Be Aware of CDC’s Interim Final Rule on SARS-CoV/SARS-CoV-2 Chimeras

Funding News Edition: December 15, 2021
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Investigators conducting SARS-related research, take note of CDC’s November 17, 2021 Interim Final Rule. It adds the following to the list of HHS select agents: SARS-CoV/SARS-CoV-2 chimeras in which SARS-CoV (already a select agent) virulence factors have been inserted into SARS-CoV-2 (not a select agent).

Institutions that already possess these SARS-CoV/SARS-CoV-2 chimeras must notify the U.S. Federal Select Agent Program (FSAP) by December 17, 2021. Since these chimeras will be considered select agents, institutions will need to register for a new or amend a current FSAP registration if they intend to continue to possess, use, or transfer these chimeras. The deadline for registering or amending an existing registration is February 15, 2022.

Any future work to develop these SARS chimeras in which virulence genes from SARS-CoV are inserted into SARS-CoV-2 or vice versa will be considered restricted experiments, which require pre-approval by CDC’s Intragovernmental Select Agents and Toxins Technical Advisory Committee.

U.S. institutions should follow Restricted Experiments Guidance and Restricted Experiments Guidance: Request To Conduct a Restricted Experiment on the FSAP website. For information on select agents or restricted experiments at non-U.S. institutions, go to our webpages Research Using Select Agents and NIAID Select Agent Research Review and Approval Procedure for Grants That Include Foreign Institutions.

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