REGULATORY UPDATE: AABB Proactively Sends Individual Risk Assessment DHQ Example Model to FDA

The AABB Donor History Task Force (DHTF) has proactively developed an Individual Risk Assessment Donor History Questionnaire (IRA DHQ) Example Model and Validation Packet that inserts Canada’s donor deferral criteria into the DHQ to demonstrate how a similar model might be used in the United States. This example model is not intended as a formal submission for Food and Drug Administration review.

The IRA DHQ Example Model has been sent to FDA to help the agency and our community visualize the types of changes that might be considered following the agency’s review of the results from the Accessing Donor Variability and New Concepts in Eligibility (ADVANCE) study and potentially other international approaches. The Example Model can also help the blood community consider the scope and extent of the changes that might be seen in a future system of documents.

The Example Model includes test cases that validate how a safe and effective individual risk assessment approach based on how Canada’s eligibility criteria might be used to effectively use the same donor screening questions for all individuals, regardless of gender or sexual orientation; to effectively identify individual risk for HIV infection for each potential blood donor based on the individual’s risk activity, regardless of gender or sexual orientation; and to ensure effective eligibility assessment while avoiding unnecessary deferral of a potential blood donor who is not at risk of HIV infection based on the individual’s risk activity, regardless of gender or sexual orientation.

With this proactive work, the Task Force will be primed to efficiently address FDA’s draft guidance recommendations, which are expected in the new year. AABB is committed to the Association’s long-standing support for a transition to an evidence-based approach for IRA and looks forward to the next historic steps. Following the issue of the draft guidance, AABB will submit joint comments during the expected 60- or 90-day comment period.

Individuals with questions may regulatory@aabb.org.