Federal Register #FDA-2026-N-6667

FDA Request for Public Comment on Information Collection for Biologics License Applications

This opportunity is a request for public comment from the Food and Drug Administration (FDA) regarding information collection for Biologics License Applications (BLAs). - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are mentioned, as this is not a procurement action - No products or services are being requested - Focus is on regulatory compliance and information collection from licensed manufacturers of biological products - FDA is seeking feedback on: - Necessity and accuracy of the information collection - Ways to enhance quality and minimize burden - Reporting, recordkeeping, and disclosure requirements - Use of specific FDA forms (FDA 356h, FDA 2252, FDA 2253, FDA 3674) - No purchase quantities, part numbers, or contract value are provided - Notable for its focus on regulatory input rather than acquisition of goods or services

Description

The Food and Drug Administration (FDA) is seeking public comments on the proposed collection of information related to Biologics License Applications (BLAs), including procedures and requirements. This collection supports statutory and regulatory requirements under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act governing biologics product licensing. The FDA invites comments on the necessity, accuracy, and ways to enhance the quality and minimize the burden of the information collection. Comments must be submitted by September 4, 2026.

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