summary
Introduced
02/03/2025
02/03/2025
In Committee
02/03/2025
02/03/2025
Crossed Over
Passed
Dead
Introduced Session
119th Congress
Bill Summary
A bill 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.
AI Summary
This bill requires the Secretary of Health and Human Services to publish an interim final rule within one year of enactment that updates various FDA regulations to replace references to "animal" tests with "nonclinical" tests. The bill specifically targets multiple sections of Title 21 of the Code of Federal Regulations, which governs drug and medical research protocols. The goal is to modernize language around research methodologies, potentially allowing for alternative testing approaches beyond traditional animal studies. The rule will become immediately effective without requiring the standard public comment period, and the FDA Commissioner is empowered to make additional regulatory changes as needed to fully implement this shift. The bill also technically amends the Federal Food, Drug, and Cosmetic Act to add a definition of "nonclinical test" to several key regulatory sections and makes a minor technical adjustment to the law's subsection numbering. By replacing "animal" with "nonclinical" terminology, the bill appears to signal openness to emerging research methods that may reduce or eliminate animal testing in pharmaceutical and medical research.
Committee Categories
Health and Social Services
Sponsors (10)
Cory Booker (D)*,
Richard Blumenthal (D),
John Neely Kennedy (R),
Angus King (I),
Ben Ray Luján (D),
Roger Marshall (R),
Rand Paul (R),
Adam Schiff (D),
Eric Schmitt (R),
Sheldon Whitehouse (D),
Last Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 02/03/2025)
Official Document
bill text
bill summary
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bill summary
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bill summary
Document Type | Source Location |
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State Bill Page | https://www.congress.gov/bill/119th-congress/senate-bill/355/all-info |
BillText | https://www.congress.gov/119/bills/s355/BILLS-119s355is.pdf |
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