FDA Modernization Act 3.0
FDA Modernization Act 3.0 would require the Secretary of Health and Human Services, acting through the FDA Commissioner, to publish a final rule that implements changes to nonclinical testing methods. The bill mandates an interim final rule within one year of enactment to implement amendments to section 505(i) of the FD&C Act that were enacted in 2023. The interim final rule would take effect immediately as an interim final rule. The core idea is to replace references to “animal” tests with references to “nonclinical” tests across a broad set of FDA regulatory sections (primarily related to INDs, NDAs, and BLAs) and to add a formal definition of “nonclinical test” into key CFR provisions. The bill also authorizes additional regulatory changes as needed to fully implement the replacement and makes a small technical amendment renaming a subsection related to clinical trial diversity plans. Overall, the bill aims to modernize regulatory language to accommodate nonclinical testing methods (e.g., in vitro models, computational methods) in place of traditional animal testing in many regulatory submissions.
Key Points
- 1Interim final rule within 1 year: The Secretary must publish an interim final rule to implement the 2023 amendments to section 505(i) and replace references to animal testing with nonclinical testing in specified FDA regulations.
- 2Immediate effectiveness: The interim final rule would become effective immediately as an interim final rule, without the usual need to show “good cause.”
- 3Broad regulatory replacement: The rule would replace references to “animal” tests with “nonclinical” tests in numerous 21 CFR sections (e.g., 312.22(c), 312.23, 314.50, 314.93, 315.6, 330.10, 601.35, and related sections) to align with nonclinical testing concepts.
- 4Definition added: The statutory definition of “nonclinical test” (from FD&C Act 505(z)) would be added to key CFR sections (312.3, 314.3, 315.2, 601.31) to standardize terminology.
- 5Additional changes allowed: The Secretary may make further changes to the listed CFR sections as needed to fully implement the replacement of “animal” tests with “nonclinical” tests.
- 6Technical amendment: A housekeeping change would rename the second subsection (z) of section 505 to subsection (aa), reflecting its use for clinical trial diversity action plans under the Health Extenders/CHIP provisions.