Guidance on the Regulation of SARS‑CoV/SARS‑CoV-2 Chimeric Viruses

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Revisions: This is a living document subject to ongoing improvement. Feedback or suggestions for improvement from registered select agent entities or the public are welcome. Submit comments directly to the Federal Select Agent Program (FSAP) via CDC’s Division of Regulatory Science and Compliance (DRSC) at LRSAT@cdc.gov.

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Introduction

This document provides information to assist entities in meeting the requirements for conducting a SARS-CoV/SARS-CoV-2 chimeric virus restricted experiment or possessing the products resulting from such restricted experiments.

Guidance on the Regulation of SARS-CoV/SARS-CoV-2 Chimeric Viruses [PDF – 488 KB]