1), (2), (3), and (4), further increase the fee revenue and fees—
“(i) for fiscal year 2023, by $44,386,150; and
“(ii) for each of fiscal years 2024 through 2027, by the amount set forth in clauses (i) through (iv) of subparagraph (B), as applicable, multiplied by the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2021.
“(B) Applicable amounts.—The amounts referred to in subparagraph (A)(ii) are the following:
“(i) For fiscal year 2024, $60,967,993.
“(ii) For fiscal year 2025, $35,799,314.
“(iii) For fiscal year 2026, $35,799, 314.
“(iv) For fiscal year 2027, $35,799,314.”
Annual fee setting.— Paragraph (6), as redesignated, of section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended by striking “ September 30, 2017” and inserting “ September 30, 2022”.
Crediting and Availability of Fees.— Section 736(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended by striking “ fiscal years 2018 through 2022” and inserting “ fiscal years 2023 through 2027”.
Written Requests for Waivers, Reductions, Exemptions, and Returns; Disputes Concerning Fees.— Section 736(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is amended to read as follows:
“(i) Written Requests for Waivers, Reductions, Exemptions, and Returns; Disputes Concerning Fees.—To qualify for consideration for a waiver or reduction under subsection (d), an exemption under subsection (k), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall—
“(1) not later than 180 days after such fee is due, submit to the Secretary a written request justifying such waiver, reduction, exemption, or return; and
“(2) include in the request any legal authorities under which the request is made.”
Orphan Drugs.— Section 736(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is amended—
in paragraph (1)(B), by striking “ during the previous year” and inserting “ as determined under paragraph (2)”; and
by amending paragraph (2) to read as follows:
“(2) Evidence of qualification.—An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that the applicant’s gross annual revenues did not exceed $50,000,000 for the last calendar year ending prior to the fiscal year for which the exemption is requested. Such certification shall be supported by—
“(A) tax returns submitted to the United States Internal Revenue Service; or
“(B) as necessary, other appropriate financial information.”
SEC. 1004. Reauthorization; Reporting Requirements.
Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) is amended—
in subsection (a)(1), by striking “ Beginning with fiscal year 2018, not” and inserting “ Not”;
by striking “ Prescription Drug User Fee Amendments of 2017” each place it appears and inserting “ Prescription Drug User Fee Amendments of 2022”;
in subsection (a)(3)(A), by striking “ Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter” and inserting “ Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this part”;
in subsection (a)(4), by striking “ Beginning with fiscal year 2020, the” and inserting “ The”;
in subsection (b), by striking “ Beginning with fiscal year 2018, not” and inserting “ Not”;
in subsection (c), by striking “ Beginning with fiscal year 2018, for” and inserting “ For”; and
in subsection (f)—
in paragraph (1), in the matter preceding subparagraph (A), by striking “ fiscal year 2022” and inserting “ fiscal year 2027”; and
in paragraph (5), by striking “ January 15, 2022” and inserting “ January 15, 2027”.
SEC. 1005. Sunset Dates.
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.
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.
Previous Sunset Provision.— Effective October 1, 2022, subsections (a) and (b) of section 104 of the FDA Reauthorization Act of 2017 (Public Law 115–52) are repealed.
SEC. 1006. Effective Date.
The amendments made by this title shall take effect on October 1, 2022, or the date of the enactment of this Act, whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) shall be assessed for all human drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act.
SEC. 1007. Savings Clause.
Notwithstanding the amendments made by this title, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.
TITLE II Fees Relating to Devices
SEC. 2001. Short Title; Finding.
Short Title.— This title may be cited as the “Medical Device User Fee Amendments of 2022”.
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 (21 U.S.C. 379i et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.
SEC. 2002. Definitions.
Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i) is amended—
in paragraph (9)—
in the matter preceding subparagraph (A), by striking “ and premarket notification submissions” and inserting “ premarket notification submissions, and de novo classification requests”;
in subparagraph (D), by striking “ and submissions” and inserting “ submissions, and de novo classification requests”;
in subparagraph (F), by striking “ and premarket notification submissions” and inserting “ premarket notification submissions, and de novo classification requests”;
in each of subparagraphs (G) and (H), by striking “ or submissions” and inserting “ submissions, or requests”; and
in subparagraph (K), by striking “ or premarket notification submissions” and inserting “ premarket notification submissions, or de novo classification requests”; and
in paragraph (11), by striking “ 2016” and inserting “ 2021”.
SEC. 2003. Authority to Assess and Use Device Fees.
Types of Fees.— Section 738(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is amended—
in paragraph (1), by striking “ fiscal year 2018” and inserting “ fiscal year 2023”; and
in paragraph (2)—
in subparagraph (A)—
in the matter preceding clause (i), by striking “ October 1, 2017” and inserting “ October 1, 2022”;
in clause (iii), by striking “ 75 percent” and inserting “ 80 percent”; and
in clause (viii), by striking “ 3.4 percent” and inserting “ 4.5 percent”;
in subparagraph (B)(iii), by striking “ or premarket notification submission” and inserting “ premarket notification submission, or de novo classification request”; and
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”.
Fee Amounts.— Section 738(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is amended—
in paragraph (1), by striking “ 2018 through 2022” and inserting “ 2023 through 2027”;
by amending paragraph (2) to read as follows:
“(2) Base fee amounts specified.—For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:
| “Fee Type | Fiscal Year 2023 | Fiscal Year 2024 | Fiscal Year 2025 | Fiscal Year 2026 | Fiscal Year 2027 |
|---|---|---|---|---|---|
| Premarket Application | $425,000 | $435,000 | $445,000 | $455,000 | $470,000 |
| Establishment Registration | $6,250 | $6,875 | $7,100 | $7,575 | $8,465”; and |
by amending paragraph (3) to read as follows:
“(3) Total revenue amounts specified.—For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:
“(A) $312,606,000 for fiscal year 2023.
“(B) $335,750,000 for fiscal year 2024.
“(C) $350,746,400 for fiscal year 2025.
“(D) $366,486,300 for fiscal year 2026.
“(E) $418,343,000 for fiscal year 2027.”
Annual Fee Setting; Adjustments.— Section 738(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended—
in paragraph (1), by striking “ 2017” and inserting “ 2022”;
in paragraph (2)—
in subparagraph (A), by striking “ 2018” and inserting “ 2023”;
in subparagraph (B)—
in the matter preceding clause (i), by striking “ fiscal year 2018” and inserting “ fiscal year 2023”; and
in clause (ii), by striking “ fiscal year 2016” and inserting “ fiscal year 2022”;
in subparagraph (C), by striking “ Washington-Baltimore, DC–MD–VA–WV” and inserting “ Washington-Arlington-Alexandria, DC–VA–MD–WV”; and
in subparagraph (D), in the matter preceding clause (i), by striking “ fiscal years 2018 through 2022” and inserting “ fiscal years 2023 through 2027”;
in paragraph (3), by striking “ 2018 through 2022” and inserting “ 2023 through 2027”;
by redesignating paragraphs (4) and (5) as paragraphs (7) and (8), respectively; and
by inserting after paragraph (3) the following:
“(4) Performance improvement adjustment.—
“(A) In general.—For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2) and (3), the base establishment registration fee amounts for such fiscal year shall be increased to reflect changes in the resource needs of the Secretary due to improved review performance goals for the process for the review of device applications identified in the letters described in section 2001(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 such goal for fiscal year 2023 is met.
“(II) For fiscal year 2026:
“(aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.
“(bb) $36,792,200 if such goal for fiscal year 2024 is met.
“(III) For fiscal year 2027:
“(aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for each of fiscal years 2024 and 2025 is not met.
“(bb) $36,792,200 if such goal for fiscal year 2024 is met and such goal for fiscal year 2025 is not met.
“(cc) $40,572,600 if such goal for fiscal year 2025 is met.
“(ii) De novo classification 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 such goal for fiscal year 2023 is met.
“(II) For fiscal year 2027:
“(aa) $6,323,500 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.
“(bb) $11,765,400 if such goal for fiscal year 2024 is met.
“(iii) Premarket notification and premarket approval amount.—For purposes of subparagraph (A), with respect to the 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal, the amounts determined under this subparagraph are as follows:
“(I) For fiscal year 2026, $1,020,000 if the 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 are not met.
“(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 2001(b) of the Medical Device User Fee Amendments of 2022 and based on data available, as follows:
“(i) The performance of the Presubmission Written Feedback goal shall be based on data available as of—
“(I) for fiscal year 2023, March 31, 2024;
“(II) for fiscal year 2024, March 31, 2025; and
“(III) for fiscal year 2025, March 31, 2026.
“(ii) The performance of the De Novo Decision goal, 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal shall be based on data available as of—
“(I) for fiscal year 2023, March 31, 2025; and
“(II) for fiscal year 2024, March 31, 2026.
“(D) Goals defined.—For purposes of this paragraph, the terms ‘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’ refer to the goals identified by the same names in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022.
“(5) Hiring adjustment.—
“(A) In general.—For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2), (3), and (4), if applicable, if the number of hires to support the process for the review of device applications falls below the thresholds specified in subparagraph (B) for the applicable fiscal years, the base establishment registration fee amounts shall be decreased as the Secretary determines necessary to achieve a reduction in total fee collections equal to the hiring adjustment amount under subparagraph (C).
“(B) Thresholds.—The thresholds specified in this subparagraph are as follows:
“(i) For fiscal year 2025, the threshold is 123 hires for fiscal year 2023.
“(ii) For fiscal year 2026, the threshold is 38 hires for fiscal year 2024.
“(iii) For fiscal year 2027, the threshold is—
“(I) 22 hires for fiscal year 2025 if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i); or
“(II) 75 hires for fiscal year 2025 if such fees are so increased.
“(C) Hiring adjustment amount.—The hiring adjustment amount for fiscal year 2025 and each subsequent fiscal year is the product of—
“(i) the number of hires by which the hiring goal specified in subparagraph (D) for the fiscal year before the prior fiscal year was not met;
“(ii) $72,877; and
“(iii) the applicable inflation adjustment under paragraph (2)(B) for the fiscal year for which the hiring goal was not met.
“(D) Hiring goals.—The hiring goals for each of fiscal years 2023 through 2025 are as follows:
“(i) For fiscal year 2023, 144 hires.
“(ii) For fiscal year 2024, 42 hires.
“(iii) For fiscal year 2025:
“(I) 24 hires if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i).
“(II) 83 hires if the base establishment registration fees are increased by the amount determined under paragraph (4)(A)(i).
“(E) Number of hires.—For purposes of this paragraph, the number of hires for a fiscal year shall be determined by the Secretary as set forth in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022.
“(6) Operating reserve adjustment.—
“(A) In general.—For each of fiscal years 2023 through 2027, after the adjustments under paragraphs (2), (3), (4), and (5), if applicable, if the Secretary has operating reserves of carryover user fees for the process for the review of device applications in excess of the designated amount in subparagraph (B), the Secretary shall decrease the base establishment registration fee amounts to provide for not more than such designated amount of operating reserves.
“(B) Designated amount.—Subject to subparagraph (C), for each fiscal year, the designated amount in this subparagraph is equal to the sum of—
“(i) 13 weeks of operating reserves of carryover user fees; and
“(ii) 1 month of operating reserves maintained pursuant to paragraph (8).
“(C) Excluded amount.—For the period of fiscal years 2023 through 2026, a total amount equal to $118,000,000 shall not be considered part of the designated amount under subparagraph (B) and shall not be subject to the decrease under subparagraph (A).”
Conditions.— Section 738(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(g)) is amended—
in paragraph (1)(A), by striking “ $320,825,000” and inserting “ $398,566,000”; and
in paragraph (2), by inserting “ de novo classification requests,” after “ class III device,”.
Crediting and Availability of Fees.— Section 738(h)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)(3)) is amended to read as follows:
“(3) Authorization of appropriations.—
“(A) In general.—For each of fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined under subparagraph (B), less the amount of reductions determined under subparagraph (C).
“(B) Revenue amount.—For purposes of this paragraph, the revenue amount for each fiscal year is the sum of—
“(i) the total revenue amount under subsection (b)(3) for the fiscal year, as adjusted under paragraphs (2) and (3) of subsection (c); and
“(ii) the performance improvement adjustment amount for the fiscal year under subsection (c)(4), if applicable.
“(C) Amount of reductions.—For purposes of this paragraph, the amount of reductions for each fiscal year is the sum of—
“(i) the hiring adjustment amount for the fiscal year under subsection (c)(5), if applicable; and
“(ii) the operating reserve adjustment amount for the fiscal year under subsection (c)(6), if applicable.”
SEC. 2004. Reauthorization; Reporting Requirements.
Performance Reports.— Section 738A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)) is amended—
by striking “ fiscal year 2018” each place it appears and inserting “ fiscal year 2023”;
by striking “ Medical Device User Fee Amendments of 2017” each place it appears and inserting “ Medical Device User Fee Amendments of 2022”;
in paragraph (1)—
in subparagraph (A), by redesignating the second clause (iv) (relating to analysis) as clause (v); and
in subparagraph (A)(iv), by striking “ fiscal year 2020” and inserting “ fiscal year 2023”; and
in paragraph (4), by striking “ 2018 through 2022” and inserting “ 2023 through 2027”.
Reauthorization.— Section 738A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(b)) is amended—
in paragraph (1), by striking “ 2022” and inserting “ 2027”; and
in paragraph (5), by striking “ 2022” and inserting “ 2027”.
SEC. 2005. Conformity Assessment Pilot Program.
Section 514(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(d)) is amended to read as follows:
“(d) Accreditation Scheme for Conformity Assessment.—
“(1) In general.—The Secretary shall establish a program under which—
“(A) testing laboratories meeting criteria specified in guidance by the Secretary may be accredited, by accreditation bodies meeting criteria specified in guidance by the Secretary, to conduct testing to support the assessment of the conformity of a device to certain standards recognized under this section; and
“(B) subject to paragraph (2), results from tests conducted to support the assessment of conformity of devices as described in subparagraph (A) conducted by testing laboratories accredited pursuant to this subsection shall be accepted by the Secretary for purposes of demonstrating such conformity unless the Secretary finds that certain results of such tests should not be so accepted.
“(2) Secretarial review of accredited laboratory results.—The Secretary may—
“(A) review the results of tests conducted by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such results or of the processes of accredited bodies or testing laboratories;
“(B) following such review, take additional measures under this Act, as the Secretary determines appropriate, such as—
“(i) suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under paragraph (1)(A); or
“(ii) requesting additional information with respect to a device; and
“(C) if the Secretary becomes aware of information materially bearing on the safety or effectiveness of a device for which an assessment of conformity was supported by testing conducted by a testing laboratory accredited under this subsection, take such additional measures under this Act, as the Secretary determines appropriate, such as—
“(i) suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under paragraph (1)(A); or
“(ii) requesting additional information with regard to such device.
“(3) Report.—The Secretary shall make available on the internet website of the Food and Drug Administration an annual report on the progress of the program under this subsection.”
SEC. 2006. Reauthorization of Third-Party Review Program.
Section 523(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m(c)) is amended by striking “ October 1” and inserting “ December 17”.
SEC. 2007. Sunset Dates.
Authorization.— Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 379j) shall cease to be effective October 1, 2027.
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.
Previous Sunset Provisions.— Effective October 1, 2022, subsections (a) and (b) of section 210 of the FDA Reauthorization Act of 2017 (Public Law 115–52) are repealed.
SEC. 2008. Effective Date.
The amendments made by this title shall take effect on October 1, 2022, or the date of the enactment of this Act, whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.) shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act received on or after October 1, 2022, regardless of the date of the enactment of this Act.
SEC. 2009. Savings Clause.
Notwithstanding the amendments made by this title, part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act (as defined in such part as of such day) that on or after October 1, 2017, but before October 1, 2022, were received by the Food and Drug Administration with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.
TITLE III Fees Relating to Generic Drugs
SEC. 3001. Short Title; Finding.
Short Title.— This title may be cited as the “Generic Drug User Fee Amendments of 2022”.
Finding.— Congress finds that the fees authorized by the amendments made by this title will be dedicated to human generic drug activities, as set forth in the goals identified for purposes of part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.
SEC. 3002. Authority to Assess and Use Human Generic Drug Fees.
Types of Fees.— Section 744B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(a)) is amended—
in the matter preceding paragraph (1), by striking “ 2018” and inserting “ 2023”;
in paragraph (2)(C), by striking “ 2018 through 2022” and inserting “ 2023 through 2027”;
in paragraph (3)(B), by striking “ 2018 through 2022” and inserting “ 2023 through 2027”;
in paragraph (4)(D), by striking “ 2018 through 2022” and inserting “ 2023 through 2027”; and
in paragraph (5)(D), by striking “ 2018 through 2022” and inserting “ 2023 through 2027”.
Fee Revenue Amounts.— Section 744B(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(b)) is amended—
in paragraph (1)—
in subparagraph (A)—
in the heading, by striking “ 2018” and inserting “ 2023”;
by striking “ 2018” and inserting “ 2023”; and
by striking “ $493,600,000” and inserting “ $582,500,000”; and
by amending subparagraph (B) to read as follows:
“(B) Fiscal years 2024 through 2027.—
“(i) In general.—For each of the fiscal years 2024 through 2027, fees under paragraphs (2) through (5) of subsection (a) shall be established to generate a total estimated revenue amount under such subsection that is equal to the base revenue amount for the fiscal year under clause (ii), as adjusted pursuant to subsection (c).
“(ii) Base revenue amount.—The base revenue amount for a fiscal year referred to in clause (i) is equal to the total revenue amount established under this paragraph for the previous fiscal year, not including any adjustments made for such previous fiscal year under subsection (c)(3).”
; and
in paragraph (2)—
in subparagraph (C), by striking “ one-third the amount” and inserting “ twenty-four percent”;
in subparagraph (D), by striking “ Seven percent” and inserting “ Six percent”; and
in subparagraph (E)(i), by striking “ Thirty-five percent” and inserting “ Thirty-six percent”.
Adjustments.— Section 744B(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(c)) is amended—
in paragraph (1)—
in the matter preceding subparagraph (A)—
by striking “ 2019” and inserting “ 2024”; and
by striking “ to equal the product of the total revenues established in such notice for the prior fiscal year multiplied” and inserting “ to equal the base revenue amount for the fiscal year (as specified in subsection (b)(1)(B)(ii)) multiplied”; and
in subparagraph (C), by striking “ Washington-Baltimore, DC–MD–VA–WV” and inserting “ Washington-Arlington-Alexandria, DC–VA–MD–WV”; and
by striking paragraph (2) and inserting the following:
“(2) Capacity planning adjustment.—
“(A) In general.—Beginning with fiscal year 2024, the Secretary shall, in addition to the adjustment under paragraph (1), further increase the fee revenue and fees under this section for a fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for human generic drug activities.
“(B) Capacity planning methodology.—The Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—
“(i) be derived from the methodology and recommendations made in the report titled ‘Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations’ announced in the Federal Register on August 3, 2020 (85 Fed. Reg. 46658); and
“(ii) incorporate approaches and attributes determined appropriate by the Secretary, including approaches and attributes made in such report, except that in incorporating such approaches and attributes the workload categories used in forecasting resources shall only be the workload categories specified in section VIII.B.2.e. of the letters described in section 3001(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 a fiscal year 2024 adjustment, the Secretary determines that during the period from April 1, 2021, through March 31, 2023—
“(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,000; or
“(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as that term is defined in section XI of the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022);
“(II) for purposes of a fiscal year 2025 adjustment, the Secretary determines that during the period from April 1, 2022, through March 31, 2024—
“(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or
“(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined);
“(III) for purposes of a fiscal year 2026 adjustment, the Secretary determines that during the period from April 1, 2023, through March 31, 2025—
“(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or
“(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); and
“(IV) for purposes of a fiscal year 2027 adjustment, the Secretary determines that during the period from April 1, 2024, through March 31, 2026—
“(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or
“(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined).
“(D) Publication in federal register.—The Secretary shall publish in the Federal Register notice referred to in subsection (a) the fee revenue and fees resulting from the adjustment and the methodology under this paragraph.
“(3) Operating reserve adjustment.—
“(A) In general.—For fiscal year 2024 and each subsequent fiscal year, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees under this section for such fiscal year if such an adjustment is necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in subparagraph (B) with respect to that fiscal year.
“(B) Number of weeks.—The number of weeks specified in this subparagraph is—
“(i) 8 weeks for fiscal year 2024;
“(ii) 9 weeks for fiscal year 2025; and
“(iii) 10 weeks for each of fiscal year 2026 and 2027.
“(C) Decrease.—If the Secretary has carryover balances for human generic drug activities in excess of 12 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 12 weeks of such operating reserves.
“(D) Rationale for adjustment.—If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under subsection (a) publishing the fee revenue and fees for the fiscal year involved.”
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—
in the paragraph heading, by striking “ 2018 through 2022” and inserting “ 2023 through 2027”; and
by striking “ more than 60 days before the first day of each of fiscal years 2018 through 2022” and inserting “ later than 60 days before the first day of each of fiscal years 2023 through 2027”.
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”.
Crediting and Availability of Fees.— Section 744B(i)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(i)(3)) is amended by striking “ fiscal years 2018 through 2022” and inserting “ fiscal years 2023 through 2027”.
SEC. 3003. Reauthorization; Reporting Requirements.
Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) is amended—
in subsection (a)(1), by striking “ Beginning with fiscal year 2018, not” and inserting “ Not”;
by striking “ Generic Drug User Fee Amendments of 2017” each place it appears and inserting “ Generic Drug User Fee Amendments of 2022”;
in subsection (a)(2), by striking “ Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter” and inserting “ Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this part”;
in subsection (a)(3), by striking “ Beginning with fiscal year 2020, the” and inserting “ The”;
in subsection (b), by striking “ Beginning with fiscal year 2018, not” and inserting “ Not”;
in subsection (c), by striking “ Beginning with fiscal year 2018, for” and inserting “ For”; and
in subsection (f)—
in paragraph (1), in the matter preceding subparagraph (A), by striking “ fiscal year 2022” and inserting “ fiscal year 2027”; and
in paragraph (5), by striking “ January 15, 2022” and inserting “ January 15, 2027”.
SEC. 3004. Sunset Dates.
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.
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.
Previous Sunset Provision.— Effective October 1, 2022, subsections (a) and (b) of section 305 of the FDA Reauthorization Act of 2017 (Public Law 115–52) are repealed.
SEC. 3005. Effective Date.
The amendments made by this title shall take effect on October 1, 2022, or the date of the enactment of this Act, whichever is later, except that fees under part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41 et seq.) shall be assessed for all abbreviated new drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act.
SEC. 3006. Savings Clause.
Notwithstanding the amendments made by this title, part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41 et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to abbreviated new drug applications (as defined in such part as of such day) that were received by the Food and Drug Administration within the meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical ingredients that were first referenced on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.
TITLE IV Fees Relating to Biosimilar Biological Products
SEC. 4001. Short Title; Finding.
Short Title.— This title may be cited as the “Biosimilar User Fee Amendments of 2022”.
Finding.— Congress finds that the fees authorized by the amendments made by this title will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.
SEC. 4002. Definitions.
Adjustment Factor.— Section 744G(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51(1)) is amended to read as follows:
“(1) The term ‘adjustment factor’ applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items) for September of the preceding fiscal year divided by such Index for September 2011.”
Biosimilar Biological Product Application.— Section 744G(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51(4)(B)(iii)) is amended—
by striking subclause (II) (relating to an allergenic extract product); and
by redesignating subclauses (III) and (IV) as subclauses (II) and (III), respectively.
SEC. 4003. Authority to Assess and Use Biosimilar Biological Product Fees.
Types of Fees.—
In general.— The matter preceding paragraph (1) in section 744H(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)) is amended by striking “ fiscal year 2018” and inserting “ fiscal year 2023”.
Initial biosimilar biological product development fee.— Clauses (iv)(I) and (v)(II) of section 744H(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)(1)(A)) are each amended by striking “ 5 days” and inserting “ 7 days”.
Annual biosimilar biological product development fee.— Section 744H(a)(1)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)(1)(B)) is amended—
in clause (i), by inserting before the period at the end the following: “ , 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”;
in clause (iii)—
in subclause (I), by striking “ or” at the end;
in subclause (II), by striking the period at the end and inserting “ ; or”; and
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
in clause (iv), by striking “ is accepted for filing on or after October 1 of such fiscal year” and inserting “ is subsequently accepted for filing”.
Reactivation fee.— Section 744H(a)(1)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)(1)(D)) is amended to read as follows:
“(D) Reactivation fee.—
“(i) In general.—A person that has discontinued participation in the biosimilar biological product development program for a product under subparagraph (C), or who has been administratively removed from 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 a fee (referred to in this section as ‘reactivation fee’) by the earlier of the following:
“(I) Not later than 7 days after the Secretary grants a request by such person for a biosimilar biological product development meeting for the product (after the date on which such participation was discontinued or the date of administrative removal, as applicable).
“(II) Upon the date of submission (after the date on which such participation was discontinued or the date of administrative removal, as applicable) by such person of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for that product.
“(ii) Application of annual fee.—A person that pays a reactivation fee for a product shall pay for such product, beginning in the next fiscal year, the annual biosimilar biological product development fee under subparagraph (B), except 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.”
Effect of failure to pay fees.— Section 744H(a)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)(1)(E)) is amended by adding at the end the following:
“(v) Administrative removal from the biosimilar biological product development program.—If a person has failed to pay an annual biosimilar biological product development fee for a product as required under subparagraph (B) for a period of 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.”
Biosimilar biological product application fee.— Section 744H(a)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)(2)(D)) is amended by inserting after “ or was withdrawn” the following: “ prior to approval”.
Biosimilar biological product program fee.— Section 744H(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)(3)) is amended—
in subparagraph (A)—
in clause (i), by striking “ and” at the end;
by redesignating clause (ii) as clause (iii); and
by inserting after clause (i) the following:
“(ii) may be dispensed only under prescription pursuant to section 503(b); and”
; and
by adding at the end the following:
“(E) Movement to discontinued list.—
“(i) Date of inclusion.—If a written request to place a product on the list referenced in subparagraph (A) of discontinued biosimilar biological products is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, 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—
“(I) the date such request was received; or
“(II) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.
“(ii) Treatment as withdrawn from sale.—For purposes of clause (i), a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.
“(iii) Special rule for 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 referenced in subparagraph (A) of discontinued biosimilar biological products, and on any subsequent day during such fiscal year the biosimilar biological product does not appear on such list, except as provided in subparagraph (D), each person who is named as the applicant in a biosimilar biological product application with respect to such product shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for such biosimilar biological product. Notwithstanding subparagraph (B), such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for each fiscal year.”
Biosimilar biological product fee.— Section 744H(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)) is amended by striking paragraph (4).
Fee Revenue Amounts.— Subsection (b) of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52) is amended—
by striking paragraph (1);
by redesignating paragraphs (2) through (4) as paragraphs (1) through (3), respectively;
by amending paragraph (1) (as so redesignated) to read as follows:
“(1) In general.—For each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsection (c), be established to generate a total revenue amount equal to the sum of—
“(A) the annual base revenue for the fiscal year (as determined under paragraph (3));
“(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));
“(C) the dollar amount equal to the strategic hiring and retention adjustment (as determined under subsection (c)(2));
“(D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3));
“(E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4));
“(F) for fiscal year 2023 an additional amount of $4,428,886; and
“(G) for fiscal year 2024 an additional amount of $320,569.”
in paragraph (2) (as so redesignated)—
in the paragraph heading, by striking “ ; limitations on fee amounts”;
by striking subparagraph (B); and
by redesignating subparagraphs (C) and (D) as subparagraphs (B) and (C), respectively; and
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).”
Adjustments; Annual Fee Setting.— Section 744H(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(c)) is amended—
in paragraph (1)—
in subparagraph (A)—
in the matter preceding clause (i), by striking “ subsection (b)(2)(B)” and inserting “ subsection (b)(1)(B)”; and
in clause (i), by striking “ subsection (b)” and inserting “ subsection (b)(1)(A)”; and
in subparagraph (B)(ii), by striking “ Washington-Baltimore, DC–MD–VA–WV” and inserting “ Washington-Arlington-Alexandria, DC–VA–MD–WV”;
by striking paragraphs (2) through (4) and inserting the following:
“(2) Strategic hiring and retention adjustment.—For each fiscal year, after the annual base revenue under subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by $150,000.
“(3) Capacity planning adjustment.—
“(A) In general.—For each fiscal year, the Secretary shall, in addition to the adjustments under paragraphs (1) and (2), further adjust the fee revenue and fees under this section for a fiscal year to reflect changes in the resource capacity needs of the Secretary for the process for the review of biosimilar biological product applications.
“(B) Methodology.—For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled ‘Biosimilar User Fee Rates for Fiscal Year 2021’ published in the Federal Register on August 4, 2020 (85 Fed. Reg. 47220). The workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and, as feasible, additional activities that are directly related to the direct review of biosimilar biological product applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved biosimilar biological products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.
“(C) Limitations.—Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year), (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year), and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment).
“(D) Publication in federal register.—The Secretary shall publish in the Federal Register notice under paragraph (5) the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.
“(4) Operating reserve adjustment.—
“(A) Increase.—For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for at least 10 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications.
“(B) Decrease.—
“(i) Fiscal year 2023.—For fiscal year 2023, if the Secretary has carryover balances for such process in excess of 33 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 33 weeks of such operating reserves.
“(ii) Fiscal year 2024.—For fiscal year 2024, if the Secretary has carryover balances for such process in excess of 27 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 27 weeks of such operating reserves.
“(iii) Fiscal year 2025 and subsequent fiscal years.—For fiscal year 2025 and subsequent fiscal years, if the Secretary has carryover balances for such process in excess of 21 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 21 weeks of such operating reserves.
“(C) Federal register notice.—If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (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
in paragraph (5), in the matter preceding subparagraph (A), by striking “ 2018” and inserting “ 2023”.
Crediting and Availability of Fees.— Subsection (f)(3) of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(f)(3)) is amended by striking “ 2018 through 2022” and inserting “ 2023 through 2027”.
Written Requests for Waivers and Returns; Disputes Concerning Fees.— Section 744H(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(h)) is amended to read as follows:
“(h) Written Requests for Waivers and Returns; Disputes Concerning Fees.—To qualify for consideration for a waiver under subsection (d), or for the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall submit to the Secretary a written request justifying such waiver or return and, except as otherwise specified in this section, such written request shall be submitted to the Secretary not later than 180 days after such fee is due. A request submitted under this paragraph shall include any legal authorities under which the request is made.”
SEC. 4004. Reauthorization; Reporting Requirements.
Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53) is amended—
in subsection (a)(1), by striking “ Beginning with fiscal year 2018, not” and inserting “ Not”;
by striking “ Biosimilar User Fee Amendments of 2017” each place it appears and inserting “ Biosimilar User Fee Amendments of 2022”;
in subsection (a)(2), by striking “ Beginning with fiscal year 2018, the” and inserting “ The”;
in subsection (a)(3)(A), by striking “ Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter” and inserting “ Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this part”;
in subsection (b), by striking “ Not later than 120 days after the end of fiscal year 2018 and each subsequent fiscal year for which fees are collected under this part” and inserting “ Not later than 120 days after the end of each fiscal year for which fees are collected under this part”;
in subsection (c), by striking “ Beginning with fiscal year 2018, and for” and inserting “ For”; and
in subsection (f)—
in paragraph (1), in the matter preceding subparagraph (A), by striking “ fiscal year 2022” and inserting “ fiscal year 2027”; and
in paragraph (3), by striking “ January 15, 2022” and inserting “ January 15, 2027”.
SEC. 4005. Sunset Dates.
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.
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.
Previous Sunset Provision.— Effective October 1, 2022, subsections (a) and (b) of section 405 of the FDA Reauthorization Act of 2017 (Public Law 115–52) are repealed.
SEC. 4006. Effective Date.
The amendments made by this title shall take effect on October 1, 2022, or the date of the enactment of this Act, whichever is later, except that fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.) shall be assessed for all biosimilar biological product applications received on or after October 1, 2022, regardless of the date of the enactment of this Act.
SEC. 4007. Savings Clause.
Notwithstanding the amendments made by this title, part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to biosimilar biological product applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.
TITLE V Reauthorization of Other Provisions
SEC. 5001. Reauthorization of the Best Pharmaceuticals for Children Program.
Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 284m(d)(1)) is amended by striking “ $25,000,000 for each of fiscal years 2018 through 2022” and inserting “ $5,273,973 for the period beginning on October 1, 2022 and ending on December 16, 2022”.
SEC. 5002. Reauthorization of the Humanitarian Device Exemption Incentive.
Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking “ October 1” and inserting “ December 17”.
SEC. 5003. Reauthorization of the Pediatric Device Consortia Program.
Section 305(e) of the Food and Drug Administration Amendments Act of 2007 (Public Law 110–85; 42 U.S.C. 282 note) is amended by striking “ $5,250,000 for each of fiscal years 2018 through 2022” and inserting “ $1,107,534 for the period beginning on October 1, 2022, and ending on December 16, 2022”.
SEC. 5004. Reauthorization of Provision Pertaining to Drugs Containing Single Enantiomers.
Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(u)(4)) is amended by striking “ October 1” and inserting “ December 17”.
SEC. 5005. Reauthorization of the Critical Path Public-Private Partnership.
Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–5(f)) is amended by striking “ $6,000,000 for each of fiscal years 2018 through 2022” and inserting “ $1,265,753 for the period beginning on October 1, 2022 and ending on December 16, 2022”.
SEC. 5006. Reauthorization of Orphan Drug Grants.
Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended by striking “ $30,000,000 for each of fiscal years 2018 through 2022” and inserting “ $6,328,767 for the period beginning on October 1, 2022, and ending on December 16, 2022”.
SEC. 5007. Reauthorization of Certain Device Inspections.
Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by striking “ October 1” and inserting “ December 17”.
SEC. 5008. Reauthorization of Reporting Requirements Related to Pending Generic Drug Applications and Priority Review Applications.
Section 807 of the FDA Reauthorization Act of 2017 (Public Law 115–52) is amended, in the matter preceding paragraph (1), by striking “ October 1” and inserting “ December 16”.