Federal Register #FDA-2026-N-5827

FDA Requests Public Comment on OTC Drug Information Collection Process

This notice is a request for public comment from the Food and Drug Administration (FDA), part of the Department of Health and Human Services, regarding information collection for time and extent applications for nonprescription (over-the-counter, OTC) drug products. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are named in this notice. - Products/Services Requested: - Public feedback on the process and burden of submitting information for classifying OTC drugs as generally recognized as safe and effective (GRAS/E), per 21 CFR part 330 - No specific products, part numbers, or purchase quantities are requested - Unique/Notable Requirements: - Focus is on regulatory information collection, not procurement - Notice references the CARES Act, which may reduce or eliminate certain submissions under the current regulations - Seeks input on the impact and necessity of the information collection process for OTC drug review

Description

The Food and Drug Administration (FDA) is seeking public comment on the proposed collection of information related to time and extent applications for nonprescription drug products. This collection supports regulations regarding over-the-counter (OTC) human drugs and the procedures for classifying OTC drugs as safe and effective. The notice also discusses the impact of the CARES Act on OTC drug review processes and anticipates no submissions under certain regulations due to statutory changes. Comments are requested to improve the efficiency and effectiveness of the information collection process.

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