Modification of Certain Terminology in Title 21; Reopening of the Comment Period
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.
Federal Register Source
This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.
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Frequently Asked Questions
What is the 2026-15671 Federal Register document?
Document 2026-15671 is a Proposed Rule published by the Department of Health and Human Services in the Federal Register on August 3, 2026. 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. View the original at https://www.federalregister.gov/documents/2026/08/03/2026-15671/modification-of-certain-terminology-in-title-21-reopening-of-the-comment-period.
Is document 2026-15671 an economically significant rule?
No. Document 2026-15671 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.