Federal Register #2026-20768

FDA seeks public comment on information collection for biologics license applications

The U.S. Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS), is seeking public comment on an information collection related to biologics licensing. - Notice type: Administrative information-collection notice; it is not a procurement opportunity or contract award. - Government entities: FDA (HHS) submitted the collection to the Office of Management and Budget for review under the Paperwork Reduction Act. - Scope: Biologics License Application requirements, including application submissions and licensed manufacturers’ reporting, recordkeeping, and disclosure obligations. - Related materials: The notice discusses applicable regulations, FDA forms, guidance documents, and estimated annual reporting burdens. - Products, services, OEMs, and vendors: None identified.

Description

The Food and Drug Administration (FDA) submitted a proposed information collection concerning biologics license applications (BLAs) to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The collection supports statutory and regulatory requirements governing biologics licensing, including reporting, recordkeeping, and disclosure requirements for licensed manufacturers of biological products. The notice describes associated regulations, forms, guidance documents, and estimated annual reporting burden. Written comments, including recommendations, are due November 9, 2026.

View original listing