Blood Donor Deferral

Overview

FDA Policy on Blood Donations from Men Who Have Sex with Other Men

Donor deferral policy based on other potential risk factors

Public Meetings

FDA Blood Products Advisory Committee, May 16, 2012 - Committee update

• Committee update on HHS activities related to the evaluation of the donor deferral
  policy for men who have had sex with other men.
  Webcast Video . You will need to scroll the time counter (directly below the video window) to 5:42. (5 hours 46 minutes)

Health and Human Services (HHS) Advisory Committee on Blood Safety and Availability (ACBSA), June 10-11, 2010

• Federal Register Announcement, agenda, webcast and public comment 

Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing, March 8, 2006 FDA Public Workshop

• Federal Register Announcement
• Complete Transcript

Blood Products Advisory Committee Meeting, January 14, 2000 to consider FDA blood or plasma donor deferral policy related to men who have had sex with men (MSMs) ~ Blood Donor Deferral for MSMs

• Agenda (PDF -13 KB)
• Briefing information
• Transcript (PDF - 677 KB) - pertinent discussion begins at transcript page 158

Blood Donor Suitability Workshop, November 23, 1998

• Agenda and Transcript (pdf 1 MB)

Related Guidance Documents

• Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Proposed Rule 11/8/2007
• Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components 10/27/2006
• Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry - 7/19/2005
• Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV - 10/21/2004
• Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires (7/2003)
• Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products - 4/23/92, defined a policy for deferral of donors based on HIV-associated signs and symptoms, medical history, laboratory test results, and certain activities that place the donor at increased risk for HIV infection