S355-119

What This Bill Does

Requires the Secretary of Health and Human Services, acting through the FDA Commissioner, to publish an interim final rule within one year implementing FDA Modernization Act 2.0 changes to section 505(i) of the Food, Drug, and Cosmetic Act. The rule must replace references to animal tests, animal data, animal studies, animal models, and animal research across listed title 21 CFR provisions with references to nonclinical tests, data, studies, models, and research. It must also add the FDCA definition of nonclinical test to CFR sections 312.3, 314.3, 315.2, and 601.31.

Who Benefits and How

Pharmaceutical companies, biotech companies, biologics sponsors, nonclinical testing laboratories, organ-on-chip developers, computational model developers, and animal welfare organizations benefit from clearer FDA rules recognizing alternatives to mandatory animal testing. Drug sponsors get regulatory text aligned with the 2023 statutory change, reducing uncertainty when they use non-animal or mixed nonclinical evidence.

Who Bears the Burden and How

HHS and FDA must complete a broad interim final rule within one year, update more than twenty CFR sections, add nonclinical-test definitions, and make the rule immediately effective without relying on the normal good-cause showing. FDA reviewers and regulated sponsors must adapt submissions and review practices to the updated terminology.

Key Provisions

• Requires HHS/FDA to publish an interim final rule within one year.
• Requires title 21 CFR references to animal tests, data, studies, models, and research to be replaced with nonclinical-test terminology.
• Requires the nonclinical-test definition to be added to CFR parts governing INDs, NDAs, antibiotic drugs, and biologics.
• Authorizes immediate effectiveness of the interim final rule without a separate good-cause showing.
• Amends FDCA section 505 to redesignate the duplicate clinical-trial-diversity subsection from subsection (z) to subsection (aa).