Referred to the House Committee on Energy and Commerce.
Requires HHS, through the FDA Commissioner, to publish an interim final rule within one year aligning FDA regulations with the 2023 amendment to section 505(i) of the FD&C Act. The rule must replace generic references to tests, data, studies, models, and research with the term “nonclinical” in specified 21 CFR sections and add a statutory definition of “nonclinical test.” The interim final rule is made immediately effective without demonstrating "good cause" under the Administrative Procedure Act.
All support modernization; liberals emphasize animal welfare and validation.
Relative to its intended legislative type, this bill is a clear, narrowly scoped administrative directive to the Department of Health and Human Services/FDA that identifies specific regulatory text changes and sets a one-year deadline for issuance of an interim final rule.
Requires HHS, through the FDA Commissioner, to publish an interim final rule within one year aligning FDA regulations with the 2023 amendment to section 505(i) of the FD&C Act.
The rule must replace generic references to tests, data, studies, models, and research with the term “nonclinical” in specified 21 CFR sections and add a statutory definition of “nonclinical test.” The interim final rule is made immediately effective without demonstrating "good cause" under the Administrative Procedure Act.
The bill also renumbers an existing FD&C Act subsection (z) to (aa) as a technical amendment.
Targeted regulatory alignment typically clears Congress, but immediate-effect IFR and stakeholder pushback create some legal and political risk.
Relative to its intended legislative type, this bill is a clear, narrowly scoped administrative directive to the Department of Health and Human Services/FDA that identifies specific regulatory text changes and sets a one-year deadline for issuance of an interim final rule. It integrates tightly with existing law by citing the FD&C Act and enumerating affected CFR sections, and it includes a technical statutory renumbering.
All support modernization; liberals emphasize animal welfare and validation.
These are examples from the analysis, not a ranked list of the most-affected groups.
All support modernization; liberals emphasize animal welfare and validation.
Likely favorable to modernizing nonclinical science and reducing animal testing where validated alternatives exist, while wanting strong safeguards.
Supportive of regulatory updates that reflect scientific advances, but wary of bypassing notice-and-comment and of any weakening of safety standards.
Sees the bill as a reasonable regulatory modernization that provides clarity, but has procedural concerns.
Will support if the rulemaking includes clear validation criteria, transparency, and limited procedural risk from immediate effectiveness.
Generally supportive because it reduces regulatory friction and updates rules to reflect modern science.
Approves of replacing vague terms with clearer language and quicker implementation, though may object to any provision weakening safety.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
Targeted regulatory alignment typically clears Congress, but immediate-effect IFR and stakeholder pushback create some legal and political risk.
The bill has not accumulated any surfaced votes yet.
All support modernization; liberals emphasize animal welfare and validation.
Targeted regulatory alignment typically clears Congress, but immediate-effect IFR and stakeholder pushback create some legal and political…
Relative to its intended legislative type, this bill is a clear, narrowly scoped administrative directive to the Department of Health and Human Services/FDA that identifies specific regulatory text changes and sets a on…
Go beyond the headline summary with full stakeholder mapping, legislative design analysis, passage barriers, and lens-by-lens tradeoff breakdowns.