Data / Federal rules / 2026-19349
Nonclinical Testing Terminology
The Food and Drug Administration published this proposed rule in the Federal Register on September 22, 2026. Comments are due by December 7, 2026.
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What the agency says
The Food and Drug Administration (FDA, Agency, or we) is proposing to substitute references to "animal" tests or studies with "nonclinical" tests or studies, add a definition of the terms "nonclinical test" and "nonclinical study," and make other comparable or conforming amendments in certain safety and reporting sections of its regulations. The proposed rule would also substitute "nonclinical" for "preclinical" and "in vitro" for consistency in terminology. These proposed amendments align with recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act) and are intended to remove an emphasis, in certain places, on the use of animal testing as the only scientific methodology to assess the safety of a drug in the nonclinical setting. These changes may also foster the development and use of scientifically valid new testing methodologies, potentially improving predictive accuracy of product safety testing while replacing, reducing, or refining animal use. The proposed rule would add no new requirements.
Key facts
- Document number
- 2026-19349
- Type
- Proposed rule
- Action
- Proposed rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 22, 2026
- Comments due
- December 7, 2026
- Dates
- Either electronic or written comments on the proposed rule or its companion direct final rule must be submitted by December 7, 2026. If FDA receives any timely significant adverse comments on this proposed rule or the direct final rule with which this proposed rule is associated, we will publish a document in the Federal Register withdrawing the direct final rule within 30 days after the comment period ends, and we will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures.
- Docket
- Docket No. FDA-2026-N-5347
- Regulation ID (RIN)
- 0910-AJ27
- Code of Federal Regulations
- 21 CFR 312; 21 CFR 314; 21 CFR 315; 21 CFR 361; 21 CFR 601
- Topics
- Administrative practice and procedure; Biologics; Confidential business information; Drugs; Exports; Imports; Investigations; Labeling; Medical research; Prescription drugs; Radiation protection; Reporting and recordkeeping requirements; Safety
- Pages
- 16
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on administrative practice and procedure · Rules on biologics · Rules on confidential business information · Published in September 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.