compliance with the prior terms of clearance.
Inventory as of this Action
36 Months From Approved
The information collection
requirements in the CGMP, donor testing, donor notification, and
"lookback" regulations provide FDA with the necessary information
to perform its duty to ensure the safety, purity, and potency of
blood and blood components. These requirements establish
accountability and traceability in the processing and handling of
blood and blood components and enable FDA to perform meaningful
inspections. The recordkeeping requirements serve preventative and
remedial purposes. The disclosure requirements identify the various
blood and blood components and important properties of the product,
demonstrate that the CGMP requirements have been met, and
facilitate the tracing back of a product to its original source.
The reporting requirements inform FDA of any deviations that occur
and that may require immediate corrective action.
The current increase to 506,637
burden hours (an increase of 79,724 hours) is attributed to an
increase in the number of total annual records under § 606.160,
which was due to an increase in the number of donations for both
Whole Blood and Source Plasma.