May 11, 2011

Recommendations

Recommendation 15

Consistent with Congressional mandates and strategic efforts to expand collection site participation, ACBSCT recommends that the Secretary recognize public cord blood bank oversight of the collection process as sufficient means to ensure safe manufacturing practices, and oppose the requirement for hospitals to register with the FDA as the establishment responsible for recovery.

Recommendation 16

Based on data from nearly two decades of practice controlled by public cord blood banks to ensure safe collection processes and protect product integrity, ACBSCT recommends that the Secretary support the collection of cord blood from uncomplicated deliveries in accredited hospitals without environmental monitoring of delivery rooms.

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