H. R. 2617—1387 
of the manufacturer to meet expected demand for its 
product; and 
‘‘(B) does not include interruptions in manufacturing 
due to matters such as routine maintenance, changes or 
discontinuance of flavors, colors, or other insignificant 
formulation characteristics, or insignificant changes in 
manufacturing so long as the manufacturer expects to 
resume operations in a short period of time. 
‘‘(b) RISK MANAGEMENT PLANS.—Each manufacturer of a critical 
food shall develop, maintain, and implement, as appropriate, a 
redundancy risk management plan that identifies and evaluates 
risks to the supply of the food, as applicable, for each establishment 
in which such food is manufactured. A risk management plan 
under this subsection— 
‘‘(1) may identify and evaluate risks to the supply of more 
than one critical food, or critical food category, manufactured 
at the same establishment; 
‘‘(2) may identify mechanisms by which the manufacturer 
would mitigate the impacts of a supply disruption through 
alternative production sites, alternative suppliers, stockpiling 
of inventory, or other means; and 
‘‘(3) shall be subject to inspection and copying by the Sec-
retary pursuant to an inspection under section 704. 
‘‘(c) FAILURE TO MEET REQUIREMENTS.— 
‘‘(1) IN GENERAL.—If a person fails to submit information 
required under, and in accordance with, subsection (a)— 
‘‘(A) the Secretary shall issue a letter to such person 
informing such person of such failure; and 
‘‘(B) not later than 45 calendar days after the issuance 
of a letter under subparagraph (A), subject to paragraph 
(2), the Secretary shall make available to the public on 
the website of the Food and Drug Administration, with 
appropriate redactions made to protect the information 
described in subsection (a)(3)— 
‘‘(i) the letter issued under subparagraph (A); and 
‘‘(ii) at the request of such person, any response 
to such letter such person submitted to the Secretary. 
‘‘(2) EXCEPTION.—If the Secretary determines that the letter 
under paragraph (1) was issued in error or, after review of 
such response, the person had a reasonable basis for not submit-
ting a notification as required under subsection (a), the require-
ments of paragraph (1)(B) shall not apply.’’. 
(l) SPECIALTY INFANT FORMULA FOR IMPORTATION.—Section 412 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), 
as amended by subsection (f)(2), is further amended by adding 
at the end the following: 
‘‘(m) WAIVER OF REQUIREMENTS FOR IMPORTATION OF SPECIALTY 
INFANT FORMULA.— 
‘‘(1) IN GENERAL.—The Secretary may, during a shortage 
of specialty infant formula as determined by the Secretary, 
waive any requirement under this Act applicable to facilitate 
the importation of specialty infant formula. Such a waiver 
may be applicable to— 
‘‘(A) the importation of specialty infant formula from 
any country that is determined by the Secretary to be
H. R. 2617—1388 
implementing and enforcing requirements for infant for-
mula that provide a similar assurance of safety and nutri-
tional adequacy as the requirements of this Act; or 
‘‘(B) the distribution and sale of such imported specialty 
infant formula. 
‘‘(2) RULE OF CONSTRUCTION.—Nothing in paragraph (1) 
shall be construed to limit the authority of the Secretary to 
require a recall of, or otherwise impose restrictions and require-
ments under this Act with respect to, specialty infant formula 
that is subject to a waiver under paragraph (1). 
‘‘(3) DEFINITION OF SPECIALTY INFANT FORMULA.—In this 
subsection, the term ‘specialty infant formula’ means infant 
formula described in subsection (h)(1).’’. 
(m) IMPORTATION FOR PERSONAL USE.— 
(1) IN
GENERAL.—Notwithstanding any provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 
during the 90-day period beginning on the date of enactment 
of this Act, an individual may, without prior notice to the 
Food and Drug Administration, import up to a 3-month supply 
of infant formula for personal use from— 
(A) Canada; 
(B) any country in the European Union; or 
(C) any other country that is determined by the Sec-
retary to be implementing and enforcing requirements for 
infant formula that provide a similar assurance of safety 
and nutritional adequacy as the requirements of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 
(2) LIMITATIONS.—Infant formula may be imported pursu-
ant to paragraph (1) only if the infant formula— 
(A) is exclusively for personal use and will not be 
commercialized or promoted; and 
(B) does not present an unreasonable risk to human 
health. 
(3) REPORTING OF ADVERSE EVENTS.—If a health care pro-
vider becomes aware of any adverse event which the health 
care provider reasonably suspects to be associated with infant 
formula imported pursuant to paragraph (1), the health care 
provider shall report such adverse event to the Commissioner 
of Food and Drugs. 
(4) PUBLIC
NOTICE.—The Secretary, acting through the 
Commissioner of Food and Drugs, shall post on the public 
website of the Food and Drug Administration notice that— 
(A) infant formula imported pursuant to paragraph 
(1) may not have been manufactured in a facility that 
has been inspected by the Food and Drug Administration; 
(B) the labeling of such infant formula may not meet 
the standards and other requirements applicable with 
respect to infant formula under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.); and 
(C) the nutritional content of infant formula imported 
pursuant to paragraph (1) may vary from that of infant 
formula meeting such standards and other requirements. 
(5) SENSE OF CONGRESS.—It is the sense of Congress that 
persons considering the personal importation of infant formula 
should consult with their pediatrician about such importation.
H. R. 2617—1389 
Subtitle E—Cosmetics 
SEC. 3501. SHORT TITLE. 
This subtitle may be cited as the ‘‘Modernization of Cosmetics 
Regulation Act of 2022’’. 
SEC. 3502. AMENDMENTS TO COSMETIC REQUIREMENTS. 
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 361 et seq.) is amended by adding at the end the following: 
‘‘SEC. 604. DEFINITIONS. 
‘‘In this chapter: 
‘‘(1) ADVERSE EVENT.—The term ‘adverse event’ means any 
health-related event associated with the use of a cosmetic 
product that is adverse. 
‘‘(2) COSMETIC
PRODUCT.—The term ‘cosmetic product’ 
means a preparation of cosmetic ingredients with a qualitatively 
and quantitatively set composition for use in a finished product. 
‘‘(3) FACILITY.— 
‘‘(A) IN
GENERAL.—The term ‘facility’ includes any 
establishment (including an establishment of an importer) 
that manufactures or processes cosmetic products distrib-
uted in the United States. 
‘‘(B) Such term does not include any of the following: 
‘‘(i) Beauty shops and salons, unless such establish-
ment manufactures or processes cosmetic products at 
that location. 
‘‘(ii) Cosmetic product retailers, including indi-
vidual sales representatives, direct sellers (as defined 
in section 3508(b)(2) of the Internal Revenue Code 
of 1986), retail distribution facilities, and pharmacies, 
unless such establishment manufactures or processes 
cosmetic products that are not sold directly to con-
sumers at that location. 
‘‘(iii) Hospitals, physicians’ offices, and health care 
clinics. 
‘‘(iv) Public health agencies and other nonprofit 
entities that provide cosmetic products directly to the 
consumer. 
‘‘(v) Entities (such as hotels and airlines) that pro-
vide complimentary cosmetic products to customers 
incidental to other services. 
‘‘(vi) Trade shows and other venues where cosmetic 
product samples are provided free of charge. 
‘‘(vii) An establishment that manufactures or proc-
esses cosmetic products that are solely for use in 
research or evaluation, including for production testing 
and not offered for retail sale. 
‘‘(viii) An establishment that solely performs one 
or more of the following with respect to cosmetic prod-
ucts: 
‘‘(I) Labeling. 
‘‘(II) Relabeling. 
‘‘(III) Packaging. 
‘‘(IV) Repackaging. 
‘‘(V) Holding. 
‘‘(VI) Distributing.
H. R. 2617—1390 
‘‘(C) CLARIFICATION.—For the purposes of subpara-
graph (B)(viii), the terms ‘packaging’ and ‘repackaging’ do 
not include filling a product container with a cosmetic 
product. 
‘‘(4) RESPONSIBLE PERSON.—The term ‘responsible person’ 
means the manufacturer, packer, or distributor of a cosmetic 
product whose name appears on the label of such cosmetic 
product in accordance with section 609(a) of this Act or section 
4(a) of the Fair Packaging and Labeling Act. 
‘‘(5) SERIOUS ADVERSE EVENT.—The term ‘serious adverse 
event’ means an adverse event that— 
‘‘(A) results in— 
‘‘(i) death; 
‘‘(ii) a life-threatening experience; 
‘‘(iii) inpatient hospitalization; 
‘‘(iv) a persistent or significant disability or inca-
pacity; 
‘‘(v) a congenital anomaly or birth defect; 
‘‘(vi) an infection; or 
‘‘(vii) significant disfigurement (including serious 
and persistent rashes, second- or third-degree burns, 
significant hair loss, or persistent or significant alter-
ation of appearance), other than as intended, under 
conditions of use that are customary or usual; or 
‘‘(B) requires, based on reasonable medical judgment, 
a medical or surgical intervention to prevent an outcome 
described in subparagraph (A). 
‘‘SEC. 605. ADVERSE EVENTS. 
‘‘(a) SERIOUS ADVERSE EVENT REPORTING REQUIREMENTS.—The 
responsible person shall submit to the Secretary any report received 
of a serious adverse event associated with the use, in the United 
States, of a cosmetic product manufactured, packed, or distributed 
by such person. 
‘‘(b) SUBMISSION OF REPORTS.— 
‘‘(1) SERIOUS ADVERSE EVENT REPORT.—The responsible per-
son shall submit to the Secretary a serious adverse event report 
accompanied by a copy of the label on or within the retail 
packaging of such cosmetic product no later than 15 business 
days after the report is received by the responsible person. 
‘‘(2) NEW MEDICAL INFORMATION.—The responsible person 
shall submit to the Secretary any new and material medical 
information, related to a serious adverse event report submitted 
to the Secretary in accordance with paragraph (1), that is 
received by the responsible person within 1 year of the initial 
report to the Secretary, no later than 15 business days after 
such information is received by such responsible person. 
‘‘(3) CONSOLIDATION
OF
REPORTS.—The Secretary shall 
develop systems to enable responsible persons to submit a 
single report that includes duplicate reports of, or new medical 
information related to, a serious adverse event. 
‘‘(c) EXEMPTIONS.—The Secretary may establish by regulation 
an exemption to any of the requirements of this section if the 
Secretary determines that such exemption would have no significant 
adverse effect on public health. 
‘‘(d) CONTACT
INFORMATION.—The responsible person shall 
receive reports of adverse events through the domestic address,
H. R. 2617—1391 
domestic telephone number, or electronic contact information 
included on the label in accordance with section 609(a). 
‘‘(e) MAINTENANCE
AND
INSPECTION
OF
ADVERSE
EVENT 
RECORDS.— 
‘‘(1) MAINTENANCE.—The responsible person shall maintain 
records related to each report of an adverse event associated 
with the use, in the United States, of a cosmetic product manu-
factured or distributed by such person received by such person, 
for a period of 6 years, except that a responsible person that 
is considered a small business for the purposes of section 612, 
who does not engage in the manufacturing or processing of 
the cosmetic products described in subsection 612(b), shall 
maintain such records for a period of 3 years. 
‘‘(2) INSPECTION.— 
‘‘(A) IN GENERAL.— The responsible person shall permit 
an authorized person to have access to records required 
to be maintained under this section during an inspection 
pursuant to section 704. 
‘‘(B) AUTHORIZED PERSON.—For purposes of this para-
graph, the term ‘authorized person’ means an officer or 
employee of the Department of Health and Human Services 
who has— 
‘‘(i) appropriate credentials, as determined by the 
Secretary; and 
‘‘(ii) been duly designated by the Secretary to have 
access to the records required under this section. 
‘‘(f) FRAGRANCE AND FLAVOR INGREDIENTS.—If the Secretary 
has reasonable grounds to believe that an ingredient or combination 
of ingredients in a fragrance or flavor has caused or contributed 
to a serious adverse event required to be reported under this section, 
the Secretary may request in writing a list of such ingredients 
or categories of ingredients in the specific fragrances or flavors 
in the cosmetic product, from the responsible person. The respon-
sible person shall ensure that the requested information is sub-
mitted to the Secretary within 30 days of such request. In response 
to a request under section 552 of title 5, United States Code, 
information submitted to the Secretary under this subsection shall 
be withheld under section 552(b)(3) of title 5, United States Code. 
‘‘(g) PROTECTED INFORMATION.—A serious adverse event report 
submitted to the Secretary under this section, including any new 
medical information submitted under subsection (b)(2), or an 
adverse event report, or any new information, voluntarily submitted 
to the Secretary shall be considered to be— 
‘‘(1) a safety report under section 756 and may be accom-
panied by a statement, which shall be a part of any report 
that is released for public disclosure, that denies that the 
report or the records constitute an admission that the product 
involved caused or contributed to the adverse event; and 
‘‘(2) a record about an individual under section 552a of 
title 5, United States Code (commonly referred to as the ‘Privacy 
Act of 1974’) and a medical or similar file the disclosure of 
which would constitute a violation of section 552 of such title 
5 (commonly referred to as the ‘Freedom of Information Act’), 
and shall not be publicly disclosed unless all personally identifi-
able information is redacted. 
‘‘(h) EFFECT OF SECTION.—
H. R. 2617—1392 
‘‘(1) IN GENERAL.—Nothing in this section shall affect the 
authority of the Secretary to provide adverse event reports 
and information to any health, food, or drug officer or employee 
of any State, territory, or political subdivision of a State or 
territory, under a memorandum of understanding between the 
Secretary and such State, territory, or political subdivision. 
‘‘(2) PERSONALLY
IDENTIFIABLE
INFORMATION.—Notwith-
standing any other provision of law, personally-identifiable 
information in adverse event reports provided by the Secretary 
to any health, food, or drug officer or employee of any State, 
territory, or political subdivision of a State or territory, shall 
not— 
‘‘(A) be made publicly available pursuant to any State 
or other law requiring disclosure of information or records; 
or 
‘‘(B) otherwise be disclosed or distributed to any party 
without the written consent of the Secretary and the person 
submitting such information to the Secretary. 
‘‘(3) USE OF REPORTS.—Nothing in this section shall permit 
a State, territory, or political subdivision of a State or territory, 
to use any safety report received from the Secretary in a 
manner inconsistent with this section. 
‘‘(4) RULE OF CONSTRUCTION.—The submission of any report 
in compliance with this section shall not be construed as an 
admission that the cosmetic product involved caused or contrib-
uted to the relevant adverse event. 
‘‘SEC. 606. GOOD MANUFACTURING PRACTICE. 
‘‘(a) IN GENERAL.—The Secretary shall by regulation establish 
good manufacturing practices for facilities that are consistent, to 
the extent practicable, and appropriate, with national and inter-
national standards, in accordance with section 601. Any such regula-
tions shall be intended to protect the public health and ensure 
that cosmetic products are not adulterated. Such regulations may 
allow for the Secretary to inspect records necessary to demonstrate 
compliance with good manufacturing practices prescribed by the 
Secretary under this paragraph during an inspection conducted 
under section 704. 
‘‘(b) CONSIDERATIONS.—In establishing regulations for good 
manufacturing practices under this section, the Secretary shall 
take into account the size and scope of the businesses engaged 
in the manufacture of cosmetics, and the risks to public health 
posed by such cosmetics, and provide sufficient flexibility to be 
practicable for all sizes and types of facilities to which such regula-
tions will apply. Such regulations shall include simplified good 
manufacturing practice requirements for smaller businesses, as 
appropriate, to ensure that such regulations do not impose undue 
economic hardship for smaller businesses, and may include longer 
compliance times for smaller businesses. Before issuing regulations 
to implement subsection (a), the Secretary shall consult with cos-
metics manufacturers, including smaller businesses, consumer 
organizations, and other experts selected by the Secretary. 
‘‘(c) TIMEFRAME.—The Secretary shall publish a notice of pro-
posed rulemaking not later than 2 years after the date of enactment 
of the Modernization of Cosmetics Regulation Act of 2022 and 
shall publish a final such rule not later than 3 years after such 
date of enactment.
H. R. 2617—1393 
‘‘SEC. 607. REGISTRATION AND PRODUCT LISTING. 
‘‘(a) SUBMISSION OF REGISTRATION.— 
‘‘(1) INITIAL REGISTRATION.— 
‘‘(A) EXISTING FACILITIES.—Every person that, on the 
date of enactment of the Modernization of Cosmetics Regu-
lation Act of 2022, owns or operates a facility that engages 
in the manufacturing or processing of a cosmetic product 
for distribution in the United States shall register each 
facility with the Secretary not later than 1 year after 
date of enactment of such Act. 
‘‘(B) NEW FACILITIES.—Every person that owns or oper-
ates a facility that first engages, after the date of enactment 
of the Modernization of Cosmetics Regulation Act of 2022, 
in manufacturing or processing of a cosmetic product for 
distribution in the United States, shall register with the 
Secretary such facility within 60 days of first engaging 
in such activity or 60 days after the deadline for registra-
tion under subparagraph (A), whichever is later. 
‘‘(2) BIENNIAL
RENEWAL
OF
REGISTRATION.—A person 
required to register a facility under paragraph (1) shall renew 
such registrations with the Secretary biennially. 
‘‘(3) CONTRACT MANUFACTURERS.—If a facility manufactures 
or processes cosmetic products on behalf of a responsible person, 
the Secretary shall require only a single registration for such 
facility even if such facility is manufacturing or processing 
its own cosmetic products or cosmetic products on behalf of 
more than one responsible person. Such single registration 
may be submitted to the Secretary by such facility or any 
responsible person whose products are manufactured or proc-
essed at such facility. 
‘‘(4) UPDATES TO CONTENT.—A person that is required to 
register under subsection (a)(1) shall notify the Secretary within 
60 days of any changes to information required under sub-
section (b)(2). 
‘‘(5) ABBREVIATED RENEWAL REGISTRATIONS.—The Secretary 
shall provide for an abbreviated registration renewal process 
for any person that owns or operates a facility that has not 
been required to submit updates under paragraph (4) for a 
registered facility since submission of the most recent registra-
tion of such facility under paragraph (1) or (2). 
‘‘(b) FORMAT; CONTENTS OF REGISTRATION.— 
‘‘(1) IN GENERAL.—Registration information under this sec-
tion may be submitted at such time and in such manner as 
the Secretary may prescribe. 
‘‘(2) CONTENTS.—The registration under subsection (a) shall 
contain— 
‘‘(A) the facility’s name, physical address, email 
address, and telephone number; 
‘‘(B) with respect to any foreign facility, the contact 
for the United States agent of the facility, and, if available, 
the electronic contact information; 
‘‘(C) the facility registration number, if any, previously 
assigned by the Secretary under subsection (d); 
‘‘(D) all brand names under which cosmetic products 
manufactured or processed in the facility are sold; and
H. R. 2617—1394 
‘‘(E) the product category or categories and responsible 
person for each cosmetic product manufactured or processed 
at the facility. 
‘‘(c) COSMETIC PRODUCT LISTING.— 
‘‘(1) IN GENERAL.—For each cosmetic product, the respon-
sible person shall submit to the Secretary a cosmetic product 
listing, or ensure that such submission is made, at such time 
and in such manner as the Secretary may prescribe. 
‘‘(2) COSMETIC PRODUCT LISTING.—The responsible person 
of a cosmetic product that is marketed on the date of enactment 
of the Modernization of Cosmetics Regulation Act of 2022 shall 
submit to the Secretary a cosmetic product listing not later 
than 1 year after the date of enactment of the Modernization 
of Cosmetics Regulation Act of 2022, or for a cosmetic product 
that is first marketed after the date of enactment of such 
Act, within 120 days of marketing such product in interstate 
commerce. Thereafter, any updates to such listing shall be 
made annually, consistent with paragraphs (4) and (5). 
‘‘(3) ABBREVIATED RENEWAL.—The Secretary shall provide 
for an abbreviated process for the renewal of any cosmetic 
product listing under this subsection with respect to which 
there has been no change since the responsible person sub-
mitted the previous listing. 
‘‘(4) CONTENTS OF LISTING.— 
‘‘(A) IN GENERAL.—Each such cosmetic product listing 
shall include— 
‘‘(i) the facility registration number of each facility 
where the cosmetic product is manufactured or proc-
essed; 
‘‘(ii) the name and contact number of the respon-
sible person and the name for the cosmetic product, 
as such name appears on the label; 
‘‘(iii) the applicable cosmetic category or categories 
for the cosmetic product; 
‘‘(iv) a list of ingredients in the cosmetic product, 
including any fragrances, flavors, or colors, with each 
ingredient identified by the name, as required under 
section 701.3 of title 21, Code of Federal Regulations 
(or any successor regulations), or by the common or 
usual name of the ingredient; and 
‘‘(v) the product listing number, if any previously 
assigned by the Secretary under subsection (d). 
‘‘(B) FLEXIBLE LISTINGS.—A single listing submission 
for a cosmetic product may include multiple cosmetic prod-
ucts with identical formulations, or formulations that differ 
only with respect to colors, fragrances or flavors, or 
quantity of contents. 
‘‘(5) UPDATES TO CONTENT.—A responsible person that is 
required to submit a cosmetic product listing shall submit any 
updates to such cosmetic product listing annually. 
‘‘(6) SUBMISSION.—A responsible person may submit 
product listing information as part of a facility registration 
or separately. 
‘‘(d) FACILITY REGISTRATION AND PRODUCT LISTING NUMBERS.— 
At the time of the initial registration of any facility under subsection 
(a)(1) or initial listing of any cosmetic product under (c)(1), the 
Secretary shall assign a facility registration number to the facility
H. R. 2617—1395 
and a product listing number to each cosmetic product. The Sec-
retary shall not make such product listing number publicly avail-
able. 
‘‘(e) CONFIDENTIALITY.—In response to a request under section 
552 of title 5, United States Code, information described in sub-
section (b)(2)(D) or (c)(4)(A)(i) that is derived from a registration 
or listing under this section shall be withheld under section 
552(b)(3) of title 5, United States Code. 
‘‘(f) SUSPENSIONS.— 
‘‘(1) SUSPENSION OF REGISTRATION OF A FACILITY.—The Sec-
retary may suspend the registration of a facility if the Secretary 
determines that a cosmetic product manufactured or processed 
by a registered facility and distributed in the United States 
has a reasonable probability of causing serious adverse health 
consequences or death to humans and the Secretary has a 
reasonable belief that other products manufactured or processed 
by the facility may be similarly affected because of a failure 
that cannot be isolated to a product or products, or is suffi-
ciently pervasive to raise concerns about other products manu-
factured in the facility. 
‘‘(2) NOTICE OF SUSPENSION.—Before suspending a facility 
registration under this section, the Secretary shall provide— 
‘‘(A) notice to the facility registrant of the cosmetic 
product or other responsible person, as appropriate, of the 
intent to suspend the facility registration, which shall 
specify the basis of the determination by the Secretary 
that the facility registration should be suspended; and 
‘‘(B) an opportunity, within 5 business days of the 
notice provided under subparagraph (A), for the responsible 
person to provide a plan for addressing the reasons for 
possible suspension of the facility registration. 
‘‘(3) HEARING ON SUSPENSION.—The Secretary shall provide 
the registrant subject to an order under paragraph (1) or (2) 
with an opportunity for an informal hearing, to be held as 
soon as possible but not later than 5 business days after the 
issuance of the order, or such other time period agreed upon 
by the Secretary and the registrant, on the actions required 
for reinstatement of registration and why the registration that 
is subject to the suspension should be reinstated. The Secretary 
shall reinstate a registration if the Secretary determines, based 
on evidence presented, that adequate grounds do not exist 
to continue the suspension of the registration. 
‘‘(4) POST-HEARING CORRECTIVE ACTION PLAN.—If, after pro-
viding opportunity for an informal hearing under paragraph 
(3), the Secretary determines that the suspension of registration 
remains necessary, the Secretary shall require the registrant 
to submit a corrective action plan to demonstrate how the 
registrant plans to correct the conditions found by the Sec-
retary. The Secretary shall review such plan not later than 
14 business days after the submission of the corrective action 
plan or such other time period as determined by the Secretary, 
in consultation with the registrant. 
‘‘(5) VACATING OF ORDER; REINSTATEMENT.—Upon a deter-
mination by the Secretary that adequate grounds do not exist 
to continue the suspension actions, the Secretary shall promptly 
vacate the suspension and reinstate the registration of the 
facility.
H. R. 2617—1396 
‘‘(6) EFFECT
OF
SUSPENSION.—If the registration of the 
facility is suspended under this section, no person shall intro-
duce or deliver for introduction into commerce in the United 
States cosmetic products from such facility. 
‘‘(7) NO DELEGATION.—The authority conferred by this sec-
tion to issue an order to suspend a registration or vacate 
an order of suspension shall not be delegated to any officer 
or employee other than the Commissioner. 
‘‘SEC. 608. SAFETY SUBSTANTIATION. 
‘‘(a) SUBSTANTIATION OF SAFETY.—A responsible person for a 
cosmetic product shall ensure, and maintain records supporting, 
that there is adequate substantiation of safety of such cosmetic 
product. 
‘‘(b) COAL-TAR HAIR DYE.—Subsection (a) shall not apply to 
coal-tar hair dye that otherwise complies with the requirements 
of section 601(a). A responsible person for a coal-tar hair dye shall 
maintain records related to the safety of such product. 
‘‘(c) DEFINITIONS.—For purposes of this section: 
‘‘(1) ADEQUATE SUBSTANTIATION OF SAFETY.—The term ‘ade-
quate substantiation of safety’ means tests or studies, research, 
analyses, or other evidence or information that is considered, 
among experts qualified by scientific training and experience 
to evaluate the safety of cosmetic products and their ingredi-
ents, sufficient to support a reasonable certainty that a cosmetic 
product is safe. 
‘‘(2) SAFE.—The term ‘safe’ means that the cosmetic 
product, including any ingredient thereof, is not injurious to 
users under the conditions of use prescribed in the labeling 
thereof, or under such conditions of use as are customary or 
usual. The Secretary shall not consider a cosmetic ingredient 
or cosmetic product injurious to users solely because it can 
cause minor and transient reactions or minor and transient 
skin irritations in some users. In determining for purposes 
of this section whether a cosmetic product is safe, the Secretary 
may consider, as appropriate and available, the cumulative 
or other relevant exposure to the cosmetic product, including 
any ingredient thereof. 
‘‘SEC. 609. LABELING. 
‘‘(a) GENERAL REQUIREMENT.—Each cosmetic product shall bear 
a label that includes a domestic address, domestic phone number, 
or electronic contact information, which may include a website, 
through which the responsible person can receive adverse event 
reports with respect to such cosmetic product. 
‘‘(b) FRAGRANCE ALLERGENS.—The responsible person shall 
identify on the label of a cosmetic product each fragrance allergen 
included in such cosmetic product. Substances that are fragrance 
allergens for purposes of this subsection shall be determined by 
the Secretary by regulation. The Secretary shall issue a notice 
of proposed rulemaking promulgating the regulation implementing 
this requirement not later than 18 months after the date of enact-
ment of the Modernization of Cosmetics Regulation Act of 2022, 
and not later than 180 days after the date on which the public 
comment period on the proposed rulemaking closes, shall issue 
a final rulemaking. In promulgating regulations implementing this 
subsection, the Secretary shall consider international, State, and 
local requirements for allergen disclosure, including the substance
H. R. 2617—1397 
and format of requirements in the European Union, and may estab-
lish threshold levels of amounts of substances subject to disclosure 
pursuant to such regulations. 
‘‘(c) COSMETIC PRODUCTS FOR PROFESSIONAL USE.— 
‘‘(1) DEFINITION OF PROFESSIONAL.—For purposes of this 
subsection, the term ‘professional’ means an individual who 
is licensed by an official State authority to practice in the 
field of cosmetology, nail care, barbering, or esthetics. 
‘‘(2) PROFESSIONAL
USE
LABELING.—A cosmetic product 
introduced into interstate commerce and intended to be used 
only by a professional shall bear a label that— 
‘‘(A) contains a clear and prominent statement that 
the product shall be administered or used only by licensed 
professionals; and 
‘‘(B) is in conformity with the requirements of the 
Secretary for cosmetics labeling under this Act and section 
4(a) of the Fair Packaging and Labeling Act. 
‘‘SEC. 610. RECORDS. 
‘‘(a) IN GENERAL.—If the Secretary has a reasonable belief 
that a cosmetic product, including an ingredient in such cosmetic 
product, and any other cosmetic product that the Secretary reason-
ably believes is likely to be affected in a similar manner, is likely 
to be adulterated such that the use or exposure to such product 
presents a threat of serious adverse health consequences or death 
to humans, each responsible person and facility shall, at the request 
of an officer or employee duly designated by the Secretary, permit 
such officer or employee, upon presentation of appropriate creden-
tials and a written notice to such person, at reasonable times 
and within reasonable limits and in a reasonable manner, to have 
access to and copy all records relating to such cosmetic product, 
and to any other cosmetic product that the Secretary reasonably 
believes is likely to be affected in a similar manner, that are 
needed to assist the Secretary in determining whether the cosmetic 
product is adulterated and presents a threat of serious adverse 
health consequences or death to humans. This subsection shall 
not be construed to extend to recipes or formulas for cosmetics, 
financial data, pricing data, personnel data (other than data as 
to qualification of technical and professional personnel performing 
functions subject to this Act), research data (other than safety 
substantiation data for cosmetic products and their ingredients), 
or sales data (other than shipment data regarding sales). 
‘‘(b) RULE OF CONSTRUCTION.—Nothing in this section shall 
be construed to limit the authority of the Secretary to inspect 
records or require establishment and maintenance of records under 
any other provision of this Act, including section 605 or 606. 
‘‘SEC. 611. MANDATORY RECALL AUTHORITY. 
‘‘(a) IN GENERAL.—If the Secretary determines that there is 
a reasonable probability that a cosmetic is adulterated under section 
601 or misbranded under section 602 and the use of or exposure 
to such cosmetic will cause serious adverse health consequences 
or death, the Secretary shall provide the responsible person with 
an opportunity to voluntarily 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
H. R. 2617—1398 
may, by order, require, as the Secretary determines necessary, 
such person to immediately cease distribution of such article. 
‘‘(b) HEARING.—The Secretary shall provide the responsible per-
son who is subject to an order under subsection (a) with an oppor-
tunity 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; 
‘‘(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 appropriate 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 subsection (c) 
shall immediately cease distribution of or recall, as applicable, 
the cosmetic and provide notification as required by such order. 
‘‘(e) NOTICE TO PERSONS AFFECTED.—If the Secretary deter-
mines 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 subsection (c) to provide either a notice 
of a recall order for, or an order to cease distribution of, such 
cosmetic, as applicable, 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— 
‘‘(1) ensure that a press release is published regarding 
the recall, and that alerts and public notices are issued, as 
appropriate, in order to provide notification— 
‘‘(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 associated with such 
article; and 
‘‘(iii) to the extent practicable, information for con-
sumers about similar cosmetics 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. 
‘‘(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.
H. R. 2617—1399 
‘‘SEC. 612. SMALL BUSINESSES. 
‘‘(a) IN GENERAL.—Responsible persons, and owners and opera-
tors 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 requirements of section 606 or 607. 
‘‘(b) REQUIREMENTS APPLICABLE TO ALL MANUFACTURERS AND 
PROCESSORS OF COSMETICS.—The exemptions under subsection (a) 
shall not apply to any responsible 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 conditions of use that 
are customary or usual. 
‘‘(2) Cosmetic products that are injected. 
‘‘(3) Cosmetic products that are intended for internal use. 
‘‘(4) Cosmetic products that are intended to alter appear-
ance 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 FACILITIES. 
‘‘(a) IN GENERAL.—Notwithstanding any other provision 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 sections 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 sub-
ject 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 cosmetic products. 
‘‘SEC. 614. PREEMPTION. 
‘‘(a) IN GENERAL.—No State or political subdivision of a State 
may establish or continue in effect any law, regulation, order, 
or other requirement for cosmetics that is different from or in 
addition to, or otherwise not identical with, any requirement 
applicable under this chapter with respect to registration and 
product listing, good manufacturing 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, ref-
erendum, regulation, or other State action, except as expressly 
provided in subsection (a). Notwithstanding subsection (a), nothing 
in this section shall be construed to prevent any State from prohib-
iting the use or limiting the amount of an ingredient in a cosmetic 
product, or from continuing in effect a requirement of any State 
that is in effect at the time of enactment of the Modernization 
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
H. R. 2617—1400 
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 section shall 
be construed to amend, expand, or limit the provisions under section 
752.’’. 
SEC. 3503. ENFORCEMENT AND CONFORMING AMENDMENTS. 
(a) IN GENERAL.— 
(1) PROHIBITED ACTS.—Section 301 of the Federal 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 information 
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 practice requirements 
of section 606. 
‘‘(g) If it is a cosmetic product, and the cosmetic product, 
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— 
(A) by striking ‘‘and (2)’’ and inserting ‘‘(2)’’; and 
(B) by inserting after ‘‘numerical count’’ the following: 
‘‘; and (3) the information required 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 inserting ‘‘564, 605, 
703’’; and 
(ii) by striking ‘‘564, 760’’ and inserting ‘‘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’’; 
(ii) by striking ‘‘defined in such section 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 section 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))—
H. R. 2617—1401 
(i) by striking ‘‘requirements of sections 760 or 
761,’’ and inserting ‘‘requirements 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 by section 802, shall 
take effect on the date that is 2 years after the date of enact-
ment of this Act. 
(c) CONFIDENTIALITY.— 
(1) IN
GENERAL.—The Secretary shall take appropriate 
measures to ensure that there are in effect effective procedures 
to prevent the unauthorized disclosure of any trade secret or 
confidential commercial information that is obtained by the 
Secretary of Health and Human Services pursuant to this sub-
title, 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 Cosmetic 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, 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 enactment 
of this Act, shall promulgate proposed regulations 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 regulations 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 ‘‘Secretary’’) shall assess the 
use of perfluoroalkyl and polyfluoroalkyl substances in cosmetic 
products and the scientific 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.
H. R. 2617—1402 
(b) REPORT.—Not later than 3 years after enactment of this 
Act, the Secretary shall publish on the website of the Food and 
Drug Administration a report summarizing the results of the assess-
ment 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 cosmetic products 
and should be phased out with the exception of appropriate allow-
ances. 
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 (including 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 STUDIES. 
(a) DRUGS.—Section 505 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355) is amended by adding at the end the 
following: 
‘‘(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 successor regulations), or, as 
appropriate, another pivotal study of a new drug (other than bio-
availability or bioequivalence 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 protocol to the Secretary for 
such a phase 3 study or other pivotal study of the drug. The 
sponsor may submit modifications to the diversity action plan. 
Any such modifications shall be in the form and manner specified 
by the Secretary in guidance. 
‘‘(4)(A) On the initiative of the Secretary or at the request 
of a sponsor, the Secretary may waive any requirement in para-
graph (1), (2), or (3) if the Secretary determines 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 investigation in accordance with a diversity action plan
H. R. 2617—1403 
would otherwise 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 submission of an 
application for an investigational device exemption is required shall 
submit to the Secretary in such application a diversity action plan 
for clinical studies of the device, in the form and manner specified 
in guidance issued by the Secretary. 
‘‘(ii) The sponsor of a device for which submission of an applica-
tion for an investigational device exemption is not required, except 
for a device being studied as described in section 812.2(c) of title 
21, Code of Federal Regulations (or successor regulations), 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 subpara-
graph (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 request 
of a sponsor, the Secretary may waive any requirement in subpara-
graph (A) or (B) if the Secretary determines 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 investigation (including in terms of the patient 
population that may use the device), if conducting a clinical inves-
tigation 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. 
‘‘(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) pertaining to the sponsor’s goals 
for clinical study enrollment, disaggregated by age group, sex, 
and racial and ethnic demographic characteristics of clinically 
relevant study populations, and may include characteristics
H. R. 2617—1404 
such as geographic location and socioeconomic status, including 
with respect to— 
(A) the rationale for the sponsor’s enrollment goals, 
which may include— 
(i) the estimated prevalence or incidence in the 
United States of the disease or condition for which 
the drug or device is being investigated in the relevant 
clinical trial, if such estimated prevalence or incidence 
is known or can be determined based on available 
data; 
(ii) what is known about the disease or condition 
for which the drug or device is being 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, which may 
include age group, sex, race, geographic location, 
socioeconomic status, and ethnicity; 
(II) non-demographic factors, including co- 
morbidities affecting the patient population; and 
(III) potential barriers to enrolling diverse 
participants, such as patient population size, 
geographic location, and socioeconomic status; and 
(v) any other data or information relevant to 
selecting appropriate enrollment goals, disaggregated 
by demographic subgroup, such as the inclusion of 
pregnant and lactating women; and 
(B) an explanation for how the sponsor intends 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 diversity 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 
(B) any updates needed to be made to a diversity 
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 sponsor’s reasons for why the 
sponsor does not expect to meet such goals. 
(b) ISSUANCE.—The Secretary shall—
H. R. 2617—1405 
(1) not later than 12 months after the date of enactment 
of this Act, issue new draft guidance or update existing draft 
guidance described in subsection (a); and 
(2) not later than 9 months after closing the comment 
period on such draft guidance, finalize such guidance. 
(c) APPLICABILITY.—Sections 505(z) and 520(g)(9) of the Federal 
Food, Drug, and Cosmetic Act, as added by section 3601, shall 
apply only with respect to clinical investigations for which enroll-
ment commences after the date that is 180 days after the publica-
tion of final guidance required under this section. 
SEC. 3603. PUBLIC WORKSHOPS TO ENHANCE CLINICAL STUDY DIVER-
SITY. 
(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 research organizations, 
academia, patients, and other stakeholders, shall convene one or 
more public workshops to solicit input from stakeholders on 
increasing the enrollment of historically underrepresented popu-
lations in clinical studies and encouraging clinical study participa-
tion that reflects the prevalence of the disease or condition among 
demographic 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 meth-
odologies for assessing such data; 
(2) considerations for the dissemination, as appropriate, 
after approval, of information to the public on clinical study 
enrollment demographic data; 
(3) the establishment of goals for enrollment in clinical 
trials, including the relevance of the estimated prevalence or 
incidence, as applicable, in the United States of the disease 
or condition for which the drug or device is being developed; 
and 
(4) approaches to support inclusion of underrepresented 
populations and to encourage clinical study participation that 
reflects the population expected to use the drug or device under 
study, including with respect to— 
(A) the establishment of inclusion and exclusion cri-
teria for certain subgroups, such as pregnant and lactating 
women and individuals with disabilities, including intellec-
tual or developmental disabilities or mental illness; 
(B) considerations regarding informed consent 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 convened under this section. 
The public comment period shall remain open for 60 days following 
the date on which each public workshop is convened.