← REGULATORY CHANGES
FEDERAL REGISTER · PROPOSED RULEMay 6, 2026PROPOSED — NOT IN FORCE

Modification of Certain Terminology in Title 21

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSPROPOSED — NOT IN FORCE
PROPOSED EFFECTIVE—
COMMENTS CLOSEJul 6, 2026 · closed
APPLIES TO · SPEQ TAGBiologics
Document type
Proposed Rule
Agency
Health and Human Services Department
Published
May 6, 2026
Comments close
July 6, 2026
Document number
2026-08826
CFR references
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
Docket
FDA-2026-N-2886
RIN
0910-AJ26
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.

Abstract as published in the Federal Register.

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