HR 2821119th CongressIn Committee

FDA Modernization Act 3.0

Introduced: Apr 10, 2025

Standard Summary

Comprehensive overview in 1-2 paragraphs

FDA Modernization Act 3.0 would require the Department of Health and Human Services, via the FDA Commissioner, to issue a final rule implementing nonclinical testing methods. Specifically, within one year of enactment, the bill mandates an interim final rule that replaces references to “animal” tests, data, studies, models, and research with “nonclinical” equivalents in a broad set of FDA regulations, and adds a definition of “nonclinical test” to the FD&C Act. The interim final rule would take effect immediately, bypassing the usual requirement to show good cause. The bill also makes a technical change to move the existing “clinical trial diversity action plans” reference from section 505(z) to 505(aa). Overall, the measure aims to accelerate and standardize the shift toward nonclinical (often non-animal) testing methods in federal drug regulation, aligning with prior amendments to 505(i) enacted in 2023.

Key Points

1Within one year of enactment, the Secretary of Health and Human Services, through the FDA, must publish an interim final rule that replaces references to “animal” tests with references to “nonclinical tests” in specified CFR provisions and adds a definition of “nonclinical test” to 21 CFR sections related to drug testing and regulation.
2The interim final rule is required to become immediately effective as an interim final rule, without the usual requirement to demonstrate good cause for bypassing standard regulatory timing.
3A broad list of CFR sections (covering major regulatory areas for INDs, NDAs/BLA approvals, clinical trial requirements, and related processes) would be updated to reflect the use of nonclinical tests instead of animal tests.
4The definition of “nonclinical test” would be added to section 505(z) of the FD&C Act (as part of this bill, the designation would be revised to 505(aa) by a technical amendment).
5The bill references and relies on amendments to 505(i) made by the Consolidated Appropriations Act, 2023, and seeks to operationalize those changes through regulatory text.

Impact Areas

Primary affected groups/areas: Pharmaceutical and biotech companies, contract research organizations (CROs), and other stakeholders involved in drug development and regulatory submissions; animal welfare advocates and groups concerned with animal testing; patients and public health interests that may benefit from reduced reliance on animal testing and faster access to new therapies.Secondary affected groups/areas: Regulatory affairs professionals and FDA staff who prepare and review submissions; laboratories and vendors that perform testing (including non-animal methods); developers of nonclinical testing technologies (in silico models, cell-based assays, organ-on-a-chip, etc.).Additional impacts: Potential regulatory and cost implications for transitioning to nonclinical methods; need for validation and acceptance of nonclinical approaches across multiple regulatory programs; rapid adoption due to immediate-effect interim rule could influence industry timelines and investment in alternative testing methods.

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