3522 
† HR 2617 EAS2 
‘‘SEC. 611. MANDATORY RECALL AUTHORITY. 
‘‘(a) IN GENERAL.—If the Secretary determines that 
there is a reasonable probability that a cosmetic is adulter-
ated under section 601 or misbranded under section 602 
and the use of or exposure to such cosmetic will cause seri-
ous adverse health consequences or death, the Secretary shall 
provide the responsible person with an opportunity to vol-
untarily cease distribution and recall such article. If the 
responsible person refuses to or does not voluntarily cease 
distribution or recall such cosmetic within the time and 
manner prescribed by the Secretary (if so prescribed), the 
Secretary may, by order, require, as the Secretary deter-
mines necessary, such person to immediately cease distribu-
tion of such article. 
‘‘(b) HEARING.—The Secretary shall provide the re-
sponsible person who is subject to an order under subsection 
(a) with an opportunity for an informal hearing, to be held 
not later than 10 days after the date of issuance of the order, 
on whether adequate evidence exists to justify the order. 
‘‘(c) ORDER RESOLUTION.—After an order is issued 
according to the process under subsections (a) and (b), the 
Secretary shall, except as provided in subsection (d)— 
‘‘(1) vacate the order, if the Secretary determines 
that inadequate grounds exist to support the actions 
required by the order;
3523 
† HR 2617 EAS2 
‘‘(2) continue the order ceasing distribution of 
the cosmetic until a date specified in such order; or 
‘‘(3) amend the order to require a recall of the 
cosmetic, including any requirements to notify appro-
priate persons, a timetable for the recall to occur, and 
a schedule for updates to be provided to the Secretary 
regarding such recall. 
‘‘(d) ACTION FOLLOWING ORDER.—Any person who is 
subject to an order pursuant to paragraph (2) or (3) of sub-
section (c) shall immediately cease distribution of or recall, 
as applicable, the cosmetic and provide notification as re-
quired by such order. 
‘‘(e) NOTICE TO PERSONS AFFECTED.—If the Sec-
retary determines necessary, the Secretary may require the 
person subject to an order pursuant to subsection (a) or an 
amended order pursuant to paragraph (2) or (3) of sub-
section (c) to provide either a notice of a recall order for, 
or an order to cease distribution of, such cosmetic, as appli-
cable, under this section to appropriate persons, including 
persons who manufacture, distribute, import, or offer for 
sale such product that is the subject of an order and to the 
public. 
‘‘(f) PUBLIC NOTIFICATION.—In conducting a recall 
under this section, the Secretary shall—
3524 
† HR 2617 EAS2 
‘‘(1) ensure that a press release is published re-
garding the recall, and that alerts and public notices 
are issued, as appropriate, in order to provide notifi-
cation— 
‘‘(A) of the recall to consumers and retailers 
to whom such cosmetic was, or may have been, 
distributed; and 
‘‘(B) that includes, at a minimum— 
‘‘(i) the name of the cosmetic subject to 
the recall; 
‘‘(ii) a description of the risk associ-
ated with such article; and 
‘‘(iii) to the extent practicable, infor-
mation for consumers about similar cos-
metics that are not affected by the recall; 
and 
‘‘(2) ensure publication, as appropriate, on the 
website of the Food and Drug Administration of an 
image of the cosmetic that is the subject of the press 
release described in paragraph (1), if available. 
‘‘(g) NO DELEGATION.—The authority conferred by 
this section to order a recall or vacate a recall order shall 
not be delegated to any officer or employee other than the 
Commissioner.
3525 
† HR 2617 EAS2 
‘‘(h) EFFECT.—Nothing in this section shall affect the 
authority of the Secretary to request or participate in a 
voluntary recall, or to issue an order to cease distribution 
or to recall under any other provision of this chapter. 
‘‘SEC. 612. SMALL BUSINESSES. 
‘‘(a) IN GENERAL.—Responsible persons, and owners 
and operators of facilities, whose average gross annual sales 
in the United States of cosmetic products for the previous 
3-year period is less than $1,000,000, adjusted for inflation, 
and who do not engage in the manufacturing or processing 
of the cosmetic products described in subsection (b), shall 
be considered small businesses and not subject to the re-
quirements of section 606 or 607. 
‘‘(b) REQUIREMENTS APPLICABLE TO ALL MANUFAC-
TURERS AND PROCESSORS OF COSMETICS.—The exemp-
tions under subsection (a) shall not apply to any respon-
sible person or facility engaged in the manufacturing or 
processing of any of the following products: 
‘‘(1) Cosmetic products that regularly come into 
contact with mucus membrane of the eye under condi-
tions of use that are customary or usual. 
‘‘(2) Cosmetic products that are injected. 
‘‘(3) Cosmetic products that are intended for in-
ternal use.
3526 
† HR 2617 EAS2 
‘‘(4) Cosmetic products that are intended to alter 
appearance for more than 24 hours under conditions 
of use that are customary or usual and removal by 
the consumer is not part of such conditions of use 
that are customary or usual. 
‘‘SEC. 613. EXEMPTION FOR CERTAIN PRODUCTS AND FA-
CILITIES. 
‘‘(a) IN GENERAL.—Notwithstanding any other provi-
sion of law, except as provided in subsection (b), a cosmetic 
product or facility that is also subject to the requirements 
of chapter V shall be exempt from the requirements of sec-
tions 605, 606, 607, 608, 609(a), 610, and 611. 
‘‘(b) EXCEPTION.—A facility described in subsection 
(a) that also manufactures or processes cosmetic products 
that are not subject to the requirements of chapter V shall 
not be exempt from the requirements of sections 605, 606, 
607, 608, 609(a), 610, and 611, with respect to such cos-
metic products. 
‘‘SEC. 614. PREEMPTION. 
‘‘(a) IN GENERAL.—No State or political subdivision 
of a State may establish or continue in effect any law, regu-
lation, order, or other requirement for cosmetics that is dif-
ferent from or in addition to, or otherwise not identical 
with, any requirement applicable under this chapter with 
respect to registration and product listing, good manufac-
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† HR 2617 EAS2 
turing practice, records, recalls, adverse event reporting, or 
safety substantiation. 
‘‘(b) LIMITATION.—Nothing in the amendments to this 
Act made by the Modernization of Cosmetics Regulation Act 
of 2022 shall be construed to preempt any State statute, 
public initiative, referendum, regulation, or other State ac-
tion, except as expressly provided in subsection (a). Not-
withstanding subsection (a), nothing in this section shall 
be construed to prevent any State from prohibiting the use 
or limiting the amount of an ingredient in a cosmetic prod-
uct, or from continuing in effect a requirement of any State 
that is in effect at the time of enactment of the Moderniza-
tion of Cosmetics Regulation Act of 2022 for the reporting 
to the State of an ingredient in a cosmetic product. 
‘‘(c) SAVINGS.—Nothing in the amendments to this Act 
made by the Modernization of Cosmetics Regulation Act of 
2022, nor any standard, rule, requirement, regulation, or 
adverse event report shall be construed to modify, preempt, 
or displace any action for damages or the liability of any 
person under the law of any State, whether statutory or 
based in common law. 
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to amend, expand, or limit the provi-
sions under section 752.’’.
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† HR 2617 EAS2 
SEC. 3503. ENFORCEMENT AND CONFORMING AMEND-
MENTS. 
(a) IN GENERAL.— 
(1) PROHIBITED ACTS.—Section 301 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331), 
as amended by section 3210, is further amended— 
(A) by adding at the end the following: 
‘‘(hhh) The failure to register or submit listing infor-
mation in accordance with section 607. 
‘‘(iii) The refusal or failure to follow an order under 
section 611.’’; and 
(B) in paragraph (d), by striking ‘‘or 564’’ 
and inserting ‘‘, 564, or 607’’. 
(2) ADULTERATED PRODUCTS.—Section 601 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
361) is amended by adding at the end the following: 
‘‘(f) If it has been manufactured or processed under 
conditions that do not meet the good manufacturing prac-
tice requirements of section 606. 
‘‘(g) If it is a cosmetic product, and the cosmetic prod-
uct, including each ingredient in the cosmetic product, does 
not have adequate substantiation for safety, as defined in 
section 608(c).’’. 
(3) MISBRANDED COSMETICS.—Section 602(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
362(b)) is amended—
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† HR 2617 EAS2 
(A) by striking ‘‘and (2)’’ and inserting 
‘‘(2)’’; and 
(B) by inserting after ‘‘numerical count’’ 
the following: ‘‘; and (3) the information re-
quired under section 609’’. 
(4) ADVERSE EVENT REPORTING.—The Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
is amended— 
(A) in section 301(e) (21 U.S.C. 331(e))— 
(i) by striking ‘‘564, 703’’ and insert-
ing ‘‘564, 605, 703’’; and 
(ii) by striking ‘‘564, 760’’ and insert-
ing ‘‘564, 605, 611, 760’’; 
(B) in section 301(ii) (21 U.S.C. 331(ii))— 
(i) by striking ‘‘760 or 761) or’’ and 
inserting ‘‘604, 760, or 761) or’’; and 
(ii) by inserting ‘‘or required under 
section 605(a)’’ after ‘‘report (as defined 
under section 760 or 761’’; 
(C) in section 801(a) (21 U.S.C. 381(a))— 
(i) by striking ‘‘under section 760 or 
761’’ and inserting ‘‘under section 605, 760, 
or 761’’;
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† HR 2617 EAS2 
(ii) by striking ‘‘defined in such sec-
tion 760 or 761’’ and inserting ‘‘defined in 
section 604, 760, or 761’’; 
(iii) by striking ‘‘of such section 760 or 
761’’ and inserting ‘‘of such section 605, 
760, or 761’’; and 
(iv) by striking ‘‘described in such sec-
tion 760 or 761’’ and inserting ‘‘described 
in such section 605, 760, or 761’’; and 
(D) in section 801(b) (21 U.S.C. 381(b))— 
(i) by striking ‘‘requirements of sec-
tions 760 or 761,’’ and inserting ‘‘require-
ments of section 605, 760, or 761’’; 
(ii) by striking ‘‘as defined in section 
760 or 761’’ and inserting ‘‘as defined in 
section 604, 760, or 761’’; and 
(iii) by striking ‘‘with section 760 or 
761’’ and inserting ‘‘with section 605, 760, 
or 761’’. 
(b) EFFECTIVE DATES.— 
(1) IN
GENERAL.—The amendments made by 
subsection (a) shall take effect on the date that is 1 
year after the date of enactment of this Act. 
(2) LABELING REQUIREMENT.—Section 609(a) of 
the Federal Food, Drug, and Cosmetic Act, as added
3531 
† HR 2617 EAS2 
by section 802, shall take effect on the date that is 2 
years after the date of enactment of this Act. 
(c) CONFIDENTIALITY.— 
(1) IN GENERAL.—The Secretary shall take ap-
propriate measures to ensure that there are in effect 
effective procedures to prevent the unauthorized dis-
closure of any trade secret or confidential commercial 
information that is obtained by the Secretary of 
Health and Human Services pursuant to this subtitle, 
including the amendments made by this subtitle. 
(2) CLARIFICATION.—Nothing in this subtitle, 
including the amendments made by this subtitle, shall 
be construed to authorize the disclosure of information 
that is prohibited from disclosure under section 301(j) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 331(j)) or section 1905 of title 18, United 
States Code, or that is subject to withholding under 
section 552(b)(4) of title 5, United States Code. 
SEC. 3504. RECORDS INSPECTION. 
Section 704(a)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 374(a)(1)) is amended by inserting 
after the second sentence the following: ‘‘In the case of a 
facility (as defined in section 604) that manufactures or 
processes cosmetic products, the inspection shall extend to 
all records and other information described in sections 605,
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† HR 2617 EAS2 
606, and 610, when the standard for records inspection 
under such section applies.’’. 
SEC. 3505. TALC-CONTAINING COSMETICS. 
The Secretary of Health and Human Services— 
(1) not later than one year after the date of en-
actment of this Act, shall promulgate proposed regula-
tions to establish and require standardized testing 
methods for detecting and identifying asbestos in talc- 
containing cosmetic products; and 
(2) not later than 180 days after the date on 
which the public comment period on the proposed reg-
ulations closes, shall issue such final regulations. 
SEC. 3506. PFAS IN COSMETICS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall assess the use of perfluoroalkyl and 
polyfluoroalkyl substances in cosmetic products and the sci-
entific evidence regarding the safety of such use in cosmetic 
products, including any risks associated with such use. In 
conducting such assessment, the Secretary may, as appro-
priate, consult with the National Center for Toxicological 
Research. 
(b) REPORT.—Not later than 3 years after enactment 
of this Act, the Secretary shall publish on the website of
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† HR 2617 EAS2 
the Food and Drug Administration a report summarizing 
the results of the assessment conducted under subsection (a). 
SEC. 3507. SENSE OF THE CONGRESS ON ANIMAL TESTING. 
It is the sense of the Congress that animal testing 
should not be used for the purposes of safety testing on cos-
metic products and should be phased out with the exception 
of appropriate allowances. 
SEC. 3508. FUNDING. 
There is authorized to be appropriated $14,200,000 for 
fiscal year 2023, $25,960,000 for fiscal year 2024, and 
$41,890,000 for each of fiscal years 2025 through 2027, for 
purposes of conducting the activities under this subtitle (in-
cluding the amendments made by this subtitle) and hiring 
personnel required to carry out this subtitle (including the 
amendments made by this subtitle). 
Subtitle F—Cross-Cutting 
Provisions 
CHAPTER 1—CLINICAL TRIAL DIVERSITY 
AND MODERNIZATION 
SEC. 3601. DIVERSITY ACTION PLANS FOR CLINICAL STUD-
IES. 
(a) DRUGS.—Section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355) is amended by adding 
at the end the following:
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† HR 2617 EAS2 
‘‘(z)(1) With respect to a clinical investigation of a 
new drug that is a phase 3 study, as defined in section 
312.21(c) of title 21, Code of Federal Regulations (or suc-
cessor regulations), or, as appropriate, another pivotal 
study of a new drug (other than bioavailability or bio-
equivalence studies), the sponsor of such drug shall submit 
to the Secretary a diversity action plan. 
‘‘(2) Such diversity action plan shall include— 
‘‘(A) the sponsor’s goals for enrollment in such 
clinical study; 
‘‘(B) the sponsor’s rationale for such goals; and 
‘‘(C) an explanation of how the sponsor intends 
to meet such goals. 
‘‘(3) The sponsor shall submit to the Secretary such 
diversity action plan, in the form and manner specified by 
the Secretary in guidance, as soon as practicable but not 
later than the date on which the sponsor submits the pro-
tocol to the Secretary for such a phase 3 study or other 
pivotal study of the drug. The sponsor may submit modi-
fications to the diversity action plan. Any such modifica-
tions shall be in the form and manner specified by the Sec-
retary in guidance. 
‘‘(4)(A) On the initiative of the Secretary or at the 
request of a sponsor, the Secretary may waive any require-
ment in paragraph (1), (2), or (3) if the Secretary deter-
3535 
† HR 2617 EAS2 
mines that a waiver is necessary based on what is known 
or what can be determined about the prevalence or incidence 
of the disease or condition for which the new drug is under 
investigation (including in terms of the patient population 
that may use the drug), if conducting a clinical investiga-
tion in accordance with a diversity action plan would oth-
erwise be impracticable, or if such waiver is necessary to 
protect public health during a public health emergency. 
‘‘(B) The Secretary shall issue a written response 
granting or denying a request from a sponsor for a waiver 
within 60 days of receiving such request. 
‘‘(5) No diversity action plan shall be required for a 
submission described in section 561.’’. 
(b) DEVICES.—Section 520(g) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j(g)) is amended 
by adding at the end the following: 
‘‘(9)(A)(i) The sponsor of a device for which submis-
sion of an application for an investigational device exemp-
tion is required shall submit to the Secretary in such appli-
cation a diversity action plan for clinical studies of the de-
vice, in the form and manner specified in guidance issued 
by the Secretary. 
‘‘(ii) The sponsor of a device for which submission of 
an application for an investigational device exemption is 
not required, except for a device being studied as described
3536 
† HR 2617 EAS2 
in section 812.2(c) of title 21, Code of Federal Regulations 
(or successor regulations), shall develop a diversity action 
plan for any clinical study with respect to the device. Such 
diversity action plan shall be submitted to the Secretary 
in any premarket notification under section 510(k), request 
for classification under section 513(f)(2), or application for 
premarket approval under section 515 for such device. 
‘‘(B) A diversity action plan under clause (i) or (ii) 
of subparagraph (A) shall include— 
‘‘(i) the sponsor’s goals for enrollment in the 
clinical study; 
‘‘(ii) the sponsor’s rationale for such goals; and 
‘‘(iii) an explanation of how the sponsor intends 
to meet such goals. 
‘‘(C)(i) On the initiative of the Secretary or at the re-
quest of a sponsor, the Secretary may waive any require-
ment in subparagraph (A) or (B) if the Secretary deter-
mines that a waiver is necessary based on what is known 
or can be determined about the prevalence or incidence of 
the disease or condition for which the device is under inves-
tigation (including in terms of the patient population that 
may use the device), if conducting a clinical investigation 
in accordance with a diversity action plan would otherwise 
be impracticable, or if such waiver is necessary to protect 
public health during a public health emergency.
3537 
† HR 2617 EAS2 
‘‘(ii) The Secretary shall issue a written response 
granting or denying a request from a sponsor for a waiver 
within 60 days of receiving such request. 
‘‘(D) No diversity action plan shall be required for a 
submission described in section 561.’’. 
SEC. 3602. GUIDANCE ON DIVERSITY ACTION PLANS FOR 
CLINICAL STUDIES. 
(a) IN GENERAL.—The Secretary shall update or issue 
guidance relating to— 
(1) the format and content of the diversity action 
plans required by sections 505(z) and 520(g)(9) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(z); 360j(g)(9)) (as amended by section 3601) per-
taining to the sponsor’s goals for clinical study enroll-
ment, disaggregated by age group, sex, and racial and 
ethnic demographic characteristics of clinically rel-
evant study populations, and may include character-
istics such as geographic location and socioeconomic 
status, including with respect to— 
(A) the rationale for the sponsor’s enroll-
ment goals, which may include— 
(i) the estimated prevalence or inci-
dence in the United States of the disease or 
condition for which the drug or device is 
being investigated in the relevant clinical
3538 
† HR 2617 EAS2 
trial, if such estimated prevalence or inci-
dence 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 investigated; 
(iii) any relevant pharmacokinetic or 
pharmacogenomic data; 
(iv) what is known about the patient 
population for such disease or condition, in-
cluding, to the extent data is available— 
(I) 
demographic 
information, 
which may include age group, sex, 
race, 
geographic 
location, 
socio-
economic status, and ethnicity; 
(II) non-demographic factors, in-
cluding co-morbidities affecting the pa-
tient population; and 
(III) potential barriers to enroll-
ing diverse participants, such as pa-
tient population size, geographic loca-
tion, and socioeconomic status; and 
(v) any other data or information rel-
evant to selecting appropriate enrollment 
goals, disaggregated by demographic sub-
3539 
† HR 2617 EAS2 
group, such as the inclusion of pregnant 
and lactating women; and 
(B) an explanation for how the sponsor in-
tends to meet such goals, including demographic- 
specific outreach and enrollment strategies, 
study-site selection, clinical study inclusion and 
exclusion practices, and any diversity training 
for study personnel; 
(2) submission of any modifications to the diver-
sity action plan; 
(3) considerations for the public posting by a 
sponsor of key information from the diversity action 
plan that would be useful to patients and providers 
on the sponsor’s website, as appropriate; 
(4) criteria that the Secretary will consider in 
assessing whether to grant a sponsor’s request to 
waive the requirement to submit a diversity action 
plan under section 505(z)(4) or 520(g)(9)(C) of the 
Federal Food, Drug, and Cosmetic Act (as amended 
by section 3601); and 
(5) how sponsors may include in regular reports 
otherwise required by the Secretary— 
(A) the sponsor’s progress in meeting the 
goals referred to in paragraph (1)(A); and
3540 
† HR 2617 EAS2 
(B) any updates needed to be made to a di-
versity action plan referred to in paragraph (1) 
to help meet goals referred to in paragraph 
(1)(A); and 
(C) if the sponsor does not expect to meet 
goals referred to in paragraph (1)(A), the spon-
sor’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 en-
actment of this Act, issue new draft guidance or up-
date existing draft guidance described in subsection 
(a); and 
(2) not later than 9 months after closing the 
comment period on such draft guidance, finalize such 
guidance. 
(c) APPLICABILITY.—Sections 505(z) and 520(g)(9) of 
the Federal Food, Drug, and Cosmetic Act, as added by sec-
tion 3601, shall apply only with respect to clinical inves-
tigations for which enrollment commences after the date 
that is 180 days after the publication of final guidance re-
quired under this section.
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† HR 2617 EAS2 
SEC. 3603. PUBLIC WORKSHOPS TO ENHANCE CLINICAL 
STUDY DIVERSITY. 
(a) IN GENERAL.—Not later than one year after the 
date of enactment of this Act, the Secretary, in consultation 
with drug sponsors, medical device sponsors, clinical re-
search organizations, academia, patients, and other stake-
holders, shall convene one or more public workshops to so-
licit input from stakeholders on increasing the enrollment 
of historically underrepresented populations in clinical 
studies and encouraging clinical study participation that 
reflects the prevalence of the disease or condition among de-
mographic subgroups, where appropriate, and other topics, 
including— 
(1) how and when to collect and present the 
prevalence or incidence data on a disease or condition 
by demographic subgroup, including possible sources 
for such data and methodologies for assessing such 
data; 
(2) considerations for the dissemination, as ap-
propriate, after approval, of information to the public 
on clinical study enrollment demographic data; 
(3) the establishment of goals for enrollment in 
clinical trials, including the relevance of the estimated 
prevalence or incidence, as applicable, in the United 
States of the disease or condition for which the drug 
or device is being developed; and
3542 
† HR 2617 EAS2 
(4) approaches to support inclusion of underrep-
resented populations and to encourage clinical study 
participation that reflects the population expected to 
use the drug or device under study, including with re-
spect to— 
(A) the establishment of inclusion and ex-
clusion criteria for certain subgroups, such as 
pregnant and lactating women and individuals 
with disabilities, including intellectual or devel-
opmental disabilities or mental illness; 
(B) considerations regarding informed con-
sent with respect to individuals with intellectual 
or developmental disabilities or mental illness, 
including ethical and scientific considerations; 
(C) the appropriate use of decentralized 
trials or digital health tools; 
(D) clinical endpoints; 
(E) biomarker selection; and 
(F) studying analysis. 
(b) PUBLIC DOCKET.—The Secretary shall establish a 
public comment period to receive written comments related 
to the topics addressed during each public workshop con-
vened under this section. The public comment period shall 
remain open for 60 days following the date on which each 
public workshop is convened.
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† HR 2617 EAS2 
(c) REPORT.—Not later than 180 days after the close 
of the public comment period for each public workshop con-
vened under this section, the Secretary shall make available 
on the public website of the Food and Drug Administration 
a report on the topics discussed at such workshop. The re-
port shall include a summary of topics and responses to 
any recommendations raised in such workshop. 
SEC. 3604. ANNUAL SUMMARY REPORT ON PROGRESS TO 
INCREASE DIVERSITY IN CLINICAL STUDIES. 
(a) IN GENERAL.—Beginning not later than 2 years 
after the date of enactment of this Act, and each year there-
after, the Secretary shall submit to the Congress, and pub-
lish on the public website of the Food and Drug Administra-
tion, a report that— 
(1) summarizes, in aggregate, the diversity ac-
tion plans received pursuant to section 505(z) or 
520(g)(9) of the Federal Food, Drug, and Cosmetic 
Act, as added by section 3601; and 
(2) contains information, in the aggregate, on— 
(A) for drugs, biological products, and de-
vices approved, licensed, cleared, or classified 
under section 505, 515, 510(k), or 513(f)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355; 360e; 360(k); and 360(f)(2)), or sec-
tion 351(a) of the Public Health Service Act (42
3544 
† HR 2617 EAS2 
U.S.C. 262(a)), whether the clinical studies con-
ducted with respect to such applications met the 
demographic subgroup enrollment goals from the 
diversity action plan submitted for such applica-
tions; and 
(B) the reasons provided, if any, for why 
enrollment goals from submitted diversity action 
plans were not met. 
(b) CONFIDENTIALITY.—Nothing in this section shall 
be construed as authorizing the Secretary to disclose any 
information that is a trade secret or confidential informa-
tion subject to section 552(b)(4) of title 5, United States 
Code, or section 1905 of title 18, United States Code. 
SEC. 3605. PUBLIC MEETING ON CLINICAL STUDY FLEXI-
BILITIES 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 shall convene a public meeting to discuss the rec-
ommendations provided by the Food and Drug Administra-
tion during the COVID–19 emergency period to mitigate 
disruption of clinical studies, including recommendations 
detailed in the guidance entitled ‘‘Conduct of Clinical 
Trials of Medical Products During the COVID–19 Public 
Health Emergency, Guidance for Industry, Investigators,
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† HR 2617 EAS2 
and Institutional Review Boards’’, as updated on August 
8, 2021, and by any subsequent updates to such guidance. 
The Secretary shall invite to such meeting representatives 
from the pharmaceutical and medical device industries who 
sponsored clinical studies during the COVID–19 emergency 
period and organizations representing patients. 
(b) TOPICS.—Not later than 90 days after the date on 
which the public meeting under subsection (a) is convened, 
the Secretary 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 discus-
sion of— 
(1) the actions sponsors took to utilize such rec-
ommendations and the frequency at which such rec-
ommendations were employed; 
(2) the characteristics of the sponsors, studies, 
and patient populations impacted by such rec-
ommendations; 
(3) a consideration of how recommendations in-
tended to mitigate disruption of clinical studies dur-
ing the COVID–19 emergency period, including any 
recommendations to consider decentralized clinical 
studies when appropriate, may have affected access to 
clinical studies for certain patient populations, espe-
3546 
† HR 2617 EAS2 
cially unrepresented or underrepresented racial and 
ethnic minorities; and 
(4) recommendations for incorporating certain 
clinical study disruption mitigation recommendations 
into current or additional guidance to improve clin-
ical study access and enrollment of diverse patient 
populations. 
(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. 3606. DECENTRALIZED CLINICAL STUDIES. 
(a) GUIDANCE.—The Secretary shall— 
(1) not later than 1 year after the date of enact-
ment of this Act, issue or revise draft guidance that 
includes recommendations to clarify and advance the 
use of decentralized clinical studies to support the de-
velopment of drugs and devices, including rec-
ommendations for how to advance the use of flexible 
and novel clinical trial designs and to help improve 
trial participant engagement, recruitment, enroll-
ment, and retention of a meaningfully diverse clinical 
population, including with respect to race, ethnicity,
3547 
† HR 2617 EAS2 
age, sex, and geographic location, when appropriate; 
and 
(2) not later than 1 year after closing the com-
ment period on such draft guidance, finalize such 
guidance. 
(b) CONTENT OF GUIDANCE.—The guidance under sub-
section (a) shall address the following: 
(1) Recommendations related to digital health 
technology or other assessment options, such as tele-
health, local laboratories, local health care providers, 
or other options for remote data collection, could sup-
port decentralized clinical studies, including guidance 
on considerations for selecting technological platforms 
and mediums, data collection and use, data integrity 
and security, and communication to study partici-
pants through digital technology. 
(2) Recommendations for subject recruitment, re-
tention, and engagement, including considerations for 
sponsors to minimize or reduce burdens for clinical 
study participants through the use of digital health 
technology, telehealth, local health care providers and 
laboratories, health care provider home visits, direct- 
to-participant engagement, electronic informed con-
sent, or other means, as appropriate.
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(3) Recommendations with respect to the evalua-
tion of data collected within a decentralized clinical 
study setting. 
(4) Recommendations for methods of remote data 
collection, including clinical trial participant experi-
ence data, through the use of digital health tech-
nologies, telemedicine, local laboratories, local health 
care providers, or other options for data collection. 
(5) Considerations for sponsors to minimize or 
reduce burdens for clinical trial participants associ-
ated with participating in a clinical trial, such as the 
use of digital technologies, telemedicine, local labora-
tories, local health care providers, or other data collec-
tion or assessment options, health care provider home 
visits, direct-to-participant shipping of investiga-
tional drugs and devices, and electronic informed con-
sent, as appropriate. 
(6) Recommendations regarding conducting de-
centralized clinical trials to facilitate and encourage 
meaningful diversity among clinical trial partici-
pants, including with respect to race, ethnicity, age, 
sex, and geographic location, as appropriate. 
(7) Recommendations for strategies and methods 
for recruiting, retaining, and engaging with clinical 
trial participants, including communication regard-
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† HR 2617 EAS2 
ing the role of clinical trial participants and commu-
nity partners to facilitate clinical trial recruitment 
and engagement, including with respect to diverse 
and underrepresented populations, as appropriate. 
(8) Considerations for review and oversight by 
sponsors and institutional review boards, including 
remote trial oversight. 
(9) Recommendations for decentralized clinical 
trial protocol designs and processes for evaluating 
such proposed clinical trial designs. 
(10) Recommendations related to digital health 
technology and other remote assessment tools that 
may support decentralized clinical trials, including 
guidance on appropriate technological platforms and 
tools, data collection and use, data integrity, and 
communication to clinical trial participants through 
such technology. 
(11) A description of the manner in which the 
Secretary will assess or evaluate data collected within 
a decentralized clinical trial to support the develop-
ment of the drug or device, if the manner is different 
from that used for a nondecentralized trial. 
(12) Considerations for sponsors to validate dig-
ital technologies and establish appropriate clinical 
endpoints for use in decentralized trials.
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(13) Considerations for privacy and security of 
personally identifiable information of trial partici-
pants. 
(14) Considerations for conducting clinical trials 
using centralized approaches in conjunction with de-
centralized approaches. 
(c) DEFINITION.—In this section, the term ‘‘decentral-
ized clinical study’’ means a clinical study in which some 
or all of the study-related activities occur at a location sepa-
rate from the investigator’s location. 
SEC. 3607. MODERNIZING CLINICAL TRIALS. 
(a) CLARIFYING THE USE OF DIGITAL HEALTH TECH-
NOLOGIES IN CLINICAL TRIALS.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary shall 
issue or revise draft guidance regarding the appro-
priate use of digital health technologies in clinical 
trials to help improve recruitment for, retention in, 
participation in, and data collection during, clinical 
trials, and provide for novel clinical trial designs uti-
lizing such technology for purposes of supporting the 
development of, and review of applications for, drugs 
and devices. Not later than 18 months after the public 
comment period on such draft guidance ends, the Sec-
3551 
† HR 2617 EAS2 
retary shall issue a revised draft guidance or final 
guidance. 
(2) CONTENT.—The guidance described in para-
graph (1) shall include— 
(A) recommendations for data collection 
methodologies by which sponsors may incor-
porate the use of digital health technologies in 
clinical trials to collect data remotely from trial 
participants; 
(B) considerations for privacy and security 
protections for data collected during a clinical 
trial, including— 
(i) recommendations for the protection 
of trial participant data that are collected 
or used in research using digital health 
technologies; 
(ii) compliance with the regulations 
promulgated under section 264(c) of the 
Health Insurance Portability and Account-
ability Act of 1996 (42 U.S.C. 1320d–2 
note), subpart B of part 50 of title 21, Code 
of Federal Regulations, subpart C of part 
56 of title 21, Code of Federal Regulations, 
the Federal policy for the protection of 
human subjects under subpart A of part 46
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of title 45, Code of Federal Regulations 
(commonly known as the ‘‘Common Rule’’), 
and part 2 of title 42, Code of Federal Reg-
ulations (or any successor regulations); and 
(iii) recommendations for the protec-
tion of clinical trial participant data 
against cybersecurity threats, as applicable; 
(C) considerations on data collection meth-
ods to help increase recruitment of clinical trial 
participants and the level of participation of 
such participants, reduce burden on clinical trial 
participants, and optimize data quality; 
(D) recommendations for the use of elec-
tronic methods to obtain informed consent from 
clinical trial participants, taking into consider-
ation applicable Federal law, including subpart 
B of part 50 of title 21, Code of Federal Regula-
tions (or successor regulations), and, as appro-
priate, State law; 
(E) best practices for communication be-
tween sponsors and the Secretary on the develop-
ment of data collection methods; 
(F) the appropriate format to submit such 
data to the Secretary;
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† HR 2617 EAS2 
(G) a description of the manner in which 
the Secretary may assess or evaluate data col-
lected through digital health technologies to sup-
port the development of the drug or device; 
(H) recommendations regarding the data 
and information needed to demonstrate that a 
digital health technology is fit-for-purpose for a 
clinical trial, and a description of how the Sec-
retary will evaluate such data and information; 
and 
(I) recommendations for increasing access 
to, and the use of, digital health technologies in 
clinical trials to facilitate the inclusion of di-
verse and underrepresented populations, as ap-
propriate, including considerations for access to, 
and the use of, digital health technologies in clin-
ical trials by people with disabilities and pedi-
atric populations. 
(b) SEAMLESS AND CONCURRENT CLINICAL TRIALS.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary shall 
issue or revise draft guidance on the use of seamless, 
concurrent, and other innovative clinical trial designs 
to support the expedited development and review of 
applications for drugs, as appropriate. Not later than
3554 
† HR 2617 EAS2 
18 months after the public comment period on such 
draft guidance ends, the Secretary shall issue a re-
vised draft guidance or final guidance. 
(2) CONTENT.—The guidance described in para-
graph (1) shall include— 
(A) recommendations on the use of expan-
sion cohorts and other seamless clinical trial de-
signs to assess different aspects of product can-
didates in one continuous trial, including how 
such clinical trial designs can be used as part of 
meeting the substantial evidence standard under 
section 505(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(d)); 
(B) recommendations on the use of clinical 
trial designs that involve the concurrent conduct 
of different or multiple clinical trial phases, and 
the concurrent conduct of preclinical testing, to 
expedite the development of new drugs and facili-
tate the timely collection of data; 
(C) recommendations for how to streamline 
trial logistics and facilitate the efficient collec-
tion and analysis of clinical trial data, includ-
ing any planned interim analyses and how such 
analyses could be used to streamline the product 
development and review processes;
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† HR 2617 EAS2 
(D) considerations to assist sponsors in en-
suring the rights, safety, and welfare of clinical 
trial participants, maintaining compliance with 
good clinical practice regulations, minimizing 
risks to clinical trial data integrity, and ensur-
ing the reliability of clinical trial results; 
(E) recommendations for communication 
between sponsors and the Food and Drug Ad-
ministration on the development of seamless, 
concurrent, or other adaptive clinical trial de-
signs, including review of, and feedback on, clin-
ical trial protocols; and 
(F) a description of the manner in which 
the Secretary will assess or evaluate data col-
lected through seamless, concurrent, or other 
adaptive clinical trial designs to support the de-
velopment of drugs. 
(c) INTERNATIONAL HARMONIZATION.—The Secretary 
shall, as appropriate, work with foreign regulators pursu-
ant to memoranda of understanding or other arrangements 
governing the exchange of information to facilitate inter-
national harmonization of the regulation and use of decen-
tralized clinical trials, digital technology in clinical trials, 
and seamless, concurrent, and other adaptive or innovative 
clinical trial designs.
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† HR 2617 EAS2 
CHAPTER 2—INSPECTIONS 
SEC. 3611. DEVICE INSPECTIONS. 
(a) IN GENERAL.—Section 704(a)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is 
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, propa-
gation, 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 a site or facility that is subject to inspection 
under paragraph (5)(C),’’; and 
(B) by striking ‘‘records requested.’’ and in-
serting the following: ‘‘records or other informa-
tion requested and a rationale for requesting 
such records or other information in advance of, 
or in lieu of, an inspection.’’. 
(2) GUIDANCE.—
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† HR 2617 EAS2 
(A) IN GENERAL.—The Secretary shall issue 
or update guidance describing— 
(i) circumstances in which the Sec-
retary intends to issue requests for records 
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 re-
quests 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 reasonable 
limits, and in a reasonable manner, ac-
counting for resource and other limitations 
that may exist, including for small busi-
nesses. 
(B) TIMING.—The Secretary shall— 
(i) not later than 1 year after the date 
of enactment of this Act, issue draft guid-
ance under subparagraph (A); and
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† HR 2617 EAS2 
(ii) not later than 1 year after the close 
of the comment period for such draft guid-
ance, issue final guidance under subpara-
graph (A). 
SEC. 3612. BIORESEARCH MONITORING INSPECTIONS. 
(a) IN GENERAL.—Section 704(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended by 
adding at the end the following: 
‘‘(5)(A) The Secretary may, to ensure the accuracy and 
reliability of studies and records or other information de-
scribed in subparagraph (B) and to assess compliance with 
applicable requirements under this Act or the Public Health 
Service Act, enter sites and facilities specified in subpara-
graph (C) in order to inspect such records or other informa-
tion. 
‘‘(B) An inspection under this paragraph shall extend 
to all records and other information related to the studies 
and submissions described in subparagraph (E), including 
records and information related to the conduct, results, and 
analyses of, and the protection of human and animal trial 
participants participating in, such studies. 
‘‘(C)(i) The sites and facilities subject to inspection by 
the Secretary under this paragraph are those owned or op-
erated by a person described in clause (ii) and which are 
(or were) utilized by such person in connection with—
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† HR 2617 EAS2 
‘‘(I) developing an application or other submis-
sion to the Secretary under this Act or the Public 
Health Service Act related to marketing authorization 
for a product described in paragraph (1); 
‘‘(II) preparing, conducting, or analyzing the re-
sults of a study described in subparagraph (E); or 
‘‘(III) holding any records or other information 
described in subparagraph (B). 
‘‘(ii) A person described in this clause is— 
‘‘(I) the sponsor of an application or submission 
specified in subparagraph (E); 
‘‘(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; 
‘‘(III) an institutional review board, or other in-
dividual or entity, engaged by contract, grant, or 
other business arrangement with a nonsponsor in pre-
paring, collecting, or analyzing records or other infor-
mation described in subparagraph (B); or 
‘‘(IV) any person not otherwise described in this 
clause that conducts, or has conducted, a study de-
scribed in subparagraph (E) yielding records or other 
information described in subparagraph (B).
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† HR 2617 EAS2 
‘‘(D)(i) Subject to clause (ii), an entity that owns or 
operates any site or facility subject to inspection under this 
paragraph shall provide the Secretary with access to records 
and other information described in subparagraph (B) that 
is held by or under the control of such entity, including— 
‘‘(I) permitting the Secretary to record or copy 
such information for purposes of this paragraph; 
‘‘(II) providing the Secretary with access to any 
electronic information system 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 inspect the fa-
cilities, equipment, written procedures, processes, and 
conditions through which records or other information 
described in subparagraph (B) is or was generated, 
held, processed, analyzed, or transferred. 
‘‘(ii) Nothing in clause (i) shall negate, supersede, or 
otherwise affect the applicability of provisions, under this 
or any other Act, preventing or limiting the disclosure of 
confidential commercial information or other information 
considered proprietary or trade secret. 
‘‘(iii) An inspection under this paragraph shall be con-
ducted at reasonable times and within reasonable limits 
and in a reasonable manner.
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† HR 2617 EAS2 
‘‘(E) The studies and submissions described in this 
subparagraph are each of the following: 
‘‘(i) Clinical and nonclinical studies submitted 
to the Secretary in support of, or otherwise related to, 
applications and other submissions to the Secretary 
under this Act or the Public Health Service Act for 
marketing authorization 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 Public 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. 
‘‘(F) This paragraph clarifies the authority of the Sec-
retary to conduct inspections of the type described in this 
paragraph and shall not be construed as a basis for infer-
ring that, prior to the date of enactment of this paragraph, 
the Secretary lacked the authority to conduct such inspec-
3562 
† HR 2617 EAS2 
tions, including under this Act or the Public Health Service 
Act.’’. 
(b) REVIEW OF PROCESSES AND PRACTICES; GUID-
ANCE FOR INDUSTRY.— 
(1) IN GENERAL.—The Secretary shall— 
(A) 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 sec-
tion 704(a)(5) of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a); and 
(B) evaluate whether any updates are need-
ed to facilitate the consistency of such processes 
and practices. 
(2) GUIDANCE.— 
(A) IN GENERAL.—The Secretary shall issue 
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 Cos-
metic Act, as added by subsection (a), including 
with respect to the types of records and informa-
tion required to be provided, best practices for 
communication between the Food and Drug Ad-
ministration and industry in advance of or dur-
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† HR 2617 EAS2 
ing an inspection or request for records or other 
information, and other inspections-related con-
duct, to the extent not specified in existing pub-
licly available Food and Drug Administration 
guides and manuals for such inspections. 
(B) TIMING.—The Secretary shall— 
(i) not later than 18 months after the 
date of enactment of this Act, issue draft 
guidance under subparagraph (A); and 
(ii) not later than 1 year after the close 
of the public comment period for such draft 
guidance, issue final guidance under sub-
paragraph (A). 
SEC. 3613. IMPROVING FOOD AND DRUG ADMINISTRATION 
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 regula-
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† HR 2617 EAS2 
tion under this Act, including the history of vio-
lations related to products exported from such 
country or region that are subject to such regula-
tion.’’. 
(b) USE OF RECORDS.—Section 704(a)(4) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)) 
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 identified during such inspections, if ap-
plicable and appropriate.’’. 
(c) RECOGNITION OF FOREIGN GOVERNMENT INSPEC-
TIONS.—Section 809 of the Federal Food, Drug, and Cos-
metic 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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† HR 2617 EAS2 
‘‘(1) IN GENERAL.—Beginning not later than 1 
year after the date of the enactment of the Food and 
Drug Omnibus Reform Act of 2022, the Secretary 
shall periodically assess whether additional arrange-
ments 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 Omnibus Reform Act 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 of the Senate a re-
port describing the findings and conclusions of each 
review conducted under paragraph (1).’’. 
SEC. 3614. 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 Committee on En-
ergy and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and Pensions 
of the Senate a report on inspections conducted by—
3566 
† HR 2617 EAS2 
(1) the Secretary of foreign establishments pursu-
ant to subsections (h) and (i) of section 510 and sec-
tion 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 con-
duct inspections of foreign facilities that could be use-
ful to the Food and Drug Administration to review 
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 arrange-
ments 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 appropriately ex-
panded;