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Bill > S355


US S355

US S355
FDA Modernization Act 3.0


summary

Introduced
02/03/2025
In Committee
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)

Last Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 02/03/2025)

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