[Congressional Record Volume 172, Number 118 (Monday, July 20, 2026)]
[House]
[Pages H4639-H4640]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FDA MODERNIZATION ACT 3.0
Mr. GUTHRIE. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 2821) to require the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, to publish a final
rule relating to nonclinical testing methods.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 2821
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FDA Modernization Act 3.0''.
SEC. 2. REGULATIONS ON NONCLINICAL TESTING METHODS.
(a) Interim Final Rule.--
(1) In general.--In order to ensure implementation of the
amendments to section 505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)) made by section 3209(a) of
the Consolidated Appropriations Act, 2023 (Public Law 117-
328; 136 Stat. 5821), not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs,
shall publish an interim final rule--
(A) to amend the sections of title 21, Code of Federal
Regulations, described in paragraph (2) to replace any
references to ``animal'' tests, data, studies, models, and
research with a reference to nonclinical tests, data,
studies, models, and research; and
(B) to add the definition of ``nonclinical test'' in
section 505(z) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(z)) to sections 312.3, 314.3, 315.2, and
601.31 of title 21, Code of Federal Regulations.
(2) CFR sections described.--The sections of title 21, Code
of Federal Regulations, described in this paragraph are the
following:
(A) Section 312.22(c).
(B) Section 312.23(a)(3)(iv).
(C) Section 312.23(a)(5)(ii).
(D) Section 312.23(a)(5)(iii).
(E) Section 312.23(a)(8).
(F) Section 312.23(a)(8)(i).
(G) Section 312.23(a)(8)(ii).
(H) Section 312.23(a)(10)(i).
(I) Section 312.23(a)(10)(ii).
(J) Section 312.33(b)(6).
(K) Section 312.82(a).
(L) Section 312.88.
(M) Section 314.50(d)(2).
(N) Section 314.50(d)(2)(iv).
(O) Section 314.50(d)(5)(i).
(P) Section 314.50(d)(5)(vi)(a).
(Q) Section 314.50(d)(5)(vi)(b).
(R) Section 314.93(e)(2).
(S) Section 315.6(d).
(T) Section 330.10(a)(2).
(U) Section 601.35(d).
(V) Any other section necessary to ensure regulatory
consistency with the amendments to section 505(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) made
by section 3209(a) of the Consolidated Appropriations Act,
2023 (Public Law 117-328; 136 Stat. 5821).
(3) Effectiveness of interim final rule.--Notwithstanding
subparagraph (B) of section 553(b) of title 5, United States
Code, the interim final rule issued by the Secretary of
Health and Human Services under paragraph (1) shall become
immediately effective as an interim final rule without
requiring the Secretary of Health and Human Services to
demonstrate good cause therefor.
(b) Technical Amendment.--Section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by
designating the second subsection (z) (relating to clinical
trial diversity action plans), as added by section 3601(a) of
the Health Extenders, Improving Access to Medicare, Medicaid,
and CHIP, and Strengthening Public Health Act of 2022
(division FF of Public Law 117-328), as subsection (aa).
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Kentucky (Mr. Guthrie) and the gentleman from New Jersey (Mr. Pallone)
each will control 20 minutes.
The Chair recognizes the gentleman from Kentucky.
General Leave
Mr. GUTHRIE. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material on this legislation.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Kentucky?
There was no objection.
Mr. GUTHRIE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in strong support of H.R. 2821, led by my
colleagues Representative Carter of Georgia and Representative
Barragan, which requires the Secretary of HHS to publish rules amending
certain regulations by replacing references to ``animal'' tests, data,
studies, models, and research with the broader term ``nonclinical''
tests, data, studies, models, and research.
Biomedical research typically utilizes animal models to explore
biological processes, analyze diseases, and explore potential
therapies. However, given the concerns and scientific limitations of
animal testing, researchers have increasingly turned to new approach
methodologies to evaluate drugs when scientifically justified.
The scientific community has worked diligently to balance animal
welfare concerns and the value of animal tests and research. I am
pleased with the progress to date and look forward to seeing continued
evidence-driven advancements in this space.
I commend the administration for their work to phase out animal
testing where it is scientifically appropriate and for achieving the
key goals in the first year of implementing the roadmap to reducing
animal testing in preclinical safety studies.
Mr. Speaker, I appreciate my colleague from Georgia for putting this
bill forward, and I reserve the balance of my time.
{time} 1450
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in support of H.R. 2821, the FDA Modernization
Act 3.0, led by Representative Barragan and Representative Carter of
Georgia.
The FDA Modernization Act 3.0 would require the Food and Drug
Administration to update regulations to replace references to animal
tests, data, studies, models, and research in specified sections of
Title 21 of the Code of Federal Regulations with references to
nonclinical tests.
This would bring FDA's regulations in line with a law passed in 2022
that allowed for alternatives to animal testing in drug development,
including those that leverage recent scientific advancements, such as
computer modeling and cell-based assays.
I encourage all my colleagues to vote ``yes'' on H.R. 2821, and I
reserve the balance of my time.
Mr. GUTHRIE. Mr. Speaker, I yield such time as he may consume to the
gentleman from Georgia (Mr. Carter), a dear friend, a great member of
the Energy and Commerce Committee, and a leader in this effort with the
FDA. With pharmaceuticals, just about anything that is very important
to the American people, he is an absolute leader in that.
Mr. CARTER of Georgia. Mr. Speaker, I thank the gentleman for
yielding.
Mr. Speaker, I rise today in strong support of my bill, H.R. 2821,
the FDA
[[Page H4640]]
Modernization Act 3.0, bipartisan legislation that ensures the FDA
fully embraces modern science while reducing unnecessary animal
testing.
Many of our families would feel incomplete without the pets and
animals that bring unconditional love into our lives. Yet every year,
millions of animals, including dogs, man's best friend, are still
subjected to testing in the development of new medicines.
As policymakers, we have a responsibility to protect those who cannot
protect themselves. That responsibility includes embracing scientific
innovation that can reduce unnecessary animal suffering while
continuing to deliver safe and effective treatments to patients.
In 2022, Congress took an important first step by passing the FDA
Modernization Act 2.0. I was proud to help lead that effort. That law
gave drug developers the ability to use modern, scientifically
validated alternatives to traditional animal testing when appropriate.
Congress made its intent clear. We wanted to encourage more
effective, more humane, and more innovative approaches to drug
development.
Unfortunately, the previous administration failed to fully implement
the law. Without clear implementation, too many researchers have lacked
the certainty they need, and too many animals continue to be used in
testing that modern science can increasingly replace.
H.R. 2821 ensures the FDA finally carries out the will of Congress.
This bill is not lowering standards. It is about raising them.
Today's researchers have access to technologies that simply did not
exist a generation ago: advanced human cell models, organ-on-a-chip
technology, artificial intelligence, and computational modeling. These
innovative tools have the potential to better predict how medicines
will perform in humans while reducing reliance on animal testing. Our
laws should reflect the science of today, not the science of decades
past.
Modernizing drug development doesn't just benefit animals. It
benefits patients. By providing greater clarity and encouraging the use
of validated alternative methods, we can make the drug development
process more efficient. That means fewer unnecessary delays and more
innovation. Ultimately, that means lifesaving treatments can reach
patients more quickly without compromising the FDA's rigorous standards
for safety and effectiveness.
This is a commonsense, bipartisan bill. It reflects a simple
principle: We can advance medical innovation while improving animal
welfare. Those goals are not in conflict. In fact, they go hand in
hand.
Mr. Speaker, the FDA Modernization Act 3.0 fulfills the promise
Congress made when we passed the FDA Modernization Act 2.0. It ensures
that modern science is fully incorporated into our regulatory process.
It helps reduce unnecessary animal testing and strengthens American
medical innovation. It also helps bring new therapies to patients more
efficiently.
I urge my colleagues to support H.R. 2821, the FDA Modernization Act
3.0.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from
Louisiana (Mr. Carter).
Mr. CARTER of Louisiana. Mr. Speaker, I rise in strong support of
H.R. 2821, the FDA Modernization Act 3.0, introduced by the gentleman
from Georgia (Mr. Carter).
I am proud to co-lead this bill with him and a bipartisan group of my
colleagues: Representatives Barragan, Buchanan, DeLauro, and
Harshbarger.
Over 3 years ago, the FDA Modernization Act 2.0 was signed into law,
allowing the agency to approve human drugs without requiring animal
testing through modern, often more effective, alternatives.
Despite this progress, the FDA has still not issued updated
regulations to clarify where alternatives to animal testing are, in
fact, permissible.
This legislation takes action to close the gap by requiring the FDA
to fully implement the reforms that Congress has already enacted and to
help reduce unnecessary animal testing in drug development. By ensuring
the full implementation of the FDA Modernization Act 2.0, this
legislation will help modernize and transform drug development for the
21st century; accelerate safer, more effective medical breakthroughs;
and advance more humane scientific research.
This is long overdue. We see the unnecessary slaughtering of animals
for research when there are other alternatives that may be, in fact,
more humane, more effective, and more cost effective, yet we continue
to do the same thing as if.
I am proud to be a part of this bill that will go a long way toward
protecting lives, advancing technological scientific finds, and
creating a better, more humane system. Overall, our bill is a big win
for patients, a big win for innovation, and a big win for animal
welfare.
Mr. Speaker, I encourage all my colleagues to vote ``yes'' on passing
this critical legislation.
Mr. GUTHRIE. Mr. Speaker, I have no additional speakers. I reserve
the balance of my time.
Mr. PALLONE. Mr. Speaker, I urge passage of this bipartisan bill, and
I yield back the balance of my time.
Mr. GUTHRIE. Mr. Speaker, I encourage a ``yes'' vote on this bill,
and I yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Kentucky (Mr. Guthrie) that the House suspend the rules
and pass the bill, H.R. 2821.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill was passed.
A motion to reconsider was laid on the table.
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