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Modification of Certain Terminology in Title 21

Comment period closed: closed 103 days ago (Jul 6, 2026).

Summary (from the Federal Register abstract)

The Food and Drug Administration (FDA, the Agency, or we) is issuing a proposed rule to modify certain terminology in Title 21 of the Code of Federal Regulations (CFR) to comply with Executive Order (E.O.) 14168, "Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government," issued on January 20, 2025. Specifically, this proposed rule, if finalized, will remove the term "gender" wherever it appears and either replace it with the term "sex," or delete reference to gender, as applicable, along with other editorial changes to improve readability.

Document type
Proposed Rule
Federal Register document number
2026-08826
Published
May 6, 2026
Action
Proposed rule.
Docket
FDA-2026-N-2886
Comments posted on Regulations.gov (at last check)
13
RIN
0910-AJ26
CFR parts
21 CFR 10, 21 CFR 56, 21 CFR 106, 21 CFR 201, 21 CFR 251, 21 CFR 310, 21 CFR 312, 21 CFR 314, 21 CFR 329, 21 CFR 600, 21 CFR 803, 21 CFR 862, 21 CFR 866, 21 CFR 870, 21 CFR 882, 21 CFR 1114
DATES section (from the document)
Submit either electronic or written comments on the proposed rule by July 6, 2026.
Topics (auto-tagged)
Clinical Vaccines / biologics Medical devices Food & dietary supplements Tobacco

Source: Federal Register API, document 2026-08826. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.