3441 
† HR 2617 EAS2 
Administration. Such engagement may in-
clude— 
(i) developing guidance for Food and 
Drug Administration staff and best prac-
tices for, and across, product review teams, 
including with respect to communication 
between sponsors and the Food and Drug 
Administration and the review of products 
under accelerated approval; 
(ii) providing training for product re-
view teams; and 
(iii) advising review divisions on best 
practices with respect to product-specific de-
velopment, review, and withdrawal of prod-
ucts under accelerated approval. 
(4) PUBLICATION OF A REPORT.—Not later than 
1 year after the date of enactment of this Act, and an-
nually thereafter, the Council shall publish on the 
public website of the Food and Drug Administration 
a report on the activities of the Council. 
(f) RULE OF CONSTRUCTION.—Nothing in this section 
(including the amendments made by this section) shall be 
construed to affect ongoing withdrawal proceedings for 
products approved pursuant to section 506(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) for which
3442 
† HR 2617 EAS2 
a notice of proposed withdrawal has been published in the 
Federal Register prior to the date of enactment of this Act. 
Such proceedings may continue under procedures in effect 
prior to the date of enactment of this Act. 
SEC. 3211. ANTIFUNGAL RESEARCH AND DEVELOPMENT. 
(a) DRAFT GUIDANCE.—Not later than 3 years after 
the date of enactment of this Act, the Secretary, acting 
through the Commissioner of Food and Drugs, shall issue 
draft guidance for industry for the purposes of assisting en-
tities seeking approval under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or licensure 
under section 351 of the Public Health Service Act (42 
U.S.C. 262) of antifungal therapies designed to treat coc-
cidioidomycosis (commonly known as Valley Fever). 
(b) FINAL GUIDANCE.—Not later than 18 months after 
the close of the public comment period on the draft guidance 
issued pursuant to subsection (a), the Secretary, acting 
through the Commissioner of Food and Drugs, shall finalize 
the draft guidance. 
(c) WORKSHOP.—To assist entities developing preven-
tive vaccines for fungal infections and coccidioidomycosis, 
the Secretary shall hold a public workshop.
3443 
† HR 2617 EAS2 
SEC. 3212. ADVANCING QUALIFIED INFECTIOUS DISEASE 
PRODUCT INNOVATION. 
(a) IN GENERAL.—Section 505E of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355f) is amended— 
(1) in subsection (c)— 
(A) in paragraph (2), by striking ‘‘; or’’ 
and inserting ‘‘;’’; 
(B) in paragraph (3), by striking the period 
and inserting ‘‘; or’’; and 
(C) by adding at the end the following: 
‘‘(4) an application pursuant to section 351(a) 
of the Public Health Service Act.’’; 
(2) in subsection (d)(1), by inserting ‘‘of this Act 
or section 351(a) of the Public Health Service Act’’ 
after ‘‘section 505(b)’’; and 
(3) by amending subsection (g) to read as fol-
lows: 
‘‘(g) QUALIFIED INFECTIOUS DISEASE PRODUCT.— 
The term ‘qualified infectious disease product’ means a 
drug (including a biological product), including an anti-
bacterial or antifungal drug, for human use that— 
‘‘(1) acts on bacteria or fungi or on substances 
produced by such bacteria or fungi; and 
‘‘(2) is intended to treat a serious or life-threat-
ening infection, including such an infection caused 
by—
3444 
† HR 2617 EAS2 
‘‘(A) an antibacterial or antifungal resist-
ant pathogen, including novel or emerging infec-
tious pathogens; or 
‘‘(B) qualifying pathogens listed by the Sec-
retary under subsection (f).’’. 
(b) PRIORITY REVIEW.—Section 524A(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360n–1(a)) 
is amended by inserting ‘‘of this Act, or section 351(a) of 
the Public Health Service Act, that requires clinical data 
(other than bioavailability studies) to demonstrate safety or 
effectiveness’’ before the period. 
SEC. 3213. ADVANCED MANUFACTURING TECHNOLOGIES 
DESIGNATION PROGRAM. 
Subchapter A of chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by 
title II, is further amended by inserting after section 506K 
the following: 
‘‘SEC. 506L. ADVANCED MANUFACTURING TECHNOLOGIES 
DESIGNATION PROGRAM. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this section, the Secretary shall initiate 
a program under which persons may request designation 
of an advanced manufacturing technology as described in 
subsection (b).
3445 
† HR 2617 EAS2 
‘‘(b) DESIGNATION PROCESS.—The Secretary shall es-
tablish a process for the designation under this section of 
methods of manufacturing drugs, including biological prod-
ucts, and active pharmaceutical ingredients of such drugs, 
as advanced manufacturing technologies. A method of man-
ufacturing, or a combination of manufacturing methods, is 
eligible for designation as an advanced manufacturing tech-
nology if such method or combination of methods incor-
porates a novel technology, or uses an established technique 
or technology in a novel way, that will substantially im-
prove the manufacturing process for a drug while main-
taining equivalent, or providing superior, drug quality, in-
cluding by— 
‘‘(1) reducing development time for a drug using 
the designated manufacturing method; or 
‘‘(2) increasing or maintaining the supply of— 
‘‘(A) a drug that is life-supporting, life-sus-
taining, or of critical importance to providing 
health care; or 
‘‘(B) a drug that is on the drug shortage list 
under section 506E. 
‘‘(c) EVALUATION AND DESIGNATION OF AN ADVANCED 
MANUFACTURING TECHNOLOGY.— 
‘‘(1) SUBMISSION.—A person who requests des-
ignation of a method of manufacturing as an ad-
3446 
† HR 2617 EAS2 
vanced manufacturing technology under this section 
shall submit to the Secretary data or information 
demonstrating that the method of manufacturing 
meets the criteria described in subsection (b) in a 
particular context of use. The Secretary may facili-
tate the development and review of such data or infor-
mation by— 
‘‘(A) providing timely advice to, and inter-
active communication with, such person regard-
ing the development of the method of manufac-
turing; and 
‘‘(B) involving senior managers and experi-
enced staff of the Food and Drug Administra-
tion, as appropriate, in a collaborative, cross- 
disciplinary review of the method of manufac-
turing, as applicable. 
‘‘(2) EVALUATION AND DESIGNATION.—Not later 
than 180 calendar days after the receipt of a request 
under paragraph (1), the Secretary shall determine 
whether to designate such method of manufacturing as 
an advanced manufacturing technology, in a par-
ticular context of use, based on the data and informa-
tion submitted under paragraph (1) and the criteria 
described in subsection (b).
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† HR 2617 EAS2 
‘‘(d) REVIEW OF ADVANCED MANUFACTURING TECH-
NOLOGIES.—If the Secretary designates a method of manu-
facturing as an advanced manufacturing technology, the 
Secretary shall— 
‘‘(1) expedite the development and review of an 
application submitted under section 505 of this Act or 
section 351 of the Public Health Service Act, includ-
ing supplemental applications, for drugs that are 
manufactured using a designated advanced manufac-
turing technology; and 
‘‘(2) allow the holder of an advanced technology 
designation, or a person authorized by the advanced 
manufacturing technology designation holder, to ref-
erence or rely upon, in an application submitted 
under section 505 of this Act or section 351 of the 
Public Health Service Act, including a supplemental 
application, data and information about the des-
ignated advanced manufacturing technology for use 
in manufacturing drugs in the same context of use for 
which the designation was granted. 
‘‘(e) IMPLEMENTATION
AND
EVALUATION
OF
AD-
VANCED MANUFACTURING TECHNOLOGIES PROGRAM.— 
‘‘(1) PUBLIC
MEETING.—The Secretary shall 
publish in the Federal Register a notice of a public 
meeting, to be held not later than 180 days after the
3448 
† HR 2617 EAS2 
date of enactment of this section, to discuss, and ob-
tain input and recommendations from relevant stake-
holders regarding— 
‘‘(A) the goals and scope of the program 
under this section, and the framework, proce-
dures, and requirements suitable for such pro-
gram; and 
‘‘(B) ways in which the Food and Drug Ad-
ministration will support the use of advanced 
manufacturing technologies and other innovative 
manufacturing approaches for drugs. 
‘‘(2) PROGRAM GUIDANCE.— 
‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) not later than 180 days after the 
public meeting under paragraph (1), issue 
draft guidance regarding the goals and im-
plementation of the program under this sec-
tion; and 
‘‘(ii) not later than 2 years after the 
date of enactment of this section, issue final 
guidance regarding the implementation of 
such program. 
‘‘(B) CONTENT.—The guidance described in 
subparagraph (A) shall address—
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† HR 2617 EAS2 
‘‘(i) the process by which a person may 
request a designation under subsection (b); 
‘‘(ii) the data and information that a 
person requesting such a designation is re-
quired to submit under subsection (c), and 
how the Secretary intends to evaluate such 
submissions; 
‘‘(iii) the process to expedite the devel-
opment and review of applications under 
subsection (d); and 
‘‘(iv) the criteria described in sub-
section (b) for eligibility for such a designa-
tion. 
‘‘(3) REPORT.—Not later than 3 years after the 
date of enactment of this section and annually there-
after, the Secretary shall publish on the website of the 
Food and Drug Administration and submit to the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives a report 
containing a description and evaluation of the pro-
gram being conducted under this section, including 
the types of innovative manufacturing approaches 
supported under the program. Such report shall in-
clude the following:
3450 
† HR 2617 EAS2 
‘‘(A) The number of persons that have re-
quested designations and that have been granted 
designations. 
‘‘(B) The number of methods of manufac-
turing that have been the subject of designation 
requests and that have been granted designations. 
‘‘(C) The average number of calendar days 
for completion of evaluations under subsection 
(c)(2). 
‘‘(D) An analysis of the factors in data sub-
missions that result in determinations to des-
ignate and not to designate after evaluation 
under subsection (c)(2). 
‘‘(E) The number of applications received 
under section 505 of this Act or section 351 of 
the Public Health Service Act, including supple-
mental applications, that have included an ad-
vanced manufacturing technology designated 
under this section, and the number of such appli-
cations approved. 
‘‘(f) SUNSET.—The Secretary— 
‘‘(1) may not consider any requests for designa-
tion submitted under subsection (c) after October 1, 
2032; and
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† HR 2617 EAS2 
‘‘(2) may continue all activities under this sec-
tion with respect to advanced manufacturing tech-
nologies that were designated pursuant to subsection 
(b) prior to such date, if the Secretary determines 
such activities are in the interest of the public 
health.’’. 
CHAPTER 2—TRANSPARENCY, PROGRAM 
INTEGRITY, 
AND 
REGULATORY 
IM-
PROVEMENTS 
SEC. 3221. SAFER DISPOSAL OF OPIOIDS. 
Section 505–1(e)(4)(B) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355–1(e)(4)(B)) is amended by 
striking ‘‘for purposes of rendering drugs nonretrievable (as 
defined in section 1300.05 of title 21, Code of Federal Regu-
lations (or any successor regulation))’’. 
SEC. 3222. THERAPEUTIC EQUIVALENCE EVALUATIONS. 
Section 505(j)(7)(A) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(7)(A)) is amended by add-
ing at the end the following: 
‘‘(v)(I) With respect to an application submitted pur-
suant to subsection (b)(2) for a drug that is subject to sec-
tion 503(b) for which the sole difference from a listed drug 
relied upon in the application is a difference in inactive 
ingredients not permitted under clause (iii) or (iv) of sec-
tion 314.94(a)(9) of title 21, Code of Federal Regulations
3452 
† HR 2617 EAS2 
(or any successor regulations), the Secretary shall make an 
evaluation with respect to whether such drug is a thera-
peutic equivalent (as defined in section 314.3 of title 21, 
Code of Federal Regulations (or any successor regulations)) 
to another approved drug product in the prescription drug 
product section of the list under this paragraph as follows: 
‘‘(aa) With respect to such an application sub-
mitted after the date of enactment of the Food and 
Drug Omnibus Reform Act of 2022, the evaluation 
shall be made with respect to a listed drug relied 
upon in the application pursuant to subsection (b)(2) 
that is a pharmaceutical equivalent (as defined in 
section 314.3 of title 21, Code of Federal Regulations 
(or any successor regulations)) to the drug in the ap-
plication pursuant to subsection (b)(2) at the time of 
approval of such application or not later than 180 
days after the date of such approval, provided that 
the request for such an evaluation is made in the 
original application (or in a resubmission to a com-
plete response letter), and all necessary data and in-
formation are submitted in the original application 
(or in a resubmission in response to a complete re-
sponse letter) for the therapeutic equivalence evalua-
tion, including information to demonstrate bioequiva-
3454 
† HR 2617 EAS2 
to the drug for which a therapeutic equivalence 
evaluation is sought; and 
‘‘(BB) the amendment or supplement, as 
applicable, containing such request, or the rel-
evant application, includes all necessary data 
and information for the therapeutic equivalence 
evaluation, 
including 
information 
to 
dem-
onstrate bioequivalence, in a form and manner 
prescribed by the Secretary. 
‘‘(II) When the Secretary makes an evaluation under 
subclause (I), the Secretary shall, in revisions made to the 
list pursuant to clause (ii), include such information for 
such drug.’’. 
SEC. 3223. PUBLIC DOCKET ON PROPOSED CHANGES TO 
THIRD-PARTY VENDORS. 
(a) IN GENERAL.— 
(1) OPENING PUBLIC DOCKET.—Not later than 
90 days after the date of enactment of this Act, the 
Secretary shall open a single public docket to solicit 
comments on factors that generally should be consid-
ered by the Secretary when reviewing requests from 
sponsors of drugs subject to risk evaluation and miti-
gation strategies to change third-party vendors en-
gaged by sponsors to aid in implementation and 
management of the strategies.
3455 
† HR 2617 EAS2 
(2) FACTORS.—Such factors include the potential 
effects of changes in third-party vendors on— 
(A) patient access; and 
(B) prescribing and administration of the 
drugs by health care providers. 
(3) CLOSING
PUBLIC
DOCKET.—The Secretary 
may close such public docket not earlier than 90 days 
after such docket is opened. 
(4) NO DELAY.—Nothing in this section shall 
delay agency action on any modification to a risk 
evaluation and mitigation strategy. 
(b) GAO REPORT.—Not later than December 31, 2026, 
the Comptroller General of the United States shall submit 
to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report on— 
(1) the number of changes in third-party vendors 
(engaged by sponsors to aid implementation and 
management of risk evaluation and mitigation strate-
gies) for an approved risk evaluation and mitigation 
strategy the Secretary has approved under section 
505–1(h) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355–1(h)); 
(2) any issues affecting patient access to the 
drug that is subject to the strategy or considerations
3456 
† HR 2617 EAS2 
with respect to the administration or prescribing of 
such drug by health care providers that arose as a re-
sult of such changes; and 
(3) how such issues were resolved, as applicable. 
SEC. 3224. ENHANCING ACCESS TO AFFORDABLE MEDI-
CINES. 
Section 505(j)(10)(A) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(10)(A)) is amended by 
striking clauses (i) through (iii) and inserting the following: 
‘‘(i) a revision to the labeling of the listed drug 
has been approved by the Secretary within 90 days 
of when the application is otherwise eligible for ap-
proval under this subsection; 
‘‘(ii) the sponsor of the application agrees to sub-
mit revised labeling for the drug that is the subject of 
the application not later than 60 days after approval 
under this subsection of the application; 
‘‘(iii) the labeling revision described under clause 
(i) does not include a change to the ‘Warnings’ sec-
tion of the labeling; and’’. 
Subtitle C—Medical Devices 
SEC. 3301. DUAL SUBMISSION FOR CERTAIN DEVICES. 
Section 513 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360c) is amended by adding at the end the 
following:
3457 
† HR 2617 EAS2 
‘‘(k) For a device authorized for emergency use under 
section 564 for which, in accordance with section 564(m), 
the Secretary has deemed a laboratory examination or pro-
cedure associated with such device to be in the category of 
examinations and procedures described in section 353(d)(3) 
of the Public Health Service Act, the sponsor of such device 
may, when submitting a request for classification under sec-
tion 513(f)(2), submit a single submission containing— 
‘‘(1) the information needed for such a request; 
and 
‘‘(2) sufficient information to enable the Sec-
retary to determine whether such laboratory examina-
tion or procedure satisfies the criteria to be cat-
egorized under section 353(d)(3) of the Public Health 
Service Act.’’. 
SEC. 3302. MEDICAL DEVICES ADVISORY COMMITTEE MEET-
INGS. 
(a) IN GENERAL.—The Secretary shall convene one or 
more panels of the Medical Devices Advisory Committee not 
less than once per year for the purpose of providing advice 
to the Secretary on topics related to medical devices used 
in pandemic preparedness and response, including topics 
related to in vitro diagnostics.
3458 
† HR 2617 EAS2 
(b) REQUIRED PANEL MEMBER.—A panel convened 
under subsection (a) shall include at least 1 population 
health-specific representative. 
(c) SUNSET.—This section shall cease to be effective on 
October 1, 2027. 
SEC. 3303. GAO REPORT ON THIRD-PARTY REVIEW. 
Not later than September 30, 2026, the Comptroller 
General of the United States shall submit to the Committee 
on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pen-
sions of the Senate a report on the third-party review pro-
gram under section 523 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360m). Such report shall include— 
(1) a description of the financial and staffing re-
sources used to carry out such program; 
(2) a description of actions taken by the Sec-
retary pursuant section 523(b)(2)(C) of the Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
360m(b)(2)(C)); and 
(3) the results of an audit of the performance of 
select persons accredited under such program. 
SEC. 3304. CERTIFICATES TO FOREIGN GOVERNMENTS. 
Section 801(e)(4) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381(e)(4)) is amended—
3459 
† HR 2617 EAS2 
(1) in subparagraph (E), by striking clause (iii); 
and 
(2) by adding at the end the following: 
‘‘(F)(i) This paragraph applies to requests for certifi-
cation under this subparagraph of a device manufactured 
by a device establishment located outside of the United 
States that is registered under section 510, if the device is 
listed pursuant to section 510(j), the device has been cleared, 
approved, or is not required to submit a premarket report 
pursuant to subsection (l) or (m) of section 510, and the 
device is imported or offered for import into the United 
States. 
‘‘(ii) The Secretary shall issue the certification as de-
scribed in clause (iii) if the device or devices for which cer-
tification is requested under this subparagraph meet the ap-
plicable requirements of this Act. 
‘‘(iii)(I) A certification for a device described in clause 
(i) shall be subject to the fee described in subparagraph (B). 
‘‘(II) Notwithstanding subparagraph (C), a certifi-
cation for a device described in clause (i) shall address and 
include the same material information as a ‘Certificate to 
Foreign Government’ and shall have a document title in-
cluding the words ‘Certificate to Foreign Government’.
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† HR 2617 EAS2 
‘‘(iv) The requirements and procedures of subpara-
graph (E) shall apply to a denial of a certification under 
this subparagraph.’’. 
SEC. 3305. ENSURING CYBERSECURITY OF MEDICAL DE-
VICES. 
(a) IN GENERAL.—Subchapter A of chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et 
seq.) is amended by adding at the end the following: 
‘‘SEC. 524B. ENSURING CYBERSECURITY OF DEVICES. 
‘‘(a) IN GENERAL.—A person who submits an applica-
tion or submission under section 510(k), 513, 515(c), 515(f), 
or 520(m) for a device that meets the definition of a cyber 
device under this section shall include such information as 
the Secretary may require to ensure that such cyber device 
meets the cybersecurity requirements under subsection (b). 
‘‘(b) CYBERSECURITY REQUIREMENTS.—The sponsor 
of an application or submission described in subsection (a) 
shall— 
‘‘(1) submit to the Secretary a plan to monitor, 
identify, and address, as appropriate, in a reasonable 
time, postmarket cybersecurity vulnerabilities and ex-
ploits, including coordinated vulnerability disclosure 
and related procedures; 
‘‘(2) design, develop, and maintain processes and 
procedures to provide a reasonable assurance that the
3461 
† HR 2617 EAS2 
device and related systems are cybersecure, and make 
available postmarket updates and patches to the de-
vice and related systems to address— 
‘‘(A) on a reasonably justified regular cycle, 
known unacceptable vulnerabilities; and 
‘‘(B) as soon as possible out of cycle, critical 
vulnerabilities that could cause uncontrolled 
risks; 
‘‘(3) provide to the Secretary a software bill of 
materials, including commercial, open-source, and off- 
the-shelf software components; and 
‘‘(4) comply with such other requirements as the 
Secretary may require through regulation to dem-
onstrate reasonable assurance that the device and re-
lated systems are cybersecure. 
‘‘(c) DEFINITION.—In this section, the term ‘cyber de-
vice’ means a device that— 
‘‘(1) includes software validated, installed, or au-
thorized by the sponsor as a device or in a device; 
‘‘(2) has the ability to connect to the internet; 
and 
‘‘(3) contains any such technological characteris-
tics validated, installed, or authorized by the sponsor 
that could be vulnerable to cybersecurity threats.
3462 
† HR 2617 EAS2 
‘‘(d) EXEMPTION.—The Secretary may identify de-
vices, or categories or types of devices, that are exempt from 
meeting the cybersecurity requirements established by this 
section and regulations promulgated pursuant to this sec-
tion. The Secretary shall publish in the Federal Register, 
and update, as appropriate, a list of the devices, or cat-
egories or types of devices, so identified by the Secretary.’’. 
(b) PROHIBITED ACT.—Section 301(q) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)) is amend-
ed by adding at the end the following: 
‘‘(3) The failure to comply with any requirement 
under section 524B(b)(2) (relating to ensuring device cyber-
security).’’. 
(c) RULE OF CONSTRUCTION.—Nothing in this section, 
including the amendments made by this section, shall be 
construed to affect the Secretary’s authority related to en-
suring that there is a reasonable assurance of the safety and 
effectiveness of devices, which may include ensuring that 
there is a reasonable assurance of the cybersecurity of cer-
tain cyber devices, including for devices approved or cleared 
prior to the date of enactment of this Act. 
(d) EFFECTIVE DATE.—The amendments made by 
subsections (a) and (b) shall take effect 90 days after the 
date of enactment of this Act. An application or submission 
submitted before such effective date shall not be subject to
3463 
† HR 2617 EAS2 
the requirements under subsection (a) or (b) of section 524B 
of the Federal Food, Drug, and Cosmetic Act, as added by 
this section. 
(e) GUIDANCE FOR INDUSTRY AND FDA STAFF ON DE-
VICE CYBERSECURITY.—Not later than 2 years after the 
date of enactment of this Act, and periodically thereafter 
as appropriate, the Secretary, in consultation with the Di-
rector of the Cybersecurity and Infrastructure Security 
Agency, shall review and, as appropriate and after solic-
iting and receiving feedback from device manufacturers, 
health care providers, third-party-device servicers, patient 
advocates, and other appropriate stakeholders, update the 
guidance entitled ‘‘Content of Premarket Submissions for 
Management of Cybersecurity in Medical Devices’’ (or a 
successor document). 
(f) RESOURCES REGARDING CYBERSECURITY OF DE-
VICES.—Not later than 180 days after the date of enactment 
of this Act, and not less than annually thereafter, the Sec-
retary shall update public information provided by the 
Food and Drug Administration, including on the website 
of the Food and Drug Administration, with information re-
garding improving cybersecurity of devices. Such informa-
tion shall include information on identifying and address-
ing cyber vulnerabilities for health care providers, health 
systems, and device manufacturers, and how such entities
3464 
† HR 2617 EAS2 
may access support through the Cybersecurity and Infra-
structure Security Agency and other Federal entities, in-
cluding the Department of Health and Human Services, to 
improve the cybersecurity of devices. 
(g) GAO REPORT.—Not later than 1 year after the 
date of enactment of this Act, the Comptroller General of 
the United States shall publish a report identifying chal-
lenges in cybersecurity for devices, including legacy devices 
that may not support certain software security updates. 
Through such report, the Comptroller General shall exam-
ine— 
(1) challenges for device manufacturers, health 
care providers, health systems, and patients in access-
ing Federal support to address vulnerabilities across 
Federal agencies; 
(2) how Federal agencies can strengthen coordi-
nation to better support cybersecurity for devices; and 
(3) statutory limitations and opportunities for 
improving cybersecurity for devices. 
(h) DEFINITION.—In this section, the term ‘‘device’’ 
has the meaning given such term in section 201(h) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).
3465 
† HR 2617 EAS2 
SEC. 3306. BANS OF DEVICES FOR ONE OR MORE INTENDED 
USES. 
(a) IN GENERAL.—Section 516(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360f(a)) is amended— 
(1) in paragraph (1), by inserting ‘‘for one or 
more intended uses’’ before the semicolon at the end; 
and 
(2) in the matter following paragraph (2), by in-
serting ‘‘or to make such intended use or uses a 
banned intended use or uses. A device that is banned 
for one or more intended uses is not a legally mar-
keted device under section 1006 when intended for 
such use or uses’’ after ‘‘banned device’’. 
(b) RULE OF CONSTRUCTION.—Nothing in this section 
shall be construed to limit the authority of the Secretary 
to amend, in accordance with section 516 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360f), as amend-
ed by this section, and chapter 5 of title 5, United States 
Code, regulations promulgated pursuant to such section 
516, as amended by this section. 
SEC. 3307. THIRD PARTY DATA TRANSPARENCY. 
(a) IN GENERAL.—To the extent the Secretary relies 
on any data, analysis, or other information or findings pro-
vided by entities that has been funded in whole or in part 
by, or otherwise performed under contract with, the Food
3466 
† HR 2617 EAS2 
and Drug Administration, in regulatory decision-making 
with respect to devices, the Secretary shall— 
(1) request access to the datasets, inputs, clinical 
or other assumptions, methods, analytical code, re-
sults, and other components underlying or comprising 
the analysis, conclusions, or other findings upon 
which the Secretary seeks to rely; and 
(2) in the event that information described in 
paragraph (1) is used to support regulatory decision- 
making, and as otherwise appropriate, to the extent 
practicable, provide the manufacturer or manufactur-
ers subject to such decision a summary of such infor-
mation, subject to protection of confidential commer-
cial information or trade secret information or per-
sonally identifiable information. 
(b) REPORT.—Not later than September 30, 2023, and 
biennially thereafter, the Secretary shall submit to the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the 
House of Representatives, and publish on the website of the 
Food and Drug Administration, a report on the number 
of postmarket device signals communications issued by the 
Secretary, the sources of data for such signals, and how such 
signals were revised or resolved.
3467 
† HR 2617 EAS2 
(c) RULE OF CONSTRUCTION.—Nothing in this section 
shall be construed to require the delay of any regulatory 
decision-making or other action of the Food and Drug Ad-
ministration. 
SEC. 3308. PREDETERMINED CHANGE CONTROL PLANS FOR 
DEVICES. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended 
by inserting after section 515B (21 U.S.C. 360e–3) the fol-
lowing: 
‘‘SEC. 515C. PREDETERMINED CHANGE CONTROL PLANS 
FOR DEVICES. 
‘‘(a) APPROVED DEVICES.— 
‘‘(1) IN
GENERAL.—Notwithstanding section 
515(d)(5)(A), a supplemental application shall not be 
required for a change to a device approved under sec-
tion 515, if such change is consistent with a predeter-
mined change control plan that is approved pursuant 
to paragraph (2). 
‘‘(2) 
PREDETERMINED
CHANGE
CONTROL 
PLAN.—The Secretary may approve a predetermined 
change control plan submitted in an application, in-
cluding a supplemental application, under section 
515 that describes planned changes that may be made 
to the device (and that would otherwise require a sup-
3468 
† HR 2617 EAS2 
plemental application under section 515), if the de-
vice remains safe and effective without any change. 
‘‘(3) SCOPE.—The Secretary may require that a 
change control plan include labeling required for safe 
and effective use of the device as such device changes 
pursuant to such plan, notification requirements if 
the device does not function as intended pursuant to 
such plan, and performance requirements for changes 
made under the plan. 
‘‘(b) CLEARED DEVICES.— 
‘‘(1) IN
GENERAL.—Notwithstanding section 
510(k), a premarket notification shall not be required 
for a change to a device cleared under section 510(k), 
if such change is consistent with an established pre-
determined change control plan granted pursuant to 
paragraph (2). 
‘‘(2) 
PREDETERMINED
CHANGE
CONTROL 
PLAN.—The Secretary may clear a predetermined 
change control plan submitted in a notification sub-
mitted under section 510(k) that describes planned 
changes that may be made to the device (and that 
would otherwise require a new notification), if— 
‘‘(A) the device remains safe and effective 
without any such change; and
3469 
† HR 2617 EAS2 
‘‘(B) the device would remain substantially 
equivalent to the predicate. 
‘‘(3) SCOPE.—The Secretary may require that a 
change control plan include labeling required for safe 
and effective use of the device as such device changes 
pursuant to such plan, notification requirements if 
the device does not function as intended pursuant to 
such plan, and performance requirements for changes 
made under the plan. 
‘‘(c) PREDICATE DEVICES.—In making a determina-
tion of substantial equivalence pursuant to section 513(i), 
the Secretary shall not compare a device to changed versions 
of a device implemented in accordance with an established 
predetermined change control plan as a predicate device. 
Only the version of the device cleared or approved, prior 
to changes made under the predetermined change control 
plan, may be used by a sponsor as a predicate device.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) CLEARED DEVICES.—Section 510(l)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360(l)(1)) is amended, in the first sentence, by insert-
ing ‘‘, or with respect to a change that is consistent 
with a predetermined change control plan cleared 
under section 515C’’ before the period at the end.
3470 
† HR 2617 EAS2 
(2) 
APPROVED
DEVICES.—Section 
515(d)(5)(A)(i) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360e(d)(5)(A)(i)) is amended by 
striking ‘‘A supplemental’’ and inserting ‘‘Unless the 
change is consistent with a predetermined change con-
trol plan approved under section 515C, a supple-
mental’’. 
(3) DOCUMENTATION
OF
RATIONALE
FOR
SIG-
NIFICANT DECISIONS.—Section 517A(a)(1) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360g– 
1(a)(1)) is amended to read as follows: 
‘‘(1) IN GENERAL.—The Secretary shall provide 
a substantive summary of the scientific and regu-
latory rationale for any significant decision of the 
Center for Devices and Radiological Health regarding 
submission or review of a report under section 510(k), 
a petition for classification under section 513(f), an 
application under section 515, or an application for 
an exemption under section 520(g), including docu-
mentation of significant controversies or differences of 
opinion and the resolution of such controversies or 
differences of opinion.’’.
3471 
† HR 2617 EAS2 
SEC. 3309. SMALL BUSINESS FEE WAIVER. 
(a) IN GENERAL.—Section 738(a)(3)(B) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend-
ed— 
(1) by striking ‘‘No fee’’ and inserting the fol-
lowing: 
‘‘(i) IN GENERAL.—No fee’’; and 
(2) by adding at the end the following: 
‘‘(ii) SMALL
BUSINESSES
FEE
WAIV-
ER.— 
‘‘(I) DEFINITION OF SMALL BUSI-
NESS.—For purposes of this clause, the 
term ‘small business’ means an entity 
that reported $1,000,000 or less of 
gross receipts or sales in its most re-
cent Federal income tax return for a 
taxable year, including such returns of 
all of its affiliates. 
‘‘(II) 
WAIVER.—The 
Secretary 
may grant a waiver of the fee required 
under subparagraph (A) for the annual 
registration (excluding the initial reg-
istration) of an establishment for a 
year, beginning on October 1, 2024, if 
the Secretary finds that the establish-
ment is a small business and paying
3472 
† HR 2617 EAS2 
the fee for such year represents a fi-
nancial hardship to the establishment 
as determined by the Secretary. 
‘‘(III) FIRMS
SUBMITTING
TAX 
RETURNS TO THE UNITED STATES IN-
TERNAL
REVENUE
SERVICE.—The es-
tablishment shall support its claim 
that it meets the definition under sub-
clause (I) by submission of a copy of 
its most recent Federal income tax re-
turn for a taxable year, and a copy of 
such returns of its affiliates, which 
show an amount of gross sales or re-
ceipts that is less than the maximum 
established in subclause (I). The estab-
lishment, and each of such affiliates, 
shall certify that the information pro-
vided is a true and accurate copy of 
the actual tax forms they submitted to 
the Internal Revenue Service. If no tax 
forms are submitted for any affiliate, 
the establishment shall certify that the 
establishment has no affiliates. 
‘‘(IV) FIRMS
NOT
SUBMITTING 
TAX RETURNS TO THE UNITED STATES
3473 
† HR 2617 EAS2 
INTERNAL REVENUE SERVICE.—In the 
case of an establishment that has not 
previously submitted a Federal income 
tax return, the establishment and each 
of its affiliates shall demonstrate that 
it meets the definition under subclause 
(I) by submission of a signed certifi-
cation, in such form as the Secretary 
may direct through a notice published 
in the Federal Register, that the estab-
lishment or affiliate meets the criteria 
for a small business and a certifi-
cation, in English, from the national 
taxing authority, if extant, of the coun-
try in which the establishment or, if 
applicable, affiliate is headquartered. 
The certification from such taxing au-
thority shall bear the official seal of 
such taxing authority and shall pro-
vide the establishment’s or affiliate’s 
gross receipts or sales for the most re-
cent year in both the local currency of 
such country and in United States dol-
lars, the exchange rate used in con-
verting such local currency to dollars,
3474 
† HR 2617 EAS2 
and the dates during which these re-
ceipts or sales were collected. The estab-
lishment shall also submit a statement 
signed by the head of the establish-
ment’s firm or by its chief financial of-
ficer that the establishment has sub-
mitted certifications for all of its affili-
ates, or that the establishment has no 
affiliates. 
‘‘(V) REQUEST FOR WAIVER.—An 
establishment seeking a fee waiver for a 
year under this clause shall submit 
supporting information to the Sec-
retary at least 60 days before the fee is 
required pursuant to subparagraph 
(C). The decision of the Secretary re-
garding whether an entity may receive 
the waiver for such year is not review-
able.’’. 
(b) TAXING AUTHORITY.—Section 738(d)(2)(B)(iii) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j(d)(2)(B)(iii)) is amended by inserting ‘‘, if extant,’’ 
after ‘‘national taxing authority’’.
3475 
† HR 2617 EAS2 
Subtitle D—Infant Formula 
SEC. 3401. PROTECTING INFANTS AND IMPROVING FOR-
MULA SUPPLY. 
(a) DEFINITIONS.— 
(1) IN GENERAL.—In this section, the term ‘‘in-
fant formula’’ has the meaning given such term in 
section 201(z) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(z)). 
(2) CRITICAL FOOD.—Section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321) is 
amended by adding at the end the following: 
‘‘(ss) The term ‘critical food’ means a food that is— 
‘‘(1) an infant formula; or 
‘‘(2) a medical food, as defined in section 5(b)(3) 
of the Orphan Drug Act.’’. 
(b) OFFICE OF CRITICAL FOODS.— 
(1) IN GENERAL.—The Secretary shall establish 
within the Center for Food Safety and Applied Nutri-
tion an office to be known as the Office of Critical 
Foods. The Secretary shall appoint a Director to lead 
such Office. 
(2) DUTIES.—The Office of Critical Foods shall 
be responsible for oversight, coordination, and facili-
tation of activities related to critical foods, as defined
3476 
† HR 2617 EAS2 
in section 201(ss) of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (a)(2). 
(c) PREMARKET SUBMISSIONS OF INFANT FORMULA 
TO ADDRESS SHORTAGES.—Section 412 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 350a) is amended 
by adding at the end the following: 
‘‘(j) PREMARKET SUBMISSIONS TO ADDRESS SHORT-
AGES.— 
‘‘(1) IN GENERAL.—The Secretary shall waive 
the 90-day premarket submission requirement under 
subsection (c) and apply a 30-day premarket submis-
sion requirement for any person who intends to intro-
duce or deliver for introduction into interstate com-
merce any new infant formula. 
‘‘(2) EFFECTIVE PERIOD.—The waiver authority 
under this subsection shall remain in effect— 
‘‘(A) for 90 days beginning on the date that 
the Secretary distributes information under sec-
tion 424(a)(2) with respect to a shortage of in-
fant formula; or 
‘‘(B) such longer period as the Secretary de-
termines appropriate, to prevent or mitigate a 
shortage of infant formula.’’. 
(d) REPORT.—Not later than one year after the date 
of enactment of this Act, the Secretary shall submit a report
3477 
† HR 2617 EAS2 
to the Committee on Health, Education, Labor, and Pen-
sions of the Senate and the Committee on Energy and Com-
merce of the House of Representatives that includes— 
(1) the number of premarket submissions for new 
infant formula the Secretary has received under sec-
tion 412(d) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350a(d)) each year since 2012; 
(2) how many of such submissions received re-
quests from the Secretary for additional information; 
(3) how long after receiving such submissions the 
Secretary sent such requests for additional informa-
tion; 
(4) what additional information the Secretary 
requested of the persons submitting such submissions; 
and 
(5) the date each new infant formula described 
in subparagraph (A) was first marketed, if available. 
(e) INFANT FORMULA FLEXIBILITIES.—The Secretary 
shall publish a list on the website of the Department of 
Health and Human Services providing information on how 
to identify appropriate substitutes for infant formula prod-
ucts in shortage that are relied upon by infants and other 
individuals with inborn errors of metabolism or other seri-
ous health conditions.
3478 
† HR 2617 EAS2 
(f) INTERNATIONAL HARMONIZATION OF INFANT FOR-
MULA REQUIREMENTS.— 
(1) IN GENERAL.—The Secretary— 
(A) shall participate in meetings with rep-
resentatives from other countries to discuss meth-
ods and approaches to harmonizing regulatory 
requirements for infant formula, including with 
respect to inspections, labeling, and nutritional 
requirements; and 
(B) may enter into arrangements or agree-
ments regarding such requirements with other 
countries, as appropriate, including arrange-
ments or agreements with a foreign government 
or agency of a foreign government to recognize 
the inspection of foreign establishments that 
manufacture infant formula for export to the 
United States. 
(2) STUDY ON INFANT FORMULA.— 
(A) IN GENERAL.—Not later than 60 days 
after the date of enactment of this Act, the Sec-
retary shall seek to enter into an agreement with 
the National Academies of Sciences, Engineering, 
and Medicine (referred to in this paragraph as 
the ‘‘National Academies’’) to examine and re-
port on challenges in supply, market competi-
3479 
† HR 2617 EAS2 
tion, and regulation of infant formula in the 
United States. 
(B) CONTENTS OF THE REPORT.—The re-
port developed pursuant to the agreement under 
subparagraph (A) shall— 
(i) assess and evaluate— 
(I) infant formula marketed in 
the United States; 
(II) any challenges in supply, or 
market competition with respect to 
such infant formula; and 
(III) any differences between in-
fant formula marketed in the United 
States and infant formula marketed in 
the European Union, including with 
respect to nutritional content and ap-
plicable labeling and other regulatory 
requirements; and 
(ii) include recommendations, includ-
ing for infant formula manufacturers, on 
measures to address supply and market 
competition in the United States. 
(C) FINAL REPORT.—The agreement under 
subparagraph (A) shall specify that the National 
Academies shall, not later than 1 year after the
3480 
† HR 2617 EAS2 
date of enactment of this Act, complete such 
study and submit a report on the results of such 
study to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives. 
(g) TRANSPARENCY AND ACCOUNTABILITY TO SUP-
PORT INFANT FORMULA INNOVATION.— 
(1) 
CONGRESSIONAL
NOTIFICATION
OF
RE-
CALL.—Section 412 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 350a), as amended by sub-
section (c), is further amended by adding at the end 
the following: 
‘‘(k) CONGRESSIONAL NOTIFICATION OF RECALL.— 
‘‘(1) IN GENERAL.—Not later than 24 hours after 
the initiation of a recall of infant formula as de-
scribed in subsection (e), the Secretary shall submit to 
the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Energy 
and Commerce of the House of Representatives a noti-
fication of such recall. 
‘‘(2) CONTENTS.—A notification under para-
graph (1) shall include the following: 
‘‘(A) If the recall is required by the Food 
and Drug Administration, a summary of the in-
3481 
† HR 2617 EAS2 
formation supporting a determination that the 
adulterated or misbranded infant formula pre-
sents a risk to human health. 
‘‘(B) If the recall is voluntarily initiated by 
the manufacturer, a summary of the information 
provided to the Food and Drug Administration 
by the manufacturer regarding infant formula 
that has left the control of the manufacturer that 
may be adulterated or misbranded. 
‘‘(C) Specification of when the Food and 
Drug Administration was first made aware of 
the instance or circumstances surrounding the 
recall. 
‘‘(D) An initial estimate of the disruption 
in domestic production that may result from the 
recall.’’. 
(2) ANNUAL
REPORT
TO
CONGRESS.—Section 
412 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350a), as amended by paragraph (1), is fur-
ther amended by adding at the end the following: 
‘‘(l) ANNUAL REPORT TO CONGRESS.— 
‘‘(1) IN GENERAL.—Not later than March 30 of 
each year, the Secretary shall submit a report to Con-
gress containing, with respect to the preceding cal-
endar year, the following information:
3482 
† HR 2617 EAS2 
‘‘(A) The number of submissions received by 
the Secretary under subsection (d). 
‘‘(B) The number of such submissions that 
included any new ingredients that were not in-
cluded in any infant formula already on the 
market. 
‘‘(C) The number of inspections conducted 
by the Food and Drug Administration or any 
agent thereof to evaluate compliance with the re-
quirements for infant formulas under subsection 
(b). 
‘‘(D) The time between any inspection re-
ferred to in subparagraph (C) and any necessary 
reinspection to evaluate compliance with the re-
quirements for infant formulas under subsection 
(b). 
‘‘(E) A breakdown of the information de-
scribed in subparagraphs (A) through (D) be-
tween foreign and domestic manufacturers and 
facilities. 
‘‘(2) CONFIDENTIALITY.—The Secretary shall en-
sure that the reports under paragraph (1) do not in-
clude any information that is a trade secret or con-
fidential information subject to section 552(b)(4) of
3483 
† HR 2617 EAS2 
title 5, United States Code, or section 1905 of title 18, 
United States Code.’’. 
(3) NEW INFANT FORMULA SUBMISSIONS.—Sec-
tion 412(d) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350a(d)) is amended by adding at the 
end the following: 
‘‘(4) The Secretary shall provide a response to a sub-
mission under this subsection not later than 45 days after 
receiving such submission.’’. 
(4) LIST OF NUTRIENTS.—Section 412(i)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
350a(i)) is amended by striking ‘‘or, if revised by the 
Secretary under paragraph (2), as so revised’’ and in-
serting the following: ‘‘, which shall be reviewed by 
the Secretary every 4 years as appropriate. In review-
ing such table, the Secretary shall consider any new 
scientific data or information related to infant for-
mula nutrients, including international infant for-
mula standards. The Secretary may revise the list of 
nutrients and the required level for any nutrient re-
quired by the table’’. 
(5) GUIDANCE.—Not later than 1 year after the 
date of enactment of this Act, the Secretary shall issue 
guidance regarding information sponsors may con-
sider including in submissions required under section
3484 
† HR 2617 EAS2 
412(d) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 350a(d)), including considerations for 
meeting each of the requirements of paragraphs (1), 
(2), and (3) of subsection (d). 
(6) 
TECHNICAL
CORRECTION.—Section 
412(c)(1)(B) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350a(c)(1)(B)) is amended by striking 
‘‘subsection (c)(1)’’ and inserting ‘‘subsection (d)(1)’’. 
(h) RESPONSE TO RECALL.— 
(1) MANUFACTURER SUBMISSION.— 
(A) IN GENERAL.—Promptly after the initi-
ation of a recall of infant formula, the manufac-
turer of the recalled infant formula shall submit 
information to the Secretary regarding such re-
call. 
(B) CONTENTS.—A submission under sub-
paragraph (A) shall include the following: 
(i) A plan (including an estimated 
timeline, as applicable) of actions the man-
ufacturer will take, suited to the individual 
circumstances of the particular recall, in-
cluding— 
(I) to identify and address any 
cause of, and contributing factor in,
3485 
† HR 2617 EAS2 
known or suspected adulteration or 
known or suspected misbranding; and 
(II) if appropriate, to restore op-
eration of the impacted facilities. 
(ii) In the case that a recall of the 
manufacturer’s infant formula products, 
and subsequent actions to respond to such 
recall, impacts over 10 percent of the pro-
duction of the infant formula intended for 
sale in the United States, a plan to backfill 
the supply of the manufacturer’s infant for-
mula supply if the current domestic supply 
of such infant formula has fallen, or is ex-
pected to fall, below the expected demand for 
the formula. 
(2) REPORT TO CONGRESS.— 
(A) IN GENERAL.—Promptly after a sub-
mission under paragraph (1) is received, the 
Secretary shall provide such submission, together 
with the information specified in subparagraph 
(B), in a report to the Committee on Health, 
Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of 
the House of Representatives.
3486 
† HR 2617 EAS2 
(B) CONTENTS.—A report under subpara-
graph (A) shall include the following: 
(i) Information concerning the current 
domestic supply of infant formula, includ-
ing— 
(I) a breakdown of the specific 
types of formula involved; and 
(II) an estimate of how long cur-
rent supplies will last. 
(ii) If a submission or submissions 
under paragraph (1) show that the recall 
and subsequent actions to respond to the re-
call impact over 10 percent of the domestic 
production of infant formula intended for 
sale in the United States— 
(I) actions to work with the im-
pacted manufacturer or other manufac-
turers to increase production; and 
(II) specification of— 
(aa) any additional authori-
ties needed regarding production 
or importation to fill a supply 
gap; and
3487 
† HR 2617 EAS2 
(bb) any supplemental fund-
ing necessary to address the short-
age. 
(3) SUNSET.—This subsection shall cease to have 
force or effect on September 30, 2026. 
(i) COORDINATION WITH MANUFACTURER.— 
(1) IN GENERAL.— 
(A) COMMUNICATION
FOLLOWING
INSPEC-
TION.—Upon completing an inspection of an in-
fant formula manufacturing facility impacted by 
a recall, the Secretary, acting through the Com-
missioner of Food and Drugs, shall provide the 
manufacturer involved a list of any actions nec-
essary to— 
(i) address deficiencies contributing to 
the potential adulteration or misbranding of 
product at the facility; and 
(ii) safely restart production at the fa-
cility. 
(B) RESPONSE
TO
MANUFACTURER.—Not 
later than 7 days after receiving a written com-
munication from a manufacturer of infant for-
mula containing corrective actions to address 
manufacturing deficiencies identified during an 
inspection of a facility engaged in the manufac-
3488 
† HR 2617 EAS2 
turing of an infant formula impacted by a re-
call, the Secretary, acting through the Commis-
sioner of Food and Drugs, shall provide a sub-
stantive response to such communication con-
cerning the sufficiency of the proposed corrective 
actions. 
(2) INSPECTIONS.—The Secretary shall ensure 
timely communication with a manufacturer of infant 
formula following an inspection of a facility engaged 
in the manufacturing of infant formula for consump-
tion in the United States. If a reinspection of a man-
ufacturer of an infant formula is required to ensure 
that such manufacturer completed any remediation 
actions or addressed any deficiencies, the Secretary 
shall reinspect such facility in a timely manner. The 
Secretary shall prioritize and expedite an inspection 
or reinspection of an establishment that could help 
mitigate or prevent a shortage of an infant formula. 
(3) ANNUAL
INSPECTIONS.—Not later than 6 
months after the date of enactment of this Act, and 
not less than once per calendar year thereafter, the 
Secretary shall conduct inspections, including unan-
nounced inspections, of the facilities (including for-
eign facilities) of each manufacturer of an infant for-
mula required to be registered under section
3489 
† HR 2617 EAS2 
412(c)(1)(A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350a(c)(1)(A)), in accordance with a 
risk-based approach and ensure timely and effective 
internal coordination and alignment among the Of-
fice of Regulatory Affairs and the Center for Food 
Safety and Applied Nutrition. In meeting the inspec-
tion requirements under this subsection, the Secretary 
may rely on inspections conducted by foreign regu-
latory authorities, under arrangements or agreements, 
and conducted by State agencies under contract, 
memoranda of understanding, or any other obliga-
tion. 
(j) NATIONAL STRATEGY ON INFANT FORMULA.— 
(1) IN GENERAL.—The Secretary, in consultation 
with the Secretary of Agriculture and other heads of 
relevant departments and agencies, shall develop and 
issue, not later than 90 days after the date of enact-
ment of this Act, a national strategy on infant for-
mula to increase the resiliency of the infant formula 
supply chain, protect against future contamination 
and other potential causes of supply disruptions and 
shortages, and ensure parents and caregivers have ac-
cess to infant formula and information they need.
3490 
† HR 2617 EAS2 
(2) IMMEDIATE NATIONAL STRATEGY.—The na-
tional strategy under paragraph (1) shall include ef-
forts— 
(A) to increase the resiliency of the infant 
formula supply chain in the short-term by— 
(i) assessing causes of any supply dis-
ruption or shortage of infant formula in ex-
istence as of the date of enactment of this 
Act and potential causes of future supply 
disruptions and shortages; 
(ii) assessing and addressing imme-
diate infant formula needs associated with 
the shortage; and 
(iii) developing a plan to increase in-
fant formula supply, including through in-
creased competition; and 
(B) to ensure the development and updating 
of education and communication materials for 
parents and caregivers that cover— 
(i) where and how to find infant for-
mula; 
(ii) comparable infant formulas on the 
market; 
(iii) what to do if a specialty infant 
formula is unavailable;
3491 
† HR 2617 EAS2 
(iv) safe practices for handling infant 
formula; and 
(v) other topics, as appropriate. 
(3) LONG-TERM STRATEGY.—Not later than 90 
days after the submission of the report described in 
subsection (f)(2), the Secretary shall update the na-
tional strategy under paragraph (1) to include efforts 
to improve preparedness against infant formula 
shortages in the long-term by— 
(A) outlining methods to improve informa-
tion-sharing between the Federal Government 
and State and local governments, and other enti-
ties as appropriate, regarding shortages; 
(B) recommending measures for protecting 
the integrity of the infant formula supply and 
preventing contamination; 
(C) outlining methods to incentivize new in-
fant formula manufacturers to increase supply 
and mitigate future shortages; and 
(D) recommending other necessary authori-
ties to gain insight into the supply chain and 
risk for shortages, and to incentivize new infant 
formula manufacturers. 
(k) MEANINGFUL DISRUPTION IN THE PRODUCTION OF 
CRITICAL FOOD.—Chapter IV of the Federal Food, Drug,
3492 
† HR 2617 EAS2 
and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 424. REQUIREMENTS FOR CRITICAL FOOD. 
‘‘(a) NOTIFICATION OF MEANINGFUL DISRUPTION FOR 
CRITICAL FOOD.— 
‘‘(1) IN GENERAL.—A manufacturer of a critical 
food (as defined in section 201(ss)) shall notify the 
Secretary of a permanent discontinuance in the man-
ufacture or an interruption of the manufacture of 
such food that is likely to lead to a meaningful dis-
ruption in the supply of such food in the United 
States, and the reasons for such discontinuance or 
interruption, as soon as practicable, but not later 
than 5 business days after such discontinuance or 
such interruption. 
‘‘(2) DISTRIBUTION OF INFORMATION.—Not later 
than 5 calendar days after receiving a notification 
under paragraph (1), if the Secretary has determined 
that such discontinuance or interruption has resulted, 
or is likely to result, in a shortage of such critical 
food, the Secretary shall distribute, to the Secretary of 
Agriculture and to the maximum extent practicable to 
the appropriate entities, as determined by the Sec-
retary through such means as the Secretary deter-
mines appropriate, information on such shortage.
3493 
† HR 2617 EAS2 
‘‘(3) CONFIDENTIALITY.—Nothing in this sub-
section authorizes the Secretary to disclose any infor-
mation 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. 
‘‘(4) MEANINGFUL
DISRUPTION.—In this sub-
section, the term ‘meaningful disruption’— 
‘‘(A) means a change in production that is 
reasonably likely to lead to a significant reduc-
tion in the supply of a critical food by a manu-
facturer that affects the ability of the manufac-
turer to meet expected demand for its product; 
and 
‘‘(B) does not include interruptions in man-
ufacturing due to matters such as routine main-
tenance, changes or discontinuance of flavors, 
colors, or other insignificant formulation charac-
teristics, or insignificant changes in manufac-
turing so long as the manufacturer expects to re-
sume 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
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† HR 2617 EAS2 
applicable, for each establishment in which such food is 
manufactured. A risk management plan under this sub-
section— 
‘‘(1) may identify and evaluate risks to the sup-
ply 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, alter-
native suppliers, stockpiling of inventory, or other 
means; and 
‘‘(3) shall be subject to inspection and copying 
by the Secretary pursuant to an inspection under sec-
tion 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 fail-
ure; 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
3495 
† HR 2617 EAS2 
Food and Drug Administration, with appro-
priate redactions made to protect the informa-
tion described in subsection (a)(3)— 
‘‘(i) the letter issued under subpara-
graph (A); and 
‘‘(ii) at the request of such person, any 
response to such letter such person sub-
mitted 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 submitting a notification as 
required under subsection (a), the requirements 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 fur-
ther 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 spe-
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† HR 2617 EAS2 
cialty infant formula. Such a waiver may be applica-
ble to— 
‘‘(A) the importation of specialty infant for-
mula from any country that is determined by 
the Secretary to be implementing and enforcing 
requirements for infant formula that provide a 
similar assurance of safety and nutritional ade-
quacy as the requirements of this Act; or 
‘‘(B) the distribution and sale of such im-
ported specialty infant formula. 
‘‘(2) RULE
OF
CONSTRUCTION.—Nothing in 
paragraph (1) shall be construed to limit the author-
ity of the Secretary to require a recall of, or otherwise 
impose restrictions and requirements under this Act 
with respect to, specialty infant formula that is sub-
ject to a waiver under paragraph (1). 
‘‘(3) DEFINITION
OF
SPECIALTY
INFANT
FOR-
MULA.—In this subsection, the term ‘specialty infant 
formula’ means infant formula described in sub-
section (h)(1).’’. 
(m) IMPORTATION FOR PERSONAL USE.— 
(1) IN GENERAL.—Notwithstanding any provi-
sion of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.), during the 90-day period begin-
ning on the date of enactment of this Act, an indi-
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† HR 2617 EAS2 
vidual 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 Secretary to be implementing and enforcing 
requirements for infant formula that provide a 
similar assurance of safety and nutritional ade-
quacy as the requirements of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 
(2) LIMITATIONS.—Infant formula may be im-
ported pursuant 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 provider becomes aware of any adverse 
event which the health care provider reasonably sus-
pects 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.
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† HR 2617 EAS2 
(4) PUBLIC
NOTICE.—The Secretary, acting 
through the Commissioner of Food and Drugs, shall 
post on the public website of the Food and Drug Ad-
ministration 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 for-
mula 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 impor-
tation of infant formula should consult with their pe-
diatrician about such importation. 
Subtitle E—Cosmetics 
SEC. 3501. SHORT TITLE. 
This subtitle may be cited as the ‘‘Modernization of 
Cosmetics Regulation Act of 2022’’.
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† HR 2617 EAS2 
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 composi-
tion for use in a finished product. 
‘‘(3) FACILITY.— 
‘‘(A) IN GENERAL.—The term ‘facility’ in-
cludes any establishment (including an establish-
ment of an importer) that manufactures or proc-
esses cosmetic products distributed in the United 
States. 
‘‘(B) Such term does not include any of the 
following: 
‘‘(i) Beauty shops and salons, unless 
such establishment manufactures or proc-
esses cosmetic products at that location. 
‘‘(ii) Cosmetic product retailers, in-
cluding individual sales representatives, di-
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† HR 2617 EAS2 
rect sellers (as defined in section 3508(b)(2) 
of the Internal Revenue Code of 1986), re-
tail distribution facilities, and pharmacies, 
unless such establishment manufactures or 
processes cosmetic products that are not sold 
directly to consumers 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 air-
lines) that provide complimentary cosmetic 
products to customers incidental to other 
services. 
‘‘(vi) Trade shows and other venues 
where cosmetic product samples are pro-
vided free of charge. 
‘‘(vii) An establishment that manufac-
tures or processes cosmetic products that are 
solely for use in research or evaluation, in-
cluding for production testing and not of-
fered for retail sale.
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† HR 2617 EAS2 
‘‘(viii) An establishment that solely 
performs one or more of the following with 
respect to cosmetic products: 
‘‘(I) Labeling. 
‘‘(II) Relabeling. 
‘‘(III) Packaging. 
‘‘(IV) Repackaging. 
‘‘(V) Holding. 
‘‘(VI) Distributing. 
‘‘(C) CLARIFICATION.—For the purposes of 
subparagraph (B)(viii), the terms ‘packaging’ 
and ‘repackaging’ do not include filling a prod-
uct container with a cosmetic product. 
‘‘(4) RESPONSIBLE PERSON.—The term ‘respon-
sible person’ means the manufacturer, packer, or dis-
tributor 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 ‘seri-
ous adverse event’ means an adverse event that— 
‘‘(A) results in— 
‘‘(i) death; 
‘‘(ii) a life-threatening experience; 
‘‘(iii) inpatient hospitalization;
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† HR 2617 EAS2 
‘‘(iv) a persistent or significant dis-
ability or incapacity; 
‘‘(v) a congenital anomaly or birth de-
fect; 
‘‘(vi) an infection; or 
‘‘(vii) significant disfigurement (in-
cluding 
serious 
and 
persistent 
rashes, 
second- or third-degree burns, significant 
hair loss, or persistent or significant alter-
ation of appearance), other than as in-
tended, under conditions of use that are cus-
tomary 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 REQUIRE-
MENTS.—The responsible person shall submit to the Sec-
retary any report received of a serious adverse event associ-
ated with the use, in the United States, of a cosmetic prod-
uct manufactured, packed, or distributed by such person. 
‘‘(b) SUBMISSION OF REPORTS.— 
‘‘(1) SERIOUS
ADVERSE
EVENT
REPORT.—The 
responsible person shall submit to the Secretary a se-
3503 
† HR 2617 EAS2 
rious 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 respon-
sible person shall submit to the Secretary any new 
and material medical information, related to a seri-
ous 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 per-
son. 
‘‘(3) CONSOLIDATION
OF
REPORTS.—The Sec-
retary shall develop systems to enable responsible per-
sons 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, domestic telephone number, or electronic contact
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† HR 2617 EAS2 
information included on the label in accordance with sec-
tion 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 manufactured or distrib-
uted by such person received by such person, for a pe-
riod of 6 years, except that a responsible person that 
is considered a small business for the purposes of sec-
tion 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 paragraph, the term ‘authorized person’ 
means an officer or employee of the Department 
of Health and Human Services who has—
3505 
† HR 2617 EAS2 
‘‘(i) appropriate credentials, as deter-
mined by the Secretary; and 
‘‘(ii) been duly designated by the Sec-
retary 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 ingre-
dient or combination of ingredients in a fragrance or flavor 
has caused or contributed to a serious adverse event re-
quired 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 
submitted 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—
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† HR 2617 EAS2 
‘‘(1) a safety report under section 756 and may 
be accompanied 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 con-
tributed to the adverse event; and 
‘‘(2) a record about an individual under section 
552a of title 5, United States Code (commonly re-
ferred 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 
identifiable information is redacted. 
‘‘(h) EFFECT OF SECTION.— 
‘‘(1) IN GENERAL.—Nothing in this section shall 
affect the authority of the Secretary to provide ad-
verse event reports and information to any health, 
food, or drug officer or employee of any State, terri-
tory, or political subdivision of a State or territory, 
under a memorandum of understanding between the 
Secretary and such State, territory, or political sub-
division. 
‘‘(2) 
PERSONALLY
IDENTIFIABLE
INFORMA-
TION.—Notwithstanding any other provision of law,
3507 
† HR 2617 EAS2 
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 Sec-
retary and the person submitting such informa-
tion to the Secretary. 
‘‘(3) USE OF REPORTS.—Nothing in this section 
shall permit a State, territory, or political subdivi-
sion 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 contributed 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
3508 
† HR 2617 EAS2 
are consistent, to the extent practicable, and appropriate, 
with national and international standards, in accordance 
with section 601. Any such regulations shall be intended 
to protect the public health and ensure that cosmetic prod-
ucts 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 regulations will apply. Such regu-
lations shall include simplified good manufacturing prac-
tice 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 reg-
ulations to implement subsection (a), the Secretary shall 
consult with cosmetics manufacturers, including smaller 
businesses, consumer organizations, and other experts se-
lected by the Secretary.
3509 
† HR 2617 EAS2 
‘‘(c) TIMEFRAME.—The Secretary shall publish a no-
tice of proposed 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. 
‘‘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 Moderniza-
tion of Cosmetics Regulation Act of 2022, owns 
or operates a facility that engages in the manu-
facturing 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 operates a facility that first engages, 
after the date of enactment of the Modernization 
of Cosmetics Regulation Act of 2022, in manu-
facturing 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
3510 
† HR 2617 EAS2 
after the deadline for registration under subpara-
graph (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 cos-
metic 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 manufac-
tured or processed at such facility. 
‘‘(4) UPDATES TO CONTENT.—A person that is 
required to register under subsection (a)(1) shall no-
tify the Secretary within 60 days of any changes to 
information required under subsection (b)(2). 
‘‘(5) ABBREVIATED RENEWAL REGISTRATIONS.— 
The Secretary shall provide for an abbreviated reg-
istration renewal process for any person that owns or 
operates a facility that has not been required to sub-
mit updates under paragraph (4) for a registered fa-
3511 
† HR 2617 EAS2 
cility since submission of the most recent registration 
of such facility under paragraph (1) or (2). 
‘‘(b) FORMAT; CONTENTS OF REGISTRATION.— 
‘‘(1) IN
GENERAL.—Registration information 
under this section may be submitted at such time and 
in such manner as the Secretary may prescribe. 
‘‘(2) CONTENTS.—The registration under sub-
section (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 facil-
ity, and, if available, the electronic contact infor-
mation; 
‘‘(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 facil-
ity are sold; and 
‘‘(E) the product category or categories and 
responsible person for each cosmetic product 
manufactured or processed at the facility. 
‘‘(c) COSMETIC PRODUCT LISTING.—
3512 
† HR 2617 EAS2 
‘‘(1) IN GENERAL.—For each cosmetic product, 
the responsible person shall submit to the Secretary a 
cosmetic product listing, or ensure that such submis-
sion is made, at such time and in such manner as 
the Secretary may prescribe. 
‘‘(2) COSMETIC PRODUCT LISTING.—The respon-
sible person of a cosmetic product that is marketed on 
the date of enactment of the Modernization of Cos-
metics Regulation Act of 2022 shall submit to the Sec-
retary 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 enact-
ment of such Act, within 120 days of marketing such 
product in interstate commerce. Thereafter, any up-
dates to such listing shall be made annually, con-
sistent with paragraphs (4) and (5). 
‘‘(3) ABBREVIATED
RENEWAL.—The Secretary 
shall provide for an abbreviated process for the re-
newal of any cosmetic product listing under this sub-
section with respect to which there has been no change 
since the responsible person submitted the previous 
listing. 
‘‘(4) CONTENTS OF LISTING.—
3513 
† HR 2617 EAS2 
‘‘(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 processed; 
‘‘(ii) the name and contact number of 
the responsible 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 cos-
metic product, including any fragrances, 
flavors, or colors, with each ingredient iden-
tified by the name, as required under sec-
tion 701.3 of title 21, Code of Federal Regu-
lations (or any successor regulations), or by 
the common or usual name of the ingre-
dient; 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 products with identical formu-
3514 
† HR 2617 EAS2 
lations, or formulations that differ only with re-
spect to colors, fragrances or flavors, or quantity 
of contents. 
‘‘(5) UPDATES TO CONTENT.—A responsible per-
son that is required to submit a cosmetic product list-
ing shall submit any updates to such cosmetic prod-
uct listing annually. 
‘‘(6) SUBMISSION.—A responsible person may 
submit product listing information as part of a facil-
ity 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 cos-
metic product under (c)(1), the Secretary shall assign a fa-
cility registration number to the facility and a product list-
ing number to each cosmetic product. The Secretary shall 
not make such product listing number publicly available. 
‘‘(e) CONFIDENTIALITY.—In response to a request 
under section 552 of title 5, United States Code, informa-
tion described in subsection (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.—
3515 
† HR 2617 EAS2 
‘‘(1) SUSPENSION OF REGISTRATION OF A FACIL-
ITY.—The Secretary may suspend the registration of 
a facility if the Secretary determines that a cosmetic 
product manufactured or processed by a registered fa-
cility and distributed in the United States has a rea-
sonable probability of causing serious adverse health 
consequences or death to humans and the Secretary 
has a reasonable belief that other products manufac-
tured or processed by the facility may be similarly af-
fected because of a failure that cannot be isolated to 
a product or products, or is sufficiently pervasive to 
raise concerns about other products manufactured in 
the facility. 
‘‘(2) NOTICE
OF
SUSPENSION.—Before sus-
pending 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
3516 
† HR 2617 EAS2 
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 in-
formal 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 reg-
istration that is subject to the suspension should be 
reinstated. The Secretary shall reinstate a registra-
tion if the Secretary determines, based on evidence 
presented, that adequate grounds do not exist to con-
tinue the suspension of the registration. 
‘‘(4) 
POST-HEARING
CORRECTIVE
ACTION 
PLAN.—If, after providing opportunity for an infor-
mal hearing under paragraph (3), the Secretary de-
termines 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 Secretary. 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
3517 
† HR 2617 EAS2 
as determined by the Secretary, in consultation with 
the registrant. 
‘‘(5) VACATING OF ORDER; REINSTATEMENT.— 
Upon a determination by the Secretary that adequate 
grounds do not exist to continue the suspension ac-
tions, the Secretary shall promptly vacate the suspen-
sion and reinstate the registration of the facility. 
‘‘(6) EFFECT OF SUSPENSION.—If the registra-
tion of the facility is suspended under this section, no 
person shall introduce or deliver for introduction into 
commerce in the United States cosmetic products from 
such facility. 
‘‘(7) NO DELEGATION.—The authority conferred 
by this section to issue an order to suspend a registra-
tion or vacate an order of suspension shall not be del-
egated to any officer or employee other than the Com-
missioner. 
‘‘SEC. 608. SAFETY SUBSTANTIATION. 
‘‘(a) SUBSTANTIATION OF SAFETY.—A responsible per-
son 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
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† HR 2617 EAS2 
coal-tar hair dye shall maintain records related to the safe-
ty of such product. 
‘‘(c) DEFINITIONS.—For purposes of this section: 
‘‘(1) ADEQUATE SUBSTANTIATION OF SAFETY.— 
The term ‘adequate 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 in-
gredients, sufficient to support a reasonable certainty 
that a cosmetic product is safe. 
‘‘(2) SAFE.—The term ‘safe’ means that the cos-
metic product, including any ingredient thereof, is 
not injurious to users under the conditions of use pre-
scribed in the labeling thereof, or under such condi-
tions 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 there-
of.
3519 
† HR 2617 EAS2 
‘‘SEC. 609. LABELING. 
‘‘(a) GENERAL REQUIREMENT.—Each cosmetic prod-
uct shall bear a label that includes a domestic address, do-
mestic 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 fra-
grance allergen included in such cosmetic product. Sub-
stances that are fragrance allergens for purposes of this sub-
section 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 enactment of the 
Modernization of Cosmetics Regulation Act of 2022, and not 
later than 180 days after the date on which the public com-
ment period on the proposed rulemaking closes, shall issue 
a final rulemaking. In promulgating regulations imple-
menting this subsection, the Secretary shall consider inter-
national, State, and local requirements for allergen disclo-
sure, including the substance and format of requirements 
in the European Union, and may establish threshold levels 
of amounts of substances subject to disclosure pursuant to 
such regulations. 
‘‘(c) COSMETIC PRODUCTS FOR PROFESSIONAL USE.—
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† HR 2617 EAS2 
‘‘(1) DEFINITION OF PROFESSIONAL.—For pur-
poses of this subsection, the term ‘professional’ means 
an individual who is licensed by an official State au-
thority to practice in the field of cosmetology, nail 
care, barbering, or esthetics. 
‘‘(2) PROFESSIONAL USE LABELING.—A cosmetic 
product introduced into interstate commerce and in-
tended to be used only by a professional shall bear a 
label that— 
‘‘(A) contains a clear and prominent state-
ment 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 reasonably 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 re-
sponsible person and facility shall, at the request of an offi-
3521 
† HR 2617 EAS2 
cer or employee duly designated by the Secretary, permit 
such officer or employee, upon presentation of appropriate 
credentials and a written notice to such person, at reason-
able 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 per-
forming 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 sec-
tion shall be construed to limit the authority of the Sec-
retary to inspect records or require establishment and 
maintenance of records under any other provision of this 
Act, including section 605 or 606.
3567 
† HR 2617 EAS2 
(4) whether the Secretary has accepted reports of 
inspections of facilities in China and India conducted 
by entities with which they have entered into such an 
agreement or arrangement; 
(5) what additional foreign governments or agen-
cies of foreign governments the Secretary has consid-
ered entering into a mutual recognition agreement 
with and, if applicable, reasons why the Secretary de-
clined to enter into a mutual recognition agreement 
with such foreign governments or agencies; 
(6) what tools, if any, the Secretary used to fa-
cilitate inspections of domestic facilities that could 
also be effectively utilized to appropriately inspect 
foreign facilities; 
(7) what steps the Secretary has taken to iden-
tify and evaluate tools and strategies the Secretary 
may use to continue oversight with respect to inspec-
tions when in-person inspections are disrupted; 
(8) how the Secretary is considering incor-
porating alternative tools into the inspection activi-
ties conducted pursuant to the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.); and 
(9) what steps the Secretary has taken to iden-
tify and evaluate how the Secretary may use alter-