I 
117TH CONGRESS 
2D SESSION 
H. R. 7667 
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 
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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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. 
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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. Savings clause. 
Sec. 208. Effective date. 
Sec. 209. Sunset dates. 
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 TRIALS 
Sec. 501. Premarket reporting of diversity action plans for clinical trials and 
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 trial diversity. 
Sec. 504. Annual report on progress to increase diversity in clinical trials and 
studies. 
Sec. 505. Public meeting on clinical trial flexibilities initiated in response to 
COVID–19 pandemic. 
Sec. 506. Decentralized clinical trials. 
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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 and gene therapies. 
Sec. 708. Reauthorization of best pharmaceuticals for children. 
Sec. 709. Reauthorization for humanitarian device exemption and demonstra-
tion grants for improving pediatric availability. 
Sec. 710. Reauthorization of provision related to exclusivity of certain drugs 
containing single enantiomers. 
Sec. 711. Reauthorization of the critical path public-private partnership pro-
gram. 
Sec. 712. Reauthorization of orphan drug grants. 
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. 
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. Medical devices advisory committee meetings. 
Sec. 807. Ensuring cybersecurity of medical devices. 
Sec. 808. Public docket on proposed modifications to approved strategies. 
Sec. 809. Facilitating exchange of product information prior to approval. 
Sec. 810. Bans of devices for one or more intended uses. 
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Sec. 811. Clarifying application of exclusive approval, certification, or licensure 
for drugs designated for rare diseases or conditions. 
Sec. 812. GAO report on third-party review. 
Sec. 813. Reauthorization of device pilot projects. 
Sec. 814. Reporting on pending generic drug applications and priority review 
applications. 
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 in this title will be dedi-
cated toward expediting the drug development process and 
the process for the review of human drug applications, in-
cluding 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, 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 Con-
gressional 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 
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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’’; 
(3) by striking ‘‘Such term does not include’’ 
and inserting the following: 
‘‘(B) Such term does not include’’; 
(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 
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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 
‘‘(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-
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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 
‘‘(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 
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‘‘(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)’’; 
(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).’’. 
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(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-
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 
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application with respect to such product, 
and who, after September 1, 1992, had 
pending before the Secretary a human 
drug application or supplement with re-
spect to such product, shall pay the annual 
prescription drug program fee established 
for a fiscal year under subsection (c)(6) for 
such prescription drug product. Such fee 
shall be due on the last business day of 
such fiscal year and shall be paid only once 
for each such product for a fiscal year in 
which the fee is payable.’’; and 
(B) by amending subparagraph (B) to read 
as follows: 
‘‘(B) EXCEPTION FOR CERTAIN PRESCRIP-
TION
DRUG
PRODUCTS.—A prescription drug 
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-
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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 
(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)); 
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‘‘(C) the dollar amount equal to the stra-
tegic hiring and reserve 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 
fiscal year as follows: 
‘‘(i) $65,773,693 for fiscal year 2023. 
‘‘(ii) $25,097,671 for fiscal year 2024. 
‘‘(iii) $14,154,169 for fiscal year 
2025. 
‘‘(iv) $4,864,860 for fiscal year 2026. 
‘‘(v) 
$1,314,620 
for 
fiscal 
year 
2027.’’. 
(2) ANNUAL BASE REVENUE.—Paragraph (3) 
of section 736(b) of the Federal Food, Drug, and 
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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– 
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— 
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(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.— 
‘‘(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 
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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 
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 
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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-
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— 
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(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 
(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: 
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‘‘(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. 
‘‘(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. 
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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 
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— 
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‘‘(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 
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 
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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 
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. 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 shall be assessed for all human drug 
applications received on or after October 1, 2022, regard-
less 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, 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 
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on or after October 1, 2017, but before October 1, 2022, 
were accepted by the Food and Drug Administration for 
filing with respect to assessing and collecting any fee re-
quired 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 
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. 
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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-
ing ‘‘premarket notification submissions, or de 
novo classification requests’’; and 
(2) in paragraph (11), by striking ‘‘2016’’ and 
inserting ‘‘2021’’. 
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(1) in paragraph (1), by striking ‘‘2017’’ and 
inserting ‘‘2022’’; 
(2) in paragraph (2)— 
(A) in subparagraph (A), by striking 
‘‘2018’’ and inserting ‘‘2023’’; 
(B) in subparagraph (B)— 
(i) in the matter preceding clause (i), 
by striking ‘‘fiscal year 2018’’ and insert-
ing ‘‘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-Alexan-
dria, DC–VA–MD–WV’’. 
(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 
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(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 
‘‘(II) the applicable inflation ad-
justment under paragraph (2)(B) for 
such fiscal year. 
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‘‘(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 
goal, the amounts determined under this 
subparagraph are as follows: 
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‘‘(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 
(A), with respect to the de novo decision 
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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. 
‘‘(II) For fiscal year 2027: 
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‘‘(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 is 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. 
‘‘(ii) The performance of the de novo 
decision goal, 510(k) decision goal, 510(k) 
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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 
process for the review of device applications 
falls below the thresholds specified in subpara-
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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 
and each subsequent fiscal year is the product 
of— 
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‘‘(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). 
‘‘(E) NUMBER OF HIRES.—For purposes 
of this paragraph, the number of hires shall be 
determined by the Secretary as set forth in the 
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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). 
‘‘(C) EXCLUDED AMOUNT.—For the period 
of fiscal years 2023 through 2026, a total 
amount equal to $118,000,000 shall not be con-
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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 
amount equal to the revenue amount deter-
mined under subparagraph (B), less the 
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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.’’. 
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— 
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(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. 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 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 accepted by 
the Food and Drug Administration for filing with respect 
to assessing and collecting any fee required by such part 
for a fiscal year prior to fiscal year 2023. 
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. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 737 and 738 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 
739j) shall cease to be effective October 1, 2027. 
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(b) REPORTING REQUIREMENTS.—Section 738A (21 
U.S.C. 739j– 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 
Medical Device User Fee Amendments of 2017 (Public 
Law 115–52) are repealed. 
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 in this title will be dedi-
cated to human generic drug activities, as set forth in the 
goals identified for purposes of part 7 of subchapter C 
of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Con-
gressional Record. 
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SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GE-
NERIC DRUG FEES. 
(a) TYPES OF FEES.—Section 744B(a) of the Fed-
eral 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)— 
(i) in the heading, by striking ‘‘2018’’ 
and inserting ‘‘2023’’; 
(ii) by striking ‘‘2018’’ and inserting 
‘‘2023’’; and 
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(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 
fiscal years 2024 through 2027, fees under 
paragraphs (2) through (5) of subsection 
(a) shall be established to generate a total 
estimated revenue amount under such 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 
(2) in paragraph (2)— 
(A) in subparagraph (C), by striking ‘‘one- 
third the amount’’ and inserting ‘‘twenty-four 
percent’’; 
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(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 inserting ‘‘to equal the base revenue 
amount for the fiscal year (as specified in 
subsection (b)(1)(B)) multiplied’’; and 
(B) in subparagraph (C), by striking 
‘‘Washington-Baltimore, 
DC–MD–VA–WV’’ 
and inserting ‘‘Washington-Arlington-Alexan-
dria, DC–VA–MD–WV’’; and 
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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’’. 
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-
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 
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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’’. 
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. 
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(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 shall be assessed for all abbreviated new 
drug applications received on or after October 1, 2022, 
regardless of the date of the enactment of this Act. 
SEC. 306. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
part 7 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act, as in effect on the day before 
the date of the enactment of this title, shall continue to 
be in effect with respect to abbreviated new drug applica-
tions (as defined in such part as of such day) that were 
received by the Food and Drug Administration within the 
meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 
355(j)(5)(A)), prior approval supplements that were sub-
mitted, and drug master files for Type II active pharma-
ceutical ingredients that were first referenced on or after 
October 1, 2017, but before October 1, 2022, with respect 
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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 in this title will be dedi-
cated to expediting the process for the review of biosimilar 
biological product applications, including postmarket safe-
ty activities, as set forth in the goals identified for pur-
poses of part 8 of subchapter C of chapter VII of the Fed-
eral Food, Drug, and Cosmetic Act, in the letters from 
the Secretary of Health and Human Services to the Chair-
man of the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Chairman of the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives, 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: 
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‘‘(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. 
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, 
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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 
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: 
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‘‘(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 
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 
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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-
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 
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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: 
‘‘(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-
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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 
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 bi-
ological product program fee, the Secretary 
shall consider such product to have been 
included on such list on the later of— 
‘‘(I) the date such request was 
received; or 
‘‘(II) if the product will be with-
drawn from sale on a future date, 
such future date when the product is 
withdrawn from sale. 
‘‘(ii) TREATMENT
AS
WITHDRAWN 
FROM SALE.—For purposes of clause (i), a 
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product shall be considered withdrawn 
from sale once the applicant has ceased its 
own distribution of the product, whether or 
not the applicant has ordered recall of all 
previously distributed lots of the product, 
except that a routine, temporary interrup-
tion in supply shall not render a product 
withdrawn 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 subpara-
graph (A) of discontinued biosimilar bio-
logical products, and on any subsequent 
day during such fiscal year the biosimilar 
biological product does not appear on such 
list, then except as provided in subpara-
graph (D), each person who is named as 
the applicant in a biosimilar biological 
product application with respect to such 
product shall pay the annual biosimilar bi-
ological product program fee established 
for a fiscal year under subsection (c)(5) for 
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such biosimilar biological product. Not-
withstanding subparagraph (B), such fee 
shall be due on the last business day of 
such fiscal year and shall be paid only once 
for each such product for each fiscal 
year.’’. 
(8) BIOSIMILAR BIOLOGICAL PRODUCT FEE.— 
Section 744H(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j–52(a)) is amended by 
striking paragraph (4). 
(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, 
except as provided in subsection (c), be established 
to generate a total revenue amount equal to the sum 
of— 
‘‘(A) the annual base revenue for the fiscal 
year (as determined under paragraph (3)); 
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‘‘(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 (as deter-
mined 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) for fiscal year 2023 an additional 
amount of $4,428,886; and 
‘‘(G) for fiscal year 2024 an additional 
amount of $320,569.’’; 
(4) in paragraph (2) (as so redesignated)— 
(A) in the paragraph heading, by striking 
‘‘; LIMITATIONS ON FEE AMOUNTS’’; 
(B) by striking subparagraph (B); and 
(C) by redesignating subparagraphs (C) 
and (D) as subparagraphs (B) and (C), respec-
tively; and 
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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 
established under paragraph (1) for the pre-
vious fiscal year, excluding any adjustments to 
such revenue 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’’ 
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and inserting ‘‘Washington-Arlington-Alexan-
dria, 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 
adjust the fee revenue and fees under this sec-
tion for a fiscal year to reflect changes in the 
resource capacity needs of the Secretary for the 
process for the review of biosimilar biological 
product applications. 
‘‘(B) METHODOLOGY.— For purposes of 
this paragraph, the Secretary shall employ the 
capacity planning methodology utilized by the 
Secretary in setting fees for fiscal year 2021, as 
described in the notice titled ‘Biosimilar User 
Fee Rates for Fiscal Year 2021’ published in 
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the Federal Register on August 4, 2020 (85 
Fed. Reg. 47220). 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 biosimilar biological product 
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 biosimilar biological prod-
ucts. Subject to the exceptions in the preceding 
sentence, the Secretary shall not include as 
workload categories in applying such method-
ology in forecasting any non-core review activi-
ties, 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 
paragraph result in fee revenue for a fiscal year 
that is less than the sum of the amounts under 
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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). 
‘‘(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 re-
serves of carryover user fees for the process for 
the review of biosimilar biological product appli-
cations. 
‘‘(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-
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retary shall decrease such fee revenue and 
fees to provide for not more than 33 weeks 
of such operating reserves. 
‘‘(ii) FISCAL
YEAR
2024.—For fiscal 
year 2024, if the Secretary has carryover 
balances for such process in excess of 27 
weeks of such operating reserves, the 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 
Secretary has carryover balances for such 
process in excess of 21 weeks of such oper-
ating 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 no-
tice under paragraph (5)(B) establishing fee 
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revenue and fees for the fiscal year involved.’’; 
and 
(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 RE-
TURNS; 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 
consideration for a waiver under subsection (d), or for the 
return of any fee paid under this section, including if the 
fee is claimed to have been paid in error, a person shall 
submit to the Secretary a written request justifying such 
waiver or return and, except as otherwise specified in this 
section, such written request shall be submitted to the Sec-
retary not later than 180 days after such fee is due. A 
request submitted under this paragraph shall include any 
legal authorities under which the request is made.’’. 
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SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 744I of the Federal Food, Drug, and Cos-
metic 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 col-
lected 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 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 effective January 31, 2028. 
(c) PREVIOUS SUNSET PROVISION.—Effective Octo-
ber 1, 2022, subsections (a) and (b) of section 405 of the 
FDA Reauthorization Act of 2017 (Public Law 115–52) 
are repealed. 
SEC. 406. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on October 1, 2022, or the date of the enactment of this 
Act, whichever is later, except that fees under part 8 of 
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subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act shall be assessed for all biosimilar bio-
logical 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, 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 col-
lecting any fee required by such part for a fiscal year prior 
to fiscal year 2023. 
TITLE V—IMPROVING DIVERSITY 
IN CLINICAL TRIALS 
SEC. 501. PREMARKET REPORTING OF DIVERSITY ACTION 
PLANS FOR CLINICAL TRIALS AND STUDIES. 
(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 to be exempt pursu-
ant to this subsection, the sponsor of a clinical investiga-
tion of such new drug shall submit to the Secretary a di-
versity action plan. 
‘‘(B) Such diversity action plan shall include— 
‘‘(i) the sponsor’s goals for enrollment in such 
clinical investigation; 
‘‘(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, in such form and manner as 
specified in the guidance required by section 524B, submit 
such diversity action plan as soon as practicable during 
drug development, but not later than— 
‘‘(i) one month prior to an End-of-Phase 2 
meeting, as described in section 312.47(b) of title 
21, Code of Federal Regulations (or successor regu-
lations); or 
‘‘(ii) if there is no End-of-Phase 2 meeting, one 
month prior to commencing enrollment for a Phase 
3 study. 
‘‘(D) The Secretary may waive the requirement in 
subparagraph (A) if the Secretary determines that a waiv-
er is necessary based on what is known about the preva-
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lence of the disease in terms of the patient population that 
may use the new drug.’’. 
(b) BIOLOGICAL PRODUCTS.—Section 351(a)(3) of 
the Public Health Service Act (42 U.S.C. 262(a)(3)) is 
amended— 
(1) by striking ‘‘(3) The Secretary’’ and insert-
ing ‘‘(3)(A) The Secretary’’; and 
(2) by adding at the end the following: 
‘‘(B)(i) In order for a biological product to be exempt 
pursuant to this paragraph, the sponsor of a clinical inves-
tigation of such biological product shall submit to the Sec-
retary a diversity action plan. 
‘‘(ii) Such diversity action plan shall include— 
‘‘(I) the sponsor’s goals for enrollment in such 
clinical investigation; 
‘‘(II) the sponsor’s rationale for such goals; and 
‘‘(III) an explanation of how the sponsor in-
tends to meet such goals. 
‘‘(iii) The sponsor shall, in such form and manner 
as specified in the guidance required by section 524B, sub-
mit such diversity action plan as soon as practicable dur-
ing biological product development, but not later than— 
‘‘(I) one month prior to an End-of-Phase 2 
meeting, as described in section 312.47(b) of title 
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21, Code of Federal Regulations (or successor regu-
lations); or 
‘‘(II) if there is no End-of-Phase 2 meeting, one 
month prior to commencing enrollment for a Phase 
3 study. 
‘‘(iv) The Secretary may waive the requirement in 
subparagraph (A) if the Secretary determines that a waiv-
er is necessary based on what is known about the preva-
lence of the disease in terms of the patient population that 
may use the biological product.’’. 
(c) 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) In order for a device to be exempt under this 
subsection, the sponsor of a clinical investigation of such 
device shall submit to the Secretary a diversity action plan 
the sponsor of a clinical investigation of such device 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 investigation; 
‘‘(ii) the sponsor’s rationale for such goals; and 
‘‘(iii) an explanation of how the sponsor intends 
to meet such goals. 
‘‘(C) Such diversity action plan shall be— 
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‘‘(i) if submission of an application for an inves-
tigational device exemption is required, submitted in 
such application; and 
‘‘(ii) if submission of an application for inves-
tigational device exemption is not required, sub-
mitted as soon as practicable during device develop-
ment, but no later than one month prior to com-
mencing enrollment for a study. 
‘‘(D) The Secretary may waive the requirement in 
subparagraph (A) if the Secretary determines that a waiv-
er is necessary based on what is known about the preva-
lence of the disease in terms of the patient population that 
may use the device.’’. 
(d) GUIDANCE.—Subchapter A of chapter V of the 
Federal 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 TRIALS AND STUDIES. 
‘‘(a) IN GENERAL.—The Secretary shall by guidance 
provide recommendations relating to— 
‘‘(1) the format and content of the diversity ac-
tion plans required by sections 505(i)(5) and 
520(g)(9) of this Act, and section 351(a)(3) of the 
Public Health Service Act, pertaining to the spon-
sor’s goals for clinical trial enrollment, disaggregated 
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by age group, sex, race, geographic location, and 
ethnicity, including with respect to— 
‘‘(A) the rationale for the sponsor’s enroll-
ment goals, which may include— 
‘‘(i) the estimated prevalence in the 
United States of the disease or condition 
for which the drug or device is being devel-
oped or investigated, if such estimated 
prevalence 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, 
including, to the extent data is available— 
‘‘(I) demographic information, in-
cluding age group, sex, race, geo-
graphic location and ethnicity; 
‘‘(II) co-morbidities frequently 
affecting the patient population; and 
‘‘(III) potential barriers to enroll-
ing diverse participants, such as pa-
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tient population size and geographic 
location; and 
‘‘(v) any other data or information the 
sponsor deems relevant to selecting appro-
priate enrollment goals, disaggregated by 
demographic subgroup, such as the inclu-
sion of pregnant and lactating women; 
‘‘(B) an explanation for how the sponsor 
intends to meet such goals, including demo-
graphic-specific outreach and enrollment strate-
gies, study-site selection, clinical trial inclusion 
and exclusion practices, and any diversity train-
ing for trial 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; 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— 
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‘‘(i) any updates needed to be made to 
a diversity action plan referred to in para-
graph (1) to help meet such goals; and 
‘‘(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 sub-
section (a); and 
‘‘(2) not later than 6 months after closing the 
comment period on such draft guidance, finalize 
such guidance.’’. 
(e) 
APPLICABILITY.—Sections 
505(i)(5) 
and 
520(g)(9) of the Federal Food, Drug, and Cosmetic Act, 
and section 351(a)(3)(B) of the Public Health Service Act, 
as added by subsections (a), (b), and (c) of this section, 
apply only with respect to clinical investigations with re-
spect to which enrollment 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 Cos-
metic Act, as added by subsection (d). 
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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, 
as added by section 501(d) of this Act, the Secretary of 
Health and Human Services shall commence an evaluation 
to assess whether additions or changes to statutes or regu-
lations are needed to assure that sponsors conduct post-
approval studies or postmarket surveillance when they do 
not meet the enrollment goals submitted in their diversity 
action plan under section 505(i)(5) or 520(g)(9) of the 
Federal Food, Drug, and Cosmetic Act, or section 
351(a)(3)(B) of the Public Health Service Act, as added 
by subsection (a), (b), or (c) of section 501 of this Act. 
(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 out-
come of the such evaluation, including any recommenda-
tions related to additional needed authorities. 
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SEC. 503. PUBLIC WORKSHOPS TO ENHANCE CLINICAL 
TRIAL DIVERSITY. 
(a) IN GENERAL.—Not later than September 30, 
2023, the Secretary of Health and Human Services, in 
consultation with drug sponsors, medical device manufac-
turers, patients, and other stakeholders, shall convene one 
or more public workshops to solicit input from stake-
holders on increasing the enrollment of historically under-
represented populations in clinical trials and encouraging 
clinical trial participation that reflects the prevalence of 
the disease or condition among demographic subgroups, 
and other topics, including— 
(1) how and when to collect and present demo-
graphic subgroup and disease or condition preva-
lence data from clinical trials, including with respect 
to— 
(A) such data intended to support post-
approval study requirements; and 
(B) the utilization of real world evidence 
(as defined in section 505F(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355g(b))); 
(2) methodologies for assessing the diversity of 
a patient population; 
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(3) methodologies for the dissemination of in-
formation to the public on clinical trial enrollment 
demographic data; 
(4) the establishment of goals for enrollment in 
clinical trials with respect to the estimated preva-
lence in the United States of the disease or condition 
for which the drug is being developed or inves-
tigated, disaggregated by demographic subgroup (in-
cluding by age group, race, ethnicity, and sex); and 
(5) approaches to support inclusion of under-
represented populations and to encourage clinical 
trial participation that reflects the prevalence of the 
disease or condition in certain demographic sub-
groups, including with respect to— 
(A) the establishment of inclusion and ex-
clusion criteria for certain demographic sub-
groups, such as pregnant and lactating women 
and individuals with disabilities, including intel-
lectual or developmental disabilities; 
(B) considerations regarding informed con-
sent with respect to individuals with intellectual 
or developmental disabilities; 
(C) clinical trial designs, including utiliza-
tion of decentralized trials or digital health 
tools; 
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(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 ad-
dressed 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 convened. 
(c) REPORT.—Not later than 180 days after the date 
of each public workshop convened under this section, the 
Secretary of Health and Human Services shall make avail-
able on the public website of the Food and Drug Adminis-
tration a report on the topics discussed at such workshop. 
The report shall include a summary of, and response to, 
recommendations raised in such workshop. 
SEC. 504. ANNUAL REPORT ON PROGRESS TO INCREASE DI-
VERSITY IN CLINICAL TRIALS AND STUDIES. 
(a) IN GENERAL.—Beginning not later than 2 years 
after the date of enactment of this Act, and each year 
thereafter, 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— 
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(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, or section 351(a)(3)(B) of the Public Health 
Service Act, as added by subsection (a), (b), or (c) 
of section 501 of this Act; and 
(2) contains information on— 
(A) whether the clinical trials conducted 
with respect to such applications met the demo-
graphic subgroup enrollment goals from the di-
versity action plan submitted for such applica-
tions; 
(B) the reasons provided for why enroll-
ment goals from submitted diversity action 
plans were not met; 
(C) any postmarket studies of a drug or 
device in a demographic subgroup or subgroups 
required or recommended by the Secretary 
based on inadequate premarket clinical trial di-
versity, including the status and completion 
date of any such study; and 
(D) additional authorities, if any, the Sec-
retary plans to use or considers necessary to en-
sure compliance with the requirements of the 
amendments made by section 501. 
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(b) CONFIDENTIALITY.—Nothing in this section shall 
be construed as authorizing the Secretary of Health and 
Human Services to disclose any information that is a 
trade secret or confidential information subject to section 
552(b)(4) of title 5, United States Code, or section 1905 
of title 18, United States Code. 
SEC. 505. PUBLIC MEETING ON CLINICAL TRIAL FLEXIBILI-
TIES INITIATED IN RESPONSE TO COVID–19 
PANDEMIC. 
(a) IN GENERAL.—Not later than 180 days after the 
date on which the COVID–19 emergency period ends, the 
Secretary of Health and Human Services shall convene a 
public meeting to discuss the recommendations provided 
by the Food and Drug Administration during the COVID– 
19 emergency period to mitigate disruption of clinical 
trials, including recommendations detailed in the March 
2020 guidance entitled ‘‘Conduct of Clinical Trials of 
Medical Products During the COVID–19 Public Health 
Emergency, Guidance for Industry, Investigators, and In-
stitutional Review Boards’’, and any subsequent updates 
to such guidance. The Secretary of Health and Human 
Services shall invite to such meeting representatives from 
the pharmaceutical and medical device industries who 
sponsored clinical trials during the COVID–19 emergency 
period and organizations representing patients. 
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(b) TOPICS.—Not later than 90 days after the date 
on which the public meeting under subsection (a) is con-
vened, 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 
meeting. Such topics shall include discussion of— 
(1) the actions drug sponsors took to utilize 
such recommendations and the frequency at which 
such recommendations were employed; 
(2) the characteristics of the sponsors, trials, 
and patient populations impacted by such rec-
ommendations; 
(3) a consideration of how recommendations in-
tended to mitigate disruption of clinical trials during 
the COVID–19 emergency period, including any rec-
ommendations to consider decentralized clinical 
trials when appropriate, may have affected access to 
clinical trials for certain patient populations, espe-
cially unrepresented racial and ethnic minorities; 
and 
(4) recommendations for incorporating certain 
clinical trial disruption mitigation recommendations 
into current or additional guidance to improve clin-
ical trial access and enrollment of diverse patient 
populations. 
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(c) COVID–19 EMERGENCY PERIOD DEFINED.—In 
this section, the term ‘‘COVID–19 emergency period’’ has 
the meaning given the term ‘‘emergency period’’ in section 
1135(g)(1)(B) of the Social Security Act (42 U.S.C. 
1320b–5(g)(1)(B)). 
SEC. 506. DECENTRALIZED CLINICAL TRIALS. 
(a) GUIDANCE.—The Secretary of Health and 
Human Services shall— 
(1) not later than 12 months after the date of 
enactment of this Act, issue draft guidance that ad-
dresses considerations for decentralized clinical 
trials, including considerations regarding the engage-
ment, enrollment, and retention of a meaningfully 
diverse clinical population, with respect to race, eth-
nicity, age, gender, and geographic location, when 
appropriate; and 
(2) not later than 6 months after closing the 
comment period on such draft guidance, finalize 
such guidance. 
(b) CONTENT OF GUIDANCE.—The guidance under 
subsection (a) shall address the following: 
(1) Recommendations for how digital health 
technology or other remote assessment options, such 
as telehealth, could support decentralized clinical 
trials, including guidance on considerations for se-
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lecting technological platforms and mediums, data 
collection and use, data integrity and security, and 
communication to study participants through digital 
technology. 
(2) Recommendations for subject recruitment 
and retention, including considerations for sponsors 
to minimize or reduce burdens for clinical trial par-
ticipants through the use of digital heath technology, 
telehealth, local health care providers and labora-
tories, or other means. 
(3) Recommendations with respect to the eval-
uation of data collected within a decentralized clin-
ical trial setting. 
(c) DEFINITION.—In this section, the term ‘‘decen-
tralized clinical trial’’ means a clinical trial in which some 
or all of the trial-related activities occur at a location sepa-
rate from the investigator’s location. 
TITLE VI—GENERIC DRUG 
COMPETITION 
SEC. 601. INCREASING TRANSPARENCY IN GENERIC DRUG 
APPLICATIONS. 
(a) IN GENERAL.—Section 505(j)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 
amended by adding at the end the following: 
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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. 
‘‘(iv) If the Secretary makes a written determination 
described in clause (iii)(II), the Secretary shall provide no-
tice and a copy of the written determination to the person 
making the request under clause (i). 
‘‘(v) The disclosures required by this subparagraph 
are disclosures authorized by law under section 1905 of 
title 18, United States Code.’’. 
(b) GUIDANCE.— 
(1) IN
GENERAL.—Not later than one year 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services shall issue 
guidance describing how the Secretary will deter-
mine whether a new drug is qualitatively and quan-
titatively the same as the listed drug (as such terms 
are used in section 505(j)(3)(H) of the Federal 
Food, Drug, and Cosmetic Act, as added by sub-
section (a)), including with respect to assessing pH 
adjusters. 
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(2) PROCESS.—In issuing guidance as required 
by paragraph (1), the Secretary of Health and 
Human Services shall— 
(A) publish draft guidance; 
(B) provide a period of at least 60 days for 
comment on the draft guidance; and 
(C) after considering any comments re-
ceived, publish final guidance. 
(c) APPLICABILITY.—Section 505(j)(3)(H) of the 
Federal Food, Drug, and Cosmetic Act, as added by sub-
section (a), applies beginning on the date of enactment 
of this Act, irrespective of the date on which the guidance 
required by subsection (b) is finalized. 
SEC. 602. ENHANCING ACCESS TO AFFORDABLE MEDI-
CINES. 
Section 505(j)(10)(A) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)(10)(A)) is amended 
by striking clauses (i) through (iv) and inserting the fol-
lowing: 
‘‘(i) a revision to the labeling of the listed drug 
has been approved by the Secretary within 90 days 
of when the application is otherwise eligible for ap-
proval under this subsection; 
‘‘(ii) the sponsor of the application agrees to 
submit revised labeling for the drug that is the sub-
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ject of the application not later than 60 days after 
approval under this subsection of the application; 
and 
‘‘(iii) the labeling revision described under 
clause (i) does not include a change to the ‘Warn-
ings’ section of the labeling.’’. 
TITLE VII—RESEARCH, DEVEL-
OPMENT, AND SUPPLY CHAIN 
IMPROVEMENTS 
Subtitle A—In General 
SEC. 701. ANIMAL TESTING ALTERNATIVES. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) is amended— 
(1) in subsection (b)(5)(B)(i)(II), by striking 
‘‘animal’’ and inserting ‘‘nonclinical tests’’; 
(2) in subsection (i)— 
(A) in paragraph (1)(A), by striking ‘‘pre-
clinical tests (including tests on animals)’’ and 
inserting ‘‘nonclinical tests’’; and 
(B) in paragraph (2)(B), by striking ‘‘ani-
mal’’ and inserting ‘‘nonclinical tests’’; and 
(3) after subsection (y), by inserting the fol-
lowing: 
‘‘(z) NONCLINICAL TEST DEFINED.—For purposes 
of this section, the term ‘nonclinical test’ means a test con-
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ducted in vitro, in silico, or in chemico, or a nonhuman 
in vivo test, that occurs before or during the clinical trial 
phase of the investigation of the safety and effectiveness 
of a drug. Such test may include the following: 
‘‘(1) Cell-based assays. 
‘‘(2) Organ chips and microphysiological sys-
tems. 
‘‘(3) Sophisticated computer modeling. 
‘‘(4) Other nonhuman or human biology-based 
test methods. 
‘‘(5) Animal tests.’’. 
SEC. 702. EMERGING TECHNOLOGY PROGRAM. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 201 et seq.) is amended by inserting after 
section 566 of such Act (21 U.S.C. 360bbb–5) the fol-
lowing: 
‘‘SEC. 566A. EMERGING TECHNOLOGY PROGRAM. 
‘‘(a) PROGRAM ESTABLISHMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish a program to support the adoption of, and im-
prove the development of, innovative approaches to 
drug product design and manufacturing. 
‘‘(2) ACTIONS.—In carrying out the program 
under paragraph (1), the Secretary may— 
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‘‘(A) facilitate and increase communication 
between public and private entities, consortia, 
and individuals with respect to innovative drug 
product design and manufacturing; 
‘‘(B) solicit information regarding, and 
conduct or support research on, innovative ap-
proaches to drug product design and manufac-
turing; 
‘‘(C) convene meetings with representatives 
of industry, academia, other Federal agencies, 
international agencies, and other interested per-
sons, as appropriate; 
‘‘(D) convene working groups to support 
drug product design and manufacturing re-
search and development; 
‘‘(E) support education and training for 
regulatory staff and scientists related to innova-
tive approaches to drug product design and 
manufacturing; 
‘‘(F) advance regulatory science related to 
the development and review of innovative ap-
proaches to drug product design and manufac-
turing; 
‘‘(G) convene or participate in working 
groups to support the harmonization of inter-
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100 
national regulatory requirements related to in-
novative approaches to drug product design and 
manufacturing; and 
‘‘(H) award grants or contracts to carry 
out or support the program under paragraph 
(1). 
‘‘(3) GRANTS
AND
CONTRACTS.—To seek a 
grant or contract under this section, an entity shall 
submit an application— 
‘‘(A) in such form and manner as the Sec-
retary may require; and 
‘‘(B) containing such information as the 
Secretary may require, including a description 
of— 
‘‘(i) how the entity will conduct the 
activities to be supported through the 
grant or contract; and 
‘‘(ii) how such activities will further 
research and development related to, or 
adoption of, innovative approaches to drug 
product design and manufacturing. 
‘‘(b) GUIDANCE.—The Secretary shall— 
‘‘(1) issue or update guidance to help facilitate 
the adoption of, and advance the development of, in-
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101 
novative approaches to drug product design and 
manufacturing; and 
‘‘(2) include in such guidance descriptions of— 
‘‘(A) any regulatory requirements related 
to the development or review of technologies re-
lated to innovative approaches to drug product 
design and manufacturing, including updates 
and improvements to such technologies after 
product approval; and 
‘‘(B) data that can be used to demonstrate 
the identity, safety, purity, and potency of 
drugs manufactured using such technologies. 
‘‘(c) REPORT TO CONGRESS.—Not later than 4 years 
after the date of enactment of this section, the Secretary 
shall submit to the Committee on Energy and Commerce 
of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate a 
report containing— 
‘‘(1) an annual accounting of the allocation of 
funds made available to carry out this section; 
‘‘(2) a description of how Food and Drug Ad-
ministration staff were utilized to carry out this sec-
tion and, as applicable, any challenges or limitations 
related to staffing; 
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102 
‘‘(3) the number of meetings held or partici-
pated in by the Food and Drug Administration, in-
cluding meetings convened as part of a working 
group described in subparagraph (D) or (G) of sub-
section (a)(2), and the topics of each such meeting; 
and 
‘‘(4) the number of drug products approved or 
licensed, after the date of enactment of this section, 
using an innovative approach to drug product design 
and manufacturing. 
‘‘(d) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $20,000,000 for each fiscal year 2023 through 
2027.’’. 
SEC. 703. IMPROVING THE TREATMENT OF RARE DISEASES 
AND CONDITIONS. 
(a) REPORT ON ORPHAN DRUG PROGRAM.— 
(1) IN GENERAL.—Not later than September 
30, 2026, the Secretary shall submit to the Com-
mittee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report 
summarizing the activities of the Food and Drug 
Administration related to designating drugs under 
section 526 of the Federal Food, Drug, and Cos-
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103 
metic Act (21 U.S.C. 360bb) for a rare disease or 
condition and approving such drugs under section 
505 of such Act (21 U.S.C. 355) or licensing such 
drugs under section 351 of the Public Health Serv-
ice Act (42 U.S.C. 262), including— 
(A) the number of applications for such 
drugs under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) or li-
censing such drugs under section 351 of the 
Public Health Service Act (42 U.S.C. 262) re-
ceived by the Food and Drug Administration, 
the number of such applications accepted and 
rejected for filing, and the number of such ap-
plications pending, approved, and disapproved 
by the Food and Drug Administration; 
(B) a description of trends in drug approv-
als for rare diseases and conditions across re-
view divisions at the Food and Drug Adminis-
tration; 
(C) the extent to which the Food and Drug 
Administration is consulting with external ex-
perts pursuant to section 569(a)(2) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb–8(a)(2)) on topics pertaining to drugs 
for a rare disease or condition, including how 
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104 
and when any such consultation is occurring; 
and 
(D) the Food and Drug Administration’s 
efforts to promote best practices in the develop-
ment of novel treatments for rare diseases, in-
cluding— 
(i) reviewer training on rare disease- 
related policies, methods, and tools; and 
(ii) new regulatory science and coordi-
nated support for patient and stakeholder 
engagement. 
(2) 
PUBLIC
AVAILABILITY.—The 
Secretary 
shall make the report under paragraph (1) available 
to the public, including by posting the report on the 
website of the Food and Drug Administration. 
(3) INFORMATION
DISCLOSURE.—Nothing in 
this subsection shall be construed to authorize the 
disclosure of information that is prohibited from dis-
closure under section 1905 of title 18, United States 
Code, or subject to withholding under paragraph (4) 
of section 552(b), United States Code (commonly re-
ferred to as the ‘‘Freedom of Information Act’’). 
(b) STUDY ON EUROPEAN UNION SAFETY AND EFFI-
CACY REVIEWS OF DRUGS FOR RARE DISEASES AND CON-
DITIONS.— 
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105 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall enter into a contract with an 
appropriate entity to conduct a study on processes 
for evaluating the safety and efficacy of drugs for 
rare diseases or conditions in the United States and 
the European Union, including— 
(A) flexibilities, authorities, or mechanisms 
available to regulators in the United States and 
the European Union specific to rare diseases or 
conditions; 
(B) the consideration and use of supple-
mental data submitted during review processes 
in the United States and the European Union, 
including data associated with open label exten-
sion studies and expanded access programs spe-
cific to rare diseases or conditions; 
(C) an assessment of collaborative efforts 
between United States and European Union 
regulators related to— 
(i) product development programs 
under review; 
(ii) policies under development re-
cently issued; and 
(iii) scientific information related to 
product development or regulation; and 
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(D) recommendations for how Congress 
can support collaborative efforts described in 
subparagraph (C). 
(2) CONSULTATION.—The contract under para-
graph (1) shall provide for consultation with relevant 
stakeholders, including— 
(A) representatives from the Food and 
Drug Administration and the European Medi-
cines Agency; 
(B) rare disease or condition patients; and 
(C) patient groups that— 
(i) represent rare disease or condition 
patients; and 
(ii) have international patient out-
reach. 
(3) REPORT.—The contract under paragraph 
(1) shall provide for, not later than 2 years after the 
date of enactment of this Act— 
(A) the completion of the study under 
paragraph (1); and 
(B) the submission of a report on the re-
sults of such study to the Committee on Energy 
and Commerce of the House of Representatives 
and the Committee on Health, Education, 
Labor, and Pensions of the Senate. 
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(4) PUBLIC AVAILABILITY.—The contract under 
paragraph (1) shall provide for the appropriate enti-
ty referred to in paragraph (1) to make the report 
under paragraph (3) available to the public, includ-
ing by posting the report on the website of the ap-
propriate entity. 
(c) PUBLIC MEETING.— 
(1) IN GENERAL.—Not later than December 31, 
2023, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and 
Drugs, shall convene one or more public meetings to 
solicit input from stakeholders regarding the ap-
proaches described in paragraph (2). 
(2) APPROACHES.—The public meeting or 
meetings under paragraph (1) shall address ap-
proaches to increasing and improving engagement 
with rare disease or condition patients, groups rep-
resenting such patients, rare disease or condition ex-
perts, and experts on small population studies, in 
order to improve the understanding with respect to 
rare diseases or conditions of— 
(A) patient burden; 
(B) treatment options; and 
(C) side effects of treatments, including— 
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(i) comparing the side effects of treat-
ments; and 
(ii) understanding the risks of side ef-
fects relative to the health status of the pa-
tient and the progression of the disease or 
condition. 
(3) PUBLIC DOCKET.—The Secretary of Health 
and Human Services shall establish a public docket 
to receive written comments related to the ap-
proaches addressed during each public meeting 
under paragraph (1). Such public docket shall re-
main open for 60 days following the date of each 
such public meeting. 
(4) REPORTS.—Not later than 180 days after 
each public meeting under paragraph (1), the Com-
missioner of Food and Drugs shall develop and pub-
lish on the website of the Food and Drug Adminis-
tration a report on— 
(A) the approaches discussed at the public 
meeting; and 
(B) any related recommendations. 
(d) CONSULTATION
ON
THE SCIENCE
OF SMALL 
POPULATION STUDIES.—Section 569(a)(2) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8(b)) 
is amended by adding at the end the following: 
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‘‘(C) SMALL POPULATION STUDIES.—The 
external experts on the list maintained pursuant 
to subparagraph (A) may include experts on the 
science of small population studies.’’. 
(e) STUDY
ON SUFFICIENCY
AND USE
OF FDA 
MECHANISMS FOR INCORPORATING THE PATIENT AND 
CLINICIAN PERSPECTIVE IN FDA PROCESSES RELATED 
TO APPLICATIONS CONCERNING DRUGS FOR RARE DIS-
EASES OR CONDITIONS.— 
(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study on the use 
of Food and Drug Administration mechanisms and 
tools to ensure that patient and physician perspec-
tives are considered and incorporated throughout the 
processes of the Food and Drug Administration— 
(A) for approving or licensing under sec-
tion 505 of the Federal Food, Drug, or Cos-
metic Act (21 U.S.C. 355) or section 351 of the 
Public Health Service Act (42 U.S.C. 262) a 
drug designated as a drug for a rare disease or 
condition under section 526 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
360bb); and 
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(B) in making any determination related 
to such a drug’s approval, including assessment 
of the drug’s— 
(i) safety or effectiveness; or 
(ii) postapproval safety monitoring. 
(2) TOPICS.—The study under paragraph (1) 
shall— 
(A) identify and compare the processes 
that the Food and Drug Administration has 
formally put in place and utilized to gather ex-
ternal expertise (including patients, patient 
groups, and physicians) on specific applications 
for diseases or conditions affecting 20,000 or 
fewer patients in the United States and specific 
applications for diseases or conditions affecting 
200,000 or fewer patients in the United States; 
(B) examine tools or mechanisms to im-
prove efforts and initiatives of the Food and 
Drug Administration to collect and consider 
such external expertise with respect to applica-
tions for diseases or conditions affecting 20,000 
or fewer patients in the United States com-
pared to applications for diseases or conditions 
affecting 200,000 or fewer patients in the 
United States throughout the application review 
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and approval or licensure processes, including 
within internal benefit-risk assessments, advi-
sory committee processes, and postapproval 
safety monitoring; and 
(C) examine processes or alternatives to 
address or resolve conflicts of interest that im-
pede the Food and Drug Administration in 
gaining external expert input on rare diseases 
or conditions with a limited set of clinical and 
research experts. 
(3) REPORT.—Not later than 2 years after the 
date of enactment of this Act, the Comptroller Gen-
eral of the United States shall— 
(A) complete the study under paragraph 
(1); 
(B) submit a report on the results of such 
study to the Congress; and 
(C) include in such report recommenda-
tions, if appropriate, for changes to the proc-
esses and authorities of the Food and Drug Ad-
ministration to improve the collection and con-
sideration of external expert opinions of pa-
tients, patient groups, and physicians with ex-
pertise in rare diseases or conditions, including 
any specific recommendations for diseases or 
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conditions affecting 20,000 or fewer patients in 
the United States. 
(f) DEFINITION.—In this section, the term ‘‘rare dis-
ease or condition’’ has the meaning given such term in 
section 526(a)(2) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bb(a)(2)). 
SEC. 704. ANTIFUNGAL RESEARCH AND DEVELOPMENT. 
(a) DRAFT GUIDANCE.—Not later than 3 years after 
the date of the enactment of this Act, the Secretary of 
Health and Human Services, acting through the Commis-
sioner of Food and Drugs, shall issue draft guidance for 
industry for the purposes of assisting entities seeking ap-
proval under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) or licensure under section 
351 of the Public Health Service Act (42 U.S.C. 262) of 
antifungal therapies designed to treat coccidioidomycosis 
(commonly known as Valley Fever). 
(b) FINAL GUIDANCE.—Not later than 18 months 
after the close of the public comment period on the draft 
guidance issued pursuant to subsection (a), the Secretary 
of Health and Human Services, acting through the Com-
missioner of Food and Drugs, shall finalize the draft guid-
ance. 
(c) WORKSHOP.—To assist entities developing pre-
ventive vaccines for fungal infections and coccidioidomy-
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cosis, the Secretary of Health and Human Services shall 
hold a public workshop. 
SEC. 705. ADVANCING QUALIFIED INFECTIOUS DISEASE 
PRODUCT INNOVATION. 
(a) IN GENERAL.—Section 505E of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355f) is amend-
ed— 
(1) in subsection (c)— 
(A) in paragraph (2), by striking ‘‘or’’ at 
the end; 
(B) in paragraph (3), by striking the pe-
riod at the end and inserting ‘‘; or’’; and 
(C) by adding at the end the following: 
‘‘(4) an application pursuant to section 351(a) 
of the Public Health Service Act.’’; 
(2) in subsection (d)(1), by inserting ‘‘of this 
Act or section 351(a) of the Public Health Service 
Act’’ after ‘‘section 505(b)’’; and 
(3) by amending subsection (g) to read as fol-
lows: 
‘‘(g) QUALIFIED INFECTIOUS DISEASE PRODUCT.— 
The term ‘qualified infectious disease product’ means a 
drug, including an antibacterial or antifungal drug or a 
biological product, for human use that— 
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‘‘(1) acts directly on bacteria or fungi or on 
substances produced by such bacteria or fungi; and 
‘‘(2) is intended to treat a serious or life-threat-
ening infection, including such an infection caused 
by— 
‘‘(A) an antibacterial or antifungal resist-
ant pathogen, including novel or emerging in-
fectious pathogens; or 
‘‘(B) qualifying pathogens listed by the 
Secretary under subsection (f).’’. 
(b) PRIORITY REVIEW.—Section 524A(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360n–1(a)) 
is amended by inserting ‘‘of this Act or section 351(a) of 
the Public Health Service Act that requires clinical data 
(other than bioavailability studies) to demonstrate safety 
or effectiveness’’ before the period at the end. 
SEC. 706. ADVANCED MANUFACTURING TECHNOLOGIES 
DESIGNATION PILOT PROGRAM. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 506J (21 U.S.C. 356j) the 
following: 
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‘‘SEC. 506K. ADVANCED MANUFACTURING TECHNOLOGIES 
DESIGNATION PILOT PROGRAM. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this section, the Secretary shall ini-
tiate a pilot program under which persons may request 
designation of an advanced manufacturing technology as 
described in subsection (b). 
‘‘(b) DESIGNATION PROCESS.—The Secretary shall 
establish a process for the designation under this section 
of methods of manufacturing drugs, including biological 
products, and active pharmaceutical ingredients of such 
drugs, as advanced manufacturing technologies. A method 
of manufacturing, or a combination of manufacturing 
methods, is eligible for designation as an advanced manu-
facturing technology if such method or combination of 
methods incorporates a novel technology, or uses an estab-
lished technique or technology in a novel way, that will 
substantially improve the manufacturing process for a 
drug and maintain equivalent or provide superior drug 
quality, including by— 
‘‘(1) reducing development time for a drug 
using the designated manufacturing method; or 
‘‘(2) increasing or maintaining the supply of— 
‘‘(A) a drug that is described in section 
506C(a) and is intended to treat a serious or 
life-threatening condition; or 
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‘‘(B) a drug that is on the drug shortage 
list under section 506E. 
‘‘(c) EVALUATION AND DESIGNATION OF AN AD-
VANCED MANUFACTURING TECHNOLOGY.— 
‘‘(1) SUBMISSION.—A person who requests des-
ignation of a method of manufacturing as an ad-
vanced manufacturing technology under this section 
shall submit to the Secretary data or information 
demonstrating that the method of manufacturing 
meets the criteria described in subsection (b) in a 
particular context of use. The Secretary may facili-
tate the development and review of such data or in-
formation by— 
‘‘(A) providing timely advice to, and inter-
active communication with, such person regard-
ing the development of the method of manufac-
turing; and 
‘‘(B) involving senior managers and experi-
enced staff of the Food and Drug Administra-
tion, as appropriate, in a collaborative, cross- 
disciplinary review of the method of manufac-
turing, as applicable. 
‘‘(2) EVALUATION
AND
DESIGNATION.—Not 
later than 180 calendar days after the receipt of a 
request under paragraph (1), the Secretary shall de-
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termine whether to designate such method of manu-
facturing as an advanced manufacturing technology, 
in a particular context of use, based on the data and 
information submitted under paragraph (1) and the 
criteria described in subsection (b). 
‘‘(d) REVIEW
OF
ADVANCED
MANUFACTURING 
TECHNOLOGIES.—If the Secretary designates a method of 
manufacturing as an advanced manufacturing technology, 
the Secretary shall— 
‘‘(1) expedite the development and review of an 
application submitted under section 505 of this Act 
or section 351 of the Public Health Service Act, in-
cluding supplemental applications, for drugs that are 
manufactured using a designated advanced manufac-
turing technology and could help mitigate or prevent 
a shortage or improve manufacturing processes and 
maintain equivalent or provide superior drug quality, 
as described in subsection (b); and 
‘‘(2) allow the holder of an advanced technology 
designation, or a person authorized by the advanced 
manufacturing technology designation holder, to ref-
erence or rely upon, in an application submitted 
under section 505 of this Act or section 351 of the 
Public Health Service Act, including a supplemental 
application, data and information about the des-
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ignated advanced manufacturing technology for use 
in manufacturing drugs in the same context of use 
for which the designation was granted. 
‘‘(e) IMPLEMENTATION AND EVALUATION OF AD-
VANCED MANUFACTURING TECHNOLOGIES PILOT.— 
‘‘(1) PUBLIC
MEETING.—The Secretary shall 
publish in the Federal Register a notice of a public 
meeting, to be held not later than 180 days after the 
date of enactment of this section, to discuss, and ob-
tain input and recommendations from relevant 
stakeholders regarding— 
‘‘(A) the goals and scope of the pilot pro-
gram, and a suitable framework, procedures, 
and requirements for such program; and 
‘‘(B) ways in which the Food and Drug 
Administration will support the use of advanced 
manufacturing technologies and other innova-
tive manufacturing approaches for drugs. 
‘‘(2) PILOT PROGRAM GUIDANCE.— 
‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) not later than 180 days after the 
public meeting under paragraph (1), issue 
draft guidance regarding the goals and im-
plementation of the pilot program under 
this section; and 
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‘‘(ii) not later than 2 years after the 
date of enactment of this section, issue 
final guidance regarding the implementa-
tion of such program. 
‘‘(B) CONTENT.—The guidance described 
in subparagraph (A) shall address— 
‘‘(i) the process by which a person 
may request a designation under sub-
section (b); 
‘‘(ii) the data and information that a 
person requesting such a designation is re-
quired to submit under subsection (c), and 
how the Secretary intends to evaluate such 
submissions; 
‘‘(iii) the process to expedite the de-
velopment and review of applications under 
subsection (d); and 
‘‘(iv) the criteria described in sub-
section (b) for eligibility for such a des-
ignation. 
‘‘(3) REPORT.—Not later than 3 years after the 
date of enactment of this section and annually there-
after, the Secretary shall publish on the website of 
the Food and Drug Administration and submit to 
the Committee on Health, Education, Labor, and 
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Pensions of the Senate and the Committee on En-
ergy and Commerce of the House of Representatives 
a report containing a description and evaluation of 
the pilot program being conducted under this sec-
tion, including the types of innovative manufacturing 
approaches supported under the program. Such re-
port shall include the following: 
‘‘(A) The number of persons that have re-
quested designations and that have been grant-
ed designations. 
‘‘(B) The number of methods of manufac-
turing that have been the subject of designation 
requests and that have been granted designa-
tions. 
‘‘(C) The average number of calendar days 
for completion of evaluations under subsection 
(c)(2). 
‘‘(D) An analysis of the factors in data 
submissions that result in determinations to 
designate and not to designate after evaluation 
under subsection (c)(2). 
‘‘(E) The number of applications received 
under section 505 of this Act or section 351 of 
the Public Health Service Act, including supple-
mental applications, that have included an ad-
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vanced manufacturing technology designated 
under this section, and the number of such ap-
plications approved. 
‘‘(f) SUNSET.—The Secretary— 
‘‘(1) may not consider any requests for designa-
tion submitted under subsection (c) after October 1, 
2029; and 
‘‘(2) may continue all activities under this sec-
tion with respect to advanced manufacturing tech-
nologies that were designated pursuant to subsection 
(d) prior to such date, if the Secretary determines 
such activities are in the interest of the public 
health.’’. 
SEC. 707. PUBLIC WORKSHOP ON CELL AND GENE THERA-
PIES. 
Not later than 3 years after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services, acting through the Commissioner of Food and 
Drugs, shall convene a public workshop with relevant 
stakeholders to discuss best practices on generating sci-
entific data necessary to further facilitate the development 
of human cell-, tissue-, and cellular-based medical prod-
ucts, and the latest scientific information about such prod-
ucts. 
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SEC. 708. REAUTHORIZATION OF BEST PHARMACEUTICALS 
FOR CHILDREN. 
Section 409I(d)(1) of the Public Health Service Act 
(42 U.S.C. 284m) is amended by striking ‘‘2018 through 
2022’’ and inserting ‘‘2023 through 2027’’. 
SEC. 709. REAUTHORIZATION FOR HUMANITARIAN DEVICE 
EXEMPTION AND DEMONSTRATION GRANTS 
FOR IMPROVING PEDIATRIC AVAILABILITY. 
(a) HUMANITARIAN DEVICE EXEMPTION.—Section 
520(m)(6)(A)(iv) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by 
striking ‘‘2022’’ and inserting ‘‘2027’’. 
(b) PEDIATRIC MEDICAL DEVICE SAFETY AND IM-
PROVEMENT ACT.—Section 305(e) of the Pediatric Med-
ical Device Safety and Improvement Act (Public Law 
110–85) is amended by striking ‘‘2018 through 2022’’ and 
inserting ‘‘2023 through 2027’’. 
SEC. 710. REAUTHORIZATION OF PROVISION RELATED TO 
EXCLUSIVITY 
OF 
CERTAIN 
DRUGS 
CON-
TAINING SINGLE ENANTIOMERS. 
Section 505(u)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(u)(4)) is amended by strik-
ing ‘‘2022’’ and inserting ‘‘2027’’. 
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SEC. 711. REAUTHORIZATION OF THE CRITICAL PATH PUB-
LIC-PRIVATE PARTNERSHIP PROGRAM. 
Section 566(f) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb–5(f)) is amended by striking 
‘‘$6,000,000 for each of fiscal years 2018 through 2022’’ 
and inserting ‘‘$10,000,000 for each of fiscal years 2023 
through 2027’’. 
SEC. 712. REAUTHORIZATION OF ORPHAN DRUG GRANTS. 
Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) 
is amended— 
(1) in subsection (a)— 
(A) by striking ‘‘and (3)’’ and inserting 
‘‘(3)’’; and 
(B) by inserting before the period at the 
end the following: ‘‘, and (4) developing regu-
latory science pertaining to the chemistry, man-
ufacturing, regulatory approval of, and controls 
of individualized medical products to treat indi-
viduals with rare diseases or conditions’’; and 
(2) in subsection (c), by striking ‘‘2018 through 
2022’’ and inserting ‘‘2023 through 2027’’. 
Subtitle B—Inspections 
SEC. 721. FACTORY INSPECTION. 
(a) IN GENERAL.—Section 704(a)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is 
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amended by striking ‘‘restricted devices’’ each place it ap-
pears and inserting ‘‘devices’’. 
(b) RECORDS OR OTHER INFORMATION.— 
(1) ESTABLISHMENTS.—Section 704(a)(4)(A) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 374(a)(4)(A)) is amended— 
(A) by striking ‘‘an establishment that is 
engaged in the manufacture, preparation, prop-
agation, compounding, or processing of a drug’’ 
and inserting ‘‘an establishment that is engaged 
in the manufacture, preparation, propagation, 
compounding, or processing of a drug or device, 
or that is subject to inspection under paragraph 
5(C),’’; and 
(B) by inserting after ‘‘a sufficient descrip-
tion of the records requested’’ the following: 
‘‘and a rationale for requesting such records or 
other information in advance of, or in lieu of, 
an inspection’’. 
(2) GUIDANCE.— 
(A) 
IN
GENERAL.—The 
Secretary 
of 
Health and Human Services shall issue guid-
ance describing— 
(i) circumstances in which the Sec-
retary intends to issue requests for records 
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or other information in advance of, or in 
lieu of, an inspection under section 
704(a)(4) of the Federal Food, Drug, and 
Cosmetic Act, as amended by paragraph 
(1); 
(ii) processes for responding to such 
requests electronically or in physical form; 
and 
(iii) factors the Secretary intends to 
consider 
in 
evaluating 
whether 
such 
records and other information are provided 
within a reasonable timeframe, within rea-
sonable limits, and in a reasonable man-
ner, accounting for resource and other lim-
itations that may exist, including for small 
businesses. 
(B) TIMING.—The Secretary of Health 
and Human Services shall— 
(i) not later than 1 year after the date 
of enactment of this Act, issue draft guid-
ance under subparagraph (A); and 
(ii) not later than 1 year after the 
close of the comment period for such draft 
guidance, issue final guidance under sub-
paragraph (A). 
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(c) BIORESEARCH MONITORING INSPECTIONS.— 
(1) IN GENERAL.—Section 704(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
374(a)) is amended by adding at the end the fol-
lowing: 
‘‘(5) BIORESEARCH MONITORING INSPECTIONS.— 
‘‘(A) IN GENERAL.—The Secretary may, to en-
sure the accuracy and reliability of studies and 
records or other information described in subpara-
graph (B) and to assess compliance with applicable 
requirements under this Act or the Public Health 
Service Act, enter sites and facilities specified in 
subparagraph (C) in order to inspect such records or 
other information. 
‘‘(B) INFORMATION
SUBJECT
TO
INSPEC-
TION.—An inspection under this paragraph shall ex-
tend to all records and other information related to 
the studies and submissions described in subpara-
graph (E), including records and information related 
to the conduct, results, and analyses of, and the pro-
tection of human and animal trial participants par-
ticipating in, such studies. 
‘‘(C) SITES AND FACILITIES SUBJECT TO IN-
SPECTION.— 
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‘‘(i) SITES AND FACILITIES DESCRIBED.— 
The sites and facilities subject to inspection by 
the Secretary under this paragraph are those 
owned or operated by a person described in 
clause (ii) and which are (or were) utilized by 
such person in connection with— 
‘‘(I) developing an application or other 
submission to the Secretary under this Act 
or the Public Health Service Act related to 
marketing authorization for a product de-
scribed in paragraph (1); 
‘‘(II) preparing, conducting, or ana-
lyzing the results of a study described in 
subparagraph (E); or 
‘‘(III) holding any records or other in-
formation described in subparagraph (B). 
‘‘(ii) PERSONS DESCRIBED.—A person de-
scribed in this clause is— 
‘‘(I) the sponsor of an application or 
submission specified in clause (i)(I); 
‘‘(II) a person engaged in any activity 
described in clause (i) on behalf of such a 
sponsor, through a contract, grant, or 
other business arrangement with such 
sponsor; 
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‘‘(III) an institutional review board, 
or other individual or entity, engaged by 
contract, grant, or other business arrange-
ment with a nonsponsor in preparing, col-
lecting, or analyzing records or other infor-
mation described in subparagraph (B); or 
‘‘(IV) any person not otherwise de-
scribed in this clause that conducts, or has 
conducted, a study described in subpara-
graph (E) yielding records or other infor-
mation described in subparagraph (B). 
‘‘(D) CONDITIONS OF INSPECTION.— 
‘‘(i) ACCESS TO INFORMATION SUBJECT TO 
INSPECTION.—Subject to clause (ii), an entity 
that owns or operates any site or facility sub-
ject to inspection under this paragraph shall 
provide the Secretary with access to records 
and other information described in subpara-
graph (B) that is held by or under the control 
of such entity, including— 
‘‘(I) permitting the Secretary to 
record or copy such information for pur-
poses of this paragraph; 
‘‘(II) providing the Secretary with ac-
cess to any electronic information system 
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129 
utilized by such entity to hold, process, 
analyze, or transfer any records or other 
information described in subparagraph 
(B); and 
‘‘(III) permitting the Secretary to in-
spect the facilities, equipment, written pro-
cedures, processes, and conditions through 
which records or other information de-
scribed in subparagraph (B) is or was gen-
erated, held, processed, analyzed, or trans-
ferred. 
‘‘(ii) NO
EFFECT
ON
APPLICABILITY
OF 
PROVISIONS FOR PROTECTION OF PROPRIETARY 
INFORMATION OR TRADE SECRETS.—Nothing in 
clause (i) shall negate, supersede, or otherwise 
affect the applicability of provisions, under this 
or any other Act, preventing or limiting the dis-
closure of confidential commercial information 
or other information considered proprietary or 
trade secret. 
‘‘(iii) 
REASONABLENESS
OF
INSPEC-
TIONS.—An inspection under this paragraph 
shall be conducted at reasonable times and 
within reasonable limits and in a reasonable 
manner. 
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130 
‘‘(E) 
STUDIES
AND
SUBMISSIONS
DE-
SCRIBED.—The studies and submissions described in 
this subparagraph are each of the following: 
‘‘(i) Clinical and nonclinical studies sub-
mitted to the Secretary in support of, or other-
wise related to, applications and other submis-
sions to the Secretary under this Act or the 
Public Health Service Act for marketing au-
thorization of a product described in paragraph 
(1). 
‘‘(ii) Postmarket safety activities conducted 
under this Act or the Public Health Service 
Act. 
‘‘(iii) Any other clinical investigation of— 
‘‘(I) a drug subject to section 505 or 
512 of this Act or section 351 of the Pub-
lic Health Service Act; or 
‘‘(II) a device subject to section 
520(g). 
‘‘(iv) Any other submissions made under 
this Act or the Public Health Service Act with 
respect to which the Secretary determines an 
inspection under this paragraph is warranted in 
the interest of public health. 
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131 
‘‘(F) CLARIFICATION.—This paragraph clarifies 
the authority of the Secretary to conduct inspections 
of the type described in this paragraph and shall not 
be construed as a basis for inferring that, prior to 
the date of enactment of this paragraph, the Sec-
retary lacked the authority to conduct such inspec-
tions, including under this Act or the Public Health 
Service Act.’’. 
(2) REVIEW
OF
PROCESSES
AND
PRACTICES; 
GUIDANCE FOR INDUSTRY.— 
(A) 
IN
GENERAL.—The 
Secretary 
of 
Health and Human Services shall— 
(i) review processes and practices in 
effect as of the date of enactment of this 
Act applicable to inspections of foreign and 
domestic sites and facilities described in 
subparagraph (C)(i) of section 704(a)(5) of 
the Federal Food, Drug, and Cosmetic 
Act, as added by paragraph (1); and 
(ii) evaluate whether any updates are 
needed to facilitate the consistency of such 
processes and practices. 
(B) GUIDANCE.— 
(i) IN
GENERAL.—The Secretary of 
Health and Human Services shall issue 
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guidance describing the processes and 
practices applicable to inspections of sites 
and facilities described in subparagraph 
(C)(i) of section 704(a)(5) of the Federal 
Food, Drug, and Cosmetic Act, as added 
by paragraph (1), including with respect to 
the types of records and information re-
quired to be provided, best practices for 
communication between the Food and 
Drug Administration and industry in ad-
vance of or during an inspection or request 
for records or other information, and other 
inspections-related conduct, to the extent 
not specified in existing publicly available 
Food and Drug Administration guides and 
manuals for such inspections. 
(ii) TIMING.—The Secretary of Health 
and Human Services shall— 
(I) not later than 18 months 
after the date of enactment of this 
Act, issue draft guidance under clause 
(i); and 
(II) not later than 1 year after 
the close of the public comment period 
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for such draft guidance, issue final 
guidance under clause (i). 
SEC. 722. USES OF CERTAIN EVIDENCE. 
Section 703 of the of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 373) is amended by adding at 
the end the following: 
‘‘(c) APPLICABILITY.—The limitations on the Sec-
retary’s use of evidence obtained under this section, or any 
evidence which is directly or indirectly derived from such 
evidence, in a criminal prosecution of the person from 
whom such evidence was obtained shall not apply to evi-
dence obtained under authorities other than this section, 
unless such limitations are specifically incorporated by ref-
erence in such other authorities.’’. 
SEC. 723. IMPROVING FDA INSPECTIONS. 
(a) RISK FACTORS FOR ESTABLISHMENTS.—Section 
510(h)(4) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360(h)(4)) is amended— 
(1) by redesignating subparagraph (F) as sub-
paragraph (G); and 
(2) by inserting after subparagraph (E) the fol-
lowing: 
‘‘(F) The compliance history of establish-
ments in the country or region in which the es-
tablishment is located that are subject to regu-
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134 
lation under this Act, including the history of 
violations related to products exported from 
such country or region that are subject to such 
regulation.’’. 
(b) USE OF RECORDS.—Section 704(a)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) 
is amended— 
(1) by redesignating subparagraph (C) as sub-
paragraph (D); and 
(2) by inserting after subparagraph (B) the fol-
lowing: 
‘‘(C) The Secretary may rely on any records or other 
information that the Secretary may inspect under this sec-
tion to satisfy requirements that may pertain to a 
preapproval or risk-based surveillance inspection, or to re-
solve deficiencies found in such inspections, if applicable 
and appropriate.’’. 
(c) RECOGNITION OF FOREIGN GOVERNMENT IN-
SPECTIONS.—Section 809 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 384e) is amended— 
(1) 
in 
subsection 
(a)(1), 
by 
inserting 
‘‘preapproval or’’ before ‘‘risk-based inspections’’; 
and 
(2) by adding at the end the following: 
‘‘(c) PERIODIC REVIEW.— 
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135 
‘‘(1) IN GENERAL.—Beginning not later than 1 
year after the date of the enactment of the Food 
and Drug Amendments of 2022 the Secretary shall 
periodically assess whether additional arrangements 
and agreements with a foreign government or an 
agency of a foreign government, as allowed under 
this section, are appropriate. 
‘‘(2) REPORTS TO CONGRESS.—Beginning not 
later than 4 years after the date of the enactment 
of the Food and Drug Amendments of 2022, and 
every 4 years thereafter, the Secretary shall submit 
to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on 
Health, Education, Labor, and Pensions a report de-
scribing the findings and conclusions of each review 
conducted under paragraph (1).’’. 
SEC. 724. GAO REPORT ON INSPECTIONS OF FOREIGN ES-
TABLISHMENTS MANUFACTURING DRUGS. 
(a) IN GENERAL.—Not later than 18 months after 
the date of the enactment of this Act, the Comptroller 
General of the United States shall submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor and Pensions of the Senate a report on inspections 
conducted by— 
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(1) the Secretary of Health and Human Serv-
ices (in this section referred to as the ‘‘Secretary’’) 
of foreign establishments pursuant to subsections (h) 
and (i) of section 510 and 704 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360, 374); or 
(2) a foreign government or an agency of a for-
eign government pursuant to section 809 of such 
Act (21 U.S.C. 384e). 
(b) CONTENTS.—The report conducted under sub-
section (a) shall include— 
(1) what alternative tools, including remote in-
spections or remote evaluations, other countries are 
utilizing to facilitate inspections of foreign establish-
ments; 
(2) how frequently trusted foreign regulators 
conduct inspections of foreign facilities that could be 
useful to the Food and Drug Administration to re-
view in lieu of its own inspections; 
(3) how frequently and under what cir-
cumstances, including for what types of inspections, 
the Secretary utilizes existing agreements or ar-
rangements under section 809 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 384e) and 
whether the use of such agreements could be appro-
priately expanded; 
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(4) whether the Secretary has accepted reports 
of inspections of facilities in China and India con-
ducted by entities with which they have entered into 
such an agreement or arrangement; 
(5) what additional foreign governments or 
agencies of foreign governments the Secretary has 
considered entering into a mutual recognition agree-
ment with and, if applicable, reasons why the Sec-
retary declined to enter into a mutual recognition 
agreement with such foreign governments or agen-
cies; 
(6) what tools, if any, the Secretary used to fa-
cilitate inspections of domestic facilities that could 
also be effectively utilized to appropriately inspect 
foreign facilities; 
(7) what steps the Secretary has taken to iden-
tify and evaluate tools and strategies the Secretary 
may use to continue oversight with respect to inspec-
tions when in-person inspections are disrupted; 
(8) how the Secretary is considering incor-
porating alternative tools into the inspection activi-
ties conducted pursuant to the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321 et seq.); and 
(9) what steps the Secretary has taken to iden-
tify and evaluate how the Secretary may use alter-
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138 
native tools to address workforce shortages to carry 
out such inspection activities. 
SEC. 725. UNANNOUNCED FOREIGN FACILITY INSPECTIONS 
PILOT PROGRAM. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall conduct a pilot program under which the 
Secretary increases the conduct of unannounced surveil-
lance inspections of foreign human drug establishments 
and evaluates the differences between such inspections of 
domestic and foreign human drug establishments, includ-
ing the impact of announcing inspections to persons who 
own or operate foreign human drug establishments in ad-
vance of an inspection. Such pilot program shall evalu-
ate— 
(1) differences in the number and type of viola-
tions of section 501(a)(2)(B) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) 
identified during unannounced and announced in-
spections of foreign human drug establishments and 
any other significant differences between each type 
of inspection; 
(2) costs and benefits associated with con-
ducting announced and unannounced inspections of 
foreign human drug establishments; 
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(3) barriers to conducting unannounced inspec-
tions of foreign human drug establishments and any 
challenges to achieving parity between domestic and 
foreign human drug establishment inspections; and 
(4) approaches for mitigating any negative ef-
fects of conducting announced inspections of foreign 
human drug establishments. 
(b) PILOT PROGRAM SCOPE.—The inspections evalu-
ated under the pilot program under this section shall be 
routine surveillance inspections and shall not include in-
spections conducted as part of the Secretary’s evaluation 
of a request for approval to market a drug submitted 
under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) or the Public Health Service Act (42 
U.S.C. 201 et seq.). 
(c) PILOT PROGRAM INITIATION.—The Secretary 
shall initiate the pilot program under this section not later 
than 180 days after the date of enactment of this Act. 
(d) REPORT.—The Secretary shall, not later than 
180 days following the completion of the pilot program 
under this section, make available on the website of the 
Food and Drug Administration a final report on the pilot 
program under this section, including— 
(1) findings and any associated recommenda-
tions with respect to the evaluation under subsection 
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(a), including any recommendations to address iden-
tified barriers to conducting unannounced inspec-
tions of foreign human drug establishments; 
(2) findings and any associated recommenda-
tions regarding how the Secretary may achieve par-
ity between domestic and foreign human drug in-
spections; and 
(3) the number of unannounced inspections 
during the pilot program that would not be unan-
nounced under existing practices. 
SEC. 726. REAUTHORIZATION OF INSPECTION PROGRAM. 
Section 704(g)(11) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by strik-
ing ‘‘2022’’ and inserting ‘‘2027’’. 
SEC. 727. ENHANCING INTRA-AGENCY COORDINATION AND 
PUBLIC HEALTH ASSESSMENT WITH REGARD 
TO COMPLIANCE ACTIVITIES. 
(a) COORDINATION.—Section 506D of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356d) is 
amended by adding at the end the following: 
‘‘(g) COORDINATION.—The Secretary shall ensure 
timely and effective internal coordination and alignment 
among the field investigators of the Food and Drug Ad-
ministration and the staff of the Center for Drug Evalua-
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tion and Research’s Office of Compliance and Drug Short-
age Program regarding— 
‘‘(1) the reviews of reports shared pursuant to 
section 704(b)(2); and 
‘‘(2) any feedback or corrective or preventive 
actions in response to such reports.’’. 
(b) REPORTING.— 
(1) IN GENERAL.—Section 506C–1(a)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356c–1(a)(2)) is amended to read as follows: 
‘‘(2)(A) describes the communication between 
the field investigators of the Food and Drug Admin-
istration and the staff of the Center for Drug Eval-
uation and Research’s Office of Compliance and 
Drug Shortage Program, including the Food and 
Drug Administration’s procedures for enabling and 
ensuring such communication; 
‘‘(B) provides the number of reports described 
in section 704(b)(2) that were required to be sent to 
the appropriate offices of the Food and Drug Ad-
ministration and the number of such reports that 
were sent; and 
‘‘(C) describes the coordination and alignment 
activities undertaken pursuant to section 506D(g);’’. 
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142 
(2) APPLICABILITY.—The amendment made by 
paragraph (1) shall apply with respect to reports 
submitted on or after March 31, 2023. 
SEC. 728. REPORTING OF MUTUAL RECOGNITION AGREE-
MENTS FOR INSPECTIONS AND REVIEW AC-
TIVITIES. 
(a) IN GENERAL.—Not later than December 31, 
2022, and annually thereafter, the Secretary of Health 
and Human Services (referred to in this section as the 
‘‘Secretary’’) shall publish a report on the public website 
of the Food and Drug Administration on the utilization 
of agreements entered into pursuant to section 809 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e) 
or otherwise entered into by the Secretary in the previous 
fiscal year to recognize inspections between drug regu-
latory authorities across countries and international re-
gions with analogous review criteria to the Food and Drug 
Administration, such as the Pharmaceutical Inspection 
Co-Operation Scheme, the Mutual Recognition Agreement 
with the European Union, and the Australia-Canada- 
Singapore-Switzerland Consortium. 
(b) CONTENT.—The report under subsection (a) shall 
include each of the following: 
(1) The total number of establishments that are 
registered under section 510(i) of the Federal Food, 
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143 
Drug, and Cosmetic Act (21 U.S.C. 360(i)), and the 
number of such establishments in each region of in-
terest. 
(2) The total number of inspections conducted 
at establishments described in paragraph (1), 
disaggregated by inspections conducted— 
(A) pursuant to an agreement or other rec-
ognition described in subsection (a); and 
(B) by employees or contractors of the 
Food and Drug Administration. 
(3) Of the inspections described in paragraph 
(2), the total number of inspections in each region 
of interest. 
(4) Of the inspections in each region of interest 
reported pursuant to paragraph (3), the number of 
inspections in each FDA inspection category. 
(5) Of the number of inspections reported 
under each of paragraphs (3) and (4)— 
(A) the number of inspections which have 
been conducted pursuant to an agreement or 
other recognition described in subsection (a); 
and 
(B) the number of inspections which have 
been conducted by employees or contractors of 
the Food and Drug Administration. 
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(c) DEFINITIONS.—In this subsection: 
(1) FDA INSPECTION
CATEGORY.—The term 
‘‘FDA inspection category’’ means the following in-
spection categories: 
(A) Inspections to support approvals of 
changes to the manufacturing process of drugs 
approved under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
or section 351 of the Public Health Service Act 
(42 U.S.C. 262). 
(B) Surveillance inspections. 
(C) For-cause inspections. 
(2) REGION OF INTEREST.—The term ‘‘region 
of interest’’ means China, India, the European 
Union, and any other geographic region as the Sec-
retary determines appropriate. 
SEC. 729. ENHANCING TRANSPARENCY OF DRUG FACILITY 
INSPECTION TIMELINES. 
Section 902 of the FDA Reauthorization Act of 2017 
(21 U.S.C. 355 note) is amended to read as follows: 
‘‘SEC. 902. ANNUAL REPORT ON INSPECTIONS. 
‘‘Not later than 120 days after the end of each fiscal 
year, the Secretary of Health and Human Services shall 
post on the public website of the Food and Drug Adminis-
tration information related to inspections of facilities, in-
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cluding inspections that are necessary for approval of a 
drug under subsection (c) or (j) of section 505 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355), ap-
proval of a device under section 515 of such Act (21 
U.S.C. 360e), or clearance of a device under section 
510(k) of such Act (21 U.S.C. 360(k)) that were con-
ducted during the previous fiscal year. Such information 
shall include the following: 
‘‘(1) The median time following a request from 
staff of the Food and Drug Administration review-
ing an application or report to the beginning of the 
inspection, including— 
‘‘(A) the median time for drugs described 
in section 505(j)(11)(A)(i) of the Federal Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
355(j)(11)(A)(i)); 
‘‘(B) the median time for drugs described 
in section 506C(a) of such Act (21 U.S.C. 
356c(a)) only; and 
‘‘(C) the median time for drugs on the 
drug shortage list in effect under section 506E 
of such Act (21 U.S.C. 356f). 
‘‘(2) The median time from the issuance of a 
report pursuant to section 704(b) of such Act (21 
U.S.C. 374(b)) to the sending of a warning letter, 
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issuance of an import alert, or holding of a regu-
latory meeting for inspections for which the Sec-
retary concluded that regulatory or enforcement ac-
tion was indicated, including the median time for 
each category of drugs listed in subparagraphs (A) 
through (C) of paragraph (1). 
‘‘(3) The median time from the sending of a 
warning letter, issuance of an import alert, or hold-
ing of a regulatory meeting to resolution of the ac-
tions indicated to address the conditions or practices 
observed during an inspection. 
‘‘(4) The number of facilities that were unable 
to implement requested corrective or preventive ac-
tions following a report pursuant to such section 
704(b), resulting in a withhold recommendation, in-
cluding the number of such times for each category 
of drugs listed in subparagraphs (A) through (C) of 
paragraph (1).’’. 
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147 
TITLE 
VIII—TRANSPARENCY, 
PROGRAM 
INTEGRITY, 
AND 
REGULATORY 
IMPROVE-
MENTS 
SEC. 801. PROMPT REPORTS OF MARKETING STATUS BY 
HOLDERS OF APPROVED APPLICATIONS FOR 
BIOLOGICAL PRODUCTS. 
(a) IN GENERAL.—Section 506I of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356i) is amended— 
(1) in subsection (a)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘The holder of an application ap-
proved under subsection (c) or (j) of section 
505’’ and inserting ‘‘The holder of an applica-
tion approved under subsection (c) or (j) of sec-
tion 505 of this Act or subsection (a) or (k) of 
section 351 of the Public Health Service Act’’; 
(B) in paragraph (2), by striking ‘‘estab-
lished name’’ and inserting ‘‘established name 
(for biological products, by proper name)’’; and 
(C) in paragraph (3), by striking ‘‘or ab-
breviated application number’’ and inserting ‘‘, 
abbreviated application number, or biologics li-
cense application number’’; and 
(2) in subsection (b)— 
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(A) in the matter preceding paragraph (1), 
by striking ‘‘The holder of an application ap-
proved under subsection (c) or (j)’’ and insert-
ing ‘‘The holder of an application approved 
under subsection (c) or (j) of section 505 of 
this Act or subsection (a) or (k) of section 351 
of the Public Health Service Act’’; 
(B) in paragraph (1), by striking ‘‘estab-
lished name’’ and inserting ‘‘established name 
(for biological products, by proper name)’’; and 
(C) in paragraph (2), by striking ‘‘or ab-
breviated application number’’ and inserting ‘‘, 
abbreviated application number, or biologics li-
cense application number’’. 
(b) ADDITIONAL ONE-TIME REPORT.—Subsection 
(c) of section 506I of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 356i) is amended to read as follows: 
‘‘(c) ADDITIONAL ONE-TIME REPORT.—Within 180 
days of the date of enactment of the Food and Drug 
Amendments of 2022, all holders of applications approved 
under subsection (a) or (k) of section 351 of the Public 
Health Service Act shall review the information in the list 
published under section 351(k)(9)(A) and shall submit a 
written notice to the Secretary— 
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‘‘(1) stating that all of the application holder’s 
biological products in the list published under sec-
tion 351(k)(9)(a) that are not listed as discontinued 
are available for sale; or 
‘‘(2) including the information required pursu-
ant to subsection (a) or (b), as applicable, for each 
of the application holder’s biological products that 
are in the list published under section 351(k)(9)(a) 
and not listed as discontinued, but have been discon-
tinued from sale or never have been available for 
sale.’’. 
(c) PURPLE BOOK.—Section 506I of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amend-
ed— 
(1) by striking subsection (d) and inserting the 
following: 
‘‘(d) FAILURE TO MEET REQUIREMENTS.—If a hold-
er of an approved application fails to submit the informa-
tion required under subsection (a), (b), or (c), the Sec-
retary may— 
‘‘(1) move the application holder’s drugs from 
the active section of the list published under section 
505(j)(7)(A) to the discontinued section of the list, 
except that the Secretary shall remove from the list 
in accordance with section 505(j)(7)(C) drugs the 
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Secretary determines have been withdrawn from sale 
for reasons of safety of effectiveness; and 
‘‘(2) identify the application holder’s biological 
products as discontinued in the list published under 
section 351(k)(9)(A) of the Public Health Service 
Act, except that the Secretary shall remove from the 
list in accordance with section 351(k)(9)(B) of such 
Act biological products for which the license has 
been revoked or suspended for reasons of safety, pu-
rity, or potency.’’; and 
(2) in subsection (e)— 
(A) by inserting after the first sentence the 
following: ‘‘The Secretary shall update the list 
published under section 351(k)(9)(A) of the 
Public Health Service Act based on information 
provided under subsections (a), (b), and (c) by 
identifying as discontinued biological products 
that are not available for sale, except that bio-
logical products for which the license has been 
revoked or suspended for safety, purity, or po-
tency reasons shall be removed from the list in 
accordance with section 351(k)(9)(B) of the 
Public Health Service Act.’’; 
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(B) by striking ‘‘monthly updates to the 
list’’ and inserting ‘‘monthly updates to the lists 
referred to in the preceding sentences’’; and 
(C) by striking ‘‘and shall update the list 
based on’’ and inserting ‘‘and shall update such 
lists based on’’. 
(d) TECHNICAL CORRECTIONS.—Section 506I(e) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356i(e)) is amended— 
(1) by striking ‘‘subsection 505(j)(7)(A)’’ and 
inserting ‘‘section 505(j)(7)(A)’’; and 
(2) by striking ‘‘subsection 505(j)(7)(C)’’ and 
inserting ‘‘section 505(j)(7)(C)’’. 
SEC. 802. ENCOURAGING BLOOD DONATION. 
Section 3003 of the 21st Century Cures Act (21 
U.S.C. 360bbb–8c note) is amended to read as follows: 
‘‘SEC. 3003. STREAMLINING PATIENT AND BLOOD DONOR 
INPUT. 
‘‘Chapter 35 of title 44, United States Code, shall 
not apply to the collection of information to which a re-
sponse is voluntary, to solicit— 
‘‘(1) the views and perspectives of patients 
under section 569C of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb–8c) (as amended 
by section 3001) or section 3002; or 
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‘‘(2) information from blood donors or potential 
blood donors to support the development of rec-
ommendations by the Secretary of Health and 
Human Services concerning blood donation.’’. 
SEC. 803. REGULATION OF CERTAIN PRODUCTS AS DRUGS. 
Section 503 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 353) is amended by adding at the end the 
following: 
‘‘(h)(1) Any contrast agent, radioactive drug, or OTC 
monograph drug shall be deemed to be a drug under sec-
tion 201(g) and not a device under section 201(h). 
‘‘(2) For purposes of this subsection: 
‘‘(A) The term ‘contrast agent’ means a drug 
that is intended for use in conjunction with an appli-
cable medical imaging device, and— 
‘‘(i) is a diagnostic radiopharmaceutical, as 
defined in sections 315.2 and 601.31 of title 
21, Code of Federal Regulations (or any suc-
cessor regulations); or 
‘‘(ii) is a diagnostic agent that improves 
the visualization of structure or function within 
the body by increasing the relative difference in 
signal intensity within the target tissue, struc-
ture, or fluid. 
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‘‘(B) The term ‘radioactive drug’ has the mean-
ing given such term in section 310.3(n) of title 21, 
Code of Federal Regulations (or any successor regu-
lations), except that such term does not include— 
‘‘(i) an implant or article similar to an im-
plant; 
‘‘(ii) an article that applies radiation from 
outside of the body; or 
‘‘(iii) the radiation source of an article de-
scribed in (i) or (ii). 
‘‘(C) The term ‘OTC monograph drug’ has the 
meaning given such term in section 744L. 
‘‘(3) Nothing in this subsection shall be construed as 
allowing for the classification a product as a drug (as de-
fined in section 201(g)) if such product— 
‘‘(A) is not described in paragraph (1); and 
‘‘(B) meets the definition of a device under sec-
tion 201(h).’’. 
SEC. 804. POSTAPPROVAL STUDIES AND PROGRAM INTEG-
RITY FOR ACCELERATED APPROVAL DRUGS. 
(a) IN GENERAL.—Section 506(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) is 
amended— 
(1) by striking paragraph (2) and inserting the 
following: 
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‘‘(2) LIMITATION.— 
‘‘(A) IN GENERAL.—Approval of a product 
under this subsection may be subject to 1 or 
both of the following requirements: 
‘‘(i) That the sponsor conduct an ap-
propriate postapproval study or studies 
(which may be augmented or supported by 
real world evidence) to verify and describe 
the predicted effect on irreversible mor-
bidity or mortality or other clinical benefit. 
‘‘(ii) That the sponsor submit copies 
of all promotional materials related to the 
product during the preapproval review pe-
riod and, following approval and for such 
period thereafter as the Secretary deter-
mines to be appropriate, at least 30 days 
prior to dissemination of the materials. 
‘‘(B) STUDIES
NOT
REQUIRED.—If the 
Secretary does not require that the sponsor of 
a product approved under accelerated approval 
conduct a postapproval study under this para-
graph, the Secretary shall publish on the 
website of the Food and Drug Administration 
the rationale for why such study is not appro-
priate or necessary. 
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‘‘(C) 
POSTAPPROVAL
STUDY
CONDI-
TIONS.—Not later than the time of approval of 
a product under accelerated approval, the Sec-
retary shall specify the conditions for a post-
approval study or studies required to be con-
ducted under this paragraph with respect to 
such product, which may include enrollment 
targets, the study protocol, and milestones, in-
cluding the target date of study completion. 
‘‘(D) 
STUDIES
BEGUN
BEFORE
AP-
PROVAL.—The Secretary may require such 
study or studies to be underway prior to ap-
proval.’’; and 
(2) by striking paragraph (3) and inserting the 
following: 
‘‘(3) 
EXPEDITED
WITHDRAWAL
OF
AP-
PROVAL.— 
‘‘(A) IN
GENERAL.—The Secretary may 
withdraw approval of a product approved under 
accelerated approval using expedited procedures 
described in subparagraph (B), if— 
‘‘(i) the sponsor fails to conduct any 
required postapproval study of the product 
with due diligence, including with respect 
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to conditions specified by the Secretary 
under paragraph (2)(C); 
‘‘(ii) a study required to verify and 
describe the predicted effect on irreversible 
morbidity or mortality or other clinical 
benefit of the product fails to verify and 
describe such effect or benefit; 
‘‘(iii) other evidence demonstrates 
that the product is not shown to be safe or 
effective under the conditions of use; or 
‘‘(iv) the sponsor disseminates false or 
misleading promotional materials with re-
spect to the product. 
‘‘(B) 
EXPEDITED
PROCEDURES
DE-
SCRIBED.—Expedited procedures described in 
this subparagraph shall consist of, prior to the 
withdrawal of accelerated approval— 
‘‘(i) providing the sponsor with— 
‘‘(I) due notice; 
‘‘(II) an explanation for the pro-
posed withdrawal; 
‘‘(III) an opportunity for a meet-
ing with the Commissioner of Food 
and Drugs or the Commissioner’s des-
ignee; and 
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‘‘(IV) an opportunity for written 
appeal to— 
‘‘(aa) the Commissioner of 
Food and Drugs; or 
‘‘(bb) a designee of the 
Commissioner who has not par-
ticipated in the proposed with-
drawal of approval (other than a 
meeting pursuant to subclause 
(III)) and is not a subordinate of 
an individual (other than the 
Commissioner) who participated 
in such proposed withdrawal; 
‘‘(ii) providing an opportunity for 
public comment on the notice proposing to 
withdraw approval; 
‘‘(iii) the publication of a summary of 
the public comments received, and the Sec-
retary’s response to such comments, on the 
website of the Food and Drug Administra-
tion; and 
‘‘(iv) convening and consulting an ad-
visory committee on issues related to the 
proposed withdrawal, if requested by the 
sponsor and if no such advisory committee 
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has previously advised the Secretary on 
such issues with respect to the withdrawal 
of the product prior to the sponsor’s re-
quest. 
‘‘(4) LABELING.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the label for a product approved 
under accelerated approval shall include— 
‘‘(i) a statement indicating that the 
product was approved under accelerated 
approval; 
‘‘(ii) a statement indicating that con-
tinued approval of the product is subject to 
postmarketing studies to verify clinical 
benefit; 
‘‘(iii) identification of the surrogate or 
intermediate endpoint or endpoints that 
supported approval and any known limita-
tions of such surrogate or intermediate 
endpoint or endpoints in determining clin-
ical benefit; and 
‘‘(iv) a succinct description of the 
product and any uncertainty about antici-
pated clinical benefit and a discussion of 
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available evidence with respect to such clin-
ical benefit. 
‘‘(B) APPLICABILITY.—The labeling re-
quirements of subparagraph (A) shall apply 
only to products approved under accelerated ap-
proval for which the predicted effect on irre-
versible morbidity or mortality or other clinical 
benefit has not been verified. 
‘‘(5) REPORTING.—Not later than September 
30, 2025, the Secretary shall submit to the Com-
mittee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report 
describing circumstances in which the Secretary con-
sidered real world evidence submitted to support 
postapproval studies required under this subsection 
that were completed after the date of enactment of 
the Food and Drug Amendments of 2022.’’. 
(b) REPORTS OF POSTMARKETING STUDIES.—Sec-
tion 506B(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356b(a)) is amended— 
(1) by redesignating paragraph (2) as para-
graph (3); and 
(2) by inserting after paragraph (1) the fol-
lowing: 
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‘‘(2) 
ACCELERATED
APPROVAL.—Notwith-
standing paragraph (1), a sponsor of a drug ap-
proved under accelerated approval shall submit to 
the Secretary a report of the progress of any study 
required under section 506(c), including progress to-
ward any agreed upon enrollment targets, mile-
stones, and other information as required by the 
Secretary, not later than 180 days after the ap-
proval of such drug and not less frequently than 
every 180 days thereafter, until the study is com-
pleted or terminated.’’. 
(c) GUIDANCE.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall issue guidance describing— 
(A) how sponsor questions related to the 
identification of novel surrogate or intermediate 
clinical endpoints may be addressed in early- 
stage development meetings with the Food and 
Drug Administration; 
(B) the use of novel clinical trial designs 
that may be used to conduct appropriate post-
approval studies as may be required under sec-
tion 506(c)(2)(A) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356(c)(2)(A)), as 
amended by subsection (a); and 
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(C) the expedited procedures described in 
section 506(c)(3)(B) of the Federal Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
356(c)(3)(B)). 
(2) FINAL
GUIDANCE.—The Secretary shall 
issue— 
(A) draft guidance under paragraph (1) 
not later than 18 months after the date of en-
actment of this Act; and 
(B) final guidance not later than 1 year 
after the close of the public comment period on 
each draft guidance. 
(d) RARE
DISEASE
ENDPOINT
ADVANCEMENT 
PILOT.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall establish a pilot program 
under which the Secretary will establish procedures 
to provide increased interaction with sponsors of 
rare disease drug development programs for pur-
poses of advancing the development of efficacy 
endpoints, including surrogate and intermediate 
endpoints, for drugs intended to treat rare diseases, 
including through— 
(A) determining eligibility of participants 
for such a program; and 
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(B) developing and implementing a process 
for applying to, and participating in, such a 
program. 
(2) PUBLIC WORKSHOPS.—The Secretary shall 
conduct up to 3 public workshops, which shall be 
completed not later than September 30, 2026, to 
discuss topics relevant to the development of 
endpoints for rare diseases, which may include dis-
cussions about— 
(A) novel endpoints developed through the 
pilot program established under this subsection; 
and 
(B) as appropriate, the use of real world 
evidence and real world data to support the val-
idation of efficacy endpoints, including surro-
gate and intermediate endpoints, for rare dis-
eases. 
(3) REPORT.—Not later than September 30, 
2027, the Secretary shall submit to the Committee 
on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report 
describing the outcomes of the pilot program estab-
lished under this subsection. 
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(4) GUIDANCE.—Not later than September 30, 
2027, the Secretary shall issue guidance describing 
best practices and strategies for development of effi-
cacy endpoints, including surrogate and intermediate 
endpoints, for rare diseases. 
(5) SUNSET.—The Secretary may not accept 
any new application or request to participate in the 
program established by this subsection on or after 
October 1, 2027. 
SEC. 805. FACILITATING THE USE OF REAL WORLD EVI-
DENCE. 
(a) GUIDANCE.—Not later than 1 year after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall issue, or revise existing, guidance 
on considerations for the use of real world data and real 
world evidence to support regulatory decisionmaking, as 
follows: 
(1) With respect to drugs, such guidance shall 
address— 
(A) the use of such data and evidence to 
support the approval of a drug application 
under section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355) or a biologi-
cal product application under section 351 of the 
Public Health Service Act (42 U.S.C. 262), or 
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to support an investigational use exemption 
under section 505(i) of the Federal Food, Drug, 
and Cosmetic Act or section 351(a)(3) of the 
Public Health Service Act; and 
(B) the use of such data and evidence ob-
tained as a result of the use of drugs author-
ized for emergency use under section 564 of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb–3) in such applications, submis-
sions, or requests; and 
(C) standards and methodologies which 
may be used for collection and analysis of real 
world evidence included in such applications, 
submissions, or requests, as appropriate. 
(2) With respect to devices, such guidance shall 
address— 
(A) the use of such data and evidence to 
support the approval, clearance, or classification 
of a device pursuant to an application or sub-
mission 
submitted 
under 
section 
510(k), 
513(f)(2), or 515 of the Federal Food, Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
360(k), 
360c(f)(2), 360e), or to support an investiga-
tional use exemption under section 520(g) of 
such Act (21 U.S.C. 360j(g)); and 
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(B) the use of such data and evidence ob-
tained as a result of the use of devices author-
ized for emergency use under section 564 of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb–3), in such applications, submis-
sions, or requests; and 
(C) standards and methodologies which 
may be used for collection and analysis of real 
world evidence included in such applications, 
submissions, or requests, as appropriate. 
(b) REPORT TO CONGRESS.—Not later than 2 years 
after the termination of the public health emergency deter-
mination by the Secretary of Health and Human Services 
under section 564 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb–3) on February 4, 2020, 
with respect to the Coronavirus Disease 2019 (COVID– 
19), the Secretary shall submit a report to the Committee 
on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and 
Pensions of the Senate on— 
(1) the number of applications submitted for 
clearance or approval under sections 505, 510(k), or 
515 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355, 360(k), 360c(f)(2), 360e) or section 
351 of the Public Health Service Act, for which an 
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authorization under section 564 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb– 
3) was previously granted; 
(2) of the number of applications so submitted, 
the number of such applications— 
(A) for which real world evidence was sub-
mitted and used to support a regulatory deci-
sion; and 
(B) for which real world evidence was sub-
mitted and determined to be insufficient to sup-
port a regulatory decision; and 
(3) a summary explanation of why, in the case 
of applications described in paragraph (2)(B), real 
world evidence could not be used to support regu-
latory decisions. 
SEC. 806. MEDICAL DEVICES ADVISORY COMMITTEE MEET-
INGS. 
(a) IN GENERAL.—The Secretary shall convene one 
or more panels of the Medical Devices Advisory Committee 
not less than once per year for the purpose of providing 
advice to the Secretary on topics related to medical devices 
in pandemic preparedness and response, including the 
issues related to in vitro diagnostics. 
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(b) REQUIRED PANEL MEMBER.—A panel convened 
under subsection (a) shall include at least 1 population 
health-specific representative. 
(c) SUNSET.—This section shall cease to be effective 
on October 1, 2027. 
SEC. 807. ENSURING CYBERSECURITY OF MEDICAL DE-
VICES. 
(a) IN GENERAL.—Subchapter A of chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.), as amended by section 501, is further amended 
by adding at the end the following: 
‘‘SEC. 524C. ENSURING CYBERSECURITY OF DEVICES. 
‘‘(a) IN GENERAL.—For purposes of ensuring cyber-
security throughout the lifecycle of a cyber device, any per-
son who submits a premarket submission for the cyber de-
vice shall include such information as the Secretary may 
require to ensure that the cyber device meets such cyberse-
curity requirements as the Secretary determines to be ap-
propriate to demonstrate a reasonable assurance of safety 
and effectiveness, including at a minimum the cybersecu-
rity requirements under subsection (b). 
‘‘(b) CYBERSECURITY REQUIREMENTS.—At a min-
imum, the manufacturer of a cyber device shall meet the 
following cybersecurity requirements: 
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‘‘(1) The manufacturer shall have a plan to ap-
propriately monitor, identify, and address in a rea-
sonable time postmarket cybersecurity vulnerabilities 
and exploits, including coordinated vulnerability dis-
closure and procedures. 
‘‘(2) The manufacturer shall design, develop, 
and maintain processes and procedures to ensure the 
device and related systems are cybersecure, and shall 
make available updates and patches to the cyber de-
vice and related systems throughout the lifecycle of 
the cyber device to address— 
‘‘(A) on a reasonably justified regular 
cycle, known unacceptable vulnerabilities; and 
‘‘(B) as soon as possible out of cycle, crit-
ical vulnerabilities that could cause uncontrolled 
risks. 
‘‘(3) The manufacturer shall provide in the la-
beling of the cyber device a software bill of mate-
rials, including commercial, open-source, and off-the- 
shelf software components. 
‘‘(4) The manufacturer shall comply with such 
other requirements as the Secretary may require to 
demonstrate reasonable assurance of the safety and 
effectiveness of the device for purposes of cybersecu-
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rity, which the Secretary may require by an order 
published in the Federal Register. 
‘‘(c) SUBSTANTIAL EQUIVALENCE.—In making a de-
termination of substantial equivalence under section 
513(i) for a cyber device, the Secretary may— 
‘‘(1) find that cybersecurity information for the 
cyber device described in the relevant premarket 
submission in the cyber device’s use environment is 
inadequate; and 
‘‘(2) issue a nonsubstantial equivalence deter-
mination based on this finding. 
‘‘(d) DEFINITION.—In this section: 
‘‘(1) CYBER DEVICE.—The term ‘cyber device’ 
means a device that— 
‘‘(A) includes software, including software 
as or in a device; 
‘‘(B) is intended to connect to the internet; 
or 
‘‘(C) contains any such technological char-
acteristics that could be vulnerable to cyberse-
curity threats. 
‘‘(2) LIFECYCLE OF THE CYBER DEVICE.—The 
term ‘lifecycle of the cyber device’ includes the 
postmarket lifecycle of the cyber device. 
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‘‘(3) PREMARKET SUBMISSION.—The term ‘pre-
market submission’ means any submission under 
section 510(k), 513, 515(c), 515(f), or 520(m). 
‘‘(e) EXEMPTION.—The Secretary may identify de-
vices or types of devices that are exempt from meeting 
the cybersecurity requirements established by this section 
and regulations promulgated pursuant to this section. The 
Secretary shall publish in the Federal Register, and up-
date, as appropriate, a list of the devices and types of de-
vices so identified by the Secretary.’’. 
(b) PROHIBITED ACT.—Section 301(q) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)) 
is amended by adding at the end the following: 
‘‘(3) The failure to comply with any requirement 
under section 524C (relating to ensuring device cybersecu-
rity).’’. 
(c) ADULTERATION.—Section 501 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amend-
ed by inserting after paragraph (j) the following: 
‘‘(k) If it is a device subject to the requirements set 
forth in section 524C (relating to ensuring device cyberse-
curity) and fails to comply with any requirement under 
that section.’’. 
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