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Congressional Daily Record
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July 20, 2026
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Download official House Record PDFReturn to issue contextMr. 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.
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.
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.
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.
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
Modernization Act 3.0, bipartisan legislation that ensures the FDA fully embraces modern science while reducing unnecessary animal testing.
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.
protect themselves. That responsibility includes embracing scientific innovation that can reduce unnecessary animal suffering while continuing to deliver safe and effective treatments to patients.
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.
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.
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).
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.
regulations to clarify where alternatives to animal testing are, in fact, permissible.
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.
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.