What does Preamble of S 355 do?

This bill requires the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule. The final rule pertains to nonclinical testing methods.

What does SHORT TITLE. of S 355 do?

This bill is formally titled the FDA Modernization Act 3.0.

What does REGULATIONS ON NONCLINICAL TESTING METHODS. of S 355 do?

This section requires the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to publish an interim final rule within one year of the Act's enactment. The interim final rule must amend sections of Title 21 of the Code of Federal Regulations to replace references to 'animal' tests with references to 'nonclinical' tests. The rule also adds the definition of 'nonclinical test' to specific sections of Title 21, Code of Federal Regulations. The rule specifies a list of CFR sections to be amended, including sections 312.22(c), 312.23(a)(3)(iv), and others listed in paragraph (2). The interim final rule will become immediately effective without requiring the Secretary to demonstrate good cause. Section 505 of the Federal Food, Drug, and Cosmetic Act is amended by redesignating the second subsection (z) as subsection (aa).

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FDA Modernization Act 3.0 — S. 355

Last updated: 12/17/2025 · Introduced: 2/3/2025

Author: Cory Booker (D-NJ)

TL;DR (AI)

This bill mandates the Food and Drug Administration (FDA) to update regulations by replacing references to 'animal' tests with 'nonclinical' tests across specified sections of Title 21 of the Code of Federal Regulations.
The FDA must publish an interim final rule within one year of enactment, defining 'nonclinical test' and amending specific CFR sections.
Section 505 of the Federal Food, Drug, and Cosmetic Act is amended by redesignating subsection (z) as subsection (aa).

119th Congresspassed senateOfficial page

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Other Sections

Includes provisions on preamble, short title., and 1 more.

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