Guidance on the Regulation of SARS‑CoV/SARS‑CoV-2 Chimeric Viruses: Request Process to Conduct SARS-CoV/SARS-CoV-2 Chimeric Virus Restricted Experiments

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The entity’s Responsible Official should submit any request to conduct a restricted experiment

via the General Discussion tab on the landing page in the eFSAP information system. The request should not be submitted as part of an amendment to an entity’s registration. Doing so may delay approval of other changes proposed in the amendment while the restricted experiment request is under review. The entity may only amend their registration after the restricted experiment is approved. The registration is updated by submitting the appropriate Animal and Plant Health Inspection Service (APHIS)/CDC Form 1 section updates related to the experiment. See Responsible Official Guidance Document (selectagents.gov) for additional information on how to update an entity’s registration.

When requesting to conduct a restricted experiment, the entity should submit the following relevant information via the General Discussion tab on the landing page in the eFSAP information system:

  • Synopsis of the proposed experiment(s) and the intended objective(s).
  • Description (including relevant sequence alignments) of the modified nucleic acid sequences (if applicable) and the predicted biological characteristics of the synthetic/recombinant product.
  • Method for creating the chimeric virus(es).
  • Identification and characteristics of the host organism used for molecular cloning (if applicable).
  • Description of biosafety level including facility containment, equipment, and special practices to be utilized for the proposed experiment(s).
  • Synopsis of any planned animal experiments (if applicable) or other relevant animal work.
  • Expected timeframe of the proposed experiment(s).
  • Description of long-term and short-term storage plans for samples.
  • Scientific references or supporting documentation, particularly with respect to the biosafety aspects of the proposed experimental product.

If an entity is unsure if their proposed work is considered a restricted experiment, they should contact FSAP for assistance.