IB 
Union Calendar No. 262 
117TH CONGRESS 
2D SESSION 
H. R. 7667 
[Report No. 117–348] 
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 HOUSE OF REPRESENTATIVES 
MAY 6, 2022 
Ms. ESHOO (for herself, Mr. GUTHRIE, Mr. PALLONE, and Mrs. RODGERS of 
Washington) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
JUNE 7, 2022 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on May 6, 2022] 
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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 bio-
logical products, and for other purposes. 
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Sec. 407. Savings clause. 
TITLE V—IMPROVING DIVERSITY IN CLINICAL STUDIES 
Sec. 501. Diversity action plans for clinical studies. 
Sec. 502. Evaluation of the need for FDA authority to mandate postapproval 
studies or postmarket surveillance due to insufficient demo-
graphic subgroup data. 
Sec. 503. Public workshops to enhance clinical study diversity. 
Sec. 504. Annual summary report on progress to increase diversity in clinical 
studies. 
Sec. 505. Public meeting on clinical study flexibilities initiated in response to 
COVID–19 pandemic. 
Sec. 506. Decentralized clinical studies. 
TITLE VI—GENERIC DRUG COMPETITION 
Sec. 601. Increasing transparency in generic drug applications. 
Sec. 602. Enhancing access to affordable medicines. 
TITLE VII—RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN 
IMPROVEMENTS 
Subtitle A—In General 
Sec. 701. Animal testing alternatives. 
Sec. 702. Emerging technology program. 
Sec. 703. Improving the treatment of rare diseases and conditions. 
Sec. 704. Antifungal research and development. 
Sec. 705. Advancing qualified infectious disease product innovation. 
Sec. 706. Advanced manufacturing technologies designation pilot program. 
Sec. 707. Public workshop on cell therapies. 
Sec. 708. Reauthorization of best pharmaceuticals for children. 
Sec. 709. Reauthorization for humanitarian device exemption and demonstration 
grants for improving pediatric availability. 
Sec. 710. Reauthorization of provision related to exclusivity of certain drugs con-
taining single enantiomers. 
Sec. 711. Reauthorization of the critical path public-private partnership pro-
gram. 
Sec. 712. Reauthorization of orphan drug grants. 
Sec. 713. Research into pediatric uses of drugs; additional authorities of Food 
and Drug Administration regarding molecularly targeted cancer 
drugs. 
Subtitle B—Inspections 
Sec. 721. Factory inspection. 
Sec. 722. Uses of certain evidence. 
Sec. 723. Improving FDA inspections. 
Sec. 724. GAO report on inspections of foreign establishments manufacturing 
drugs. 
Sec. 725. Unannounced foreign facility inspections pilot program. 
Sec. 726. Reauthorization of inspection program. 
Sec. 727. Enhancing intra-agency coordination and public health assessment with 
regard to compliance activities. 
Sec. 728. Reporting of mutual recognition agreements for inspections and review 
activities. 
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Sec. 729. Enhancing transparency of drug facility inspection timelines. 
TITLE VIII—TRANSPARENCY, PROGRAM INTEGRITY, AND 
REGULATORY IMPROVEMENTS 
Sec. 801. Prompt reports of marketing status by holders of approved applications 
for biological products. 
Sec. 802. Encouraging blood donation. 
Sec. 803. Regulation of certain products as drugs. 
Sec. 804. Postapproval studies and program integrity for accelerated approval 
drugs. 
Sec. 805. Facilitating the use of real world evidence. 
Sec. 806. Dual Submission for Certain Devices. 
Sec. 807. Medical Devices Advisory Committee meetings. 
Sec. 808. Ensuring cybersecurity of medical devices. 
Sec. 809. Public docket on proposed changes to third-party vendors. 
Sec. 810. Facilitating exchange of product information prior to approval. 
Sec. 811. Bans of devices for one or more intended uses. 
Sec. 812. Clarifying application of exclusive approval, certification, or licensure 
for drugs designated for rare diseases or conditions. 
Sec. 813. GAO report on third-party review. 
Sec. 814. Reporting on pending generic drug applications and priority review 
applications. 
Sec. 815. FDA Workforce Improvements. 
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.—The Congress finds that the fees author-
ized by the amendments made by this title will be dedicated 
toward expediting the drug development process and the 
process for the review of human drug applications, includ-
ing 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 
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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. 
(a) HUMAN DRUG APPLICATION.—Section 735(1) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379g(1)) is amended 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 re-
spect to a standardized allergenic extract product submitted 
pursuant to a notification to the applicant from the Sec-
retary regarding the existence of a potency test that meas-
ures the allergenic activity of an allergenic extract product 
licensed by the applicant before October 1, 2022, does not 
include an application with respect to’’. 
(b) PRESCRIPTION DRUG PRODUCT.—Section 735(3) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379g(3)) is amended— 
(1) by redesignating subparagraphs (A), (B), 
and (C) as clauses (i), (ii), and (iii), respectively; 
(2) by striking ‘‘(3) The term’’ and inserting 
‘‘(3)(A) The term’’; 
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(3) by striking ‘‘Such term does not include 
whole blood’’ and inserting the following: 
‘‘(B) Such term does not include whole blood’’; 
(4) by striking ‘‘an allergenic extract product,’’ 
and inserting ‘‘an allergenic extract product licensed 
before October 1, 2022, a standardized allergenic ex-
tract product submitted pursuant to a notification to 
the applicant from the Secretary regarding the exist-
ence of a potency test that measures the allergenic ac-
tivity of an allergenic extract product licensed by the 
applicant before October 1, 2022,’’ ; and 
(5) by adding at the end the following: 
‘‘(C)(i) If a written request to place a prod-
uct in the discontinued section of either of the 
lists referenced in subparagraph (A)(iii) is sub-
mitted to the Secretary on behalf of an appli-
cant, and the request identifies the date the prod-
uct is withdrawn from sale, then for purposes of 
assessing the prescription drug program fee 
under section 736(a)(2), the Secretary shall con-
sider such product to have been included in the 
discontinued section on the later of— 
‘‘(I) the date such request was received; 
or 
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‘‘(II) if the product will be withdrawn 
from sale on a future date, such future date 
when the product is withdrawn from sale. 
‘‘(ii) For purposes of this subparagraph, a 
product shall be considered withdrawn from sale 
once the applicant has ceased its own distribu-
tion of the product, whether or not the applicant 
has ordered recall of all previously distributed 
lots of the product, except that a routine, tem-
porary interruption in supply shall not render a 
product withdrawn from sale.’’. 
(c) SKIN-TEST DIAGNOSTIC PRODUCT.—Section 735 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) 
is amended by adding at the end the following: 
‘‘(12) The term ‘skin-test diagnostic product’— 
‘‘(A) means a product— 
‘‘(i) for prick, scratch, intradermal, or 
subcutaneous administration; 
‘‘(ii) expected to produce a limited, 
local reaction at the site of administration 
(if positive), rather than a systemic effect; 
‘‘(iii) not intended to be a preventive 
or therapeutic intervention; and 
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‘‘(iv) intended to detect an immediate- 
or delayed-type skin hypersensitivity reac-
tion to aid in the diagnosis of— 
‘‘(I) an allergy to an anti-
microbial 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 de-
scribed in subparagraph (A).’’. 
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES. 
(a) TYPES OF FEES.— 
(1) HUMAN
DRUG
APPLICATION
FEE.—Section 
736(a) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379h(a)) is amended— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘fiscal year 2018’’ and inserting ‘‘fis-
cal year 2023’’; 
(B) in paragraph (1)(A), by striking 
‘‘(c)(5)’’ each place it appears and inserting 
‘‘(c)(6)’’; 
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(C) in paragraph (1)(C), by inserting 
‘‘prior to approval’’ after ‘‘or was withdrawn’’; 
and 
(D) in paragraph (1), by adding at the end 
the following: 
‘‘(H) EXCEPTION
FOR
SKIN-TEST
DIAG-
NOSTIC PRODUCTS.—A human drug application 
for a skin-test diagnostic product shall not be 
subject to a fee under subparagraph (A).’’. 
(2) PRESCRIPTION DRUG PROGRAM FEE.—Sec-
tion 736(a)(2) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379h(a)(2)) is amended— 
(A) in subparagraph (A)— 
(i) by striking ‘‘Except as provided in 
subparagraphs (B) and (C)’’ and inserting 
the following: 
‘‘(i) FEE.—Except as provided in sub-
paragraphs (B) and (C)’’; 
(ii) by striking ‘‘subsection (c)(5)’’ and 
inserting ‘‘subsection (c)(6)’’; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(ii) SPECIAL RULE.—If a drug prod-
uct that is identified in a human drug ap-
plication approved as of October 1 of a fis-
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cal year is not a prescription drug product 
as of that date because the drug product is 
in the discontinued section of a list ref-
erenced in section 735(3)(A)(iii), and on 
any subsequent day during such fiscal year 
the drug product is a prescription drug 
product, then except as provided in sub-
paragraphs (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 with respect to 
such product, shall pay the annual pre-
scription drug program fee established for a 
fiscal year under subsection (c)(6) for such 
prescription drug product. Such fee shall be 
due on the last business day of such fiscal 
year and shall be paid only once for each 
such product for a fiscal year in which the 
fee is payable.’’; and 
(B) by amending subparagraph (B) to read 
as follows: 
‘‘(B) EXCEPTION FOR CERTAIN PRESCRIP-
TION
DRUG
PRODUCTS.—A prescription drug 
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program fee shall not be assessed for a prescrip-
tion 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 great-
er than or equal to 100 mL, not including 
powders for reconstitution or pharmacy 
bulk packages) identified on the list com-
piled under section 505(j)(7); 
‘‘(ii) pharmaceutically equivalent (as 
defined in section 314.3 of title 21, Code of 
Federal Regulations (or any successor regu-
lation)) 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.— 
(1) IN
GENERAL.—Paragraph (1) of section 
736(b) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379h(b)) is amended to read as follows: 
‘‘(1) IN GENERAL.—For each of the fiscal years 
2023 through 2027, fees under subsection (a) shall, ex-
cept as provided in subsections (c), (d), (f), and (g), 
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be established to generate a total revenue amount 
under such subsection that is equal to the sum of— 
‘‘(A) the annual base revenue for the fiscal 
year (as determined under paragraph (3)); 
‘‘(B) the dollar amount equal to the infla-
tion adjustment for the fiscal year (as deter-
mined under subsection (c)(1)); 
‘‘(C) the dollar amount equal to the stra-
tegic hiring and retention adjustment for the fis-
cal year (as determined under subsection (c)(2)); 
‘‘(D) the dollar amount equal to the capac-
ity planning adjustment for the fiscal year (as 
determined under subsection (c)(3)); 
‘‘(E) the dollar amount equal to the oper-
ating reserve adjustment for the fiscal year, if 
applicable (as determined under subsection 
(c)(4)); 
‘‘(F) the dollar amount equal to the addi-
tional direct cost adjustment for the fiscal year 
(as determined under subsection (c)(5)); and 
‘‘(G) additional dollar amounts for each fis-
cal year as follows: 
‘‘(i) $65,773,693 for fiscal year 2023. 
‘‘(ii) $25,097,671 for fiscal year 2024. 
‘‘(iii) $14,154,169 for fiscal year 2025. 
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‘‘(iv) $4,864,860 for fiscal year 2026. 
‘‘(v) $1,314,620 for fiscal year 2027.’’. 
(2) ANNUAL BASE REVENUE.—Paragraph (3) of 
section 736(b) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379h(b)) is amended to read as 
follows: 
‘‘(3) ANNUAL BASE REVENUE.—For purposes of 
paragraph (1), the dollar amount of the annual base 
revenue for a fiscal year shall be— 
‘‘(A) for fiscal year 2023, $1,151,522,958; 
and 
‘‘(B) for fiscal years 2024 through 2027, the 
dollar amount of the total revenue amount estab-
lished under paragraph (1) for the previous fis-
cal year, not including any adjustments made 
under subsection (c)(4) or (c)(5).’’. 
(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 
(1) 
INFLATION
ADJUSTMENT.—Section 
736(c)(1)(B)(ii) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379h(c)(1)(B)(ii)) is amended 
by striking ‘‘Washington-Baltimore, DC–MD–VA– 
WV’’ and inserting ‘‘Washington-Arlington-Alexan-
dria, DC–VA–MD–WV’’. 
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paragraphs (1) and (2), such revenue shall be 
adjusted further for such fiscal year, in accord-
ance with this paragraph, to reflect changes in 
the resource capacity needs of the Secretary for 
the process for the review of human drug appli-
cations. 
‘‘(B) METHODOLOGY.—For purposes of this 
paragraph, the Secretary shall employ the capac-
ity planning methodology utilized by the Sec-
retary in setting fees for fiscal year 2021, as de-
scribed in the notice titled ‘Prescription Drug 
User Fee Rates for Fiscal Year 2021’ published 
in the Federal Register on August 3, 2020 (85 
Fed. Reg. 46651). The workload categories used 
in applying such methodology in forecasting 
shall include only the activities described in that 
notice and, as feasible, additional activities that 
are also directly related to the direct review of 
applications and supplements, including addi-
tional formal meeting types, the direct review of 
postmarketing commitments and requirements, 
the direct review of risk evaluation and mitiga-
tion strategies, and the direct review of annual 
reports for approved prescription drug products. 
Subject to the exceptions in the preceding sen-
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tence, the Secretary shall not include as work-
load categories in applying such methodology in 
forecasting any non-core review activities, in-
cluding those activities that the Secretary ref-
erenced for potential future use in such notice 
but did not utilize in setting fees for fiscal year 
2021. 
‘‘(C) LIMITATION.—Under no circumstances 
shall an adjustment under this paragraph result 
in fee revenue for a fiscal year that is less than 
the sum of the amounts under subsections 
(b)(1)(A) (the annual base revenue for the fiscal 
year), (b)(1)(B) (the dollar amount of the infla-
tion adjustment for the fiscal year), and 
(b)(1)(C) (the dollar amount of the strategic hir-
ing and retention adjustment for the fiscal year). 
‘‘(D) 
PUBLICATION
IN
FEDERAL
REG-
ISTER.—The Secretary shall publish in the Fed-
eral Register notice under paragraph (6) of the 
fee revenue and fees resulting from the adjust-
ment and the methodologies under this para-
graph.’’. 
(4) OPERATING RESERVE ADJUSTMENT.—Para-
graph (4), as redesignated, of section 736(c) of the 
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Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h(c)) is amended— 
(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 operating reserves of carryover user fees for 
the process for the review of human drug appli-
cations for each fiscal year in at least the fol-
lowing amounts: 
‘‘(i) For fiscal year 2023, at least 8 
weeks of operating reserves. 
‘‘(ii) For fiscal year 2024, at least 9 
weeks of operating reserves. 
‘‘(iii) For fiscal year 2025 and subse-
quent fiscal years, at least 10 weeks of oper-
ating reserves.’’; and 
(B) in subparagraph (C), by striking 
‘‘paragraph (5)’’ and inserting ‘‘paragraph (6)’’. 
(5) ADDITIONAL DIRECT COST ADJUSTMENT.— 
Paragraph (5), as redesignated, of section 736(c) of 
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the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h(c)) is amended to read as follows: 
‘‘(5) ADDITIONAL DIRECT COST ADJUSTMENT.— 
‘‘(A) INCREASE.—The Secretary shall, in 
addition to adjustments under paragraphs (1), 
(2), (3), and (4), further increase the fee revenue 
and fees— 
‘‘(i) 
for 
fiscal 
year 
2023, 
by 
$44,386,150; and 
‘‘(ii) for each of fiscal years 2024 
through 2027, by the amount set forth in 
clauses (i) through (iv) of subparagraph 
(B), as applicable, multiplied by the Con-
sumer Price Index for urban consumers 
(Washington-Arlington-Alexandria, 
DC– 
VA–MD–WV; Not Seasonally Adjusted; All 
Items; Annual Index) for the most recent 
year of available data, divided by such 
Index for 2021. 
‘‘(B) APPLICABLE AMOUNTS.—The amounts 
referred to in subparagraph (A)(ii) are the fol-
lowing: 
‘‘(i) For fiscal year 2024, $60,967,993. 
‘‘(ii) For fiscal year 2025, $35,799,314. 
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‘‘(iii) For fiscal year 2026, $35,799, 
314. 
‘‘(iv) 
For 
fiscal 
year 
2027, 
$35,799,314.’’. 
(6) ANNUAL FEE SETTING.—Paragraph (6), as 
redesignated, of section 736(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is 
amended by striking ‘‘September 30, 2017’’ and in-
serting ‘‘September 30, 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 ‘‘fiscal years 
2018 through 2022’’ and inserting ‘‘fiscal years 2023 
through 2027’’. 
(e) WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, 
EXEMPTIONS, 
AND
RETURNS; DISPUTES
CONCERNING 
FEES.—Section 736(i) of the Federal Food, Drug, and Cos-
metic 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 reduc-
tion under subsection (d), an exemption under subsection 
(k), or the return of any fee paid under this section, includ-
ing if the fee is claimed to have been paid in error, a person 
shall— 
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‘‘(1) not later than 180 days after such fee is 
due, submit to the Secretary a written request justi-
fying such waiver, reduction, exemption, or return; 
and 
‘‘(2) include in the request 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) by amending paragraph (2) to read as fol-
lows: 
‘‘(2) EVIDENCE OF QUALIFICATION.—An exemp-
tion under paragraph (1) applies with respect to a 
drug only if the applicant involved submits a certifi-
cation that the applicant’s gross annual revenues did 
not exceed $50,000,000 for the last calendar year end-
ing prior to the fiscal year for which the exemption 
is requested. Such certification shall be supported 
by— 
‘‘(A) tax returns submitted to the United 
States Internal Revenue Service; or 
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‘‘(B) as necessary, other appropriate finan-
cial information.’’. 
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 736B of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379h–2) is amended— 
(1) in subsection (a)(1), by striking ‘‘Beginning 
with fiscal year 2018, not’’ and inserting ‘‘Not’’; 
(2) by striking ‘‘Prescription Drug User Fee 
Amendments of 2017’’ each place it appears and in-
serting ‘‘Prescription Drug User Fee Amendments of 
2022’’; 
(3) in subsection (a)(3)(A), by striking ‘‘Not 
later than 30 calendar days after the end of the sec-
ond quarter of fiscal year 2018, and not later than 
30 calendar days after the end of each quarter of each 
fiscal year thereafter’’ and inserting ‘‘Not later than 
30 calendar days after the end of each quarter of each 
fiscal year for which fees are collected under this 
part’’; 
(4) in subsection (a)(3)(B), by adding at the end 
the following: 
‘‘(v) For fiscal years 2023 and 2024, of 
the meeting requests from sponsors for 
which the Secretary has determined that a 
face-to-face meeting is appropriate, the 
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(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 re-
pealed. 
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 sub-
chapter 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 on or after October 1, 2017, but before 
October 1, 2022, were accepted by the Food and Drug Ad-
ministration for filing with respect to assessing and col-
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lecting 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.—The Congress finds that the fees author-
ized under the amendments made by this title will be dedi-
cated toward expediting the process for the review of device 
applications and for assuring the safety and effectiveness 
of devices, as set forth in the goals identified for purposes 
of part 3 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), in the 
letters from the Secretary of Health and Human Services 
to the Chairman of the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Chairman of 
the Committee on Energy and Commerce of the House of 
Representatives, as set forth in the Congressional Record. 
SEC. 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 
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submissions’’ and inserting ‘‘premarket notifica-
tion submissions, and de novo classification re-
quests’’; 
(B) in subparagraph (D), by striking ‘‘and 
submissions’’ and inserting ‘‘submissions, and 
requests’’; 
(C) in subparagraph (F), by striking ‘‘and 
premarket notification submissions’’ and insert-
ing ‘‘premarket notification submissions, and de 
novo classification requests’’; 
(D) in each of subparagraphs (G) and (H), 
by striking ‘‘or submissions’’ and inserting ‘‘sub-
missions, or requests’’; and 
(E) in subparagraph (K), by striking ‘‘or 
premarket notification submissions’’ and insert-
ing ‘‘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 ‘‘fiscal year 
2018’’ and inserting ‘‘fiscal year 2023’’; and 
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(2) in paragraph (2)— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i), 
by striking ‘‘October 1, 2017’’ and inserting 
‘‘October 1, 2022’’; 
(ii) in clause (iii), by striking ‘‘75 per-
cent’’ 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 in-
serting ‘‘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 re-
quest’’. 
(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 paragraph (2) to read as fol-
lows: 
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‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For pur-
poses of paragraph (1), the base fee amounts specified 
in this paragraph are as follows: 
‘‘Fee Type 
Fiscal 
Year 
2023 
Fiscal 
Year 
2024 
Fiscal 
Year 
2025 
Fiscal 
Year 
2026 
Fiscal 
Year 
2027 
Premarket Application ................................
$425,000 
$435,000 
$445,000 
$455,000 
$470,000 
Establishment Registration .........................
$6,250 
$6,875 
$7,100 
$7,575 
$8,465’’; 
and 
(3) by amending paragraph (3) to read as fol-
lows: 
‘‘(3) TOTAL
REVENUE
AMOUNTS
SPECIFIED.— 
For purposes of paragraph (1), the total revenue 
amounts specified in this paragraph are as follows: 
‘‘(A) $312,606,000 for fiscal year 2023. 
‘‘(B) $335,750,000 for fiscal year 2024. 
‘‘(C) $350,746,400 for fiscal year 2025. 
‘‘(D) $366,486,300 for fiscal year 2026. 
‘‘(E) $418,343,000 for fiscal year 2027.’’. 
(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 in-
serting ‘‘2022’’; 
(2) in paragraph (2)— 
(A) in subparagraph (A), by striking 
‘‘2018’’ and inserting ‘‘2023’’; 
(B) in subparagraph (B)— 
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(i) in the matter preceding clause (i), 
by striking ‘‘fiscal year 2018’’ and inserting 
‘‘fiscal year 2023’’; and 
(ii) in clause (ii), by striking ‘‘fiscal 
year 2016’’ and inserting ‘‘fiscal year 
2022’’; 
(C) in subparagraph (C), by striking 
‘‘Washington-Baltimore, DC–MD–VA–WV’’ and 
inserting 
‘‘Washington-Arlington-Alexandria, 
DC–VA–MD–WV’’; and 
(D) in subparagraph (D), in the matter 
preceding clause (i), by striking ‘‘fiscal years 
2018 through 2022’’ and inserting ‘‘fiscal years 
2023 through 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 fol-
lowing: 
‘‘(4) 
PERFORMANCE
IMPROVEMENT
ADJUST-
MENT.— 
‘‘(A) IN GENERAL.—For each of fiscal years 
2025 through 2027, after the adjustments under 
paragraphs (2) and (3), the base establishment 
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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 de-
scribed 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: 
‘‘(i) For fiscal year 2025, the product 
of— 
‘‘(I) the amount determined under 
subparagraph (B)(i)(I); and 
‘‘(II) the applicable inflation ad-
justment under paragraph (2)(B) for 
such fiscal year. 
‘‘(ii) For fiscal year 2026, the product 
of— 
‘‘(I) the sum of the amounts deter-
mined under subparagraphs (B)(i)(II), 
(B)(ii)(I), and (B)(iii)(I); and 
‘‘(II) the applicable inflation ad-
justment under paragraph (2)(B) for 
such fiscal year. 
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‘‘(III) For fiscal year 2027: 
‘‘(aa) $15,396,600 if such 
goal for fiscal year 2023 is met 
and such goal for each of fiscal 
years 2024 and 2025 is not met. 
‘‘(bb) $36,792,200 if such 
goal for fiscal year 2024 is met 
and such goal for fiscal year 2025 
is not met. 
‘‘(cc) $40,572,600 if such 
goal for fiscal year 2025 is met. 
‘‘(ii) 
DE
NOVO
CLASSIFICATION 
AMOUNT.—For purposes of subparagraph 
(A), with respect to the de novo decision 
goal, the amounts determined under this 
subparagraph are as follows: 
‘‘(I) 
For 
fiscal 
year 
2026, 
$6,323,500 if such goal for fiscal year 
2023 is met. 
‘‘(II) For fiscal year 2027: 
‘‘(aa) $6,323,500 if such goal 
for fiscal year 2023 is met and 
such goal for fiscal year 2024 is 
not met. 
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‘‘(bb) $11,765,400 if such 
goal for fiscal year 2024 is met. 
‘‘(iii) PREMARKET NOTIFICATION AND 
PREMARKET APPROVAL AMOUNT.—For pur-
poses of subparagraph (A), with respect to 
the 510(k) decision goal, 510(k) shared out-
come total time to decision goal, PMA deci-
sion goal, and PMA shared outcome total 
time to decision goal, the amounts deter-
mined under this subparagraph are as fol-
lows: 
‘‘(I) 
For 
fiscal 
year 
2026, 
$1,020,000 if the four goals for fiscal 
year 2023 are met. 
‘‘(II) For fiscal year 2027: 
‘‘(aa) $1,020,000 if the four 
goals for fiscal year 2023 are met 
and one or more of the four goals 
for fiscal year 2024 are not met. 
‘‘(bb) $3,906,000 if the four 
goals for fiscal year 2024 are met. 
‘‘(C) 
PERFORMANCE
CALCULATION.—For 
purposes of this paragraph, performance of the 
goals listed in subparagraph (D) shall be deter-
mined as specified in the letters described in sec-
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tion 201(b) of the Medical Device User Fee 
Amendments of 2022 and based on data avail-
able as of the following dates: 
‘‘(i) The performance of the pre-sub-
mission written feedback goal shall be based 
on data available as of— 
‘‘(I) for fiscal year 2023, March 
31, 2024; 
‘‘(II) for fiscal year 2024, March 
31, 2025; and 
‘‘(III) for fiscal year 2025, March 
31, 2026. 
‘‘(ii) The performance of the de novo 
decision goal, 510(k) decision goal, 510(k) 
shared outcome total time to decision goal, 
PMA decision goal, and PMA shared out-
come total time to decision goal shall be 
based on data available as of— 
‘‘(I) for fiscal year 2023, March 
31, 2025; and 
‘‘(II) for fiscal year 2024, March 
31, 2026. 
‘‘(D) GOALS
DEFINED.—For purposes of 
this paragraph, the terms ‘pre-submission writ-
ten feedback goal’, ‘de novo decision goal’, ‘510(k) 
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decision goal’, ‘510(k) shared outcome total time 
to decision goal’, ‘PMA decision goal’, and ‘PMA 
shared outcome total time to decision goal’ refer 
to the goals identified by the same names in the 
letters described in section 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 (2), (3), and (4), if applicable, if the 
number of hires to support the process for the re-
view of device applications falls below the thresh-
olds specified in subparagraph (B) for the appli-
cable fiscal years, the base establishment registra-
tion fee amounts shall be decreased as the Sec-
retary determines necessary to achieve a reduc-
tion in total fee collections equal to the hiring 
adjustment amount under subparagraph (C). 
‘‘(B) THRESHOLDS.—The thresholds speci-
fied in this subparagraph are as follows: 
‘‘(i) For fiscal year 2025, the threshold 
is 123 hires for fiscal year 2023. 
‘‘(ii) For fiscal year 2026, the thresh-
old is 38 hires for fiscal year 2024. 
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‘‘(iii) For fiscal year 2027, the thresh-
old is— 
‘‘(I) 22 hires for fiscal year 2025 
if the base establishment registration 
fees are not increased by the amount 
determined under paragraph (4)(A)(i); 
or 
‘‘(II) 75 hires for fiscal year 2025 
if such fees are so increased. 
‘‘(C) HIRING
ADJUSTMENT
AMOUNT.—The 
hiring adjustment amount for fiscal year 2025 
and each subsequent fiscal year is the product 
of— 
‘‘(i) the number of hires by which the 
hiring goal specified in subparagraph (D) 
for the fiscal year before the prior fiscal 
year was not met; 
‘‘(ii) $72,877; and 
‘‘(iii) the applicable inflation adjust-
ment under paragraph (2)(B) for the fiscal 
year for which the hiring goal was not met. 
‘‘(D) HIRING GOALS.—The hiring goals for 
each of fiscal years 2023 through 2025 are as fol-
lows: 
‘‘(i) For fiscal year 2023, 144 hires. 
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‘‘(ii) For fiscal year 2024, 42 hires. 
‘‘(iii) For fiscal year 2025: 
‘‘(I) 24 hires if the base establish-
ment registration fees are not increased 
by the amount determined under para-
graph (4)(A)(i). 
‘‘(II) 83 hires if the base establish-
ment registration fees are increased by 
the amount determined under para-
graph (4)(A)(i). 
‘‘(E) NUMBER OF HIRES.—For purposes of 
this paragraph, the number of hires shall be de-
termined by the Secretary as set forth in the let-
ters 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 (2), (3), (4), and (5), if applicable, 
if the Secretary has operating reserves of carry-
over user fees for the process for the review of de-
vice applications in excess of the designated 
amount in subparagraph (B), the Secretary shall 
decrease the base establishment registration fee 
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amounts to provide for not more than such des-
ignated amount of operating reserves. 
‘‘(B) DESIGNATED
AMOUNT.—Subject to 
subparagraph (C), for each fiscal year, the des-
ignated amount in this subparagraph is equal to 
the sum of— 
‘‘(i) 13 weeks of operating reserves of 
carryover user fees; and 
‘‘(ii) 1 month of operating reserves 
maintained pursuant to paragraph (8). 
‘‘(C) EXCLUDED AMOUNT.—For the period 
of fiscal years 2023 through 2026, a total 
amount equal to $118,000,000 shall not be con-
sidered part of the designated amount under sub-
paragraph (B) and shall not be subject to the de-
crease under subparagraph (A).’’. 
(d) SMALL BUSINESSES.—Section 738 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended 
in each of subsections (d)(2)(B)(iii) and (e)(2)(B)(iii) by 
inserting ‘‘, if extant,’’ after ‘‘national taxing authority’’. 
(e) CONDITIONS.—Section 738(g) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j(g)) is amended— 
(1) 
in 
paragraph 
(1)(A), 
by 
striking 
‘‘$320,825,000’’ and inserting ‘‘$398,566,000’’; and 
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(2) in paragraph (2), by inserting ‘‘de novo clas-
sification requests,’’ after ‘‘class III device,’’. 
(f) CREDITING AND AVAILABILITY OF FEES.—Section 
738(h)(3) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j(h)(3)) is amended to read as follows: 
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(A) IN GENERAL.—For each of fiscal years 
2023 through 2027, there is authorized to be ap-
propriated for fees under this section an amount 
equal to the revenue amount determined under 
subparagraph (B), less the amount of reductions 
determined under subparagraph (C). 
‘‘(B) REVENUE AMOUNT.—For purposes of 
this paragraph, the revenue amount for each fis-
cal year is the sum of— 
‘‘(i) the total revenue amount under 
subsection (b)(3) for the fiscal year, as ad-
justed under paragraphs (2) and (3) of sub-
section (c); and 
‘‘(ii) the performance improvement ad-
justment amount for the fiscal year under 
subsection (c)(4), if applicable. 
‘‘(C) REDUCTIONS.—For purposes of this 
paragraph, the amount of reductions for each fis-
cal year is the sum of— 
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‘‘(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 REQUIREMENTS. 
(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 in-
serting ‘‘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), 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’’. 
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(b) REAUTHORIZATION.—Section 738A(b) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(b)) 
is amended— 
(1) in paragraph (1), by striking ‘‘2022’’ and in-
serting ‘‘2027’’; and 
(2) in paragraph (5), by striking ‘‘2022’’ and in-
serting ‘‘2027’’. 
SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM. 
Section 514(d) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360d(d)) is amended to read as fol-
lows: 
‘‘(d) ACCREDITATION SCHEME FOR CONFORMITY AS-
SESSMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall establish 
a program under which— 
‘‘(A) testing laboratories meeting criteria 
specified in guidance by the Secretary may be 
accredited by accreditation bodies meeting cri-
teria specified in guidance by the Secretary, to 
conduct testing to support the assessment of the 
conformity of a device to certain standards rec-
ognized under this section; and 
‘‘(B) subject to paragraph (2), results from 
tests conducted to support the assessment of con-
formity of devices as described in subparagraph 
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(A) conducted by testing laboratories accredited 
pursuant to this subsection shall be accepted by 
the Secretary for purposes of demonstrating such 
conformity unless the Secretary finds that cer-
tain results of such tests should not be so accept-
ed. 
‘‘(2) SECRETARIAL REVIEW OF ACCREDITED LAB-
ORATORY RESULTS.—The Secretary may— 
‘‘(A) review the results of tests conducted by 
testing laboratories accredited pursuant to this 
subsection, including by conducting periodic au-
dits of such results or of the processes of accred-
ited bodies or testing laboratories; 
‘‘(B) following such review, take additional 
measures under this Act, as the Secretary deter-
mines appropriate, such as— 
‘‘(i) suspension or withdrawal of ac-
creditation of a testing laboratory or rec-
ognition of an accreditation body under 
paragraph (1)(A); or 
‘‘(ii) requesting additional information 
with respect to a device; and 
‘‘(C) if the Secretary becomes aware of in-
formation materially bearing on the safety or ef-
fectiveness of a device for which an assessment of 
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conformity was supported by testing conducted 
by a testing laboratory accredited under this 
subsection, take such additional measures under 
this Act, as the Secretary determines appro-
priate, such as— 
‘‘(i) suspension or withdrawal of ac-
creditation of a testing laboratory or rec-
ognition of an accreditation body under 
paragraph (1)(A); or 
‘‘(ii) requesting additional information 
with regard to such device. 
‘‘(3) IMPLEMENTATION AND REPORTING.— 
‘‘(A) PILOT
PROGRAM
TRANSITION.—After 
September 30, 2023, the pilot program pre-
viously initiated under this subsection, as in ef-
fect prior to the date of enactment of the Medical 
Device User Fee Amendments of 2022, shall be 
considered to be completed, and the Secretary 
may continue operating a program consistent 
with this subsection. 
‘‘(B) REPORT.—The Secretary shall make 
available on the internet website of the Food and 
Drug Administration an annual report on the 
progress of the pilot program under this sub-
section.’’. 
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SEC. 206. REAUTHORIZATION OF THIRD-PARTY REVIEW 
PROGRAM. 
Section 523(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360m(c)) is amended by striking 
‘‘2022’’ and inserting ‘‘2027’’. 
SEC. 207. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 737 and 738 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 
379j) shall cease to be effective October 1, 2027. 
(b) REPORTING REQUIREMENTS.—Section 738A (21 
U.S.C. 379j– 1) of the Federal Food, Drug, and Cosmetic 
Act (regarding reauthorization and reporting requirements) 
shall cease to be effective January 31, 2028. 
(c) PREVIOUS SUNSET PROVISIONS.—Effective October 
1, 2022, subsections (a) and (b) of section 210 of the FDA 
Reauthorization Act of 2017 (Public Law 115–52) are re-
pealed. 
SEC. 208. 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 sub-
chapter 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. 
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SEC. 209. 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 ‘‘Ge-
neric Drug User Fee Amendments of 2022’’. 
(b) FINDING.—The Congress finds that the fees author-
ized by the amendments made by this title will be dedicated 
to human generic drug activities, as set forth in the goals 
identified for purposes of part 7 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–41 et seq.), in the letters from the Secretary of Health 
and Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Chairman of the Committee on Energy and Commerce 
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of the House of Representatives, as set forth in the Congres-
sional Record. 
SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GE-
NERIC 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 ‘‘fiscal year 2018’’ and inserting ‘‘fiscal year 
2023’’; 
(2) in paragraph (2)(C), by striking ‘‘2018 
through 2022’’ and inserting ‘‘2023 through 2027’’; 
(3) in paragraph (3)(B), by striking ‘‘2018 
through 2022’’ and inserting ‘‘2023 through 2027’’; 
(4) in paragraph (4)(D), by striking ‘‘2018 
through 2022’’ and inserting ‘‘2023 through 2027’’; 
and 
(5) in paragraph (5)(D), by striking ‘‘2018 
through 2022’’ and inserting ‘‘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)— 
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(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) by amending subparagraph (B) to read 
as follows: 
‘‘(B) FISCAL YEARS 2024 THROUGH 2027.— 
‘‘(i) IN GENERAL.—For each of the fis-
cal years 2024 through 2027, fees under 
paragraphs (2) through (5) of subsection (a) 
shall be established to generate a total esti-
mated revenue amount under such sub-
section that is equal to the base revenue 
amount for the fiscal year under clause (ii), 
as adjusted pursuant to subsection (c). 
‘‘(ii) BASE
REVENUE
AMOUNT.—The 
base revenue amount for a fiscal year re-
ferred to in clause (i) is equal to the total 
revenue amount established under this 
paragraph for the previous fiscal year, not 
including any adjustments made for such 
previous 
fiscal 
year 
under 
subsection 
(c)(3).’’; and 
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(2) in paragraph (2)— 
(A) in subparagraph (C), by striking ‘‘one- 
third the amount’’ and inserting ‘‘twenty-four 
percent’’; 
(B) in subparagraph (D), by striking 
‘‘Seven percent’’ and inserting ‘‘Six percent’’; 
and 
(C) in subparagraph (E)(i), by striking 
‘‘Thirty-five percent’’ and inserting ‘‘Thirty-six 
percent’’. 
(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 ‘‘to equal the product of 
the total revenues established in such notice 
for the prior fiscal year multiplied’’ and in-
serting ‘‘to equal the base revenue amount 
for the fiscal year (as specified in subsection 
(b)(1)(B)) multiplied’’; and 
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(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 in-
crease the fee revenue and fees under this section 
for a fiscal year, in accordance with this para-
graph, 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 plan-
ning methodology for purposes of this paragraph, 
which shall— 
‘‘(i) be derived from the methodology 
and recommendations made in the report ti-
tled 
‘Independent 
Evaluation 
of 
the 
GDUFA Resource Capacity Planning Ad-
justment Methodology: Evaluation and Rec-
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ommendations’ announced in the Federal 
Register on August 3, 2020; 
‘‘(ii) incorporate approaches and at-
tributes determined appropriate by the Sec-
retary, including approaches and attributes 
made in such report, except that in incor-
porating such approaches and attributes the 
workload categories used in forecasting re-
sources shall only be the workload categories 
specified in section VIII.B.2.e. of the letters 
described in section 301(b) of the Generic 
Drug User Fee Amendments of 2022; and 
‘‘(iii) be effective beginning with fiscal 
year 2024. 
‘‘(C) LIMITATIONS.— 
‘‘(i) IN
GENERAL.—Under no cir-
cumstances 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) PERCENTAGE
LIMITATION.—An 
adjustment under this paragraph shall not 
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exceed three percent of the sum described in 
clause (i) for the fiscal year, except that 
such limitation shall be four percent if— 
‘‘(I) for purposes of a fiscal year 
2024 adjustment, the Secretary deter-
mines that during the period from 
April 1, 2021, through March 31, 
2023— 
‘‘(aa) the total number of ab-
breviated new drug applications 
submitted was greater than or 
equal to 2,000; or 
‘‘(bb) thirty-five percent or 
more of abbreviated new drug ap-
plications 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 Amend-
ments of 2022); 
‘‘(II) for purposes of a fiscal year 
2025 adjustment, the Secretary deter-
mines that during the period from 
April 1, 2022, through March 31, 
2024— 
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‘‘(aa) the total number of ab-
breviated new drug applications 
submitted was greater than or 
equal to 2,300; or 
‘‘(bb) thirty-five percent or 
more of abbreviated new drug ap-
plications submitted related to 
complex products (as so defined); 
‘‘(III) for purposes of a fiscal year 
2026 adjustment, the Secretary deter-
mines that during the period from 
April 1, 2023, through March 31, 
2025— 
‘‘(aa) the total number of ab-
breviated new drug applications 
submitted was greater than or 
equal to 2,300; or 
‘‘(bb) thirty-five percent or 
more of abbreviated new drug ap-
plications submitted related to 
complex products (as so defined); 
and 
‘‘(IV) for purposes of a fiscal year 
2027 adjustment, the Secretary deter-
mines that during the period from 
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April 1, 2024, through March 31, 
2026— 
‘‘(aa) the total number of ab-
breviated new drug applications 
submitted was greater than or 
equal to 2,300; or 
‘‘(bb) thirty-five percent or 
more of abbreviated new drug ap-
plications submitted related to 
complex products (as so defined). 
‘‘(D) 
PUBLICATION
IN
FEDERAL
REG-
ISTER.—The Secretary shall publish in the Fed-
eral Register notice referred to in subsection (a) 
the fee revenue and fees resulting from the ad-
justment and the methodology under this para-
graph. 
‘‘(3) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For fiscal year 2024 
and each subsequent fiscal year, the Secretary 
may, in addition to adjustments under para-
graphs (1) and (2), further increase the fee rev-
enue and fees under this section for such fiscal 
year if such an adjustment is necessary to pro-
vide operating reserves of carryover user fees for 
human generic drug activities for not more than 
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the number of weeks specified in subparagraph 
(B) with respect to that fiscal year. 
‘‘(B) NUMBER OF WEEKS.—The number of 
weeks specified in this subparagraph is— 
‘‘(i) 8 weeks for fiscal year 2024; 
‘‘(ii) 9 weeks for fiscal year 2025; and 
‘‘(iii) 10 weeks for each of fiscal year 
2026 and 2027. 
‘‘(C) DECREASE.—If the Secretary has car-
ryover balances for human generic drug activi-
ties in excess of 12 weeks of the operating re-
serves referred to in subparagraph (A), the Sec-
retary shall decrease the fee revenue and fees re-
ferred 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 de-
crease (as applicable) in fee revenue and fees 
shall be contained in the annual Federal Reg-
ister 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— 
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(1) in the paragraph heading, by striking ‘‘2018 
THROUGH 2022’’ and inserting ‘‘2023 THROUGH 2027’’; 
and 
(2) by striking ‘‘more than 60 days before the 
first day of each of fiscal years 2018 through 2022’’ 
and inserting ‘‘later than 60 days before the first day 
of each of fiscal years 2023 through 2027’’. 
(e) CREDITING AND AVAILABILITY OF FEES.—Section 
744B(i)(3) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–42(i)(3)) is amended by striking ‘‘fiscal 
years 2018 through 2022’’ and inserting ‘‘fiscal years 2023 
through 2027’’. 
(f) 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’’. 
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)(1), by striking ‘‘Beginning 
with fiscal year 2018, not’’ and inserting ‘‘Not’’; 
(2) by striking ‘‘Generic Drug User Fee Amend-
ments of 2017’’ each place it appears and inserting 
‘‘Generic Drug User Fee Amendments of 2022’’; 
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(3) in subsection (a)(2), by striking ‘‘Not later 
than 30 calendar days after the end of the second 
quarter of fiscal year 2018, and not later than 30 cal-
endar days after the end of each quarter of each fiscal 
year thereafter’’ and inserting ‘‘Not later than 30 cal-
endar days after the end of each quarter of each fiscal 
year for which fees are collected under this part’’; 
(4) in subsection (a)(3), by striking ‘‘Beginning 
with fiscal year 2020, the’’ and inserting ‘‘The’’; 
(5) in subsection (b), by striking ‘‘Beginning 
with fiscal year 2018, not’’ and inserting ‘‘Not’’; 
(6) in subsection (c), by striking ‘‘Beginning 
with fiscal year 2018, for’’ and inserting ‘‘For’’; and 
(7) in subsection (f)— 
(A) in paragraph (1), in the matter pre-
ceding subparagraph (A), by striking ‘‘fiscal 
year 2022’’ and inserting ‘‘fiscal year 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. 
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(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 re-
pealed. 
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 sub-
chapter 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 (21 U.S.C. 379j–41 et seq.), as in 
effect on the day before the date of the enactment of this 
title, shall continue to be in effect with respect to abbre-
viated new drug applications (as defined in such part as 
of such day) that were received by the Food and Drug Ad-
ministration within the meaning of section 505(j)(5)(A) of 
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such Act (21 U.S.C. 355(j)(5)(A)), prior approval supple-
ments that were submitted, and drug master files for Type 
II active pharmaceutical ingredients that were first ref-
erenced on or after October 1, 2017, but before October 1, 
2022, with respect to assessing and collecting any fee re-
quired 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.—The Congress finds that the fees author-
ized by the amendments made by this title will be dedicated 
to expediting the process for the review of biosimilar biologi-
cal product applications, including postmarket safety ac-
tivities, 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. 
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SEC. 402. DEFINITIONS. 
(a) ADJUSTMENT FACTOR.—Section 744G(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
51(1)) is amended to read as follows: 
‘‘(1) The term ‘adjustment factor’ applicable to a 
fiscal year is the Consumer Price Index for urban 
consumers (Washington-Arlington-Alexandria, DC– 
VA–MD–WV; Not Seasonally Adjusted; All items; An-
nual Index) for September of the preceding fiscal year 
divided by such Index for September 2011.’’. 
(b) BIOSIMILAR
BIOLOGICAL
PRODUCT
APPLICA-
TION.—Section 744G(4)(B)(iii) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–51(4)(B)(iii)) is amend-
ed— 
(1) by striking subclause (II) (relating to an al-
lergenic extract product); and 
(2) by redesignating subclauses (III) and (IV) as 
subclauses (II) and (III), respectively. 
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR 
FEES. 
(a) TYPES OF FEES.— 
(1) IN GENERAL.—The matter preceding para-
graph (1) in section 744H(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)) is 
amended by striking ‘‘fiscal year 2018’’ and inserting 
‘‘fiscal year 2023’’. 
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(2) INITIAL
BIOSIMILAR
BIOLOGICAL
PRODUCT 
DEVELOPMENT FEE.—Clauses (iv)(I) and (v)(II) of 
section 744H(a)(1)(A) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j–52(a)(1)(A)) are each 
amended by striking ‘‘5 days’’ and inserting ‘‘7 
days’’. 
(3) ANNUAL BIOSIMILAR BIOLOGICAL PRODUCT 
DEVELOPMENT
FEE.—Section 744H(a)(1)(B) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–52(a)(1)(B)) is amended— 
(A) in clause (i), by inserting before the pe-
riod at the end the following: ‘‘, except where 
such product (including, where applicable, own-
ership 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, in 
which case such licensee, assignee, or successor 
shall pay the annual biosimilar biological prod-
uct development fee’’; 
(B) in clause (iii)— 
(i) in subclause (I), by striking ‘‘or’’ at 
the end; 
(ii) in subclause (II), by striking the 
period at the end and inserting ‘‘; or’’; and 
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(iii) by adding at the end the fol-
lowing: 
‘‘(III) been administratively re-
moved from the biosimilar biological 
product development program for the 
product under subparagraph (E)(v).’’; 
and 
(C) in clause (iv), by striking ‘‘is accepted 
for filing on or after October 1 of such fiscal 
year’’ and inserting ‘‘is subsequently accepted for 
filing’’. 
(4) REACTIVATION FEE.—Section 744H(a)(1)(D) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–52(a)(1)(D)) is amended to read as fol-
lows: 
‘‘(D) REACTIVATION FEE.— 
‘‘(i) IN GENERAL.—A person that has 
discontinued participation in the biosimilar 
biological product development program for 
a product under subparagraph (C), or who 
has been administratively removed from the 
biosimilar biological product development 
program for a product under subparagraph 
(E)(v), shall, if the person seeks to resume 
participation in such program, pay all an-
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nual biosimilar biological product develop-
ment fees previously assessed for such prod-
uct and still owed and a fee (referred to in 
this section as ‘reactivation fee’) by the ear-
lier of the following: 
‘‘(I) Not later than 7 days after 
the Secretary grants a request by such 
person for a biosimilar biological prod-
uct development meeting for the prod-
uct (after the date on which such par-
ticipation was discontinued or the date 
of administrative removal, as applica-
ble). 
‘‘(II) Upon the date of submission 
(after the date on which such partici-
pation was discontinued or the date of 
administrative removal, as applicable) 
by such person of an investigational 
new drug application describing an in-
vestigation that the Secretary deter-
mines is intended to support a bio-
similar biological product application 
for that product. 
‘‘(ii) APPLICATION OF ANNUAL FEE.— 
A person that pays a reactivation fee for a 
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product shall pay for such product, begin-
ning in the next fiscal year, the annual bio-
similar biological product development fee 
under subparagraph (B), except where such 
product (including, where applicable, own-
ership of the relevant investigational new 
drug application) is transferred to a li-
censee, assignee, or successor of such person, 
and written notice of such transfer is pro-
vided to the Secretary, in which case such 
licensee, assignee, or successor shall pay the 
annual biosimilar biological product devel-
opment fee.’’. 
(5) EFFECT OF FAILURE TO PAY FEES.—Section 
744H(a)(1)(E) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379j–52(a)(1)(E)) is amended 
by adding at the end the following: 
‘‘(v) ADMINISTRATIVE REMOVAL FROM 
THE BIOSIMILAR BIOLOGICAL PRODUCT DE-
VELOPMENT
PROGRAM.—If a person has 
failed to pay an annual biosimilar biologi-
cal product development fee for a product as 
required under subparagraph (B) for a pe-
riod of two consecutive fiscal years, the Sec-
retary may administratively remove such 
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person from the biosimilar biological prod-
uct development program for the product. 
At least 30 days prior to administratively 
removing a person from the biosimilar bio-
logical product development program for a 
product under this clause, the Secretary 
shall provide written notice to such person 
of the intended administrative removal.’’. 
(6) BIOSIMILAR BIOLOGICAL PRODUCT APPLICA-
TION
FEE.—Section 744H(a)(2)(D) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
52(a)(2)(D)) is amended by inserting after ‘‘or was 
withdrawn’’ the following: ‘‘prior to approval’’. 
(7) BIOSIMILAR BIOLOGICAL PRODUCT PROGRAM 
FEE.—Section 744H(a)(3) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–52(a)(3)) is 
amended— 
(A) in subparagraph (A)— 
(i) in clause (i), by striking ‘‘and’’ at 
the end; 
(ii) by redesignating clause (ii) as 
clause (iii); and 
(iii) by inserting after clause (i) the 
following: 
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‘‘(ii) may be dispensed only under pre-
scription pursuant to section 503(b); and’’; 
and 
(B) by adding at the end the following: 
‘‘(E) MOVEMENT TO DISCONTINUED LIST.— 
‘‘(i) DATE OF INCLUSION.—If a writ-
ten request to place a product on the list 
referenced in subparagraph (A) of discon-
tinued biosimilar biological products is sub-
mitted to the Secretary on behalf of an ap-
plicant, and the request identifies the date 
the product is withdrawn from sale, then for 
purposes of assessing the biosimilar biologi-
cal product program fee, the Secretary shall 
consider such product to have been included 
on such list on the later of— 
‘‘(I) the date such request was re-
ceived; or 
‘‘(II) if the product will be with-
drawn from sale on a future date, such 
future date when the product is with-
drawn from sale. 
‘‘(ii) 
TREATMENT
AS
WITHDRAWN 
FROM SALE.—For purposes of clause (i), a 
product shall be considered withdrawn from 
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sale once the applicant has ceased its own 
distribution of the product, whether or not 
the applicant has ordered recall of all pre-
viously distributed lots of the product, ex-
cept that a routine, temporary interruption 
in supply shall not render a product with-
drawn from sale. 
‘‘(iii) SPECIAL RULE.—If a biosimilar 
biological product that is identified in a 
biosimilar biological product application 
approved as of October 1 of a fiscal year 
appears, as of October 1 of such fiscal year, 
on the list referenced in subparagraph (A) 
of discontinued biosimilar biological prod-
ucts, and on any subsequent day during 
such fiscal year the biosimilar biological 
product does not appear on such list, then 
except as provided in subparagraph (D), 
each person who is named as the applicant 
in a biosimilar biological product applica-
tion with respect to such product shall pay 
the annual biosimilar biological product 
program fee established for a fiscal year 
under subsection (c)(5) for such biosimilar 
biological product. Notwithstanding sub-
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paragraph (B), such fee shall be due on the 
last business day of such fiscal year and 
shall be paid only once for each such prod-
uct for each fiscal year.’’. 
(8) BIOSIMILAR
BIOLOGICAL
PRODUCT
FEE.— 
Section 744H(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379j–52(a)) is amended by 
striking paragraph (4). 
(c) FEE REVENUE AMOUNTS.—Subsection (b) of sec-
tion 744H of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–52) is amended— 
(1) by striking paragraph (1); 
(2) by redesignating paragraphs (2) through (4) 
as paragraphs (1) through (3), respectively; 
(3) by amending paragraph (1) (as so redesig-
nated) to read as follows: 
‘‘(1) IN GENERAL.—For each of the fiscal years 
2023 through 2027, fees under subsection (a) shall, ex-
cept as provided in subsection (c), be established to 
generate a total revenue amount equal to the sum 
of— 
‘‘(A) the annual base revenue for the fiscal 
year (as determined under paragraph (3)); 
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(5) by amending paragraph (3) (as so redesig-
nated) 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 estab-
lished under paragraph (1) for the previous fis-
cal year, excluding any adjustments to such rev-
enue amount under subsection (c)(4).’’. 
(d) 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 in-
serting ‘‘subsection (b)(1)(B)’’; and 
(ii) in clause (i), by striking ‘‘sub-
section (b)’’ and inserting ‘‘subsection 
(b)(1)(A)’’; and 
(B) in subparagraph (B)(ii), by striking 
‘‘Washington-Baltimore, DC–MD–VA–WV’’ and 
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inserting 
‘‘Washington-Arlington-Alexandria, 
DC–VA–MD–WV’’; 
(2) by striking paragraphs (2) through (4) and 
inserting the following: 
‘‘(2) STRATEGIC
HIRING
AND
RETENTION
AD-
JUSTMENT.—For each fiscal year, after the annual 
base revenue under subsection (b)(1)(A) is adjusted 
for inflation in accordance with paragraph (1), the 
Secretary shall further increase the fee revenue and 
fees by $150,000. 
‘‘(3) CAPACITY PLANNING ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For each fiscal year, 
the Secretary shall, in addition to the adjust-
ments under paragraphs (1) and (2), further ad-
just the fee revenue and fees under this section 
for a fiscal year to reflect changes in the resource 
capacity needs of the Secretary for the process 
for the review of biosimilar biological product 
applications. 
‘‘(B) METHODOLOGY.—For purposes of this 
paragraph, the Secretary shall employ the capac-
ity planning methodology utilized by the Sec-
retary in setting fees for fiscal year 2021, as de-
scribed in the notice titled ‘Biosimilar User Fee 
Rates for Fiscal Year 2021’ published in the Fed-
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eral Register on August 4, 2020 (85 Fed. Reg. 
47220). The workload categories used in apply-
ing such methodology in forecasting shall include 
only the activities described in that notice and, 
as feasible, additional activities that are also di-
rectly related to the direct review of biosimilar 
biological product applications and supplements, 
including additional formal meeting types, the 
direct review of postmarketing commitments and 
requirements, the direct review of risk evaluation 
and mitigation strategies, and the direct review 
of annual reports for approved biosimilar bio-
logical products. Subject to the exceptions in the 
preceding sentence, the Secretary shall not in-
clude as workload categories in applying such 
methodology in forecasting any non-core review 
activities, including those activities that the Sec-
retary referenced for potential future use in such 
notice but did not utilize in setting fees for fiscal 
year 2021. 
‘‘(C) 
LIMITATIONS.—Under 
no 
cir-
cumstances shall an adjustment under this para-
graph result in fee revenue for a fiscal year that 
is less than the sum of the amounts under sub-
sections (b)(1)(A) (the annual base revenue for 
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the fiscal year), (b)(1)(B) (the dollar amount of 
the inflation adjustment for the fiscal year), and 
(b)(1)(C) (the dollar amount of the strategic hir-
ing and retention adjustment). 
‘‘(D) 
PUBLICATION
IN
FEDERAL
REG-
ISTER.—The Secretary shall publish in the Fed-
eral Register notice under paragraph (5) the fee 
revenue and fees resulting from the adjustment 
and the methodologies under this paragraph. 
‘‘(4) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) INCREASE.—For fiscal year 2023 and 
subsequent fiscal years, the Secretary shall, in 
addition to adjustments under paragraphs (1), 
(2), and (3), further increase the fee revenue and 
fees if such an adjustment is necessary to provide 
for at least 10 weeks of operating reserves of car-
ryover user fees for the process for the review of 
biosimilar biological product applications. 
‘‘(B) DECREASE.— 
‘‘(i) FISCAL
YEAR
2023.—For fiscal 
year 2023, if the Secretary has carryover 
balances for such process in excess of 33 
weeks of such operating reserves, the Sec-
retary shall decrease such fee revenue and 
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fees to provide for not more than 33 weeks 
of such operating reserves. 
‘‘(ii) FISCAL
YEAR
2024.—For fiscal 
year 2024, if the Secretary has carryover 
balances for such process in excess of 27 
weeks of such operating reserves, the Sec-
retary shall decrease such fee revenue and 
fees to provide for not more than 27 weeks 
of such operating reserves. 
‘‘(iii) FISCAL YEAR 2025 AND SUBSE-
QUENT
FISCAL
YEARS.—For fiscal year 
2025 and subsequent fiscal years, if the Sec-
retary has carryover balances for such proc-
ess 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 in-
crease or decrease 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 
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(3) in paragraph (5), in the matter preceding 
subparagraph (A), by striking ‘‘2018’’ and inserting 
‘‘2023’’. 
(e) CREDITING AND AVAILABILITY OF FEES.—Sub-
section (f)(3) of section 744H of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–52(f)(3)) is amended by 
striking ‘‘2018 through 2022’’ and inserting ‘‘2023 through 
2027’’. 
(f) WRITTEN REQUESTS FOR WAIVERS AND RETURNS; 
DISPUTES CONCERNING FEES.—Section 744H(h) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
52(h)) is amended to read as follows: 
‘‘(h) WRITTEN REQUESTS
FOR WAIVERS
AND RE-
TURNS; DISPUTES CONCERNING FEES.—To qualify for con-
sideration for a waiver under subsection (d), or for the re-
turn 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 Sec-
retary not later than 180 days after such fee is due. A re-
quest submitted under this paragraph shall include any 
legal authorities under which the request is made.’’. 
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SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 744I of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–53) is amended— 
(1) in subsection (a)(1), by striking ‘‘Beginning 
with fiscal year 2018, not’’ and inserting ‘‘Not’’; 
(2) by striking ‘‘Biosimilar User Fee Amend-
ments of 2017’’ each place it appears and inserting 
‘‘Biosimilar User Fee Amendments of 2022’’; 
(3) in subsection (a)(2), by striking ‘‘Beginning 
with fiscal year 2018, the’’ and inserting ‘‘The’’; 
(4) in subsection (a)(3)(A), by striking ‘‘Not 
later than 30 calendar days after the end of the sec-
ond quarter of fiscal year 2018, and not later than 
30 calendar days after the end of each quarter of each 
fiscal year thereafter’’ and inserting ‘‘Not later than 
30 calendar days after the end of each quarter of each 
fiscal year for which fees are collected under this 
part’’; 
(5) in subsection (b), by striking ‘‘Not later than 
120 days after the end of fiscal year 2018 and each 
subsequent fiscal year for which fees are collected 
under this part’’ and inserting ‘‘Not later than 120 
days after the end of each fiscal year for which fees 
are collected under this part’’; 
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(6) in subsection (c), by striking ‘‘Beginning 
with fiscal year 2018, and for’’ and inserting ‘‘For’’; 
and 
(7) in subsection (f)— 
(A) in paragraph (1), in the matter pre-
ceding subparagraph (A), by striking ‘‘fiscal 
year 2022’’ and inserting ‘‘fiscal year 2027’’; 
and 
(B) in paragraph (3), by striking ‘‘January 
15, 2022’’ and inserting ‘‘January 15, 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 shall cease to be ef-
fective 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 re-
pealed. 
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 sub-
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chapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j–51 et seq.) shall be assessed 
for all biosimilar biological product applications received 
on or after October 1, 2022, regardless of the date of the 
enactment of this Act. 
SEC. 407. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
part 8 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.), as in 
effect on the day before the date of the enactment of this 
title, shall continue to be in effect with respect to biosimilar 
biological product applications and supplements (as defined 
in such part as of such day) that were accepted by the Food 
and Drug Administration for filing on or after October 1, 
2017, but before October 1, 2022, with respect to assessing 
and collecting any fee required by such part for a fiscal 
year prior to fiscal year 2023. 
TITLE V—IMPROVING DIVERSITY 
IN CLINICAL STUDIES 
SEC. 501. DIVERSITY ACTION PLANS FOR CLINICAL STUD-
IES. 
(a) DRUGS.—Section 505(i) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(i)) is amended by adding 
at the end the following: 
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‘‘(5)(A) In order for a new drug that is being studied 
in a phase 3 study, as defined in section 312.21(c) of title 
21, Code of Federal Regulations (or successor regulations), 
or other pivotal study (other than bioavailability or bio-
equivalence studies), to be exempt pursuant to this sub-
section, the sponsor of a clinical investigation of such new 
drug shall submit to the Secretary a diversity action plan. 
‘‘(B) Such diversity action plan shall include— 
‘‘(i) the sponsor’s goals for enrollment in such 
clinical study; 
‘‘(ii) the sponsor’s rationale for such goals; and 
‘‘(iii) an explanation of how the sponsor intends 
to meet such goals. 
‘‘(C) The sponsor shall submit such diversity action 
plan in the form and manner specified in the guidance re-
quired by section 524B as soon as practicable but no later 
than when the sponsor seeks feedback regarding such a 
phase 3 study or other pivotal study of the drug. 
‘‘(D) The Secretary may waive the requirement in sub-
paragraph (A) if the Secretary determines that a waiver 
is necessary based on what is known about the prevalence 
of the disease in terms of the patient population that may 
use the new drug. 
‘‘(E) No diversity action plan shall be required for a 
submission described in section 561.’’. 
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(b) DEVICES.—Section 520(g) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j(g)) is amended 
by adding at the end the following: 
‘‘(9)(A)(i) In order for a device in a clinical study for 
which submission of an application for an investigational 
device exemption is required to be exempt under this sub-
section, the sponsor of such study shall submit to the Sec-
retary in such application a diversity action plan in the 
form and manner specified in the guidance required by sec-
tion 524B. 
‘‘(ii) In order for a device in a clinical study for which 
submission of an application for an investigational device 
exemption is not required, except for a device being studied 
as described in section 812.2(c) of title 21, Code of Federal 
Regulations (or successor regulations), to be exempt under 
this subsection, the sponsor of such study shall develop and 
implement a diversity action plan. Such diversity action 
plan shall be submitted to the Secretary in any premarket 
notification under section 510(k), request for classification 
under section 513(f)(2), or application for premarket ap-
proval under section 515 for such device. 
‘‘(B) A diversity action plan under clause (i) or (ii) 
of subparagraph (A) shall include— 
‘‘(i) the sponsor’s goals for enrollment in the 
clinical study; 
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‘‘(ii) the sponsor’s rationale for such goals; and 
‘‘(iii) an explanation of how the sponsor intends 
to meet such goals. 
‘‘(C) The Secretary may waive the requirement in sub-
paragraph (A) or (B) if the Secretary determines that a 
waiver is necessary based on what is known about the prev-
alence of the disease in terms of the patient population that 
may use the device. 
‘‘(D) No diversity action plan shall be required for a 
submission described in section 561.’’. 
(c) GUIDANCE.—Subchapter A of chapter V of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) 
is amended by adding at the end the following: 
‘‘SEC. 524B. GUIDANCE ON DIVERSITY ACTION PLANS FOR 
CLINICAL STUDIES. 
‘‘(a) IN GENERAL.—The Secretary shall issue guidance 
relating to— 
‘‘(1) the format and content of the diversity ac-
tion plans required by sections 505(i)(5) and 
520(g)(9) pertaining to the sponsor’s goals for clinical 
study enrollment, disaggregated by age group, sex, 
race, geographic location, socioeconomic status, and 
ethnicity, including with respect to— 
‘‘(A) the rationale for the sponsor’s enroll-
ment goals, which may include— 
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‘‘(i) the estimated prevalence or inci-
dence in the United States of the disease or 
condition for which the drug or device is 
being developed or investigated, if such esti-
mated prevalence or incidence is known or 
can be determined based on available data; 
‘‘(ii) what is known about the disease 
or condition for which the drug or device is 
being developed or investigated; 
‘‘(iii) any relevant pharmacokinetic or 
pharmacogenomic data; 
‘‘(iv) what is known about the patient 
population for such disease or condition, in-
cluding, to the extent data is available— 
‘‘(I) demographic information, in-
cluding age group, sex, race, geo-
graphic location, socioeconomic status, 
and ethnicity; 
‘‘(II) non-demographic factors, in-
cluding co-morbidities affecting the pa-
tient population; and 
‘‘(III) potential barriers to enroll-
ing diverse participants, such as pa-
tient population size, geographic loca-
tion, and socioeconomic status; and 
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‘‘(v) any other data or information rel-
evant to selecting appropriate enrollment 
goals, disaggregated by demographic sub-
group, such as the inclusion of pregnant 
and lactating women; 
‘‘(B) an explanation for how the sponsor in-
tends to meet such goals, including demographic- 
specific outreach and enrollment strategies, 
study-site selection, clinical study inclusion and 
exclusion practices, and any diversity training 
for study personnel; and 
‘‘(C) procedures for the public posting of key 
information from the diversity action plan that 
would be useful to patients and providers on the 
sponsor’s website, as appropriate; and 
‘‘(2) how sponsors should include in regular re-
ports to the Secretary— 
‘‘(A) the sponsor’s progress in meeting the 
goals referred to in paragraph (1)(A); and 
‘‘(B) if the sponsor does not expect to meet 
such goals— 
‘‘(i) any updates needed to be made to 
a diversity action plan referred to in para-
graph (1) to help meet such goals; and 
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‘‘(ii) the sponsor’s reasons for why the 
sponsor does not expect to meet such goals. 
‘‘(b) ISSUANCE.—The Secretary shall— 
‘‘(1) not later than 12 months after the date of 
enactment of this section, issue new draft guidance or 
update existing draft guidance described in subsection 
(a); and 
‘‘(2) not later than 9 months after closing the 
comment period on such draft guidance, finalize such 
guidance.’’. 
(d) APPLICABILITY.—Sections 505(i)(5) and 520(g)(9) 
of the Federal Food, Drug, and Cosmetic Act, as added by 
subsections (a) and (b) of this section, apply only with re-
spect to clinical investigations with respect to which enroll-
ment commences after the date that is 180 days after the 
publication of final guidance under section 524B(b)(2) of 
the Federal Food, Drug, and Cosmetic Act, as added by sub-
section (c). 
SEC. 502. EVALUATION OF THE NEED FOR FDA AUTHORITY 
TO MANDATE POSTAPPROVAL STUDIES OR 
POSTMARKET SURVEILLANCE DUE TO INSUF-
FICIENT DEMOGRAPHIC SUBGROUP DATA. 
(a) IN GENERAL.—Not later than 2 years after the 
date of publication of final guidance pursuant to section 
524B(b)(2) of the Federal Food, Drug, and Cosmetic Act, 
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as added by section 501(c) of this Act, the Secretary of 
Health and Human Services shall commence an evaluation 
to assess whether additions or changes to statutes or regula-
tions are warranted to ensure that sponsors conduct post- 
approval studies or postmarket surveillance where— 
(1) premarket studies collected insufficient data 
for underrepresented subgroups according to the goals 
specified in the diversity action plans of such spon-
sors; and 
(2) the Secretary has requested additional stud-
ies be conducted. 
(b) DETERMINATION AND REPORTING.—Not later than 
180 days after the commencement of the evaluation under 
subsection (a), the Secretary of Health and Human Services 
shall submit a report to the Congress on the outcome of such 
evaluation, including any recommendations related to addi-
tional needed authorities. 
SEC. 503. PUBLIC WORKSHOPS TO ENHANCE CLINICAL 
STUDY DIVERSITY. 
(a) IN GENERAL.—Not later than one year after the 
date of enactment of this Act, the Secretary of Health and 
Human Services, in consultation with drug sponsors, med-
ical device manufacturers, patients, and other stakeholders, 
shall convene one or more public workshops to solicit input 
from stakeholders on increasing the enrollment of histori-
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cally underrepresented populations in clinical studies and 
encouraging clinical study participation that reflects the 
prevalence of the disease or condition among demographic 
subgroups, where appropriate, and other topics, includ-
ing— 
(1) how and when to collect and present the 
prevalence or incidence data on a disease or condition 
by demographic subgroup, including possible sources 
for such data and methodologies for assessing such 
data; 
(2) considerations for the dissemination, after 
approval, of information to the public on clinical 
study enrollment demographic data; 
(3) the establishment of goals for enrollment in 
clinical trials, including the relevance of the estimated 
prevalence or incidence, as applicable, in the United 
States of the disease or condition for which the drug 
or device is being developed; and 
(4) approaches to support inclusion of underrep-
resented populations and to encourage clinical study 
participation that reflects the population expected to 
use the drug or device under study, including with re-
spect to— 
(A) the establishment of inclusion and ex-
clusion criteria for certain subgroups, such as 
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pregnant and lactating women and individuals 
with disabilities, including intellectual or devel-
opmental disabilities or mental illness; 
(B) considerations regarding informed con-
sent with respect to individuals with intellectual 
or developmental disabilities or mental illness, 
including ethical and scientific considerations; 
(C) the appropriate use of decentralized 
trials or digital health tools; 
(D) clinical endpoints; 
(E) biomarker selection; and 
(F) studying analysis. 
(b) PUBLIC DOCKET.—The Secretary of Health and 
Human Services shall establish a public comment period 
to receive written comments related to the topics addressed 
during each public workshop convened under this section. 
The public comment period shall remain open for 60 days 
following the date on which each public workshop is con-
vened. 
(c) REPORT.—Not later than 180 days after the close 
of the public comment period for each public workshop con-
vened under this section, the Secretary of Health and 
Human Services shall make available on the public website 
of the Food and Drug Administration a report on the topics 
discussed at such workshop. The report shall include a sum-
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mary of, and response to, recommendations raised in such 
workshop. 
SEC. 504. ANNUAL SUMMARY REPORT ON PROGRESS TO IN-
CREASE DIVERSITY IN CLINICAL STUDIES. 
(a) IN GENERAL.—Beginning not later than 2 years 
after the date of enactment of this Act, and each year there-
after, the Secretary of Health and Human Services shall 
submit to the Congress, and publish on the public website 
of the Food and Drug Administration, a report that— 
(1) summarizes, in aggregate, the diversity ac-
tion plans received pursuant to section 505(i)(5) or 
520(g)(9) of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a) or (b) of section 501 
of this Act; and 
(2) contains information on— 
(A) for drugs, biological products, and de-
vices approved, licensed, cleared, or classified 
under section 505, 515, 510(k), or 513(f)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355; 360e; 360(k); and 360(f)(2)), or sec-
tion 351(a) of the Public Health Service Act (42 
U.S.C. 262(a)), whether the clinical studies con-
ducted with respect to such applications met the 
demographic subgroup enrollment goals from the 
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