federal_register: 2020-13066

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2020-13066 Revised Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry." The revised guidance provides blood establishments that collect blood and blood components with FDA's recommendations to reduce the risk of transfusion-transmitted malaria. The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma. Blood establishments are not required to assess Source Plasma donors for malaria risk. The guidance announced in this notice supersedes the guidance entitled "Recommendations for Donor Questioning, Deferral, Reentry, and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry" dated August 2013 and updated August 2014. 2020-06-17 2020 6 https://www.federalregister.gov/documents/2020/06/17/2020-13066/revised-recommendations-to-reduce-the-risk-of-transfusion-transmitted-malaria-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2020-06-17/pdf/2020-13066.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry." The revised guidance provides blood...

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