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.
Sponsors
Legislative Progress
Passed SenateMr. Booker (for himself, Mr. Schmitt, Mr. King, Mr. Kennedy, …
Passed Senate (inferred from es version)
Summary
What This Bill Does
This bill requires the FDA to issue regulations within one year implementing the FDA Modernization Act 2.0 (passed in 2023), which eliminated the mandate for animal testing in drug development. The FDA must update dozens of CFR sections to replace "animal tests" with "nonclinical tests" and add the new statutory definition.
Who Benefits and How
Drug developers and pharmaceutical companies benefit from regulatory clarity enabling use of alternative testing methods (organ-on-chip, computer modeling, etc.) instead of mandatory animal studies. Animal welfare organizations benefit from reduced animal testing requirements. Drug development timelines may improve with faster, cheaper alternatives.
Who Bears the Burden and How
FDA must complete comprehensive rulemaking within 1 year, updating over 20 CFR sections. The rule becomes effective immediately without normal comment period.
Key Provisions
- Mandates FDA interim final rule within 1 year of enactment
- Lists 20+ specific CFR sections requiring updates
- Allows rule to take effect immediately without prior comment period
- Fixes technical drafting error in prior law (duplicate subsection (z) renumbered)
Evidence Chain:
This summary is derived from the structured analysis below. See "Detailed Analysis" for per-title beneficiaries/burden bearers with clause-level evidence links.
Primary Purpose
Requires FDA to update regulations within 1 year to replace references to "animal tests" with "nonclinical tests," implementing the 2023 law allowing alternatives to animal testing in drug development.
Policy Domains
Legislative Strategy
"Force timely implementation of prior law through mandatory rulemaking deadline with expedited process"
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → Secretary of Health and Human Services
- "the_commissioner"
- → Commissioner of Food and Drugs
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology