REGULATORY UPDATE: Blood Community Submits Comments on HCT/P Draft Guidances

February 05, 2025

AABB, America’s Blood Centers (ABC) and the American Red Cross (ARC) submitted four sets of joint comments to the Food and Drug Administration this week related to recent guidance on determining donor eligibility of HCT/P donors, recommendations to reduce the risk of transmission of HIV by HCT/P donors, recommendations to reduce the risk of HCV by HCT/P donors and recommendations to reduce the risk of HBV by HCT/P donors.

The comments support FDA’s commitment to evolving policies that result in new, evidence-based recommendations using the same risk-based donor eligibility questions for all HCT/P donors and removing unnecessary deferrals. The comments also support the updated guidance format, which incorporates separate guidance documents with recommendations to reduce the risk of transmission of specific communicable disease agents or diseases.

The HIV, HCV and HBV comments request clarification of the risk assessment for a secondary sexual partner. As written, the recommendations “result in an inconsistent eligibility determination of certain donors based on sexual contact with individuals who are themselves eligible to donate.”

The joint comments also request an extended implementation period of at least one year to allow facilities to focus on successful implementation of these complex changes.

Members with questions may contact regulatory@aabb.org.