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FDA Modernization Act 3.0: Updating Regulations on Nonclinical Testing Methods

This Act requires the Secretary of Health and Human Services (acting through the FDA Commissioner) to publish an interim final rule within one year. This rule aims to replace references to animal tests, data, and studies with references to "nonclinical" methods in specific sections of the Code of Federal Regulations. This change implements amendments to the Federal Food, Drug, and Cosmetic Act made in 2023.
Key points
The FDA must publish a rule within one year replacing references to animal testing with "nonclinical tests" in specific regulations.
The change applies to specific sections of Title 21 of the Code of Federal Regulations related to drug approval.
The definition of "nonclinical test" will be added to relevant sections of federal regulations.
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Status:
Expired
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Additional Information
FDA Modernization Act 3.0
Print number: S 5046
Sponsor: Sen. Booker, Cory A. [D-NJ]
Process start date: 2024-09-12
System Note: Lustra is free, publicly auditable civic infrastructure, with full source code available on GitHub. You are reading sterilized legislative data, processed by our radical neutrality engine to strip political spin and retain factual mechanics. We process only official government data. Original documents remain the authoritative source, always verify them if you can.
Summarized by: gemini-3-pro-preview
Source data: api.congress.gov
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Summary & Status

Key Questions about FDA Modernization Act 3.0: Updating Regulations on Nonclinical Testing Methods

A structured overview of the legislative process, official sources, status and civic context.

What is the official ID of this bill?

The official print number for this legislation is S 5046.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2024-09-12.

What are the main provisions?

Key points include:

  • The FDA must publish a rule within one year replacing references to animal testing with "nonclinical tests" in specific regulations.
  • The change applies to specific sections of Title 21 of the Code of Federal Regulations related to drug approval.
  • The definition of "nonclinical test" will be added to relevant sections of federal regulations.

What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Booker, Cory A. [D-NJ].

What is the latest detailed status?

The latest detailed status is: Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7044)

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-30.

Analysis and Potential Impact of S 5046

We don't know, that is up to you to decide. Summarizing raw data with AI is fundamentally different from predicting socio-economic outcomes. As of 2026, we believe impact assessment strictly requires a human in the loop to verify and judge. Review our public AI processing logs for full transparency, and use Lustra to track active legislation for instant status push notifications.

CATEGORIES

Health