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) Traumatic brain injury.-- ``(A) In general.--Subject to subparagraph (B), the term `traumatic brain injury'-- ``(i) means an acquired injury to the brain; ``(ii) may include-- ``(I) brain injuries caused by anoxia due to trauma; and ``(II) damage to the brain from an internal or external source that results in infection, toxicity, surgery, or vascular disorders not associated with aging; and ``(iii) does not include brain dysfunction caused by congenital or degenerative disorders, or birth trauma. ``(B) Revisions to definition.--The Secretary may revise the definition of the term `traumatic brain injury' under this paragraph, as the Secretary determines necessary, after consultation with States and other appropriate public or nonprofit private entities.''; and (E) by striking subsection (i).”
“A waiver provided by the Secretary under this paragraph shall apply only to the fiscal year involved.''; (C) in subsection (e)(3)(B)-- (i) by striking ``(such as third party payers, State agencies, community-based providers, schools, and educators)''; and (ii) by inserting ``(such as third party payers, State agencies, community-based providers, schools, and educators)'' after ``professionals''; (D) in subsection (h), by striking paragraphs (1) and (2) and inserting the following: ``(1) American indian consortium; state.--The terms `American Indian consortium' and `State' have the meanings given such terms in section 1253.”
“``(4) Waiver.--The Secretary may, upon the request of a State or American Indian consortium, waive not more than 50 percent of the matching fund amount under paragraph (1), if the Secretary determines that such matching fund amount would result in an inability of the State or American Indian consortium to carry out the purposes under subsection (a).”
“300d-52) is amended-- (A) in subsection (b)(2)-- (i) by inserting ``, taking into consideration populations that may be at higher risk for traumatic brain injuries'' after ``outreach programs''; and (ii) by inserting ``Tribal,'' after ``State,''; (B) in subsection (c), by adding at the end the following: ``(3) Maintenance of effort.--With respect to activities for which a grant awarded under subsection (a) is to be expended, a State or American Indian consortium shall agree to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the level of such expenditures maintained by the State or American Indian consortium for the fiscal year preceding the fiscal year for which the State or American Indian consortium receives such a grant.”
“Such website, to the extent feasible, shall include aggregated information on populations that may be at higher risk for traumatic brain injuries and strategies for preventing or reducing risk of traumatic brain injury that are tailored to such populations.''. (3) Authorization of appropriations.--Section 394A of the Public Health Service Act (42 U.S.C. 280b-3) is amended-- (A) in subsection (a), by striking ``1994, and'' and inserting ``1994,''; and (B) in subsection (b), by striking ``appropriated'' and all that follows through ``2024'' and inserting ``appropriated $9,250,000 for each of fiscal years 2026 through 2030''. (b) State Grant Programs.-- (1) State grants for projects regarding traumatic brain injury.--Section 1252 of the Public Health Service Act (42 U.S.C.”
“(2) National program for traumatic brain injury surveillance and registries.--Section 393C of the Public Health Service Act (42 U.S.C. 280b-1d) is amended-- (A) by amending the section heading to read as follows: ``the bill pascrell, jr., national program for traumatic brain injury surveillance and registries''; (B) in subsection (a)-- (i) in the matter preceding paragraph (1), by inserting ``to identify populations that may be at higher risk for traumatic brain injuries, to collect data on the causes of, and risk factors for, traumatic brain injuries,'' after ``related disability,''; (ii) in paragraph (1), by inserting ``, including the occupation of the individual, when relevant to the circumstances surrounding the injury'' before the semicolon; and (iii) in paragraph (4), by inserting ``short- and long- term'' before ``outcomes''; (C) by striking subsection (b); (D) by redesignating subsection (c) as subsection (b); (E) in subsection (b), as so redesignated, by inserting ``and evidence-based practices to identify and address concussion'' before the period at the end; and (F) by adding at the end the following: ``(c) Availability of Information.--The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall make publicly available aggregated information on traumatic brain injury and concussion described in this section, including on the website of the Centers for Disease Control and Prevention.”
“280b-1c) is amended-- (A) in subsection (a), by inserting ``and prevalence'' after ``incidence''; (B) in subsection (b)-- (i) in paragraph (1), by inserting ``and reduction of associated injuries and fatalities'' before the semicolon; (ii) in paragraph (2), by inserting ``and related risk factors'' before the semicolon; and (iii) in paragraph (3)-- (I) in the matter preceding subparagraph (A), by striking ``2020'' each place it appears and inserting ``2030''; and (II) in subparagraph (A)-- (aa) in clause (i), by striking ``; and'' and inserting ``of traumatic brain injury;''; (bb) by redesignating clause (ii) as clause (iv); (cc) by inserting after clause (i) the following: ``(ii) populations at higher risk of traumatic brain injury, including populations whose increased risk is due to occupational or circumstantial factors; ``(iii) causes of, and risk factors for, traumatic brain injury; and''; and (dd) in clause (iv), as so redesignated, by striking ``arising from traumatic brain injury'' and inserting ``, which may include related mental health and other conditions, arising from traumatic brain injury, including''; and (C) in subsection (c), by inserting ``, and other relevant Federal departments and agencies'' before the period at the end.”
“Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 1493) to reauthorize and make improvements to Federal programs relating to the prevention, detection, and treatment of traumatic brain injuries, and for other purposes, as amended. The Clerk read the title of the bill. The text of the bill is as follows: H.R. 1493 Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. PROGRAMS TO PREVENT, DETECT, AND TREAT TRAUMATIC BRAIN INJURIES. (a) The Bill Pascrell, Jr., National Program for Traumatic Brain Injury Surveillance and Registries.-- (1) Prevention of traumatic brain injury.--Section 393B of the Public Health Service Act (42 U.S.C.”
“Mr. Speaker, I yield myself the balance of my time. Mr. Speaker, I agree with my friend from New Jersey. Dental care is important. I encourage a ``yes'' vote on the 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. 2001, 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. ____________________”
“Mr. Speaker, I yield 5 minutes to the gentleman from Idaho (Mr. Simpson), my good friend, who is a member of the Committee on Appropriations, and also a dentist, so he knows this issue well.”
“Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in strong support of H.R. 2001 led by my colleagues Representative Kelly and Representative Simpson, which reauthorizes a grant program that helps States develop and implement programs to address the need for dental professionals in areas facing a workforce shortage. Oral health is foundational to a person's overall health, as poor oral health may cause issues with daily tasks, like eating, and negatively impacts a person's ability to take part in school or work. This legislation is a bipartisan effort to help improve the oral health of all Americans by ensuring that communities across the Nation have access to strong oral health programs despite dental workforce shortages. Mr.”
“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. 2001. The SPEAKER pro tempore. Is there objection to the request of the gentleman from Kentucky? There was no objection.”
“Guthrie) and the gentleman from New Jersey (Mr. Pallone) each will control 20 minutes. The Chair recognizes the gentleman from Kentucky. General Leave”
“Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 2001) to amend the Public Health Service Act to reauthorize a grant program for addressing dental workforce needs, as amended. The Clerk read the title of the bill. The text of the bill is as follows: H.R. 2001 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 ``Action for Dental Health Act''. SEC. 2. ACTION FOR DENTAL HEALTH. Section 340G(f) of the Public Health Service Act (42 U.S.C. 256g(f)) is amended by striking ``$13,903,000 for each of fiscal years 2019 through 2023'' and inserting ``$15,000,000 for each of fiscal years 2026 through 2030, to remain available until expended''. The SPEAKER pro tempore. Pursuant to the rule, the gentleman from Kentucky (Mr.”
“Mr. Speaker, I encourage a ``yes'' vote on the 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. 3747, 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. ____________________”
“Mr. Speaker, I yield 3 minutes to the gentleman from Ohio (Mr. Balderson), my good friend and very important member of the Energy and Commerce Committee.”
“Speaker, I am proud to support this legislation. I encourage my colleagues to support this bill, and I reserve the balance of my time.”
“Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in strong support of H.R. 3747, led by my colleagues Representatives Balderson and Barragan, which would reauthorize the technology-enabled collaborative learning program. The technology-enabled collaborative learning program health education model connects healthcare professionals through interactive videoconferencing, which helps meet people where they are by promoting access to specialty care for people who otherwise may not be able to access it because of where they live. This is a valuable tool for clinicians to both continue learning and improve existing knowledge of best practices to support and care for patients in their communities. This is particularly effective for patients in rural communities, and I represent many. Mr.”
“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. 3747. The SPEAKER pro tempore. Is there objection to the request of the gentleman from Kentucky? There was no objection.”
“254c-20) is amended-- (1) in subsection (a)(1), by striking ``entities'' and inserting ``entities, including a public or nonprofit private entity,''; and (2) in subsection (b), by inserting ``dementia care,'' after ``palliative care,''. (b) Authorization of Appropriations.--Section 330N(k) of the Public Health Service Act (42 U.S.C. 254c-20(k)) is amended by striking ``fiscal years 2022 through 2026'' and inserting ``fiscal years 2027 through 2031''. 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. Speaker, I move to suspend the rules and pass the bill (H.R. 3747) to amend the Public Health Service Act to reauthorize the Project ECHO Grant Program, to establish grants under such program to disseminate knowledge and build capacity to address Alzheimer's disease and other dementias, and for other purposes, as amended. [[Page H4644]] The Clerk read the title of the bill. The text of the bill is as follows: H.R. 3747 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 ``Accelerating Access to Dementia and Alzheimer's Provider Training Act'' or the ``AADAPT Act''. SEC. 2. EXPANDING CAPACITY FOR HEALTH OUTCOMES. (a) In General.--Section 330N of the Public Health Service Act (42 U.S.C.”
“Mr. Speaker, I yield myself the balance of my time. Mr. Speaker, in closing, I encourage a ``yes'' vote on the 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. 5160, 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. ____________________”
“Mr. Speaker, I yield such much time as he may consume to the gentleman from Florida (Mr. Bilirakis), a very important member of our committee and chairman of the Commerce, Manufacturing, and Trade Subcommittee.”
“Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of H.R. 5160, led by my colleagues Representatives Smith and Matsui to reauthorize the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory program. The C.W. Bill Young Cell Transplantation Program supports patients across the country with identifying matching and facilitating the distribution of bone marrow peripheral blood stem cells and cord blood donors for those who need blood stem cell transplants. This is critically important for those patients without a related family member who is unable to donate. For some patients, blood stem cell transplants are an opportunity for remission or even a cure when other treatments have failed. This bill ensures patients have access to these lifesaving opportunities. Mr.”
“Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks and include extraneous material on H.R. 5160. The SPEAKER pro tempore. Is there objection to the request of the gentleman from Kentucky? There was no objection.”
“(e) Definitions.--Section 2(g) of such Act, as redesignated by subsection (d)(1) of this section, is amended-- (1) by redesignating paragraphs (4) and (5) as paragraphs (5) and (6), respectively; and (2) by inserting after paragraph (3) the following: ``(4) The term `high quality cord blood unit' means a cord blood unit that meets current industry standards and any requirements of the Food and Drug Administration.''. (f) Authorization of Appropriations.--Section 2(h) of such Act, as redesignated by subsection (d)(1) of this section, is amended by striking ``fiscal years 2022 through 2026'' and inserting ``fiscal years 2027 through 2031''. 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.”
“``(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.”
“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.”
“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. REAUTHORIZATION OF THE C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM. Section 379B of the Public Health Service Act (42 U.S.C.”
“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. ____________________”
“[[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. I encourage my colleagues to support this bill, and I reserve the balance of my time.”
“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. 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.”
“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.”
“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. 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. 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. 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.”
“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. ____________________”
“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.”
“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. 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.”
“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.”
“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”
“(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).”
“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.”
“Mr. 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. ____________________”
“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. 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.”