S. 355 — FDA Modernization Act 3.0

This section directs the Secretary of HHS, acting through the FDA Commissioner, to issue an interim final rule within one year of enactment amending specified sections of 21 CFR (e.g., §§ 312.22(c), 312.23(a)(3)(iv), 314.50(d)(2), and others related to investigational new drug applications, new drug applications, and biological licensing)—as well as any other sections necessary—to replace references to "animal" tests, data, studies, models, and research with "nonclinical" equivalents, in order to implement amendments to FD&C Act §505(i) made by §3209(a) of the Consolidated Appropriations Act, 2023 (P.L. 117-328); the rule also adds the definition of "nonclinical test" from FD&C Act §505(z) to 21 CFR §§ 312.3, 314.3, 315.2, and 601.31 and takes immediate effect without a good cause determination. This section further makes a technical amendment to FD&C Act §505 (21 U.S.C. 355) by redesignating the second subsection (z)—added by §3601(a) of the Health Extenders Act of 2022 (div. FF, P.L. 117-328) and concerning clinical trial diversity action plans—as subsection (aa).