The Circular of Information (the Circular) is made available through the important work of the AABB's Circular of Information Task Force. This webpage provides the background information for compliance with FDA requirements under 21 CFR 606.122 for use of the Circular, including information on purchase options, implementation, and updated language. AABB encourages you to review the information for important changes.
Please contact Regulatory Affairs with your questions at
The User Guide for the December 2021 Circular provides blood collection establishments, transfusion services and clinical staff with information to supplement their understanding of the regulatory responsibilities for implementation and use of the Circular. The User Guide also provides information about appropriate use of the electronic version of the Circular (eCircular provided in USB format to blood manufacturers). The User Guide includes a Change Table highlighting significant changes and new information included in the December 2021 Circular. New in this version:
AABB has made the Circular publicly available for review (as a pdf document) to ensure access to the content. This posted watermarked version may not be copied, printed or used as the extension of labeling.
Under 21 CFR 606.122(h), FDA states “the circular of information must include the names and results of all tests performed when necessary for safe and effective use.” As new testing requirements are implemented or new information becomes available, the December 2021 Circular must be updated to accurately reflect the changes. Until the new language is incorporated into the next version of the Circular and consistent with historic practices, AABB recommends:
NOTE: The version date of December 2021 for the Circular must not be changed.
On May 12, 2021, the FDA’s July 2018 Zika virus (ZIKV) Testing Guidance was withdrawn because the agency has determined that testing for ZIKV, or pathogen reduction as an alternative to testing for ZIKV, is not necessary to comply with the requirements of 21 CFR 610.40(a)(3) because ZIKV is no longer a Relevant Transfusion-Transmitted Infection (RTTI). FDA requires establishments to update the Circular at the time testing is discontinued and report the changes to your Circular “in the annual report under 21 CFR 601.12(d).”
Accordingly, the recommendation was not included in the December 2021 Circular. For Blood Centers that continue to have ZIKV tested units in their distributed inventory and to satisfy FDA’s expectations, AABB recommends adding this statement to your Circular at the time testing is discontinued:
“Blood components collected between [insert date-date] were tested with a licensed nucleic acid test (NAT) for Zika Virus RNA and found to be nonreactive.”
At the time your blood center no longer has ZIKV-tested units in your distributed inventory, you can opt to delete this statement from your Circular of Information.