Federal Register #FDA2026N2886

FDA Proposed Rule: Editorial Changes to Terminology in Title 21 CFR

The Food and Drug Administration (FDA) is proposing editorial updates to federal regulations in response to an executive order: - Government Buyer: - Department of Health and Human Services (HHS), Food and Drug Administration (FDA) - Scope of Proposed Rule: - Amends terminology in Title 21 of the Code of Federal Regulations (CFR) - Replaces the term "gender" with "sex" or removes references to gender, as appropriate - Affects multiple regulatory areas, including: - Institutional review boards - Drugs and biological products - Medical devices - Labeling requirements - Tobacco product applications - OEMs and Vendors: - No Original Equipment Manufacturers (OEMs) or vendors are involved, as this is a regulatory/editorial action - Products/Services Requested: - No products or services are being procured - Unique/Notable Requirements: - Changes are editorial only and do not impact industry practices - Minimal economic effect expected - No procurement or acquisition activity involved

Description

The Food and Drug Administration (FDA) is issuing a proposed rule to modify certain terminology in Title 21 of the Code of Federal Regulations (CFR) to comply with Executive Order 14168. The rule proposes to remove the term "gender" wherever it appears and replace it with the term "sex" or delete references to gender, along with other editorial changes to improve readability. This change affects various parts of Title 21 related to institutional review boards, drugs, biological products, medical devices, labeling, and tobacco product applications. The proposed rule does not impact industry practices and is expected to have minimal economic impact.

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