FDA Seeks Comment on Reinstated Deviation Reporting Collection

The Food and Drug Administration is seeking comment on the reinstatement of its information collection for biological product deviation and human cells, tissues, and cellular and tissue-based product (HCT/P) deviation reporting. The collection covers existing reporting requirements for licensed manufacturers, registered blood establishments, transfusion services and HCT/P establishments.

FDA estimates the collection will generate 17,818 responses annually and require 34,191 hours, an increase of 2,642 responses and 4,612 hours from previous estimates. The agency attributed the increase to a higher number of product deviation reports received in fiscal year 2024, particularly under the reporting requirements for blood establishments and transfusion services. FDA said the increase likely reflects revised recommendations in its 2020 guidance on biological product deviation reporting for blood and plasma establishments.

Comments are due Oct. 16.