REGULATORY UPDATE: FDA Revises Comment Period for CGMP Regulations, Donor “Lookback” Period to Reflect Platelet Bacterial Risk Control Strategy Guidance

July 07, 2021

The Food and Drug Administration revised a Feb. 11 information collection request on the reporting burden estimate for current good manufacturing practice, donation testing, donor notification and “lookback” regulations for blood and blood components. The revised Federal Register notice (FRN) now references the December 2020 guidance on platelet bacterial risk control strategies. FDA received no comments in response to the original information collection request and issued the revision on its own initiative. 

The December 2020 guidance recommends that blood collection establishments notify transfusion services if a distributed platelet product is subsequently identified as positive for bacterial contamination. It also recommends that blood establishments communicate to their consignees the type of storage containers in which the platelets are stored. Because the agency assumes such notification is a usual and customary business practice for blood establishments, the agency estimates no burden for the information collection.

The revised FRN includes the estimated annual reporting burden, estimated annual recordkeeping burden and estimated annual third-party disclosure burden. FDA adjusted the burden estimate for this information collection since last OMB review to reflect an overall increase of 79,024 hours annually. The agency attributes this adjustment to an increase in the number of registered blood establishments (1,789) during the past 3 years.