FDA Seeks Comment on BPD, HCT/P Deviation Reporting

The Food and Drug Administration is seeking public comment on a proposed extension of its information collection related to the reporting of biological product deviations (BPD) and human cells, tissues and cellular and tissue-based product (HCT/P) deviations in manufacturing.

FDA estimates 17,818 total annual responses and 43,246 total burden hours, reflecting an increase of approximately 13,603 hours compared with fiscal year 2024. The agency attributes the increase primarily to a higher number of deviation reports submitted by blood and plasma establishments following issuance of revised guidance document, “Biological Product Deviation Reporting for Blood and Plasma Establishments,” in March 2020.

Interested parties may submit electronic or written comments through April 27. Instructions are available in the Federal Register notice.