# 2026-19349: FDA Proposes Axing 'Animal' from Drug Testing Regulations

2026-19349, Nonclinical Testing Terminology, is a Federal Register proposed rule from Health and Human Services Department, Food and Drug Administration published 2026-09-22, effective 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.; PRIA reads it as touching household money (as of 2026-09-29).

- Canonical: https://policyrisk.com/federal-register/2026-19349
- As of: 2026-09-29
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-19349
- Title: Nonclinical Testing Terminology
- Type: Proposed Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 60036
- Published: 2026-09-22
- Effective: 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.
- 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 Proposes Axing 'Animal' from Drug Testing Regulations

## Summary

The FDA wants to update its rules by swapping out the word “animal” tests for “nonclinical” tests to better reflect modern science. This change affects drug safety testing rules, encourages new testing methods that might use fewer animals, and doesn’t add any new costs or requirements. Anyone interested can comment on these changes until December 7, 2026.

## Abstract

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.

## Effects PRIA read

- Regulatory Terms Switched to “Nonclinical”: benefit, medium. FDA will replace terms like “animal test,” “animal study,” “preclinical,” and “in vitro” with the word “nonclinical” across drug and biological product rules in 21 CFR parts 312, 314, 315, 361, and 601 and will add regulatory definitions for “nonclinical test” and “nonclinical study.” The agency sa…
- NAMs and Other Methods Explicitly Included: benefit, medium. FDA explicitly defines “nonclinical test/study” to include methods such as cell-based assays, organ chips and microphysiological systems, computer modeling (in silico), in chemico methods, bioprinting, and animal tests, and indicates that pharmacology, toxicology, and pharmacokinetic data in INDs,…
- No New Testing Costs Or Requirements: benefit, low. FDA states the proposed terminology changes would add no new requirements on industry and are expected to generate no costs; the Agency characterizes the rule as an Executive Order 14192 deregulatory action. The rule is presented as allowing broader nonclinical methods without increasing submission…

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## Sources
- [2026-19349 on federalregister.gov](https://www.federalregister.gov/documents/2026/09/22/2026-19349/nonclinical-testing-terminology)
- [2026-19349 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-09-22/pdf/2026-19349.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2026-19349 (as of 2026-09-29).