Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Establishment of a Public Docket; Request for Comments

概要

The Food and Drug Administration (FDA or Agency) is establishing a public docket for comment on the Agency's blood donor deferral recommendations for reducing the risk of human immunodeficiency virus (HIV) transmission as described in the document entitled "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry" dated December 2015. Interested persons are invited to submit comments, supported by scientific evidence such as data from research, regarding potential blood donor deferral policy options to reduce the risk of HIV transmission, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments. Additionally, comments are invited regarding the design of potential studies to evaluate the feasibility and effectiveness of such alternative deferral options. FDA will take the comments received into account as it continues to reevaluate and update blood donor deferral policies as new scientific information becomes available.