FDA intends to interview blood donors to collect risk factor information associated with testing positive for transfusion-transmissible infections (TTI). This collection of information is part of a larger initiative called Transfusion-Transmissible Infections Monitoring System (TTIMS), which is a collaborative project funded by FDA, the NHLBI of the National Institutes of Health (NIH), and the Department of Health and Human Services (HHS) Office of the Assistant Secretary of Health with input from other agencies in HHS including the Centers for Disease Control and Prevention (CDC). FDA will use these scientific data collected through such interview-based risk factor elicitation of blood donors to monitor and help ensure the safety of the United States blood supply. FDA issued a document entitled ‘‘Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products, Guidance for Industry’’ dated December 2015, which changed the blood donor criterion for men who have sex with men (MSM) from an indefinite (permanent) deferral to a 12-month deferral since last MSM contact. The impact of this change in the deferral criteria requires a national monitoring effort as part of TTIMS to assess if the relative proportions of risk factors for infection in blood donors have changed following the adoption of the 12-month donor deferral for MSM. TTIMS will use similar procedures as the ones used in previous OMB approved information collection “Transfusion-transmitted retrovirus and hepatitis virus rates and risk factors: Improving the safety of the US blood supply through hemovigilance” (OMB control number 0925-0630) to monitor and evaluate risk factors among human immunodeficiency virus (HIV)-positive donors and recently Hepatitis C virus (HCV) or Hepatitis B virus (HBV) infected donors as well as controls. The study will help identify the specific risk factors for TTI and their prevalence in blood donors, and help inform FDA on the proportion of incident (new) infections among all HIV positive blood donors. Donations with incident infections have the greatest potential transmission risk because they could be missed during routine blood screening. The study will help FDA evaluate the effectiveness of screening strategies in reducing the risk of HIV transmission from at-risk donors and to evaluate if there are unexpected consequences associated with the recent change in donor deferral policy such as an increase in HIV incidence among donors. These data also will inform FDA regarding future 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, and to inform the design of potential studies to evaluate the feasibility and effectiveness of such alternative deferral options.
The latest form for Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute - Sponsored Transfusion-Transmissible Infections Monitoring System - Risk Factor Elicitation expires 2023-08-31 and can be found here.
Justification for No Material/Nonsubstantive Change
Supporting Statement B
Supporting Statement A
Approved without change
|No material or nonsubstantive change to a currently approved collection
Approved without change
|Extension without change of a currently approved collection
Approved with change
|New collection (Request for a new OMB Control Number)