Federal Register #2026-15671

FDA Reopens Comment Period for Proposed Rule Modifying Terminology in Title 21

This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, announces the reopening of the comment period for a proposed regulatory change. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Purpose: - Reopening comment period for a proposed rule to update terminology in Title 21 of the Code of Federal Regulations (CFR) - Proposed changes involve replacing or deleting references to 'gender' with 'sex' or removing them, in line with Executive Order 14168 - Changes are editorial and intended to improve clarity and readability - No procurement activity: - No products, services, OEMs, or vendors are mentioned - No part numbers, quantities, or acquisition requirements - Participation: - FDA invites interested parties to submit comments electronically or in writing - Notable Requirements: - The notice is strictly regulatory and does not involve any procurement, acquisition, or purchase of goods or services

Description

The Food and Drug Administration (FDA) is reopening the comment period for a proposed rule to modify certain terminology in Title 21 of the Code of Federal Regulations (CFR). The rule aims to replace or delete references to "gender" with "sex" or remove them to comply with Executive Order 14168. The changes include editorial modifications to improve readability. Interested persons are invited to submit comments electronically or in writing by October 2, 2026.

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