# Federal Register 2026-19350 — effective 2027-02-04 — Nonclinical Testing Terminology — Food and Drug Administration

For Federal Register 2026-19350, effective date is 2027-02-04; agency is Food and Drug Administration; published is 2026-09-22; cfr parts amended is 21 CFR 312, 21 CFR 314, 21 CFR 315, 21 CFR 361, 21 CFR 601, recorded from its source on 2026-09-24; source re-checked 2026-11-03.

- **FR document number:** 2026-19350 _(verified: appears in the quote below)_
- **Rule:** Nonclinical Testing Terminology _(verified: appears in the quote below)_
- **Agency:** Food and Drug Administration _(verified: appears in the quote below)_
- **Effective date:** 2027-02-04 _(verified: appears in the quote below)_
- **DATES, as printed:** This rule is effective February 4, 2027. Either electronic or written comments on the direct final rule or its companion proposed rule must be submitted by December 7, 2026. If FDA receives no significant adverse comments within the specified comment period, the Agency intends to publish a document confirming the effective date of the direct final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule within 30 days after the comment period on this direct final rule ends. _(verified: appears in the quote below)_
- **CFR parts amended:** 21 CFR 312, 21 CFR 314, 21 CFR 315, 21 CFR 361, 21 CFR 601 _(our reading, not quoted from the source)_
- **Published:** 2026-09-22 _(verified: appears in the quote below)_

## What the source says

> {"document_number":"2026-19350","title":"Nonclinical Testing Terminology","agency_names":["Health and Human Services Department","Food and Drug Administration"],"effective_on":"2027-02-04","dates":"This rule is effective February 4, 2027. Either electronic or written comments on the direct final rule or its companion proposed rule must be submitted by December 7, 2026. If FDA receives no significant adverse comments within the specified comment period, the Agency intends to publish a document confirming the effective date of the direct final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule within 30 days after the comment period on this direct final rule ends.","cfr_references":[{"chapter":null,"citation_url":null,"part":"312","title":21},{"chapter":null,"citation_url":null,"part":"314","title":21},{"chapter":null,"citation_url":null,"part":"315","title":21},{"chapter":null,"citation_url":null,"part":"361","title":21},{"chapter":null,"citation_url":null,"part":"601","title":21}],"publication_date":"2026-09-22","html_url":"https://www.federalregister.gov/documents/2026/09/22/2026-19350/nonclinical-testing-terminology"}

## Source

- https://www.federalregister.gov/api/v1/documents.json?per_page=1000&order=oldest&conditions%5Btype%5D%5B%5D=RULE&conditions%5Beffective_date%5D%5Bgte%5D=2027-01-01&conditions%5Beffective_date%5D%5Blte%5D=2027-12-31&fields%5B%5D=document_number&fields%5B%5D=title&fields%5B%5D=agency_names&fields%5B%5D=effective_on&fields%5B%5D=dates&fields%5B%5D=cfr_references&fields%5B%5D=publication_date&fields%5B%5D=html_url

Last verified: 2026-11-03. Review by: 2026-11-16.
Part of [Federal rules taking effect: every US final rule in the Federal Register, by effective date](https://referencesource.org/federal-rules-taking-effect/).