FDA Modernization Act 3.0
The source supplies the latest action, but no lifecycle stage.
Latest action (21 Jul 2026): Received in the Senate.
What this bill does
H.R. 2821, the "FDA Modernization Act 3.0," would direct the Secretary of Health and Human Services, acting through the FDA Commissioner, to issue an interim final rule within one year of enactment updating specific FDA regulations. The rule would replace references to "animal" tests, data, studies, models, and research with the broader term "nonclinical" tests, data, studies, models, and research, and would add a formal definition of "nonclinical test" to several sections of the Code of Federal Regulations. This is meant to align existing FDA regulations with a 2022 statutory change (made through the Consolidated Appropriations Act, 2023) that already permits certain alternatives to animal testing in drug development. The bill also makes a technical correction to renumber a duplicate subsection in the Federal Food, Drug, and Cosmetic Act.
The bill primarily affects the FDA's regulatory framework governing drug and biologic development, including rules on investigational new drug applications, marketing applications, and related testing standards. It would allow the interim rule to take effect immediately upon publication, without the agency needing to show "good cause" to bypass standard rulemaking delay requirements. Pharmaceutical developers, researchers, and others navigating FDA approval processes would be affected by the updated terminology and definitions, which are intended to make clear that nonclinical testing methods beyond traditional animal studies can be used to meet certain regulatory requirements.
The bill passed the House by voice vote on July 20, 2026, under a suspension of the rules procedure, indicating broad, non-controversial support. It now goes to the Senate for consideration. If the Senate passes it, either in identical form or with changes requiring reconciliation with the House, it would then go to the President for signature or veto before it could become law.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official summary
FDA Modernization Act 3.0
This bill requires the Food and Drug Administration (FDA) to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023 that authorized the use of certain alternatives to animal testing to support investigational use of a new drug.
The rule must replace references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research throughout the FDA’s regulations governing investigational new drug applications.
The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.
Timeline
21 Jul 2026
Received in the Senate.
Common questions
- What does H.R. 2821 do?
- H.R. 2821, the "FDA Modernization Act 3.0," would direct the Secretary of Health and Human Services, acting through the FDA Commissioner, to issue an interim final rule within one year of enactment updating specific FDA regulations. The rule would replace references to "animal" tests, data, studies, models, and research with the broader term "nonclinical" tests, data, studies, models, and research, and would add a formal definition of "nonclinical test" to several sections of the Code of Federal Regulations. This is meant to align existing FDA regulations with a 2022 statutory change (made through the Consolidated Appropriations Act, 2023) that already permits certain alternatives to animal testing in drug development. The bill also makes a technical correction to renumber a duplicate subsection in the Federal Food, Drug, and Cosmetic Act. The bill primarily affects the FDA's regulatory framework governing drug and biologic development, including rules on investigational new drug applications, marketing applications, and related testing standards. It would allow the interim rule to take effect immediately upon publication, without the agency needing to show "good cause" to bypass standard rulemaking delay requirements. Pharmaceutical developers, researchers, and others navigating FDA approval processes would be affected by the updated terminology and definitions, which are intended to make clear that nonclinical testing methods beyond traditional animal studies can be used to meet certain regulatory requirements. The bill passed the House by voice vote on July 20, 2026, under a suspension of the rules procedure, indicating broad, non-controversial support. It now goes to the Senate for consideration. If the Senate passes it, either in identical form or with changes requiring reconciliation with the House, it would then go to the President for signature or veto before it could become law.
- Has H.R. 2821 become law?
- The source does not supply a confirmed lifecycle stage for H.R. 2821. Check the latest action and official source below.
- Who sponsored H.R. 2821?
- H.R. 2821 was sponsored by Rep. Carter, Earl L. "Buddy" [R-GA-1] (R-GA), with 41 cosponsors.
- What's the latest action on H.R. 2821?
- Received in the Senate. (21 Jul 2026).
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