Analysis of Public Docket Established to Solicit Comment on Recommendations in December 2015 HIV Guidance

The Food and Drug Administration (FDA) published a Federal Register Notice to establish a public docket to receive comments on the FDA’s recommendations for reducing the risk of human immunodeficiency virus (HIV) transmission by blood donation as described in the December 2015 guidance document "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products." The published Notice was issued under the docket number used for the December 2015 guidance document and provides 120 days for response.

When the FDA issued the December 2015 guidance, it also committed to continuing to reevaluate and update blood donor deferral policies as new scientific information becomes available. FDA noted that, because the process must be data-driven, the agency could not specify a time for when future policy changes might occur. While establishing the public docket allows the opportunity for a wide range of comments, the Notice lists specific information the FDA is interested in evaluating. FDA stated that “Specifically, we invite interested persons to submit to the docket comments supported by scientific evidence regarding possible revisions to FDA's blood donor deferral policies to reduce the risk of HIV transmission by blood and blood products. FDA requests that commenters provide scientific evidence, such as data from research, to support any suggestions. Additionally, comments are invited regarding the design of potential studies to evaluate the feasibility or effectiveness of such alternative deferral policy options. FDA recognizes that many stakeholders have expressed the desire to move from a time-based deferral period to a deferral policy based on individual risk assessment.”

The FDA explained that when preparing the 2015 guidance document, “FDA rigorously examined several alternative options, including individual risk assessment. Ultimately, FDA concluded that the 12-month deferral period is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population.” FDA also worked with the National Heart, Lung, and Blood Institute at the National Institutes of Health and representative blood organizations to implement a nationally representative transfusion-transmissible infections monitoring system (TTIMS) for the U.S. blood supply. This system provides critical information to help inform future actions that FDA may take on blood donor policies.

Recognizing that comments to the docket will likely include requests for a move toward a deferral policy based on individual risk assessments, the Notice included the following request for information on individual risk assessments.

An individual risk assessment would involve asking potential donors a series of questions designed to defer donors with high risk behaviors. In particular, we invite commenters to address the following and provide supporting scientific evidence such as data from research:

1. What questions would most effectively identify individuals at risk of transmitting HIV through blood donation?
2. Are there specific questions that could be asked that might best capture the recent risk of
   a donor acquiring HIV infection, such as within the 2 to 4 weeks immediately preceding
   blood donation?
3. How specific can the questions be regarding sexual practices while remaining understandable and acceptable to all blood donors? For example, could questions about specific sexual behaviors be asked if they helped to identify which donors should be at least temporarily deferred because of risk factors? To the extent the questions are explicit about sexual practices, how willing will donors be to answer such questions accurately?
4. Under what circumstances would a short deferral period for high risk behavior be appropriate?  For each short deferral period identified, please specify the duration of the deferral and provide the scientific rationale.
5. What changes might be necessary within blood collection establishments to assure that
   accurate, individual HIV risk assessments are performed?
6. How best to design a potential study to evaluate the feasibility and effectiveness of alternative deferral options such as individual risk assessment?