America’s Blood Centers, the Association for the Advancement of Blood & Biotherapies, and the American Red Cross (ARC) have submitted four joint comment letters to the U.S. Food and Drug Administration (FDA) regarding human cells, tissues, and cellular and tissue-based products (HCT/Ps) draft guidances. The February 5th blood community comments on FDA’s HCT/P guidances addressed:
- Recommendations for Determining Eligibility of Donors of HCT/Ps;
- Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by HCT/Ps;
- Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by HCT/Ps; and
- Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by HCT/Ps.
The blood community comments on FDA’s HCT/P donor eligibility guidance regarding requested an extended implementation period of at least one year to, “allow facilities to focus on successful implementation of changes to highly complex systems which must be updated, tested, and validated for performance [including] changes to the establishment computer system, HCT/P Donor History Questionnaires, flowcharts, Circular of Information, policies and procedures, and extensive staff training and education.”
While all four comment letters expressed support for the FDA draft guidance recommendations and updated guidance formats by the FDA, the blood community asked the agency in the comments on the HIV risk draft guidance, the HBV risk draft guidance, and the HCV risk draft guidance to provide clarification of the risk assessment timeframe for the secondary sexual partner through a, “timebound recommendation for the secondary sexual partner similar to the recommendations for blood donors in the May 2023 guidance.”