[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4535 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  2d Session
                                S. 4535

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 14, 2022

   Mr. Burr introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


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

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

Sec. 1. Short title; table of contents.
                    TITLE I--FEES RELATING TO DRUGS

Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Reauthorization; reporting requirement.
Sec. 105. Sunset dates.
Sec. 106. Effective date.
Sec. 107. Savings clause.
                   TITLE II--FEES RELATING TO DEVICES

Sec. 201. Short title; finding.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirement.
Sec. 205. Accreditation programs.
Sec. 206. Sunset dates.
Sec. 207. Effective date.
Sec. 208. Savings clause.
               TITLE III--FEES RELATING TO GENERIC DRUGS

Sec. 301. Short title; finding.
Sec. 302. Authority to assess and use human generic drug fees.
Sec. 303. Reauthorization; reporting requirements.
Sec. 304. Sunset dates.
Sec. 305. Effective date.
Sec. 306. Savings clause.
       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

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

Sec. 501. Reauthorization of the critical path public-private 
                            partnership.
Sec. 502. Reauthorization of the best pharmaceuticals for children 
                            program.
Sec. 503. Reauthorization of the humanitarian device exemption 
                            incentive.
Sec. 504. Reauthorization of the pediatric device consortia program.
Sec. 505. Reauthorization of provision pertaining to drugs containing 
                            single enantiomers.
Sec. 506. Reauthorization of orphan drug grants.
Sec. 507. Reauthorization of certain device inspections.

                    TITLE I--FEES RELATING TO DRUGS

SEC. 101. SHORT TITLE; FINDING.

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

SEC. 102. DEFINITIONS.

    Section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379g) is amended--
            (1) in paragraph (1), in the matter following subparagraph 
        (B), by striking ``an allergenic extract product, or'' and 
        inserting ``does not include an application with respect to an 
        allergenic extract product licensed before October 1, 2022, 
        does not include an application with respect to a standardized 
        allergenic extract product submitted pursuant to a notification 
        to the applicant from the Secretary regarding the existence of 
        a potency test that measures the allergenic activity of an 
        allergenic extract product licensed by the applicant before 
        October 1, 2022, does not include an application with respect 
        to'';
            (2) in paragraph (3), in the matter following subparagraph 
        (C)--
                    (A) by inserting ``licensed before October 1, 2022, 
                a standardized allergenic extract product submitted 
                pursuant to a notification to the applicant from the 
                Secretary regarding the existence of a potency test 
                that measures the allergenic activity of an allergenic 
                extract product licensed by the applicant before 
                October 1, 2022,'' after ``an allergenic extract 
                product''; and
                    (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
            (3) by adding at the end the following:
            ``(12) The term `skin-test diagnostic product'--
                    ``(A) means a product--
                            ``(i) for prick, scratch, intradermal, or 
                        subcutaneous administration;
                            ``(ii) expected to produce a limited, local 
                        reaction at the site of administration (if 
                        positive), rather than a systemic effect;
                            ``(iii) not intended to be a preventive or 
                        therapeutic intervention; and
                            ``(iv) intended to detect an immediate or 
                        delayed-type skin hypersensitivity reaction to 
                        aid in the diagnosis of--
                                    ``(I) an allergy to an 
                                antimicrobial agent;
                                    ``(II) an allergy that is not to an 
                                antimicrobial agent, if the diagnostic 
                                product was authorized for marketing 
                                prior to October 1, 2022; or
                                    ``(III) infection with fungal or 
                                mycobacterial pathogens; and
                    ``(B) includes positive and negative controls 
                required to interpret the results of a product 
                described in subparagraph (A).''.

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

    (a) Types of Fees.--Section 736(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``2018'' and inserting ``2023'';
            (2) in paragraph (1)--
                    (A) in subparagraph (A), by striking ``subsection 
                (c)(5)'' each place it appears and inserting 
                ``subsection (c)(6)'';
                    (B) in subparagraph (C), by inserting ``prior to 
                approval'' after ``or was withdrawn''; and
                    (C) by adding at the end the following:
                    ``(H) Exception for skin-test diagnostic 
                products.--A human drug application for a skin-test 
                diagnostic product shall not be subject to a fee under 
                subparagraph (A).''; and
            (3) in paragraph (2)--
                    (A) in subparagraph (A)--
                            (i) by striking ``subsection (c)(5)'' and 
                        inserting ``subsection (c)(6)'';
                            (ii) by striking ``Except as provided'' and 
                        inserting the following:
                            ``(i) Payment of fees.--Except as 
                        provided''; and
                            (iii) by adding at the end the following:
                            ``(ii) Previously discontinued drug 
                        products.--If a drug product that is identified 
                        in a human drug application approved as of 
                        October 1 of a fiscal year is not a 
                        prescription drug product as of that date 
                        because the drug product is in the discontinued 
                        section of a list identified in section 735(3), 
                        and on any subsequent day during such fiscal 
                        year the drug product is a prescription drug 
                        product, then except as provided in 
                        subparagraphs (B) and (C), each person who is 
                        named as the applicant in a human drug 
                        application with respect to such product, and 
                        who, after September 1, 1992, had pending 
                        before the Secretary a human drug application 
                        or supplement, shall pay the annual 
                        prescription drug program fee established for a 
                        fiscal year under subsection (c)(6) for such 
                        prescription drug product. Such fee shall be 
                        due on the last business day of such fiscal 
                        year and shall be paid only once for each 
                        product for a fiscal year in which the fee is 
                        payable.''; and
                    (B) by amending subparagraph (B) to read as 
                follows:
                    ``(B) Exception for certain prescription drug 
                products.--A prescription drug program fee shall not be 
                assessed for a prescription drug product under 
                subparagraph (A) if such product is--
                            ``(i) a large volume parenteral product (a 
                        sterile aqueous drug product packaged in a 
                        single-dose container with a volume greater 
                        than or equal to 100 mL, not including powders 
                        for reconstitution or pharmacy bulk packages) 
                        identified on the list compiled under section 
                        505(j)(7);
                            ``(ii) pharmaceutically equivalent (as 
                        defined in section 314.3 of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulations)), to another product on the list 
                        of products compiled under section 505(j)(7) 
                        (not including the discontinued section of such 
                        list); or
                            ``(iii) a skin-test diagnostic product.''.
    (b) Fee Revenue Amounts.--Section 736(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h(b)) is amended--
            (1) in paragraph (1)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``2018 through 2022'' and inserting ``2023 
                through 2027'';
                    (B) by redesignating subparagraphs (C) through (F) 
                as subparagraphs (D) through (G), respectively;
                    (C) by inserting after subparagraph (B) the 
                following:
                    ``(C) The dollar amount equal to the strategic 
                hiring and retention adjustment for the fiscal year (as 
                determined under subsection (c)(2));'';
                    (D) in subparagraph (D), as so redesignated, by 
                striking ``(c)(2)'' and inserting ``(c)(3)'';
                    (E) in subparagraph (E), as so redesignated, by 
                striking ``(c)(3)'' and inserting ``(c)(4)'';
                    (F) in subparagraph (F), as so redesignated, by 
                striking ``(c)(4)'' and inserting ``(c)(5)''; and
                    (G) in subparagraph (G), as so redesignated, by 
                striking clauses (i) through (v) and inserting the 
                following:
                            ``(i) $65,773,693 for fiscal year 2023.
                            ``(ii) $25,097,671 for fiscal year 2024.
                            ``(iii) $14,154,169 for fiscal year 2025.
                            ``(iv) $4,864,860 for fiscal year 2026.
                            ``(v) $1,314,620 for fiscal year 2027.''; 
                        and
            (2) in paragraph (3)--
                    (A) in subparagraph (A), by striking ``2018, 
                $878,590,000'' and inserting ``2023, $1,151,522,958''; 
                and
                    (B) in subparagraph (B)--
                            (i) by striking ``2019 through 2022'' and 
                        inserting ``2024 through 2027''; and
                            (ii) by striking ``subsection (c)(3) or 
                        (c)(4)'' and inserting ``subsection (c)(4) or 
                        (c)(5)''.
    (c) Adjustments; Annual Fee Setting.--Section 736(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended--
            (1) in paragraph (1)(B)(ii), by striking ``Washington-
        Baltimore, DC-MD-VA-WV'' and inserting ``Washington-Arlington-
        Alexandria, DC-VA-MD-WV'';
            (2) by redesignating paragraphs (2) through (6) as 
        paragraphs (3) through (7), respectively;
            (3) by inserting after paragraph (1) the following:
            ``(2) Strategic hiring and retention adjustment.--For each 
        fiscal year, after the annual base revenue established in 
        subsection (b)(1)(A) is adjusted for inflation in accordance 
        with paragraph (1), the Secretary shall further increase the 
        fee revenue and fees--
                    ``(A) for fiscal year 2023, by $9,000,000; and
                    ``(B) for fiscal year 2024 and each subsequent 
                fiscal year, by $4,000,000.'';
            (4) in paragraph (3), as so redesignated--
                    (A) in subparagraph (A)--
                            (i) by striking ``for inflation''; and
                            (ii) by striking ``paragraph (1)'' and 
                        inserting ``paragraphs (1) and (2)'';
                    (B) by amending subparagraph (B) to read as 
                follows:
                    ``(B) Methodology.--For purposes of this paragraph, 
                the Secretary shall employ the capacity planning 
                methodology utilized by the Secretary in setting fees 
                for fiscal year 2021, as described in the notice titled 
                `Prescription Drug User Fee Rates for Fiscal Year 2021' 
                (85 Fed. Reg. 46651; August 3, 2020). The workload 
                categories used in forecasting shall include only the 
                activities described in such notice and, as feasible, 
                additional activities that are directly related to the 
                direct review of applications and supplements, 
                including additional formal meeting types, the direct 
                review of postmarketing commitments and requirements, 
                the direct review of risk evaluation and mitigation 
                strategies, and the direct review of annual reports for 
                approved prescription drug products. Subject to the 
                exceptions in the preceding sentence, the Secretary 
                shall not include as workload categories in forecasting 
                any non-core review activities, including any 
                activities that the Secretary referenced for potential 
                future use in such notice but did not utilize in the 
                setting fees for fiscal year 2021.'';
                    (C) by striking subparagraph (C);
                    (D) by redesignating subparagraphs (D) and (E) as 
                subparagraphs (C) and (D), respectively;
                    (E) in subparagraph (C), as so redesignated--
                            (i) by striking ``year) and'' and inserting 
                        ``year),''; and
                            (ii) by striking the period and inserting 
                        ``, and subsection (b)(1)(C) (the dollar amount 
                        of the strategic hiring and retention 
                        adjustment).''; and
                    (F) in subparagraph (D), as so redesignated, by 
                striking ``paragraph (5)'' and inserting ``paragraph 
                (6)'';
            (5) in paragraph (4), as so redesignated--
                    (A) by amending subparagraph (A) to read as 
                follows:
                    ``(A) Increase.--For fiscal year 2023 and 
                subsequent fiscal years, the Secretary shall, in 
                addition to adjustments under paragraphs (1), (2), and 
                (3), further increase the fee revenue and fees if such 
                an adjustment is necessary to provide for at least the 
                following amounts of operating reserves of carryover 
                user fees for the process for the review of human drug 
                applications for each fiscal year, as follows:
                            ``(i) For fiscal year 2023, at least 8 
                        weeks of operating reserves.
                            ``(ii) For fiscal year 2024, at least 9 
                        weeks of operating reserves.
                            ``(iii) For fiscal year 2025 and subsequent 
                        fiscal years, at least 10 weeks of operating 
                        reserves.''; and
                    (B) in subparagraph (C), by striking ``paragraph 
                (5)'' and inserting ``paragraph (6)'';
            (6) by amending paragraph (5), as so redesignated, to read 
        as follows:
            ``(5) Additional direct cost adjustment.--The Secretary 
        shall, in addition to adjustments under paragraphs (1), (2), 
        (3), and (4), further increase the fee revenue and fees--
                    ``(A) for fiscal year 2023, by $44,386,150; and
                    ``(B) for fiscal years 2024 through 2027, by the 
                amount set forth in clauses (i) through (iv), as 
                applicable, multiplied by the Consumer Price Index for 
                urban consumers (Washington-Arlington-Alexandria, DC-
                VA-MD-WV; Not Seasonally Adjusted; All Items; Annual 
                Index) for the most recent year of available data, 
                divided by such Index for 2021--
                            ``(i) for fiscal year 2024, $60,967,993;
                            ``(ii) for fiscal year 2025, $35,799,314;
                            ``(iii) for fiscal year 2026, $35,799,314; 
                        and
                            ``(iv) for fiscal year 2027, 
                        $35,799,314.''; and
            (7) in paragraph (6), as so redesignated, by striking 
        ``2017'' and inserting ``2022''.
    (d) Crediting and Availability of Fees.--Section 736(g)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended 
by striking ``2018 through 2022'' and inserting ``2023 through 2027''.
    (e) Written Requests for Waivers, Reductions, and Refunds.--Section 
736(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(i)) 
is amended to read as follows:
    ``(i) Written Requests for Waivers, Reductions, Exemptions, and 
Returns; Disputes Concerning Fees.--To qualify for consideration for a 
waiver or reduction under subsection (d), an exemption under subsection 
(k), or the return of any fee paid under this section, including if the 
fee is claimed to have been paid in error, a person shall submit to the 
Secretary a written request justifying such waiver, reduction, 
exemption, or return not later than 180 days after such fee is due. A 
request submitted under this paragraph shall include any legal 
authorities under which the request is made.''.
    (f) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(k)) is amended--
            (1) in paragraph (1)(B), by striking ``during the previous 
        year'' and inserting ``, as determined under paragraph (2)''; 
        and
            (2) in paragraph (2), by striking ``that its gross annual 
        revenues'' and all that follows through the period at the end 
        and inserting ``supported by tax returns submitted to the 
        Internal Revenue Service, or, as necessary, by other 
        appropriate financial information, that its gross annual 
        revenues did not exceed $50,000,000 for the last calendar year 
        ending prior to the fiscal year for which the exemption is 
        requested.''.

SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENT.

    Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h-2) is amended--
            (1) by striking ``2018'' each place it appears and 
        inserting ``2023'';
            (2) by striking ``Prescription Drug User Fee Amendments of 
        2017'' each place it appears and inserting ``Prescription Drug 
        User Fee Amendments of 2022'';
            (3) in subsection (a)(4), by striking ``2020'' and 
        inserting ``2023''; and
            (4) in subsection (f), by striking ``2022'' each place it 
        appears and inserting ``2027''.

SEC. 105. SUNSET DATES.

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

SEC. 106. EFFECTIVE DATE.

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

SEC. 107. SAVINGS CLAUSE.

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

                   TITLE II--FEES RELATING TO DEVICES

SEC. 201. SHORT TITLE; FINDING.

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

SEC. 202. DEFINITIONS.

    Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379i) is amended--
            (1) in paragraph (9)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``and premarket notification submissions'' and 
                inserting ``premarket notification submissions, and de 
                novo classification requests'';
                    (B) in subparagraph (D), by striking ``and 
                submissions'' and inserting ``submissions, and de novo 
                classification requests'';
                    (C) in subparagraph (F), by striking ``and 
                premarket notification submissions'' and inserting 
                ``premarket notification submissions, and de novo 
                classification requests'';
                    (D) in subparagraphs (G) and (H), by striking ``or 
                submissions'' each place it appears and inserting 
                ``submissions, or requests''; and
                    (E) in subparagraph (K), by striking ``or premarket 
                notification submissions'' and inserting ``premarket 
                notification submissions, or de novo classification 
                requests''; and
            (2) in paragraph (11), by striking ``2016'' and inserting 
        ``2021''.

SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.

    (a) Types of Fees.--Section 738(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(a)) is amended--
            (1) in paragraph (1), by striking ``2018'' and inserting 
        ``2023''; and
            (2) in paragraph (2)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i), by 
                        striking ``2017'' and inserting ``2022'';
                            (ii) in clause (iii), by striking ``75 
                        percent'' and inserting ``80 percent''; and
                            (iii) in clause (viii), by striking ``3.4 
                        percent'' and inserting ``4.5 percent'';
                    (B) in subparagraph (B)(iii), by striking ``or 
                premarket notification submission'' and inserting 
                ``premarket notification submission, or de novo 
                classification request''; and
                    (C) in subparagraph (C), by striking ``or periodic 
                reporting concerning a class III device'' and inserting 
                ``periodic reporting concerning a class III device, or 
                de novo classification request''.
    (b) Fee Amounts.--Section 738(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(b)) is amended--
            (1) in paragraph (1), by striking ``2018 through 2022'' and 
        inserting ``2023 through 2027'';
            (2) by amending the table in paragraph (2) to read as 
        follows:


----------------------------------------------------------------------------------------------------------------
                                                            Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                       ``Fee Type                         Year 2023  Year 2024  Year 2025  Year 2026  Year  2027
----------------------------------------------------------------------------------------------------------------
Premarket Application...................................   $425,000   $435,000   $445,000   $455,000    $470,000
Establishment Registration..............................     $6,250     $6,875     $7,100     $7,575   $8,465'';
----------------------------------------------------------------------------------------------------------------

        and
            (3) in paragraph (3), by amending subparagraphs (A) through 
        (E) to read as follows:
                    ``(A) $312,606,000 for fiscal year 2023.
                    ``(B) $335,750,000 for fiscal year 2024.
                    ``(C) $350,746,400 for fiscal year 2025.
                    ``(D) $366,486,300 for fiscal year 2026.
                    ``(E) $418,343,000 for fiscal year 2027.''.
    (c) Annual Fee Setting; Adjustments.--Section 738(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended--
            (1) in paragraph (1), by striking ``2017'' and inserting 
        ``2022'';
            (2) in paragraph (2)--
                    (A) by striking ``2018'' each place it appears and 
                inserting ``2023'';
                    (B) in subparagraph (B)(ii), by striking ``2016'' 
                and inserting ``2022'';
                    (C) in subparagraph (C)(i)(II), by striking 
                ``Washington-Baltimore, DC-MD-VA-WV'' and inserting 
                ``Washington-Arlington-Alexandria, DC-VA-MD-WV''; and
                    (D) in subparagraph (D), by striking ``2022'' and 
                inserting ``2027'';
            (3) in paragraph (3), by striking ``2018 through 2022'' and 
        inserting ``2023 through 2027'';
            (4) by redesignating paragraphs (4) and (5) as paragraphs 
        (7) and (8), respectively; and
            (5) by inserting after paragraph (3) the following:
            ``(4) Performance improvement adjustment.--
                    ``(A) In general.--For each of fiscal years 2025 
                through 2027, after the adjustment under paragraph (3), 
                the base establishment registration fee amounts for 
                such fiscal year shall be increased to reflect changes 
                in the resource needs of the Secretary due to improved 
                review performance goals for the process for the review 
                of device applications identified in the letters 
                described in section 201(b) of the Medical Device User 
                Fee Amendments of 2022, as the Secretary determines 
                necessary to achieve an increase in total fee 
                collections for such fiscal year, equal to the 
                following amounts, as applicable:
                            ``(i) For fiscal year 2025, the product 
                        of--
                                    ``(I) the amount determined under 
                                subparagraph (B)(i)(I); and
                                    ``(II) the applicable inflation 
                                adjustment under paragraph (2)(B) for 
                                such fiscal year.
                            ``(ii) For fiscal year 2026, the product 
                        of--
                                    ``(I) the sum of the amounts 
                                determined under subparagraphs 
                                (B)(i)(II), (B)(ii)(I), and 
                                (B)(iii)(I); and
                                    ``(II) the applicable inflation 
                                adjustment under paragraph (2)(B) for 
                                such fiscal year.
                            ``(iii) For fiscal year 2027, the product 
                        of--
                                    ``(I) the sum of the amounts 
                                determined under subparagraphs 
                                (B)(i)(III), (B)(ii)(II), and 
                                (B)(iii)(II); and
                                    ``(II) the applicable inflation 
                                adjustment under paragraph (2)(B) for 
                                such fiscal year.
                    ``(B) Amounts.--
                            ``(i) Presubmission amount.--For purposes 
                        of subparagraph (A), with respect to the 
                        presubmission written feedback goal, the 
                        amounts determined under this subparagraph are 
                        as follows:
                                    ``(I) For fiscal year 2025, 
                                $15,396,600 if the goal for fiscal year 
                                2023 is met.
                                    ``(II) For fiscal year 2026--
                                            ``(aa) $15,396,600 if the 
                                        goal for fiscal year 2023 is 
                                        met and the goal for fiscal 
                                        year 2024 is missed; or
                                            ``(bb) $36,792,200 if the 
                                        goal for fiscal year 2024 is 
                                        met.
                                    ``(III) For fiscal year 2027--
                                            ``(aa) $15,396,600 if the 
                                        goal for fiscal year 2023 is 
                                        met and the goal for each of 
                                        fiscal years 2024 and 2025 is 
                                        missed;
                                            ``(bb) $36,792,200 if the 
                                        goal for fiscal year 2024 is 
                                        met and the goal for fiscal 
                                        year 2025 is missed; or
                                            ``(cc) $40,572,600 if the 
                                        goal for fiscal year 2025 is 
                                        met.
                            ``(ii) De novo classification request 
                        amount.--For purposes of subparagraph (A), with 
                        respect to the de novo decision goal, the 
                        amounts determined under this subparagraph are 
                        as follows:
                                    ``(I) For fiscal year 2026, 
                                $6,323,500 if the goal for fiscal year 
                                2023 is met.
                                    ``(II) For fiscal year 2027--
                                            ``(aa) $6,323,500 if the 
                                        goal for fiscal year 2023 is 
                                        met and the goal for fiscal 
                                        year 2024 is missed; or
                                            ``(bb) $11,765,400 if the 
                                        goal for fiscal year 2024 is 
                                        met.
                            ``(iii) Premarket notification and 
                        premarket approval amount.--For purposes of 
                        subparagraph (A), with respect to the 510(k) 
                        decision goal, 510(k) shared outcome total time 
                        to decision goal, PMA decision goal, and PMA 
                        shared outcome total time to decision goal, the 
                        amounts determined under this subparagraph are 
                        as follows:
                                    ``(I) For fiscal year 2026, 
                                $1,020,000 if the 4 goals for fiscal 
                                year 2023 are met.
                                    ``(II) For fiscal year 2027--
                                            ``(aa) $1,020,000 if the 4 
                                        goals for fiscal year 2023 are 
                                        met and one or more of the 4 
                                        goals for fiscal year 2024 is 
                                        missed; or
                                            ``(bb) $3,906,000 if the 4 
                                        goals for fiscal year 2024 are 
                                        met.
                    ``(C) Performance calculation.--For purposes of 
                this paragraph, performance of the following goals 
                shall be determined as specified in the letters 
                described in section 201(b) of the Medical Device User 
                Fee Amendments of 2022 and based on data available as 
                of the applicable dates as follows:
                            ``(i) The performance of the presubmission 
                        written feedback goal--
                                    ``(I) for fiscal year 2023, shall 
                                be based on data available as of March 
                                31, 2024;
                                    ``(II) for fiscal year 2024, shall 
                                be based on data available as of March 
                                31, 2025; and
                                    ``(III) for fiscal year 2025, shall 
                                be based on data available as of March 
                                31, 2026.
                            ``(ii) The performance of the de novo 
                        decision goal, 510(k) decision goal, 510(k) 
                        shared outcome total time to decision goal, PMA 
                        decision goal, and PMA shared outcome total 
                        time to decision goal--
                                    ``(I) for fiscal year 2023, shall 
                                be based on data available as of March 
                                31, 2025; and
                                    ``(II) for fiscal year 2024, shall 
                                be based on data available as of March 
                                31, 2026.
                    ``(D) Definitions.--For purposes of this paragraph, 
                the terms `presubmission written feedback goal', `de 
                novo decision goal', `510(k) decision goal', `510(k) 
                shared outcome total time to decision goal', `PMA 
                decision goal', and `PMA shared outcome total time to 
                decision goal' have the meanings given such terms in 
                the goals identified in the letters described in 
                section 201(b) of the Medical Device User Fee 
                Amendments of 2022.
            ``(5) Hiring adjustment.--
                    ``(A) In general.--For each of fiscal years 2025 
                through 2027, after the adjustments under paragraphs 
                (3) and (4), if applicable, the base establishment 
                registration fee amounts shall be decreased as the 
                Secretary determines necessary to achieve a reduction 
                in total fee collections equal to the hiring adjustment 
                amount under subparagraph (B), if the number of hires 
                to support the process for the review of device 
                applications falls below the following thresholds for 
                the applicable fiscal years:
                            ``(i) For fiscal year 2025, 85 percent of 
                        the hiring goal specified in subparagraph (C) 
                        for fiscal year 2023.
                            ``(ii) For fiscal year 2026, 90 percent of 
                        the hiring goal specified in subparagraph (C) 
                        for fiscal year 2024.
                            ``(iii) For fiscal year 2027, 90 percent of 
                        the hiring goal specified in subparagraph (C) 
                        for fiscal year 2025.
                    ``(B) Hiring adjustment amount.--The hiring 
                adjustment amount for fiscal year 2025 and each 
                subsequent fiscal year is the product of--
                            ``(i) the number of hires by which the 
                        hiring goal specified in subparagraph (C) for 
                        the fiscal year before the prior fiscal year 
                        was missed;
                            ``(ii) $72,877; and
                            ``(iii) the applicable inflation adjustment 
                        under paragraph (2)(B) for the fiscal year for 
                        which the hiring goal was missed.
                    ``(C) Hiring goals.--
                            ``(i) In general.--For purposes of 
                        subparagraph (B), the hiring goals for each of 
                        fiscal years 2023 through 2025 are as follows:
                                    ``(I) For fiscal year 2023, 144 
                                hires.
                                    ``(II) For fiscal year 2024, 42 
                                hires.
                                    ``(III) For fiscal year 2025--
                                            ``(aa) 24 hires if the base 
                                        establishment registration fees 
                                        are not increased by the amount 
                                        determined under paragraph 
                                        (4)(A)(i); or
                                            ``(bb) 83 hires if the base 
                                        establishment registration fees 
                                        are increased by the amount 
                                        determined under paragraph 
                                        (4)(A)(i).
                            ``(ii) Number of hires.--For purposes of 
                        this paragraph, the number of hires for a 
                        fiscal year shall be determined by the 
                        Secretary, as set forth in the letters 
                        described in section 201(b) of the Medical 
                        Device User Fee Amendments of 2022.
            ``(6) Operating reserve adjustment.--
                    ``(A) In general.--For each of fiscal years 2023 
                through 2027, after the adjustments under paragraphs 
                (3), (4), and (5), if applicable, if the Secretary has 
                operating reserves of carryover user fees for the 
                process for the review of device applications in excess 
                of the designated amount in subparagraph (B), the 
                Secretary shall decrease the base establishment 
                registration fee amounts to provide for not more than 
                such designated amount of operating reserves.
                    ``(B) Designated amount.--Subject to subparagraph 
                (C), for each fiscal year, the designated amount in 
                this subparagraph is equal to the sum of--
                            ``(i) 13 weeks of operating reserves of 
                        carryover user fees; and
                            ``(ii) the 1 month of operating reserves 
                        described in paragraph (8).
                    ``(C) Excluded amount.--For the period of fiscal 
                years 2023 through 2026, a total amount equal to 
                $118,000,000 shall not be considered part of the 
                designated amount under subparagraph (B) and shall not 
                be subject to the decrease under subparagraph (A).''.
    (d) 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,''.
    (e) Authorization of Appropriations.--Section 738(h)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)(3)) is amended 
to read as follows:
            ``(3) Authorization of appropriations.--
                    ``(A) In general.--For each of the fiscal years 
                2023 through 2027, there is authorized to be 
                appropriated for fees under this section an amount 
                equal to the revenue amount determined in subparagraph 
                (B), less the amount of reductions determined in 
                subparagraph (C).
                    ``(B) Revenue amount.--For purposes of this 
                paragraph, the revenue amount for each fiscal year is 
                the sum of--
                            ``(i) the total revenue amount under 
                        subsection (b)(3) for the fiscal year, as 
                        adjusted under subsection (c)(2); and
                            ``(ii) the performance improvement 
                        adjustment amount for the fiscal year under 
                        subsection (c)(4)(A), if applicable.
                    ``(C) Amount of reductions.--For purposes of this 
                paragraph, the amount of reductions for each fiscal 
                year is the sum of--
                            ``(i) the hiring adjustment amount for the 
                        fiscal year under subsection (c)(5), if 
                        applicable; and
                            ``(ii) the operating reserve adjustment 
                        amount for the fiscal year under subsection 
                        (c)(6), if applicable.''.

SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENT.

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

SEC. 205. ACCREDITATION PROGRAMS.

    (a) Accreditation Scheme for Conformity Assessment.--Section 514(d) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(d)) is 
amended--
            (1) in the subsection heading, by striking ``Pilot'';
            (2) in paragraph (1)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``pilot'';
                    (B) in subparagraph (A)--
                            (i) by inserting ``meeting criteria 
                        specified by the Secretary in guidance'' after 
                        ``testing laboratories'';
                            (ii) by inserting ``in guidance'' after 
                        ``by the Secretary''; and
                            (iii) by striking ``assess the conformance 
                        of a device with'' and inserting ``conduct 
                        testing to support the assessment of the 
                        conformance of a device to''; and
                    (C) in subparagraph (B)--
                            (i) by striking ``determinations'' and 
                        inserting ``results'';
                            (ii) by inserting ``to support'' after ``so 
                        accredited''; and
                            (iii) by striking ``a particular such 
                        determination'' and inserting ``particular such 
                        results'';
            (3) in paragraph (2)--
                    (A) in the paragraph heading, by striking 
                ``determinations'' and inserting ``results'';
                    (B) in subparagraph (A)--
                            (i) by striking ``determinations by testing 
                        laboratories'' and all that follows through 
                        ``such determinations or'' and inserting 
                        ``results by testing laboratories accredited 
                        pursuant to this subsection, including by 
                        conducting periodic audits of such results or 
                        of the'';
                            (ii) by inserting a comma after ``or 
                        testing laboratories'';
                            (iii) by inserting ``or recognition of an 
                        accreditation body'' after ``accreditation of 
                        such testing laboratory''; and
                            (iv) by striking ``such device'' and 
                        inserting ``a device''; and
                    (C) in subparagraph (B)--
                            (i) by striking ``by a testing laboratory 
                        so accredited'' and inserting ``under this 
                        subsection''; and
                            (ii) by inserting ``or recognition of an 
                        accreditation body'' before ``under paragraph 
                        (1)(A)'';
            (4) in paragraph (3)(C)--
                    (A) in the subparagraph heading, by inserting ``and 
                transition'' after ``initiation''; and
                    (B) by adding at the end the following: ``After 
                September 30, 2023, such pilot program will be 
                considered to be completed, and the Secretary shall 
                have the authority to continue operating a program 
                consistent with this subsection.''; and
            (5) by striking paragraph (4).
    (b) Accredited Persons.--Section 523(c) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360m(c)) is amended by striking ``2022'' 
and inserting ``2027''.

SEC. 206. SUNSET DATES.

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

SEC. 207. EFFECTIVE DATE.

    The amendments made by this title shall take effect on October 1, 
2022, or the date of the enactment of this Act, whichever is later, 
except that fees under part 3 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.) 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. 208. SAVINGS CLAUSE.

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

               TITLE III--FEES RELATING TO GENERIC DRUGS

SEC. 301. SHORT TITLE; FINDING.

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

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

    (a) Types of Fees.--Section 744B(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``2018'' and inserting ``2023'';
            (2) in paragraph (2)(C), by striking ``fiscal years 2018 
        through 2022'' and inserting ``fiscal years 2023 through 
        2027'';
            (3) in paragraph (3)(B), by striking ``fiscal years 2018 
        through 2022'' and inserting ``fiscal years 2023 through 
        2027'';
            (4) in paragraph (4)(D), by striking ``fiscal years 2018 
        through 2022'' and inserting ``fiscal years 2023 through 
        2027''; and
            (5) in paragraph (5)(D), by striking ``fiscal years 2018 
        through 2022'' and inserting ``fiscal years 2023 through 
        2027''.
    (b) Fee Revenue Amounts.--Section 744B(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-42(b)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A)--
                            (i) in the heading, by striking ``2018'' 
                        and inserting ``2023'';
                            (ii) by striking ``2018'' and inserting 
                        ``2023''; and
                            (iii) by striking ``$493,600,000'' and 
                        inserting ``$582,500,000''; and
                    (B) in subparagraph (B)--
                            (i) in the heading, by striking ``2019 
                        through 2022'' and inserting ``2024 through 
                        2027'';
                            (ii) by striking ``For each'' and inserting 
                        the following:
                            ``(i) In general.--For each'';
                            (iii) by striking ``2019 through 2022'' and 
                        inserting ``2024 through 2027'';
                            (iv) by striking ``$493,600,000'' and 
                        inserting ``the base revenue amount under 
                        clause (ii)''; and
                            (v) by adding at the end the following:
                            ``(ii) Base revenue amount.--The base 
                        revenue amount for a fiscal year is the total 
                        revenue amount established under this paragraph 
                        for the previous fiscal year, not including any 
                        adjustments made for such previous fiscal year 
                        under subsection (c)(3).''; and
            (2) in paragraph (2)--
                    (A) in subparagraph (C), by striking ``one-third 
                the amount'' and inserting ``24 percent'';
                    (B) in subparagraph (D), by striking ``Seven'' and 
                inserting ``Six''; and
                    (C) in subparagraph (E)(i), by striking ``Thirty-
                five'' and inserting ``Thirty-six''.
    (c) Adjustments.--Section 744B(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--
            (1) in paragraph (1)--
                    (A) in the matter preceding subparagraph (A)--
                            (i) by striking ``2019'' and inserting 
                        ``2024''; and
                            (ii) by striking ``the product of the total 
                        revenues established in such notice for the 
                        prior fiscal year'' and inserting ``the base 
                        revenue amount for the fiscal year determined 
                        under subsection (b)(1)(B)(ii)''; and
                    (B) in subparagraph (C), by striking ``Washington-
                Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
                Arlington-Alexandria, DC-VA-MD-WV''; and
            (2) by striking paragraph (2) and inserting the following:
            ``(2) Capacity planning adjustment.--
                    ``(A) In general.--Beginning with fiscal year 2024, 
                the Secretary shall, in addition to the adjustment 
                under paragraph (1), further increase the fee revenue 
                and fees under this section for a fiscal year, in 
                accordance with this paragraph, to reflect changes in 
                the resource capacity needs of the Secretary for human 
                generic drug activities.
                    ``(B) Capacity planning methodology.--The Secretary 
                shall establish a capacity planning methodology for 
                purposes of this paragraph, which shall--
                            ``(i) be derived from the methodology and 
                        recommendations made in the report titled 
                        `Independent Evaluation of the GDUFA Resource 
                        Capacity Planning Adjustment Methodology: 
                        Evaluation and Recommendations' as announced in 
                        the Federal Register on August 3, 2020 (85 Fed. 
                        Reg. 46658); and
                            ``(ii) incorporate approaches and 
                        attributes determined appropriate by the 
                        Secretary, including those made in such report 
                        recommendations, except the workload categories 
                        used in forecasting resources shall only be 
                        those specified in section VIII.B.2.e. of the 
                        letters described in section 301(b) of the 
                        Generic Drug User Fee Amendments of 2022.
                    ``(C) Limitations.--
                            ``(i) In general.--Under no circumstances 
                        shall an adjustment under this paragraph result 
                        in fee revenue for a fiscal year that is less 
                        than the sum of the amounts under subsection 
                        (b)(1)(B)(ii) (the base revenue amount for the 
                        fiscal year) and paragraph (1) (the dollar 
                        amount of the inflation adjustment for the 
                        fiscal year).
                            ``(ii) Additional limitation.--An 
                        adjustment under this paragraph shall not 
                        exceed 3 percent of the sum described in clause 
                        (i) for the fiscal year, except that such 
                        limitation shall be 4 percent if--
                                    ``(I) for purposes of an adjustment 
                                for fiscal year 2024, the Secretary 
                                determines that, during the period from 
                                April 1, 2021, through March 31, 2023--
                                            ``(aa) the total number of 
                                        abbreviated new drug 
                                        applications submitted was 
                                        greater than or equal to 2,000; 
                                        or
                                            ``(bb) thirty-five percent 
                                        or more of abbreviated new drug 
                                        applications submitted related 
                                        to complex products (as that 
                                        term is defined in section XI 
                                        of the letters described in 
                                        section 301(b) of the Generic 
                                        Drug User Fee Amendments of 
                                        2022);
                                    ``(II) for purposes of an 
                                adjustment for fiscal year 2025, the 
                                Secretary determines that, during the 
                                period from April 1, 2022, through 
                                March 31, 2024--
                                            ``(aa) the total number of 
                                        abbreviated new drug 
                                        applications submitted was 
                                        greater than or equal to 2,300; 
                                        or
                                            ``(bb) thirty-five percent 
                                        or more of abbreviated new drug 
                                        applications submitted related 
                                        to complex products (as so 
                                        defined);
                                    ``(III) for purposes of an 
                                adjustment for fiscal year 2026, the 
                                Secretary determines that, during the 
                                period from April 1, 2023, through 
                                March 31, 2025--
                                            ``(aa) the total number of 
                                        abbreviated new drug 
                                        applications submitted was 
                                        greater than or equal to 2,300; 
                                        or
                                            ``(bb) thirty-five percent 
                                        or more of abbreviated new drug 
                                        applications submitted related 
                                        to complex products (as so 
                                        defined); and
                                    ``(IV) for purposes of an 
                                adjustment for fiscal year 2027, the 
                                Secretary determines that, during the 
                                period from April 1, 2024, through 
                                March 31, 2026--
                                            ``(aa) the total number of 
                                        abbreviated new drug 
                                        applications submitted was 
                                        greater than or equal to 2,300; 
                                        or
                                            ``(bb) thirty-five percent 
                                        or more of abbreviated new drug 
                                        applications submitted related 
                                        to complex products (as so 
                                        defined).
                    ``(D) Publication in federal register.--The 
                Secretary shall publish in the Federal Register notice 
                under subsection (a), the fee revenue and fees 
                resulting from the adjustment and the methodology under 
                this paragraph.
            ``(3) Operating reserve adjustment.--
                    ``(A) In general.--For fiscal year 2024 and 
                subsequent fiscal years, the Secretary may, in addition 
                to adjustments under paragraphs (1) and (2), further 
                increase the fee revenue and fees under this section if 
                such an adjustment is necessary to provide operating 
                reserves of carryover user fees for human generic drug 
                activities for not more than the number of weeks 
                specified in subparagraph (B).
                    ``(B) Number of weeks.--The number of weeks 
                specified in this subparagraph is--
                            ``(i) 8 weeks for fiscal year 2024;
                            ``(ii) 9 weeks for fiscal year 2025; and
                            ``(iii) 10 weeks for each of fiscal year 
                        2026 and 2027.
                    ``(C) Decrease.--If the Secretary has carryover 
                balances for human generic drug activities in excess of 
                12 weeks of the operating reserves referred to in 
                subparagraph (A), the Secretary shall decrease the fee 
                revenue and fees referred to in such subparagraph to 
                provide for not more than 12 weeks of such operating 
                reserves.
                    ``(D) Rationale for adjustment.--If an adjustment 
                under this paragraph is made, the rationale for the 
                amount of the increase or decrease (as applicable) in 
                fee revenue and fees shall be contained in the annual 
                Federal Register notice under subsection (a) publishing 
                the fee revenue and fees for the fiscal year 
                involved.''.
    (d) Annual Fee Setting.--Section 744B(d)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-42(d)(1)) is amended--
            (1) in the heading, by striking ``2018 through 2022'' and 
        inserting ``2023 through 2027'';
            (2) by striking ``more'' and inserting ``later''; and
            (3) by striking ``2018 through 2022'' and inserting ``2023 
        through 2027''.
    (e) Effect of Failure To Pay Fees.--The heading of paragraph (3) of 
section 744B(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-42(g)) is amended by striking ``and prior approval supplement 
fee''.
    (f) Crediting and Availability of Fees.--Section 744B(i)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(i)(3)) is 
amended by striking ``2018 through 2022'' and inserting ``2023 through 
2027''.

SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.

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

SEC. 304. SUNSET DATES.

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

SEC. 305. EFFECTIVE DATE.

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

SEC. 306. SAVINGS CLAUSE.

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

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

SEC. 401. SHORT TITLE; FINDING.

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

SEC. 402. DEFINITIONS.

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

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

    (a) Types of Fees.--Section 744H(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-52(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``2018'' and inserting ``2023'';
            (2) in paragraph (1)--
                    (A) in subparagraph (A)--
                            (i) in clause (iv)(I), by striking ``5 
                        days'' and inserting ``7 days''; and
                            (ii) in clause (v)(II), by striking ``5 
                        days'' and inserting ``7 days'';
                    (B) in subparagraph (B)--
                            (i) in clause (i), by inserting ``, except 
                        that, in the case that such product (including, 
                        where applicable, ownership of the relevant 
                        investigational new drug application) is 
                        transferred to a licensee, assignee, or 
                        successor of such person, and written notice of 
                        such transfer is provided to the Secretary, 
                        such licensee, assignee or successor shall pay 
                        the annual biosimilar biological product 
                        development fee'' before the period;
                            (ii) in clause (iii)--
                                    (I) in subclause (I), by striking 
                                ``; or'' and inserting a semicolon;
                                    (II) in subclause (II), by striking 
                                the period and inserting ``; or''; and
                                    (III) by adding at the end the 
                                following:
                                    ``(III) been administratively 
                                removed from the biosimilar biological 
                                product development program for the 
                                product under subparagraph (E)(v).''; 
                                and
                            (iii) in clause (iv), by striking 
                        ``accepted for filing on or after October 1 of 
                        such fiscal year'' and inserting ``subsequently 
                        accepted for filing'';
                    (C) in subparagraph (D)--
                            (i) in clause (i)--
                                    (I) in the matter preceding 
                                subclause (I), by striking ``shall, if 
                                the person seeks to resume 
                                participation in such program, pay'' 
                                and inserting ``or who has been 
                                administratively removed from such 
                                program for a product under 
                                subparagraph (E)(v) shall, if the 
                                person seeks to resume participation in 
                                such program, pay all annual biosimilar 
                                biological product development fees 
                                previously assessed for such product 
                                and still owed and'';
                                    (II) in subclause (I)--
                                            (aa) by striking ``5 days'' 
                                        and inserting ``7 days''; and
                                            (bb) by inserting ``or the 
                                        date of administrative removal, 
                                        as applicable'' after 
                                        ``discontinued''; and
                                    (III) in subclause (II), by 
                                inserting ``or the date of 
                                administrative removal, as applicable'' 
                                after ``discontinued''; and
                            (ii) in clause (ii), by inserting ``, 
                        except that, in the case that such product 
                        (including, where applicable, ownership of the 
                        relevant investigational new drug application) 
                        is transferred to a licensee, assignee, or 
                        successor of such person, and written notice of 
                        such transfer is provided to the Secretary, 
                        such licensee, assignee or successor shall pay 
                        the annual biosimilar biological product 
                        development fee'' before the period at the end; 
                        and
                    (D) in subparagraph (E), by adding at the end the 
                following:
                            ``(v) Administrative removal from the 
                        biosimilar biological product development 
                        program.--If a person has failed to pay an 
                        annual biosimilar biological product 
                        development fee for a product as required under 
                        subparagraph (B) for a period of 2 consecutive 
                        fiscal years, the Secretary may 
                        administratively remove such person from the 
                        biosimilar biological product development 
                        program for the product. At least 30 days prior 
                        to administratively removing a person from the 
                        biosimilar biological product development 
                        program for a product under this clause, the 
                        Secretary shall provide written notice to such 
                        person of the intended administrative 
                        removal.'';
            (3) in paragraph (2)(D), by inserting ``prior to approval'' 
        after ``withdrawn'';
            (4) in paragraph (3)--
                    (A) in subparagraph (A)--
                            (i) in clause (i), by striking ``; and'' 
                        and inserting a semicolon;
                            (ii) by redesignating clause (ii) as clause 
                        (iii); and
                            (iii) by inserting the following after 
                        clause (i):
                            ``(ii) may be dispensed only under 
                        prescription pursuant to section 503(b); and''; 
                        and
                    (B) by adding at the end the following:
                    ``(E) Movement to discontinued list.--
                            ``(i) Written request to place on 
                        discontinued list.--
                                    ``(I) In general.--If a written 
                                request to place a product on the list 
                                of discontinued biosimilar biological 
                                products referred to in subparagraph 
                                (A)(iii) is submitted to the Secretary 
                                on behalf of an applicant, and the 
                                request identifies the date the product 
                                is, or will be, withdrawn from sale, 
                                then for purposes of assessing the 
                                biosimilar biological product program 
                                fee, the Secretary shall consider such 
                                product to have been included on such 
                                list on the later of--
                                            ``(aa) the date such 
                                        request was received; or
                                            ``(bb) if the product will 
                                        be withdrawn from sale on a 
                                        future date, such future date 
                                        when the product is withdrawn 
                                        from sale.
                                    ``(II) Withdrawn from sale 
                                defined.--For purposes of this clause, 
                                a product shall be considered withdrawn 
                                from sale once the applicant has ceased 
                                its own distribution of the product, 
                                whether or not the applicant has 
                                ordered recall of all previously 
                                distributed lots of the product, except 
                                that a routine, temporary interruption 
                                in supply shall not render a product 
                                withdrawn from sale.
                            ``(ii) Products removed from discontinued 
                        list.--If a biosimilar biological product that 
                        is identified in a biosimilar biological 
                        product application approved as of October 1 of 
                        a fiscal year appears, as of October 1 of such 
                        fiscal year, on the list of discontinued 
                        biosimilar biological products referred to in 
                        subparagraph (A)(iii), and on any subsequent 
                        day during such fiscal year the biosimilar 
                        biological product does not appear on such 
                        list, except as provided in subparagraph (D), 
                        each person who is named as the applicant in 
                        the biosimilar biological product application 
                        shall pay the annual biosimilar biological 
                        product program fee established for a fiscal 
                        year under subsection (c)(5) for such 
                        biosimilar biological product. Notwithstanding 
                        subparagraph (B), such fee shall be due on the 
                        last business day of such fiscal year and shall 
                        be paid only once for each product for each 
                        fiscal year.''; and
            (5) by striking paragraph (4).
    (b) Fee Revenue Amounts.--Section 744H(b) of the Federal Food, 
Drug, and Cosmetic Act ((21 U.S.C. 379j-52(b)) is amended--
            (1) by striking paragraph (1);
            (2) by redesignating paragraphs (2) through (4) as 
        paragraphs (1) through (3), respectively;
            (3) in paragraph (1), as so redesignated--
                    (A) in the paragraph heading, by striking 
                ``Subsequent fiscal years'' and inserting ``In 
                general'';
                    (B) in the matter preceding subparagraph (A), by 
                striking ``2019 through 2022'' and inserting ``2023 
                through 2027'';
                    (C) in subparagraph (A), by striking ``paragraph 
                (4)'' and inserting ``paragraph (3)'';
                    (D) by redesignating subparagraphs (C) and (D) as 
                subparagraphs (D) and (E), respectively;
                    (E) by inserting after subparagraph (B) the 
                following:
                    ``(C) the dollar amount equal to the strategic 
                hiring and retention adjustment (as determined under 
                subsection (c)(2));'';
                    (F) in subparagraph (D), as so redesignated, by 
                striking ``subsection (c)(2)); and'' and inserting 
                ``subsection (c)(3));'';
                    (G) in subparagraph (E), as so redesignated, by 
                striking ``subsection (c)(3)).'' and inserting 
                ``subsection (c)(4)); and''; and
                    (H) by adding at the end the following:
                    ``(F) for fiscal years 2023 and 2024, additional 
                dollar amounts equal to--
                            ``(i) $4,428,886 for fiscal year 2023; and
                            ``(ii) $320,569 for fiscal year 2024.'';
            (4) in paragraph (2), as so redesignated--
                    (A) in the paragraph heading, by striking ``; 
                limitations on fee amounts'';
                    (B) by striking subparagraph (B); and
                    (C) by redesignating subaparagraphs (C) and (D) as 
                subparagraphs (B) and (C), respectively; and
            (5) by amending paragraph (3), as so redesignated, to read 
        as follows:
            ``(3) Annual base revenue.--For purposes of paragraph (1), 
        the dollar amount of the annual base revenue for a fiscal year 
        shall be--
                    ``(A) for fiscal year 2023, $43,376,922; and
                    ``(B) for fiscal years 2024 through 2027, the 
                dollar amount of the total revenue amount established 
                under paragraph (1) for the previous fiscal year, 
                excluding any adjustments to such revenue amount under 
                subsection (c)(4).''.
    (c) Adjustments; Annual Fee Setting.--Section 744H(c) of the 
Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 379j-52(c)) is 
amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i), by 
                        striking ``subsection (b)(2)(B)'' and inserting 
                        ``subsection (b)(1)(B)''; and
                            (ii) in clause (i), by striking 
                        ``subsection (b)'' and inserting ``subsection 
                        (b)(1)(A)''; and
                    (B) in subparagraph (B)(ii), by striking 
                ``Washington-Baltimore, DC-MD-VA-WV'' and inserting 
                ``Washington-Arlington-Alexandria, DC-VA-MD-WV'';
            (2) by striking paragraph (4);
            (3) by redesignating paragraphs (2) and (3) as paragraphs 
        (3) and (4), respectively;
            (4) by inserting after paragraph (1) the following:
            ``(2) Strategic hiring and retention adjustment.--For each 
        fiscal year beginning in fiscal year 2023, after the annual 
        base revenue under subsection (b)(1)(A) is adjusted for 
        inflation in accordance with paragraph (1), the Secretary shall 
        further increase the fee revenue and fees by $150,000.'';
            (5) in paragraph (3), as so redesignated--
                    (A) in subparagraph (A)--
                            (i) by striking ``Beginning with the fiscal 
                        year described in subparagraph (B)(ii)(II)'' 
                        and inserting ``For each fiscal year''; and
                            (ii) by striking ``adjustment under 
                        paragraph (1), further increase'' and inserting 
                        ``adjustments under paragraphs (1) and (2), 
                        further adjust'';
                    (B) by amending subparagraph (B) to read as 
                follows:
                    ``(B) Methodology.--For purposes of this paragraph, 
                the Secretary shall employ the capacity planning 
                methodology utilized by the Secretary in setting fees 
                for fiscal year 2021, as described in the notice titled 
                `Biosimilar User Fee Rates for Fiscal Year 2021' (85 
                Fed. Reg. 47220; August 4, 2020). The workload 
                categories used in forecasting shall include only the 
                activities described in such notice and, as feasible, 
                additional activities that are also directly related to 
                the direct review of biosimilar biological product 
                applications and supplements, including additional 
                formal meeting types and the direct review of 
                postmarketing commitments and requirements, the direct 
                review of risk evaluation and mitigation strategies, 
                and the direct review of annual reports for approved 
                biosimilar biological products. Subject to the 
                exceptions in the preceding sentence, the Secretary 
                shall not include as workload categories in forecasting 
                any non-core review activities, including any 
                activities that the Secretary referenced for potential 
                future use in such notice but did not utilize in 
                setting fees for fiscal year 2021.''; and
                    (C) in subparagraph (C)--
                            (i) by striking ``subsections (b)(2)(A)'' 
                        and inserting ``subsections (b)(1)(A)'';
                            (ii) by striking ``and (b)(2)(B)'' and 
                        inserting ``, (b)(1)(B)''; and
                            (iii) by inserting ``, and (b)(1)(C) (the 
                        dollar amount of the strategic hiring and 
                        retention adjustment)'' before the period at 
                        the end;
            (6) by amending paragraph (4), as so redesignated, to read 
        as follows:
            ``(4) Operating reserve adjustment.--
                    ``(A) Increase.--For fiscal year 2023 and 
                subsequent fiscal years, the Secretary shall, in 
                addition to adjustments under paragraphs (1), (2), and 
                (3), further increase the fee revenue and fees if such 
                an adjustment is necessary to provide for at least 10 
                weeks of operating reserves of carryover user fees for 
                the process for the review of biosimilar biological 
                product applications.
                    ``(B) Decrease.--
                            ``(i) Fiscal year 2023.--For fiscal year 
                        2023, if the Secretary has carryover balances 
                        for the process for the review of biosimilar 
                        biological product applications in excess of 33 
                        weeks of such operating reserves, the Secretary 
                        shall decrease such fee revenue and fees to 
                        provide for not more than 33 weeks of such 
                        operating reserves.
                            ``(ii) Fiscal year 2024.--For fiscal year 
                        2024, if the Secretary has carryover balances 
                        for the process for the review of biosimilar 
                        biological product applications in excess of 27 
                        weeks of such operating reserves, the Secretary 
                        shall decrease such fee revenue and fees to 
                        provide for not more than 27 weeks of such 
                        operating reserves.
                            ``(iii) Fiscal year 2025 and subsequent 
                        fiscal years.--For fiscal year 2025 and 
                        subsequent fiscal years, if the Secretary has 
                        carryover balances for the process for the 
                        review of biosimilar biological product 
                        applications in excess of 21 weeks of such 
                        operating reserves, the Secretary shall 
                        decrease such fee revenue and fees to provide 
                        for not more than 21 weeks of such operating 
                        reserves.
                    ``(C) Federal register notice.--If an adjustment 
                under subparagraph (A) or (B) is made, the rationale 
                for the amount of the increase or decrease (as 
                applicable) in fee revenue and fees shall be contained 
                in the annual Federal Register notice under paragraph 
                (5)(B) establishing fee revenue and fees for the fiscal 
                year involved.''; and
            (7) in paragraph (5), in the matter preceding subparagraph 
        (A), by striking ``2018'' and inserting ``2023''.
    (d) Crediting and Availability of Fees.--Section 744H(f)(3) of the 
Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 379j-52(f)(3)) is 
amended by striking ``2018 through 2022'' and inserting ``2023 through 
2027''.
    (e) Written Requests for Waivers and Refunds.--Subsection (h) of 
section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-52) is amended to read as follows:
    ``(h) Written Requests for Waivers and Returns; Disputes Concerning 
Fees.--To qualify for consideration for a waiver under subsection (d), 
or the return of any fee paid under this section, including if the fee 
is claimed to have been paid in error, a person shall submit to the 
Secretary a written request justifying such waiver or return and, 
except as otherwise specified in this section, such written request 
shall be submitted to the Secretary not later than 180 days after such 
fee is due. A request submitted under this paragraph shall include any 
legal authorities under which the request is made.''.

SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-53) is amended--
            (1) by striking ``2018'' each place it appears and 
        inserting ``2023'';
            (2) by striking ``Biosimilar User Fee Amendments of 2017'' 
        each place it appears and inserting ``Biosimilar User Fee 
        Amendments of 2022'';
            (3) in subsection (a)(4), by striking ``2020'' and 
        inserting ``2023''; and
            (4) in subsection (f), by striking ``2022'' each place it 
        appears and inserting ``2027''.

SEC. 405. SUNSET DATES.

    (a) Authorization.--Sections 744G and 744H of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-51, 379j-52) shall cease to be 
effective October 1, 2027.
    (b) Reporting Requirements.--Section 744I of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-53) shall cease to be effective 
January 31, 2028.
    (c) Previous Sunset Provision.--Effective October 1, 2022, 
subsections (a) and (b) of section 405 of the FDA Reauthorization Act 
of 2017 (Public Law 115-52) are repealed.

SEC. 406. EFFECTIVE DATE.

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

SEC. 407. SAVINGS CLAUSE.

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

                    TITLE V--OTHER REAUTHORIZATIONS

SEC. 501. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 
              PARTNERSHIP.

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

SEC. 502. REAUTHORIZATION OF THE BEST PHARMACEUTICALS FOR CHILDREN 
              PROGRAM.

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

SEC. 503. REAUTHORIZATION OF THE HUMANITARIAN DEVICE EXEMPTION 
              INCENTIVE.

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

SEC. 504. REAUTHORIZATION OF THE PEDIATRIC DEVICE CONSORTIA PROGRAM.

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

SEC. 505. 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, 2022'' and 
inserting ``October 1, 2027''.

SEC. 506. REAUTHORIZATION OF ORPHAN DRUG GRANTS.

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

SEC. 507. REAUTHORIZATION OF CERTAIN DEVICE INSPECTIONS.

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