# 2026-19350: FDA Dumps 'Animal Testing' Term for Woke 'Nonclinical' Lingo

2026-19350, Nonclinical Testing Terminology, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-09-22, effective 2027-02-04; PRIA reads it as touching household money (as of 2026-09-29).

- Canonical: https://policyrisk.com/federal-register/2026-19350
- As of: 2026-09-29
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-19350
- Title: Nonclinical Testing Terminology
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 59988
- Published: 2026-09-22
- Effective: 2027-02-04
- Comments close: 2026-12-07
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: 0910-AJ27
- Last updated: 2026-09-29

## In one line

FDA Dumps 'Animal Testing' Term for Woke 'Nonclinical' Lingo

## Summary

The FDA is updating its rules to replace the words “animal” tests with “nonclinical” tests, making room for new, smarter ways to check drug safety without relying only on animal testing. This change affects drug makers and researchers but won’t add new costs or requirements. The rule kicks in on February 4, 2027, and comments are open until December 7, 2026.

## Abstract

The Food and Drug Administration (FDA, Agency, or we) is issuing a direct final rule that substitutes references to "animal" tests or studies with "nonclinical" tests or studies, adds a definition of the terms "nonclinical test" and "nonclinical study," and makes other comparable or conforming amendments in certain safety and reporting sections of its regulations. The direct final rule also substitutes "nonclinical" for "preclinical" and "in vitro" for consistency in terminology. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial changes in terminology that are not expected to affect industry practice and FDA anticipates no significant adverse comments. These 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 rule adds no new requirements.

## Effects PRIA read

- Terminology Update Lets More Test Types: benefit, low. FDA is replacing references to “animal” and some uses of “preclinical” with the term “nonclinical” and is adding definitions for “nonclinical test” and “nonclinical study.” The change explicitly includes tests done in vitro, in silico, in chemico, organ chips, computer modeling, and animal tests, a…
- No New Testing Costs or Requirements: benefit, low. FDA states this direct final rule adds no new regulatory requirements and is expected to generate no costs for industry. The Agency describes the change as noncontroversial and effective February 4, 2027, with comments accepted through December 7, 2026.

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## Sources
- [2026-19350 on federalregister.gov](https://www.federalregister.gov/documents/2026/09/22/2026-19350/nonclinical-testing-terminology)
- [2026-19350 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-09-22/pdf/2026-19350.pdf)

## Related
- [Previous: 2026-19329, Radio Broadcasting Services; Various Locations](https://policyrisk.com/federal-register/2026-19329)
- [Next: 2026-19389, Softwood Lumber Board Assessment Rate Clarification and Changes to Membership](https://policyrisk.com/federal-register/2026-19389)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-19350 (as of 2026-09-29).