Brett Guthrie
Representative for Kentucky · Republican · United States
“(d) Study on Long-Term Symptoms or Conditions Related to Traumatic Brain Injury.-- (1) In general.--The Secretary, in consultation with stakeholders and the heads of other relevant Federal departments and agencies, as appropriate, shall conduct, either directly or through a contract with a nonprofit private entity, a study to-- (A) examin…”
“(d) Study on Long-Term Symptoms or Conditions Related to Traumatic Brain Injury.-- (1) In general.--The Secretary, in consultation with stakeholders and the heads of other relevant Federal departments and agencies, as appropriate, shall conduct, either directly or through a contract with a nonprofit private entity, a study to-- (A) examin…”
“300n-5(a))-- (A) by striking ``2011, and'' and inserting ``2011,''; and (B) by inserting ``, and $235,500,000 for each of fiscal years 2026 through 2030'' before the period at the end.”
“300n-5(a))-- (A) by striking ``2011, and'' and inserting ``2011,''; and (B) by inserting ``, and $235,500,000 for each of fiscal years 2026 through 2030'' before the period at the end.”
“360aa note) is amended-- (1) in the section heading, by striking ``als and other rare neurodegenerative disease action plan'' and inserting ``fda rare neurodegenerative disease action plan''; and (2) by adding at the end the following: ``(c) FDA Rare Neurodegenerative Disease Action Plan.-- ``(1) In general.--Not later than 18 months afte…”
“360aa note) is amended-- (1) in the section heading, by striking ``als and other rare neurodegenerative disease action plan'' and inserting ``fda rare neurodegenerative disease action plan''; and (2) by adding at the end the following: ``(c) FDA Rare Neurodegenerative Disease Action Plan.-- ``(1) In general.--Not later than 18 months afte…”
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“``(2) Considerations.--In carrying out paragraph (1), the Secretary may-- ``(A) on the Secretary's own initiative or upon petition by a qualified cord blood bank, make determinations regarding the continued storage of cord blood units based on the best available scientific and clinical evidence; or ``(B) prioritize the collection, retention, or disposition of cord blood units based on scientific, clinical, or operational considerations that the Secretary determines to be relevant.''.”
“274k note) is amended-- (1) by redesignating subsections (e), (f), and (g) and as subsections (f), (g), and (h), respectively; and (2) by inserting after subsection (d) the following: ``(e) Inventory Management.-- ``(1) In general.--The Secretary shall manage the size and composition of the National Cord Blood Inventory to maximize clinical utility, ensure genetic diversity, and promote the efficient use of resources.”
“274k note) is amended to read as follows: ``(4) Consideration of best science.--The Secretary shall take into consideration current scientific and clinical information in order to maximize the availability of high- quality cord blood units meeting applicable clinical and quality standards for transplant when entering into contracts under this section, or when extending a period of funding under such a contract under paragraph (2).''. (d) Inventory Management.--Section 2 of such Act (42 U.S.C.”
“274k note) is amended-- (1) in paragraph (2), by striking ``in perpetuity or''; and (2) by amending paragraph (5) to read as follows: ``(5) if the Secretary determines through an assessment, or through petition by the applicant, that a cord blood bank is no longer operational, does not meet the requirements described in subsection (d)(4), or does not meet the requirements of section 379(d)(4) of the Public Health Service Act, and as a result may not distribute the high- quality units, the Secretary may transfer the units collected pursuant to this section to another qualified cord blood bank or entity approved by the Secretary to ensure continued availability of high-quality cord blood units.''. (c) Duration of Contracts.--Section 2(d)(4) of such Act (42 U.S.C.”
“REAUTHORIZATION OF THE C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM. Section 379B of the Public Health Service Act (42 U.S.C. 274m) is amended-- (1) by striking ``appropriated $31,009,000'' and inserting the following: ``appropriated-- ``(1) $31,009,000''; (2) in paragraph (1), as so inserted, by striking the period at the end and inserting ``; and''; and (3) by adding at the end the following: ``(2) $33,009,000 for each of fiscal years 2027 through 2031.''. SEC. 3. CORD BLOOD INVENTORY. (a) In General.--Section 2(a) of the Stem Cell Therapeutic and Research Act of 2005 (42 U.S.C. 274k note) is amended by striking ``at least 150,000 new units of high-quality cord blood'' and inserting ``a sufficient supply, as determined by the Secretary, of high-quality cord blood units''. (b) Application.--Section 2(c) of such Act (42 U.S.C.”
“Congressional Record, Volume 172 Issue 118 (Monday, July 20, 2026) [Congressional Record Volume 172, Number 118 (Monday, July 20, 2026)] [House] [Pages H4642-H4643] From the Congressional Record Online through the Government Publishing Office [ www.gpo.gov ] {time} 1510 STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT OF 2025 Mr. GUTHRIE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 5160) to reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes, as amended. The Clerk read the title of the bill. The text of the bill is as follows: H.R. 5160 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 ``Stem Cell Therapeutic and Research Reauthorization Act of 2025''. SEC. 2.”
“Speaker, again, I would urge my colleagues to support this bill on a bipartisan basis, 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 (Mr. Newhouse). 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. 4348. 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. ____________________”
“Tick-borne diseases are a large and growing problem in New York, with more than 18,000 cases of Lyme disease reported in New York State in 2024. Lyme can cause serious health consequences, and for some, long- term complications persist after treatment. With a warming climate, tick populations and ranges are on the rise, leading to fears that tick-borne diseases will continue to increase in frequency in the years to come. Already, warning signs are blaring that 2026 could be the worst year for tick exposures since 2017, based on CDC tracking data. In this backdrop, research investments and public health resources are more vital than ever. That is what the Kay Hagan Tick Act will deliver. I am proud to have worked on this commonsense bipartisan bill, and I would urge all of my colleagues to support this legislation. Mr. PALLONE. Mr.”
“4348, as well as his Staff Director Megan Jackson and Health Subcommittee staff Jay Gulshen and Emma Schultheis. Special thanks to Ranking Member Frank Pallone, Health Subcommittee Chair Morgan Griffith and Ranking Member Diana DeGette as well as original cosponsors Lloyd Doggett, Paul Tonko, and Tom Kean. Mr. GUTHRIE. Mr. Speaker, I reserve the balance of my time. Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from New York (Mr. Tonko). Mr. TONKO. Mr. Speaker, I rise in strong support of the Kay Hagan Tick Act legislation that I am leading along with my colleagues, Representatives Chris Smith, Lloyd Doggett, and Tom Kean. The Kay Hagan Tick Act would reauthorize key programs at the CDC that fund both research and support for local public health agencies to address tick-borne diseases such as Lyme disease.”
“434--again as we did in the original law--authorizes cooperative agreement funding for states and localities--$100 million over five years--to tangibly assist state public health departments and other local entities to support the development and implementation of evidence-based research, interventions, and treatment with respect to-- [[Page H4642]] educating and informing the public, based on evidence-based public health research and data, about Lyme Disease and other vector-borne diseases; supporting early detection and diagnosis; supporting prevention; improving treatment; and supporting care planning and management for individuals with Lyme disease and other tick- and vector-borne diseases. I thank the Chairman Brett Guthrie for his personal and extraordinarily strong support of H.R.”
“Disseminate and implement public health tools, programs, and collaborations to prevent, detect, diagnose, and respond to VBD threats. H.R. 4348, supports this whole of government assault on Lyme and other vector borne diseases. H.R. 4348 again authorizes $50 million over five years for the regional centers of excellence, which coordinate with academia and local public health agencies to conduct research on Lyme in their areas and train public health professionals to identify and treat Lyme. Finally, H.R.”
“It also, as we did in the original law, authorizes $100 million over 5 years to tangibly assist States' public health departments and other local entities to support the development and implementation of evidence-based research interventions and treatment with respect to the Lyme disease epidemic. I urge my colleagues to support it. Mr. Speaker, in February, 2024, HHS released the National Public Health Strategy to Prevent and Control Vector-borne Diseases in People with mutually reinforcing goals to: Better understand when, where, and how people are exposed to and get sick or die from VBDs. Develop, evaluate, and improve tools, methods, and guidance to diagnose VBDs and their pathogens. Develop, evaluate, and improve tools, methods, and guidance to prevent and control VBDs. Develop and assess drugs and treatment strategies for VBDs.”
“I introduced my first comprehensive bill--one of many, at times we had over 100 cosponsors--called the Lyme Disease Initiative Act of 1998, almost 30 years ago. We could not move it. It was blocked over and over again. There were some people in HHS and at CDC and elsewhere who were saying, just take 2 weeks of doxycycline and you are cured. When you have chronic Lyme, it takes a very serious effort, very often with a Lyme literate doctor, in order to overcome and put that disease into remission. In February 2024, I remind my colleagues, HHS released the National Public Health Strategy to prevent and control vector-borne diseases. It is an excellent strategy. We are acting on that now as well. It also supports the whole-of-government assault on Lyme. It authorizes $50 million over 5 years for Regional Centers of Excellence.”
“The original Kay Hagan Tick Act, which I led in 2019 here in the House and Susan Collins led it in the Senate, became part of the appropriations act in 2020. The act created, among other things, a whole-of-government national strategy to combat Lyme and other tick- borne diseases with special focus on surveillance, diagnosis, treatment, education, and prevention. I would note parenthetically that I have been working on Lyme disease since 1992, when Pat Smith--no relation--of Wall Township, who actually formed the Lyme Disease Association of America, came up to me in Wall Township and said: What are you doing about Lyme? I said: Nothing. We had lunch. I have been working on it ever since.”
“Vector-borne diseases are now endemic in regions of the country where they have not historically been present. Disease-laden ticks are now found in all 48 contiguous States. The problem is exploding. It is not abating. It is, therefore, critical that Congress take immediate action to support and further sustain ongoing efforts to combat these insidious diseases that kill and disable. I urge my colleagues to support H.R. 4348, a 5-year reauthorization of the Kay Hagan Tick Act, a law that expires on September 30th. My colleagues will recall that our distinguished colleague, North Carolina Senator Kay Hagan, suffered a tick bite and died in 2019 from encephalitis caused by the Powassan virus. The current law and reauthorization is named in her honor.”
“More than 476,000 Americans are diagnosed with Lyme disease each year, and recent data show emergency room visits for tick bites reached their highest springtime level in nearly a decade.'' Secretary Kennedy also announced new actions to combat Alpha-gal syndrome, a tick-associated condition that can trigger potentially serious allergic reactions to red meat and other products. The CDC estimates nearly 500,000 Americans are living with Alpha-gal syndrome, though emerging evidence suggests the true number may be significantly higher. Mr. Speaker, as my colleagues know, ticks not only transmit Lyme disease but other deadly and debilitating illnesses, such as Alpha-gal, babesiosis, Powassan disease, Rocky Mountain spotted fever, and anaplasmosis.”
“Today, the Trump administration is launching one of the most ambitious Federal efforts ever to combat Lyme disease by accelerating research, expanding innovation, and improving care for patients and families. We are going after this disease at its source, driving faster diagnostics and new prevention strategies, and delivering the urgency and action Americans deserve.'' He said: ``The initiative will develop and deploy practical strategies to target and eliminate ticks on wildlife before they can spread diseases to humans.'' That has been lacking for decades. They are going after the ticks themselves. ``Lyme disease,'' Mr. Speaker, he said: ``remains one of the Nation's fastest growing vector-borne health threats.”
“Speaker, I thank Chairman Guthrie for his personal and extraordinarily strong support of H.R. 4348, and his staff, director Megan Jackson, Health Subcommittee staff Jay Gulshen and Emma Schultheis. I also thank my good friend, Frank Pallone, our Health Subcommittee Chair Morgan Griffith, Ranking Member Diana DeGette, as well as the original sponsors, Lloyd Doggett, Paul Tonko, and Tom Kean. Mr. Speaker, at a May 29th press conference in New Hampshire, HHS Secretary Robert F. Kennedy, Jr., who has been a tremendous leader in the war on Lyme disease, announced a ``sweeping plan to combat Lyme disease and to advance treatment.'' Secretary Kennedy said: ``Millions of Americans battling Lyme disease and other tick-borne illnesses have spent years searching for answers, treatment, and support.”
“4348 would expand research, improve testing, and coordinate vector-borne disease efforts across the Federal Government. The bill would also reauthorize funding for Regional Centers of Excellence for surveillance, prevention, and response to vector-borne diseases and reauthorize grants to State health departments to support vector-borne disease infrastructure. Tick and vector-borne disease have rapidly increased, Mr. Speaker, particularly in the northeastern part of our country. I encourage all of my colleagues to honor the legacy of Senator Kay Hagan, who died of complications from a tick-borne disease, by voting ``yes'' on H.R. 4348. Mr. Speaker, I reserve the balance of my time. Mr. GUTHRIE. Mr. Speaker, I yield to the gentleman from New Jersey (Mr. Smith). Mr. SMITH of New Jersey. Mr.”
“I encourage my colleagues to support this bill, and I reserve the balance of my time. Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of H.R. 4348, the Kay Hagan Tick Act, sponsored by my colleagues Chris Smith of New Jersey and Lloyd Doggett of Texas. I understand that Mr. Kean from New Jersey is also a sponsor. This bill reauthorizes the national strategy and regional centers of excellence in vector-borne diseases. Tick-borne diseases, including Lyme disease, have rapidly increased over the last decades. The Centers for Disease Control and Prevention estimates that nearly a half million people may, in fact, be diagnosed and treated for Lyme disease every year in the United States. That is a dramatic increase from 30,000 annual cases just two decades ago. {time} 1500 H.R.”
“Doggett), which authorizes the national and regional centers for excellence in vector-borne disease in the CDC's cooperative agreements with health departments in high-risk areas for vector-borne diseases. Vectors like mosquitoes, ticks, and fleas carry dangerous diseases, and vector-borne diseases can happen to anyone. They can have debilitating effects. Preventing these diseases is a bipartisan issue that I hope we all can support. [[Page H4641]] In addition to thanking the bill's sponsors for their leadership in advancing the efforts to reduce the alarming threat of vector-borne disease, I also thank the administration for their support of this bill and for their commitment to the American people by combating Lyme disease, which affects almost half a million Americans annually.”
“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 to revise and extend their remarks on the legislation and to include extraneous material on H.R. 4348. 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 in strong support of H.R. 4348, led by my colleagues, the gentleman from New Jersey (Mr. Smith) and the gentleman from Texas (Mr.”
“247b-23) is amended-- (1) in subsection (b), in the matter preceding paragraph (1), by striking ``the Tick-Borne Disease Working Group established under section 2062 of the 21st Century Cures Act (42 U.S.C. 284s) and other individuals, as appropriate'' and inserting ``appropriate individuals''; (2) in subsection (c)(4), by inserting ``, including by increasing capacity to identify, report, prevent, and respond to such diseases'' before the period at the end; and (3) in subsection (f), by striking ``2021 through 2025'' and inserting ``2026 through 2030''. (b) Enhanced Support To Assist Health Departments in Addressing Vector-Borne Diseases.--Section 2822(c) of the Public Health Service Act (42 U.S.C. 300hh-32(c)) is amended by striking ``2021 through 2025'' and inserting ``2026 through 2030''. The SPEAKER pro tempore.”
“Congressional Record, Volume 172 Issue 118 (Monday, July 20, 2026) [Congressional Record Volume 172, Number 118 (Monday, July 20, 2026)] [House] [Pages H4640-H4642] From the Congressional Record Online through the Government Publishing Office [ www.gpo.gov ] REAUTHORIZING THE KAY HAGAN TICK ACT Mr. GUTHRIE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 4348) to reauthorize the Kay Hagan Tick Act, and for other purposes. The Clerk read the title of the bill. The text of the bill is as follows: H.R. 4348 Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. REAUTHORIZATION OF PROGRAMS. (a) National Strategy and Regional Centers of Excellence in Vector-Borne Disease.--Section 317U of the Public Health Service Act (42 U.S.C.”
“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. ____________________”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“(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.”
“(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).”
“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).”
“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.”
“Congressional Record, Volume 172 Issue 118 (Monday, July 20, 2026) [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.”
“Speaker, I encourage my colleagues to vote for this bipartisan 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. 2715, as amended. The question was taken; and (two-thirds being in the affirmative) the rules were suspended and the bill, as amended, was passed. A motion to reconsider was laid on the table. ____________________”
“Since 2021, Louisiana shrimpers have seen the value of their catch drop by more than 50 percent, falling from $131 million in 2021 to just $61 million in 2024. As you can see, this is, in fact, a real threat. Passing this bill will deter bad actors from flooding the market with unsafe products and provide American fishermen with a fair playing field, allowing them to sustainably harvest millions of additional pounds of shrimp and other seafood each year. This is a real issue, and I am proud to be working in a bipartisan way to address an issue that will impact not just Louisiana but our entire country. Mr. Speaker, I urge the passage of this critical legislation. Mr. PALLONE. Mr. Speaker, I urge support for this bipartisan bill, and I yield back the balance of my time. Mr. GUTHRIE. Mr.”
“Meanwhile, some foreign producers cut corners and still get multiple chances to dump noncompliant and often dangerous products into the American marketplace. Seafood imports continue to pour into the United States, increasing in [[Page H4639]] volume each year, undercutting domestic fishermen. Last year, the U.S. imported 6.4 billion pounds of foreign seafood, a 10 percent increase from 2019. As imports have increased, American commercial seafood landings have declined. In 2024, the U.S. commercial landings totaled 7.7 billion pounds, the first time landings have been below 8 billion pounds since 1988. Louisiana's commercial fishing industry has particularly been hit hard by this flood of foreign imports.”
“Beyond food, there has been a rise in imports of dangerous vape devices and e-liquids containing banned substances and excessive nicotine, as well as counterfeit drugs like GLP-1s. This threat is real and documented. Exporters, especially Chinese exporters, have been caught resubmitting rejected shipments at different ports. This bill closes that loophole and creates a deterrent for bad actors. Congressman Higgins and I have worked hand in hand with our domestic fishing industry on this legislation, including the Southern Shrimp Alliance. American fishermen perform backbreaking work and operate under strict U.S. food safety, labor, and environmental rules that raise their costs significantly.”
“knowing they can withdraw the shipment if FDA flags it. They can then try to enter through a different port where the shipment may not be caught, a practice known as port shopping. This loophole endangers our health and undermines our food and drug safety systems. This bill authorizes the Food and Drug Administration to require an importer to destroy an FDA-regulated product that was refused entry into the U.S. because it poses a significant public health concern with the cost of the destruction at the importer's expense. This bill also prohibits the unauthorized movement of any article designated for destruction by the FDA. Some imported foods, especially seafood, have been found to be contaminated with carcinogenic drugs, pesticides, and other harmful impurities.”
“It makes no sense not to allow the FDA to destroy these products. Mr. Speaker, I support this bill, and I reserve the balance of my time. Mr. PALLONE. Mr. Speaker, I yield 4 minutes to the gentleman from Louisiana (Mr. Carter), a member of our committee, my colleague, and the Democratic sponsor of this bill. Mr. CARTER of Louisiana. Mr. Speaker, I rise today in support of H.R. 2715, the Destruction of Hazardous Imports Act, which I introduced with my Louisiana colleague Representative Clay Higgins. This bill will protect American consumers and create a level playing field for American businesses by authorizing the Food and Drug Administration to order the destruction of imported products found to pose a significant public health concern. Under current law, foreign exporters can ship contaminated or counterfeit products to the U.S.”
“We need to make sure Americans are not unwittingly exposed to harmful products, and this authority is going to prevent that. Mr. Speaker, I encourage all my colleagues to vote ``yes'' on H.R. 2715, and I reserve the balance of my time. Mr. GUTHRIE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I really appreciate my friends from Louisiana, both of them, for bringing this forward. This is important. Think about what we are talking about here. Contaminated seafood, illicit drugs, and all of these other things are getting stopped at a port of entry, but FDA has no authority to destroy them. As my friend from New Jersey said, they get returned and come in through another port. As good as our people are at our ports of entry, if you keep sending the same thing through over and over, eventually it is going to get through.”
“This bill would provide the Food and Drug Administration with the authority to require importers to destroy products that pose a significant public health concern, preventing them from being shipped to another port of entry. These products have, in fact, included food contaminated with salmonella, listeria, and carcinogenic unapproved animal drugs, as well as misbranded medical devices. It also includes illegal e-cigarette products that are flooding the market from places like China. These are dangerous products, Mr. Speaker. Providing the FDA with the authority to compel destruction and requiring the importer to pay for such destruction will provide a strong disincentive to those seeking to prioritize profits over product safety.”
“2715 supports the administration and follows through by adding the FDA's existing authority to destroy imported medical devices and medications with any article that poses a health risk to the public. As we work to improve our Nation's health and reverse the lingering effects of unfair trade policies, it is essential that the FDA has the authority to eliminate toxic foods and drugs from our country. The Destruction of Hazardous Imports Act protects Americans' health and prioritizes our domestic industry. I urge full support and swift passage, Mr. Speaker. {time} 1440 Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of H.R. 2715, the Destruction of Hazardous Imports Act, led by Representatives Carter and Higgins of Louisiana.”