Federal Register #FDA-2026-N-7606

FDA Announces Process for Data Requests to Inform OTC Monograph Drug Activities

This notice from the Food and Drug Administration (FDA) outlines a new process for requesting data from the public to inform over-the-counter (OTC) monograph drug activities. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or commercial vendors are mentioned in this notice - No products or services are being procured or requested - Key details: - The notice describes how the FDA will issue Data Requests to gather information for future OTC monograph drug regulatory actions - Procedures are provided for submitting data, viewing public submissions, and subscribing to alerts for future Data Requests - The process is distinct from other regulatory activities such as GRASE finalizations, stakeholder feedback on test methods, and expedited safety orders - No contract, procurement, or award is associated with this notice

Description

The Food and Drug Administration (FDA) is announcing the process for issuing Data Requests to the public to help inform certain future over-the-counter (OTC) monograph drug activities. This includes the development of FDA-initiated proposed orders to modify conditions described in an OTC monograph. The notice informs the public and interested parties about the process FDA is implementing to issue these Data Requests, including instructions on submission and public viewing of data. The FDA also provides information on how to receive alerts about these Data Requests and mentions that this process is separate from other related regulatory activities.

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