II 
117TH CONGRESS 
2D SESSION 
H. R. 7667 
IN THE SENATE OF THE UNITED STATES 
JUNE 9, 2022 
Received 
AN ACT 
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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food and Drug 
Amendments of 2022’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. 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 requirements. 
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 requirements. 
Sec. 205. Conformity assessment pilot program. 
Sec. 206. Reauthorization of third-party review program. 
Sec. 207. Sunset dates. 
Sec. 208. Effective date. 
Sec. 209. 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 fees. 
Sec. 404. Reauthorization; reporting requirements. 
Sec. 405. Sunset dates. 
Sec. 406. Effective date. 
Sec. 407. Savings clause. 
TITLE V—IMPROVING DIVERSITY IN CLINICAL STUDIES 
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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. National Centers of Excellence in Advanced and Continuous Pharma-
ceutical Manufacturing. 
Sec. 707. Advanced manufacturing technologies designation pilot program. 
Sec. 708. Public workshop on cell therapies. 
Sec. 709. Reauthorization of best pharmaceuticals for children. 
Sec. 710. Reauthorization for humanitarian device exemption and demonstra-
tion grants for improving pediatric availability. 
Sec. 711. Reauthorization of provision related to exclusivity of certain drugs 
containing single enantiomers. 
Sec. 712. Reauthorization of the critical path public-private partnership pro-
gram. 
Sec. 713. Reauthorization of orphan drug grants. 
Sec. 714. Research into pediatric uses of drugs; additional authorities of Food 
and Drug Administration regarding molecularly targeted can-
cer 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 re-
view activities. 
Sec. 729. Enhancing transparency of drug facility inspection timelines. 
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TITLE VIII—TRANSPARENCY, PROGRAM INTEGRITY, AND 
REGULATORY IMPROVEMENTS 
Sec. 801. Prompt reports of marketing status by holders of approved applica-
tions 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 IX—MISCELLANEOUS 
Sec. 901. Determination of budgetary effects. 
Sec. 902. Medicaid Improvement Fund. 
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 au-
thorized by the amendments made by this title will be 
dedicated toward expediting the drug development process 
and the process for the review of human drug applications, 
including postmarket drug safety activities, as set forth 
in the goals identified for purposes of part 2 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379g et seq.), in the letters from the Sec-
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retary of Health and Human Services to the Chairman 
of the Committee on Health, Education, Labor, and Pen-
sions of the Senate and the Chairman of the Committee 
on Energy and Commerce of the House of Representa-
tives, 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 applica-
tion 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 ex-
tract 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 
activity 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 
product in the discontinued section of either of 
the lists referenced in subparagraph (A)(iii) is 
submitted to the Secretary on behalf of an ap-
plicant, and the request identifies the date the 
product is withdrawn from sale, then for pur-
poses of assessing the prescription drug pro-
gram fee under section 736(a)(2), the Secretary 
shall consider such product to have been in-
cluded in the discontinued section on the later 
of— 
‘‘(I) the date such request was re-
ceived; 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 dis-
tribution of the product, whether or not the ap-
plicant has ordered recall of all previously dis-
tributed lots of the product, except that a rou-
tine, temporary 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 con-
trols required to interpret the results of a prod-
uct described 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 
‘‘fiscal 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, shall pay 
the annual prescription drug program fee 
established for a fiscal year under sub-
section (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 pre-
scription 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 in-
cluding powders for reconstitution or phar-
macy bulk packages) identified on the list 
compiled under section 505(j)(7); 
‘‘(ii) pharmaceutically equivalent (as 
defined in section 314.3 of title 21, Code 
of Federal Regulations (or any successor 
regulation)) to another product on the list 
of 
products 
compiled 
under 
section 
505(j)(7) (not including the discontinued 
section of such list); or 
‘‘(iii) a skin-test diagnostic product.’’. 
(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, 
except as provided in subsections (c), (d), (f), and 
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(g), be established to generate a total revenue 
amount under such subsection that is equal to the 
sum of— 
‘‘(A) the annual base revenue for the fiscal 
year (as determined under paragraph (3)); 
‘‘(B) the dollar amount equal to the 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 
fiscal 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 
fiscal year as follows: 
‘‘(i) $65,773,693 for fiscal year 2023. 
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‘‘(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.’’. 
(2) ANNUAL BASE REVENUE.—Paragraph (3) 
of section 736(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(b)) is amended to 
read as follows: 
‘‘(3) ANNUAL BASE REVENUE.—For purposes 
of paragraph (1), the dollar amount of the annual 
base revenue for a fiscal year shall be— 
‘‘(A) for fiscal year 2023, $1,151,522,958; 
and 
‘‘(B) for fiscal years 2024 through 2027, 
the dollar amount of the total revenue amount 
established under paragraph (1) for the pre-
vious fiscal 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 
Cosmetic Act (21 U.S.C. 379h(c)(1)(B)(ii)) is 
amended by striking ‘‘Washington-Baltimore, DC– 
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MD–VA–WV’’ and inserting ‘‘Washington-Arlington- 
Alexandria, DC–VA–MD–WV’’. 
(2) STRATEGIC
HIRING
AND
RETENTION
AD-
JUSTMENT.—Section 736(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is 
amended— 
(A) 
by 
redesignating 
paragraphs 
(2) 
through (6) as paragraphs (3) through (7), re-
spectively; and 
(B) by inserting after paragraph (1) the 
following: 
‘‘(2) STRATEGIC HIRING AND RETENTION AD-
JUSTMENT.—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 rev-
enue and fees by the following amounts: 
‘‘(A) For fiscal year 2023, $9,000,000. 
‘‘(B) For each of fiscal years 2024 through 
2027, $4,000,000.’’. 
(3) CAPACITY PLANNING ADJUSTMENT.—Para-
graph (3), as redesignated, of section 736(c) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h(c)) is amended to read as follows: 
‘‘(3) CAPACITY PLANNING ADJUSTMENT.— 
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‘‘(A) IN GENERAL.—For each fiscal year, 
after the annual base revenue established in 
subsection (b)(1)(A) is adjusted in accordance 
with paragraphs (1) and (2), such revenue shall 
be adjusted further for such fiscal year, in ac-
cordance with this paragraph, to reflect changes 
in the resource capacity needs of the Secretary 
for the process for the review of human drug 
applications. 
‘‘(B) METHODOLOGY.—For purposes of 
this paragraph, the Secretary shall employ the 
capacity planning methodology utilized by the 
Secretary in setting fees for fiscal year 2021, as 
described in the notice titled ‘Prescription Drug 
User Fee Rates for Fiscal Year 2021’ published 
in the Federal Register on August 3, 2020 (85 
Fed. Reg. 46651). The workload categories 
used in applying such methodology in fore-
casting shall include only the activities de-
scribed in that notice and, as feasible, addi-
tional activities that are also directly related to 
the direct review of applications and supple-
ments, including additional formal meeting 
types, the direct review of postmarketing com-
mitments and requirements, the direct review of 
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risk evaluation and mitigation strategies, and 
the direct review of annual reports for approved 
prescription drug products. Subject to the ex-
ceptions in the preceding sentence, the Sec-
retary shall not include as workload categories 
in applying such methodology in forecasting any 
non-core review activities, including those activi-
ties that the Secretary referenced for potential 
future use in such notice but did not utilize in 
setting fees for fiscal year 2021. 
‘‘(C) 
LIMITATION.—Under 
no 
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 
subsections (b)(1)(A) (the annual base revenue 
for the fiscal year), (b)(1)(B) (the dollar 
amount of the inflation adjustment for the fis-
cal year), and (b)(1)(C) (the dollar amount of 
the strategic hiring 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-
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ment and the methodologies under this para-
graph.’’. 
(4) OPERATING RESERVE ADJUSTMENT.—Para-
graph (4), as redesignated, of section 736(c) of the 
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 applications for each fiscal year in at least 
the following amounts: 
‘‘(i) For fiscal year 2023, at least 8 
weeks of operating reserves. 
‘‘(ii) For fiscal year 2024, at least 9 
weeks of operating reserves. 
‘‘(iii) For fiscal year 2025 and subse-
quent fiscal years, at least 10 weeks of op-
erating reserves.’’; and 
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(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 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379h(c)) is amended to read as follows: 
‘‘(5) 
ADDITIONAL
DIRECT
COST
ADJUST-
MENT.— 
‘‘(A) INCREASE.—The Secretary shall, in 
addition to adjustments under paragraphs (1), 
(2), (3), and (4), further increase the fee rev-
enue 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. 
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‘‘(B) 
APPLICABLE
AMOUNTS.—The 
amounts referred to in subparagraph (A)(ii) are 
the following: 
‘‘(i) 
For 
fiscal 
year 
2024, 
$60,967,993. 
‘‘(ii) 
For 
fiscal 
year 
2025, 
$35,799,314. 
‘‘(iii) For fiscal year 2026, $35,799, 
314. 
‘‘(iv) 
For 
fiscal 
year 
2027, 
$35,799,314.’’. 
(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.—Sec-
tion 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, REDUC-
TIONS, EXEMPTIONS, AND RETURNS; DISPUTES CON-
CERNING FEES.—Section 736(i) of the Federal Food, 
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Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is amended 
to read as follows: 
‘‘(i) WRITTEN REQUESTS
FOR WAIVERS, REDUC-
TIONS, EXEMPTIONS, AND RETURNS; DISPUTES CON-
CERNING FEES.—To qualify for consideration for a waiver 
or reduction under subsection (d), an exemption under 
subsection (k), or the return of any fee paid under this 
section, including if the fee is claimed to have been paid 
in error, a person shall— 
‘‘(1) not later than 180 days after such fee is 
due, submit to the Secretary a written request 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 ex-
emption under paragraph (1) applies with respect to 
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a drug only if the applicant involved submits a cer-
tification that the applicant’s gross annual revenues 
did not exceed $50,000,000 for the last calendar 
year ending prior to the fiscal year for which the ex-
emption is requested. Such certification shall be sup-
ported by— 
‘‘(A) tax returns submitted to the United 
States Internal Revenue Service; or 
‘‘(B) as necessary, other appropriate finan-
cial information.’’. 
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 736B of the Federal Food, Drug, and Cos-
metic 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 
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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 
number of face-to-face meetings requested 
by sponsors to be conducted in person (in 
such manner as the Secretary shall pre-
scribe on the internet website of the Food 
and Drug Administration), and the num-
ber of such in-person meetings granted by 
the Secretary.’’; 
(5) in subsection (a)(4), by striking ‘‘Beginning 
with fiscal year 2020, the’’ and inserting ‘‘The’’; 
(6) in subsection (b), by striking ‘‘Beginning 
with fiscal year 2018, not’’ and inserting ‘‘Not’’; 
(7) in subsection (c), by striking ‘‘Beginning 
with fiscal year 2018, for’’ and inserting ‘‘For’’; and 
(8) in subsection (f)— 
(A) in paragraph (1), in the matter pre-
ceding subparagraph (A), by striking ‘‘fiscal 
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year 2022’’ and inserting ‘‘fiscal year 2027’’; 
and 
(B) in paragraph (5), by striking ‘‘January 
15, 2022’’ and inserting ‘‘January 15, 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 Octo-
ber 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 as-
sessed for all human drug applications received on or after 
October 1, 2022, regardless of the date of the enactment 
of this Act. 
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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 Administration for filing with respect to assess-
ing 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.—The Congress finds that the fees au-
thorized 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 effec-
tiveness 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 
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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 Con-
gressional 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 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 
‘‘submissions, or requests’’; and 
(E) in subparagraph (K), by striking ‘‘or 
premarket notification submissions’’ and insert-
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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: 
‘‘(2) BASE
FEE
AMOUNTS
SPECIFIED.—For 
purposes of paragraph (1), the base fee amounts 
specified in this paragraph are as follows: 
‘‘Fee Type 
Fiscal 
Year 
2023 
Fiscal 
Year 
2024 
Fiscal 
Year 
2025 
Fiscal 
Year 
2026 
Fiscal 
Year 
2027 
Premarket Application ........................
$425,000 
$435,000 
$445,000 
$455,000 
$470,000 
Establishment Registration ................
$6,250 
$6,875 
$7,100 
$7,575 
$8,465’’; 
and 
(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.’’. 
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(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 adjust-
ments under paragraphs (2) and (3), the base 
establishment registration fee amounts for such 
fiscal year shall be increased to reflect changes 
in the resource needs of the Secretary due to 
improved review performance goals for the proc-
ess for the review of device applications identi-
fied 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: 
‘‘(i) For fiscal year 2025, the product 
of— 
‘‘(I) 
the 
amount 
determined 
under subparagraph (B)(i)(I); and 
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‘‘(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 de-
termined 
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. 
‘‘(iii) For fiscal year 2027, the prod-
uct of— 
‘‘(I) the sum of the amounts de-
termined 
under 
subparagraphs 
(B)(i)(III), 
(B)(ii)(II), 
and 
(B)(iii)(II); and 
‘‘(II) the applicable inflation ad-
justment under paragraph (2)(B) for 
such fiscal year. 
‘‘(B) AMOUNTS.— 
‘‘(i) PRE-SUBMISSION AMOUNT.—For 
purposes of subparagraph (A), with respect 
to the pre-submission written feedback 
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goal, the amounts determined under this 
subparagraph are as follows: 
‘‘(I) 
For 
fiscal 
year 
2025, 
$15,396,600 if such goal for fiscal 
year 2023 is met. 
‘‘(II) For fiscal year 2026: 
‘‘(aa) $15,396,600 if such 
goal for fiscal year 2023 is met 
and such goal for fiscal year 
2024 is not met. 
‘‘(bb) $36,792,200 if such 
goal for fiscal year 2024 is met. 
‘‘(III) For fiscal year 2027: 
‘‘(aa) $15,396,600 if such 
goal for fiscal year 2023 is met 
and such goal for each of fiscal 
years 2024 and 2025 is not met. 
‘‘(bb) $36,792,200 if such 
goal for fiscal year 2024 is met 
and such goal for fiscal year 
2025 is not met. 
‘‘(cc) $40,572,600 if such 
goal for fiscal year 2025 is met. 
‘‘(ii) 
DE
NOVO
CLASSIFICATION 
AMOUNT.—For purposes of subparagraph 
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(A), with respect to the de novo decision 
goal, the amounts determined under this 
subparagraph are as follows: 
‘‘(I) 
For 
fiscal 
year 
2026, 
$6,323,500 if such goal for fiscal year 
2023 is met. 
‘‘(II) For fiscal year 2027: 
‘‘(aa) $6,323,500 if such 
goal for fiscal year 2023 is met 
and such goal for fiscal year 
2024 is not met. 
‘‘(bb) $11,765,400 if such 
goal for fiscal year 2024 is met. 
‘‘(iii) PREMARKET NOTIFICATION AND 
PREMARKET
APPROVAL
AMOUNT.—For 
purposes of subparagraph (A), with respect 
to the 510(k) decision goal, 510(k) shared 
outcome total time to decision goal, PMA 
decision goal, and PMA shared outcome 
total time to decision goal, the amounts de-
termined under this subparagraph are as 
follows: 
‘‘(I) 
For 
fiscal 
year 
2026, 
$1,020,000 if the four goals for fiscal 
year 2023 are met. 
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‘‘(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 
section 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. 
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‘‘(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) 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 Amend-
ments of 2022. 
‘‘(5) HIRING ADJUSTMENT.— 
‘‘(A) IN
GENERAL.—For each of fiscal 
years 2025 through 2027, after the adjust-
ments under paragraphs (2), (3), and (4), if ap-
plicable, if the number of hires to support the 
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process for the review of device applications 
falls below the thresholds specified in subpara-
graph (B) for the applicable fiscal years, the 
base establishment registration fee amounts 
shall be decreased as the Secretary determines 
necessary to achieve a reduction in total fee col-
lections 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 thresh-
old is 123 hires for fiscal year 2023. 
‘‘(ii) For fiscal year 2026, the thresh-
old is 38 hires for fiscal year 2024. 
‘‘(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 
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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 
follows: 
‘‘(i) For fiscal year 2023, 144 hires. 
‘‘(ii) For fiscal year 2024, 42 hires. 
‘‘(iii) For fiscal year 2025: 
‘‘(I) 24 hires if the base estab-
lishment registration fees are not in-
creased by the amount determined 
under paragraph (4)(A)(i). 
‘‘(II) 83 hires if the base estab-
lishment registration fees are in-
creased by the amount determined 
under paragraph (4)(A)(i). 
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‘‘(E) NUMBER OF HIRES.—For purposes 
of this paragraph, the number of hires shall be 
determined by the Secretary as set forth in the 
letters described in section 201(b) of the Med-
ical Device User Fee Amendments of 2022. 
‘‘(6) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) IN
GENERAL.—For each of fiscal 
years 2023 through 2027, after the adjust-
ments under paragraphs (2), (3), (4), and (5), 
if applicable, if the Secretary has operating re-
serves 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 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). 
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‘‘(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 
subparagraph (B) and shall not be subject to 
the decrease under subparagraph (A).’’. 
(d) SMALL BUSINESSES.—Section 738 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend-
ed in each of subsections (d)(2)(B)(iii) and (e)(2)(B)(iii) 
by inserting ‘‘, if extant,’’ after ‘‘national taxing author-
ity’’. 
(e) CONDITIONS.—Section 738(g) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(g)) is 
amended— 
(1) 
in 
paragraph 
(1)(A), 
by 
striking 
‘‘$320,825,000’’ and inserting ‘‘$398,566,000’’; and 
(2) in paragraph (2), by inserting ‘‘de novo 
classification requests,’’ after ‘‘class III device,’’. 
(f) CREDITING AND AVAILABILITY OF FEES.—Sec-
tion 738(h)(3) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j(h)(3)) is amended to read as follows: 
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(A) IN
GENERAL.—For each of fiscal 
years 2023 through 2027, there is authorized to 
be appropriated for fees under this section an 
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amount equal to the revenue amount deter-
mined under subparagraph (B), less the 
amount of reductions determined under sub-
paragraph (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 ad-
justed under paragraphs (2) and (3) of 
subsection (c); and 
‘‘(ii) the performance improvement 
adjustment amount for the fiscal year 
under subsection (c)(4), if applicable. 
‘‘(C) 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 sub-
section (c)(6), if applicable.’’. 
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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’’. 
(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’’. 
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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 estab-
lish 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 
recognized under this section; and 
‘‘(B) subject to paragraph (2), results 
from tests conducted to support the assessment 
of conformity of devices as described in sub-
paragraph (A) conducted by testing laboratories 
accredited pursuant to this subsection shall be 
accepted by the Secretary for purposes of dem-
onstrating such conformity unless the Secretary 
finds that certain results of such tests should 
not be so accepted. 
‘‘(2) SECRETARIAL
REVIEW
OF
ACCREDITED 
LABORATORY RESULTS.—The Secretary may— 
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‘‘(A) review the results of tests conducted 
by testing laboratories accredited pursuant to 
this subsection, including by conducting peri-
odic audits of such results or of the processes 
of accredited bodies or testing laboratories; 
‘‘(B) following such review, take additional 
measures under this Act, as the Secretary de-
termines 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 
effectiveness of a device for which an assess-
ment of conformity was supported by testing 
conducted by a testing laboratory accredited 
under this subsection, take such additional 
measures under this Act, as the Secretary de-
termines appropriate, such as— 
‘‘(i) suspension or withdrawal of ac-
creditation of a testing laboratory or rec-
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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 Med-
ical 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 
subsection.’’. 
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’’. 
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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 require-
ments) shall cease to be effective January 31, 2028. 
(c) PREVIOUS SUNSET PROVISIONS.—Effective Octo-
ber 1, 2022, subsections (a) and (b) of section 210 of the 
FDA Reauthorization Act of 2017 (Public Law 115–52) 
are repealed. 
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 
subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379i et seq.) shall be as-
sessed for all submissions listed in section 738(a)(2)(A) 
of such Act received on or after October 1, 2022, regard-
less of the date of the enactment of this Act. 
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 
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title, shall continue to be in effect with respect to the sub-
missions listed in section 738(a)(2)(A) of such Act (as de-
fined 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 au-
thorized 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 Pen-
sions of the Senate and the Chairman of the Committee 
on Energy and Commerce of the House of Representa-
tives, as set forth in the Congressional Record. 
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(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 sec-
tion for a fiscal year, in accordance with this 
paragraph, to reflect changes in the resource 
capacity needs of the Secretary for human ge-
neric drug activities. 
‘‘(B) 
CAPACITY
PLANNING
METHOD-
OLOGY.—The Secretary shall establish a capac-
ity 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 Ad-
justment Methodology: Evaluation and 
Recommendations’ announced in the Fed-
eral Register on August 3, 2020; 
‘‘(ii) incorporate approaches and at-
tributes determined appropriate by the 
Secretary, including approaches and at-
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tributes made in such report, except that 
in incorporating such approaches and at-
tributes the workload categories used in 
forecasting resources shall only be the 
workload categories specified in section 
VIII.B.2.e. of the letters described in sec-
tion 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 
exceed three percent of the sum described 
in clause (i) for the fiscal year, except that 
such limitation shall be four percent if— 
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‘‘(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 
abbreviated new drug applica-
tions 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 let-
ters described in section 301(b) 
of the Generic Drug User Fee 
Amendments 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— 
‘‘(aa) the total number of 
abbreviated new drug applica-
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tions 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 
determines that during the period 
from April 1, 2023, through March 
31, 2025— 
‘‘(aa) the total number of 
abbreviated new drug applica-
tions 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 
determines that during the period 
from April 1, 2024, through March 
31, 2026— 
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‘‘(aa) the total number of 
abbreviated new drug applica-
tions 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 the number of weeks specified in subpara-
graph (B) with respect to that fiscal year. 
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‘‘(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 ac-
tivities 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 Reg-
ister notice under subsection (a) publishing the 
fee revenue and fees for the fiscal year in-
volved.’’. 
(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.—Sec-
tion 744B(i)(3) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–42(i)(3)) is amended by striking ‘‘fis-
cal years 2018 through 2022’’ and inserting ‘‘fiscal years 
2023 through 2027’’. 
(f) EFFECT OF FAILURE TO PAY FEES.—The head-
ing 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 Cos-
metic 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 
Amendments of 2017’’ each place it appears and in-
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serting ‘‘Generic Drug User Fee Amendments of 
2022’’; 
(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 
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), 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’’. 
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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 Octo-
ber 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 (21 U.S.C. 379j–41 et seq.), as 
in effect on the day before the date of the enactment of 
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this title, shall continue to be in effect with respect to ab-
breviated 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 sup-
plements 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.—The Congress finds that the fees au-
thorized by the amendments made by this title will be 
dedicated to expediting the process for the review of bio-
similar 
biological 
product 
applications, 
including 
postmarket safety activities, as set forth in the goals iden-
tified 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 
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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. 
(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; 
Annual 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 amended— 
(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. 
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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 insert-
ing ‘‘fiscal year 2023’’. 
(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 
period 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, as-
signee, or successor of such person, and written 
notice of such transfer is provided to the Sec-
retary, in which case such licensee, assignee, or 
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successor shall pay the annual biosimilar bio-
logical product 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 
(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 Cos-
metic Act (21 U.S.C. 379j–52(a)(1)(D)) is amended 
to read as follows: 
‘‘(D) REACTIVATION FEE.— 
‘‘(i) IN GENERAL.—A person that has 
discontinued participation in the biosimilar 
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biological product development program for 
a product under subparagraph (C), or who 
has been administratively removed from 
the biosimilar biological product develop-
ment program for a product under sub-
paragraph (E)(v), shall, if the person seeks 
to resume participation in such program, 
pay all annual biosimilar biological product 
development fees previously assessed for 
such product and still owed and a fee (re-
ferred to in this section as ‘reactivation 
fee’) by the earlier of the following: 
‘‘(I) Not later than 7 days after 
the Secretary grants a request by 
such person for a biosimilar biological 
product development meeting for the 
product (after the date on which such 
participation was discontinued or the 
date of administrative removal, as ap-
plicable). 
‘‘(II) Upon the date of submis-
sion (after the date on which such 
participation was discontinued or the 
date of administrative removal, as ap-
plicable) by such person of an inves-
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tigational new drug application de-
scribing an investigation that the Sec-
retary determines is intended to sup-
port a biosimilar biological product 
application for that product. 
‘‘(ii) 
APPLICATION
OF
ANNUAL 
FEE.—A person that pays a reactivation 
fee for a product shall pay for such prod-
uct, beginning in the next fiscal year, the 
annual biosimilar biological product devel-
opment fee under subparagraph (B), ex-
cept where such product (including, where 
applicable, ownership of the relevant inves-
tigational new drug application) is trans-
ferred 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 suc-
cessor shall pay the annual biosimilar bio-
logical product development fee.’’. 
(5) EFFECT OF FAILURE TO PAY FEES.—Sec-
tion 744H(a)(1)(E) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j–52(a)(1)(E)) is 
amended by adding at the end the following: 
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‘‘(v) ADMINISTRATIVE REMOVAL FROM 
THE
BIOSIMILAR
BIOLOGICAL
PRODUCT 
DEVELOPMENT 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 
period of two consecutive fiscal years, the 
Secretary may administratively remove 
such person from the biosimilar biological 
product development program for the prod-
uct. At least 30 days prior to administra-
tively removing a person from the bio-
similar biological product development pro-
gram 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
PRO-
GRAM
FEE.—Section 744H(a)(3) of the Federal 
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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: 
‘‘(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 bi-
ological product program fee, the Secretary 
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shall inform the person whether such new drug is quali-
tatively and quantitatively the same as the listed drug. 
‘‘(ii) Notwithstanding section 301(j), if the Secretary 
determines that such new drug is not qualitatively or 
quantitatively the same as the listed drug, the Secretary 
shall identify and disclose to the person— 
‘‘(I) the ingredient or ingredients that cause the 
new drug not to be qualitatively or quantitatively the 
same as the listed drug; and 
‘‘(II) for any ingredient for which there is an 
identified quantitative deviation, the amount of such 
deviation. 
‘‘(iii) If the Secretary determines that such new drug 
is qualitatively and quantitatively the same as the listed 
drug, the Secretary shall not change or rescind such deter-
mination after the submission of an abbreviated applica-
tion for such new drug under this subsection unless— 
‘‘(I) the formulation of the listed drug has been 
changed and the Secretary has determined that the 
prior listed drug formulation was withdrawn for rea-
sons of safety or effectiveness; or 
‘‘(II) the Secretary makes a written determina-
tion that the prior determination must be changed 
because an error has been identified. 
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