Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute Sponsored Transfusion Transmissible Infections Monitoring System Risk Factor Elicitation

United States Food and Drug Administration
Donor Risk Assessment Questionnaire for the Food and Drug Administration (FDA)/National
Heart, Lung, and Blood Institute (NHLBI)-Sponsored Transfusion-Transmissible Infections
Monitoring System (TTIMS)—Risk Factor Elicitation (RFE)
OMB Control No. 0910-0841
JUSTIFICATION MEMORANDUM FOR 83-C CHANGE REQUEST
The Food and Drug Administration (FDA or we) is submitting this nonmaterial/non-substantive
change request (83-C) to obtain Office of Management and Budget (OMB) approval of a
modification to the study approved under control number 0910-0841. The current OMB approval
allows FDA to interview blood donors to collect risk factor information associated with testing
positive for a transfusion-transmissible infection (TTI). This study currently monitors and
evaluates risk factors among HIV-positive donors and recently HCV or HBV infected donors as
well as controls. To ensure adequate data quality, we would like to change the characteristics of
the universe of respondents by adding donors who test positive for syphilis and including
additional donors testing positive or reactive for other tests for Hepatitis B.
The proposed modification does not impact the current approved burden estimate. We estimate
no change to the questionnaire or in the time needed to complete an interview. With the lower
than anticipated rates of infections in donors, there exists the capacity to increase the scope of the
monitoring program without increasing the total respondent burden hours. Including all study
sites, we expect no more than 250 of these syphilis and additional control interviews per year (83
active syphilis cases and 167 controls). Thus, the total number of annual interviews is expected
to remain under the existing OMB approval of 600 per year. At 0.5 hour per interview, the total
burden hours remain unchanged at 300 hours.
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 U.S. blood supply.