REGULATORY UPDATE: AABB Requests Early FDA Review of DHQ v4.0 System of Documents

As part of our ongoing commitment to support the blood collection community, AABB submitted the Donor History Questionnaire version 4.0 (DHQ v4.0) System of Documents to the Food and Drug Administration for formal review and acceptance today. The DHQ v4.0 incorporates FDA’s new donor eligibility recommendations outlined in the January 2023 draft HIV guidance.

AABB is using a proactive approach to step outside of the established linear process and work in parallel with FDA. In doing so, AABB seeks to facilitate early communication with blood collection establishments and provide an advance view of the DHQ v4.0 system of documents. Under the special circumstances related to this historic policy change, it is AABB’s goal to reduce delays associated with the regulatory process.

The advanced preparation of the Donor History Task Force made it possible to submit these documents early and facilitate planning and education to support a smooth transition, effective implementation, and a safe and adequate blood supply. AABB appreciates FDA’s support of this process change as the blood community strives to complete the extensive work necessary to implement the new recommendations.

AABB reminds the blood community that:

(1) The DHQ review process includes bi-directional communication regarding FDA-required revisions to the DHQ based on comments, feedback, additional information and data provided by FDA.

(2) The DHQ v4.0 System of Documents are subject to change and are posted to the AABB website for planning purposes only.

(3) These documents should not be considered final until formally recognized by FDA in a Level 2 guidance and announced by AABB.

Individuals with questions may contact regulatory@aabb.org.