Federal Register #FDA-2025-N-6869

FDA Seeks Public Comment on Medication Guide Information Collection Requirements

This opportunity involves the Food and Drug Administration (FDA), under the Department of Health and Human Services, seeking public comment on its proposed information collection for Medication Guides associated with human prescription drug and biological products. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No Original Equipment Manufacturers (OEMs) or commercial vendors are specified in this notice - No products or services are being procured; the notice is focused on regulatory information collection - Key requirements: - Addresses content, format, exemptions, and deferrals for Medication Guides - Applies to manufacturers, distributors, and authorized dispensers of prescription drug and biological products - Seeks input on estimated annual reporting and third-party disclosure burdens - The notice is regulatory in nature and does not involve the purchase of goods or services

Description

The Food and Drug Administration (FDA) has submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. This collection pertains to the distribution of Medication Guides for human prescription drug and biological products used primarily on an outpatient basis, required for products posing serious public health concerns. The regulations set forth requirements for content, format, exemptions, and deferrals of Medication Guides to ensure patients receive important drug information. The FDA is seeking public comments on this information collection by July 31, 2026.

View original listing