# Nonclinical Testing Terminology

**Action Urgency Score:** 35/100

| Field | Value |
|---|---|
| Agency | Health and Human Services Department; Food and Drug Administration |
| Type | Proposed rule |
| Action | Proposed rule. |
| Published | 2026-09-22 |
| Comments close | 2026-12-07 |
| Significant | No |
| CFR parts | 21 CFR 312, 21 CFR 314, 21 CFR 315, 21 CFR 361, 21 CFR 601 |
| Summary | 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 Servi |
| Document number | 2026-19349 |

## Why this score
- Upcoming deadline.

Source: Federal Register API (Office of the Federal Register) (https://www.federalregister.gov/documents/2026/09/22/2026-19349/nonclinical-testing-terminology). Last refreshed: 2026-11-04T21:40:49.974Z.
Data from the Federal Register API; the published Federal Register document is authoritative. Informational only, not legal advice.