FDA Seeks Comments on Biologics Reporting Requirements

The Food and Drug Administration is seeking public comment on existing reporting and recordkeeping requirements for licensed biologics, including blood and blood products.

The requirements cover license applications and annual reports from licensed manufacturers, as well as biological product deviation reports from licensed manufacturers, unlicensed registered blood establishments and transfusion services.

FDA estimates the collection’s annual burden at 34,191 hours across 17,818 responses, an increase of approximately 4,612 hours and 2,642 responses compared with previous estimates.

Interested individuals may submit comments online by Nov. 9.