REGULATORY UPDATE: AABB to Proactively Share an Individual Risk Assessment DHQ Example Model with FDA

The AABB Donor History Task Force (DHTF) has worked collaboratively to complete an Individual Risk Assessment Donor History Questionnaire (IRA DHQ) Example Model. The example model was developed in July, inserting the Canadian donor eligibility criteria into the draft DHQ version 3.0, to demonstrate how a similar model might be used in the United States.

AABB understands that the Food and Drug Administration will be actively considering the Canadian criteria as the agency updates the U.S. donor eligibility criteria. This example model is not intended as a formal submission to FDA for review and has no impact on the FDA’s current review of the DHQ v3.0, which was formally submitted in September.

AABB will share the IRA DHQ Example Model with FDA early next week as a packet of resources to support and inform the agency’s work in the weeks ahead. It is intended to help FDA visualize the types of changes that might be considered, depending on data and results from the Accessing donor Variability And New Concepts in eligibility (ADVANCE) pilot study.

The IRA DHQ Example Model was developed to demonstrate effective use of the same donor screening questions for all individuals, regardless of gender or sexual orientation; effective identification of individual risk for HIV infection for each potential blood donor based on the individual’s risk activity, regardless of gender or sexual orientation; and accurate eligibility, 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.

At the time FDA releases a draft guidance, AABB and AABB members will know for the first time precisely what FDA will require. Revisions to the DHQ IRA Example Model incorporating the Canadian eligibility criteria are expected and will build on the proactive work previously completed by the DHTF.

The new requirements will be incorporated into DHQ v3.0 and will become a draft DHQ v4.0. Following formal submission to FDA for review and acceptance, AABB will share the draft DHQ v4.0 documents, as was done with DHQ v3.0, to ensure full access and to provide members maximum time as they determine how/if they will begin preparations at this draft stage.

The DHTF’s foresight and commitment to proactively develop the DHQ IRA Example Model will be pivotal to the rapid development and formal submission to FDA of a historic DHQ v4.0, which will, for the first time, include individual risk assessment eligibility criteria.

Email regulatory@aabb.org with questions.