REGULATORY UPDATE: FDA Publishes FRNs for April 2020 CJD, HIV and Malaria Guidance Documents

June 19, 2020

The Food and Drug Administration published Federal Register notices (FRNs) on Tuesday for the April 2020 Creutzfeldt-Jakob Disease (CJD), HIV and malaria guidance documents. In April, FDA released a statement outlining its process for making guidance documents available for immediate implementation to address the urgent need for blood during the COVID-19 pandemic. The process, which follows FDA’s established good guidance practices regulations, allowed the agency to issue the HIV and malaria documents without prior public comment. Rather than publishing a separate Notice of Availability (NOA) for each COVID-19-related guidance, FDA stated that it would periodically publish a consolidated NOA.

Although issued without prior public comment, FDA is soliciting comments, will review all comments received and revise the documents as appropriate. Each guidance document and FRN specifies the docket number to which comments can be submitted. On June 5, AABB submitted comments on the April 2020 HIV guidance. Members with questions may contact regulatory@aabb.org.