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FDA Invites Comments on Proposal to Revise Lifetime Deferral on Blood Donation by Gay Men

FDAIn a Federal Register notice published Friday, May 15, 2015, the Food and Drug Administration (FDA) is inviting public comments on the following draft recommendations: Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products [PDF 135KB].

This draft guidance, to establishments that collect blood or blood components, proposes a policy change to the blood donor deferral period for men who have sex with men (MSM) from indefinite deferral to 1 year since the last sexual contact. The indefinite deferral was first put in place in 1985, due to the strong clustering of AIDS illness in the MSM community. On April 23, 1992, the FDA issued a memo which contains the current recommendations regarding deferral for MSM and other persons whose behaviors are associated with high rates of HIV exposure.

In order to ensure that the FDA considers your comments on this draft guidance before it begins work on the final version of the guidance, please submit either electronic or written comments on the draft guidance by July 14, 2015.