Comment Request Regarding Proposed Agency Information Collection Activities Regarding Risk Factor Elicitation for the Transfusion-Transmissible Infection Monitoring System

In today’s Federal Register, FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency, under the Paperwork Reduction Act of 1995. The notice is required to seek Office of Management and Budget approval to conduct a survey intended to assess risk factors associated with transfusion-transmissible infections (TTI) in blood donors. The survey will be conducted under the Transfusion-Transmissible Infections Monitoring System program, and will also include interviews/epidemiologic surveys of donors with donations testing positive for a TTI, as well as donors with donations testing negative as controls. Monitoring behavioral risk factors for viral infections in both infected and uninfected donors is particularly important at this time because of the recent change in the deferral policy for men who have sex with men (MSM).

The current survey will help identify the specific risk factors for HIV and the prevalence of the risk factors in blood donors. This will help inform FDA on the proportion of new infections among all HIV positive blood donors. Donations from individuals recently infected with HIV have the greatest potential transmission risk because on rare occasions they could be missed during routine blood testing. The TTIMS study will enable a correlation of the positive test results with the risk interview survey data, so the probable reasons for infection can be determined. The study will help the FDA evaluate the effectiveness of screening strategies in reducing the risk of HIV transmission from donors with risk factors, and to evaluate if there are unexpected consequences associated with the recent change in the donor deferral policy such as an increase in HIV incidence among donors. 

The results from the survey will inform the 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. The information will also help with the design of potential studies to evaluate the feasibility and effectiveness of such alternative deferral options.

This is a separate action, and should not be confused with the opening of the public docket in July 2016, which requested comments supported by scientific evidence regarding potential blood donor deferral policy options to reduce the risk of HIV transmission by blood and blood products. However, both actions are part of the agency’s ongoing activities to assess the safety of the blood supply and to help evaluate its blood donor deferral policies.

Comments may be submitted in either written or electronic form in accordance with the instructions provided in the notice.

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the HIV Liaison Program visit the FDA Patient Network