Babesia and Plasmodia are protozoan parasites that infect red blood cells and can be readily transmitted from blood donor to patient. The rate of transfusion-transmitted malaria (TTM) has decreased significantly in recent years, while the risk of transfusion-related Babesia infection appears to be increasing. This session will evaluate whether the current donor qualification requirements for individuals with malaria risk represent an effective balance between the competing imperatives of blood safety and availability. Discussion of Babesia will build on the recent workshop convened by FDA to evaluate how industry and regulators might develop a novel approach that minimizes the risk for transfusion-transmitted babesiosis while limiting the loss of blood donors.