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Modification of Certain Terminology in Title 21; Reopening of the Comment Period

Comment period closed: closed 15 days ago (Oct 2, 2026).

Summary (from the Federal Register abstract)

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the proposed rule that appeared in the Federal Register of May 6, 2026, 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. The Agency is taking this action to allow interested persons additional time to submit comments.

Document type
Proposed Rule
Federal Register document number
2026-15671
Published
Aug 3, 2026
Action
Proposed rule; reopening of the comment period.
Docket
FDA-2026-N-2886
Comments posted on Regulations.gov (at last check)
0
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)
FDA is reopening the comment period on the proposed rule published on May 6, 2026 (91 FR 24380). Submit either electronic or written comments on the proposed rule by October 2, 2026.
Topics (auto-tagged)
Clinical Vaccines / biologics Medical devices Food & dietary supplements Tobacco

Source: Federal Register API, document 2026-15671. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.