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Requires the Department of Health and Human Services, acting through the FDA, to issue an interim final rule within one year to update FDA regulations so they use the term “nonclinical” (tests, data, studies, models, research) where appropriate, add a statutory definition of “nonclinical test” into several CFR provisions, make that interim final rule immediately effective upon publication (no showing of "good cause" required), and make a minor technical renumbering change to the Federal Food, Drug, and Cosmetic Act. The change is procedural and focuses on aligning regulatory terminology and definitions across FDA regulations. The measure directs a specific regulatory action and timing (one year) for the agency, alters rulemaking effect for that action (immediate effectiveness), and standardizes language to refer to “nonclinical” testing methods rather than prior terminology where applicable.
The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, must publish an interim final rule not later than 1 year after the date of enactment to implement amendments to section 505(i) of the Federal Food, Drug, and Cosmetic Act. The interim final rule must amend specified regulations to replace references to tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research.
The interim final rule must add the definition of “nonclinical test” (from section 505(z) of the FD&C Act (21 U.S.C. 355(z))) to 21 CFR sections 312.3, 314.3, 315.2, and 601.31.
The interim final rule must amend the specific list of CFR provisions named in the section (e.g., 21 CFR 312.22(c); 312.23(a)(3)(iv); 312.23(a)(5)(ii); 312.23(a)(5)(iii); 312.23(a)(8); 312.23(a)(8)(i); 312.23(a)(8)(ii); 312.23(a)(10)(i); 312.23(a)(10)(ii); 312.33(b)(6); 312.82(a); 312.88; 314.50(d)(2); 314.50(d)(2)(iv); 314.50(d)(5)(i); 314.50(d)(5)(vi)(a); 314.50(d)(5)(vi)(b); 314.93(e)(2); 315.6(d); 330.10(a)(2); 601.35(d)) to ensure consistency with the amendments to section 505(i).
The interim final rule may also amend any other CFR section necessary to ensure regulatory consistency with the amendments to section 505(i) of the FD&C Act.
Notwithstanding 5 U.S.C. 553(b)(B), the interim final rule shall become immediately effective as an interim final rule without requiring the Secretary to demonstrate good cause.
Who is affected and how:
FDA / HHS: The agency must devote staff and resources to draft, publish, and implement an interim final rule within a one-year deadline. Making the rule immediately effective reduces the agency's need to justify emergency effectiveness for this specific action, but requires readiness to apply the new language immediately on publication.
Regulated industry (drug, biologic, device manufacturers, and sponsors): Companies and their regulatory affairs teams will need to update internal documents, submissions, standard operating procedures, and references that cite or align with FDA regulations to reflect the defined term "nonclinical test." The change is mainly terminological, so substantive scientific or approval requirements are not directly altered, but compliance documents and cross-references will require review and update.
Research institutions and laboratories (including academic and commercial research entities, including those using animal models): Regulatory references in study protocols, data submission formats, and premarket packages may need to be updated to use the new statutory language. The insertion of a statutory definition may improve clarity about what kinds of nonclinical work are covered by particular regulatory citations.
Regulatory affairs and legal practitioners: Will need to interpret the new statutory definition across affected CFR provisions, advise clients on transitional compliance, and update filings and templates.
Patients and the public: Indirect effect—this is a procedural/terminology alignment intended to reduce ambiguity in regulatory language. It does not directly change safety standards, approvals, or access to products.
Potential benefits and risks:
Overall, the legislation directs a targeted administrative action to standardize terminology and definitions in FDA regulation, with limited substantive regulatory impact but clear operational impacts for agency drafting and industry compliance updates.
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Referred to the House Committee on Energy and Commerce.
Introduced April 10, 2025 by Buddy Carter · Last progress April 10, 2025
Referred to the House Committee on Energy and Commerce.
Introduced in House