2021 SA Grams

Today, the Centers for Disease Control and Prevention (CDC)’s Division of Select Agents and Toxins published an Interim Final Rule adding SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins.  In addition, the work to create this chimeric virus is a ‘restricted experiment’ and requires prior approval from CDC before performing the experiment.

The regulation, available at https://www.federalregister.gov/d/2021-25204external icon, was published in the Federal Register and CDC will accept public comments on the addition of the agent for the next 60 days.  Comments on the Interim Final Rule should be submitted via the regulations.gov website; a direct link is available hereexternal icon.

HHS/CDC believes that immediate regulatory oversight of these experiments and the resulting chimeric viruses is essential to protect the public from the potential consequences of a release of these viruses. Once the 60-day public comment period has closed, CDC will consider the comments received.  In the meantime:

  • Within 30 days of the publication of the notice in the Federal Register (by December 17, 2021), any individual or entity that possesses SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors must provide notice to the Federal Select Agent Program regarding their possession of this agent.
  • By 90 days after the publication (by February 15, 2022), any individual or entity that intends to continue to possess, use, or transfer this agent will be required to either register in accordance with the select agent regulations (42 CFR part 73), or amend their current registration [in accordance with § 73.7(h)] and meet all of the requirements of the select agent regulations.

If you have any questions, please contact CDC’s Division of Select Agents and Toxins at lrsat@cdc.gov or 404-718-2000.

The Federal Select Agent Program (FSAP) has been asked to notify the regulated community of the following on behalf of the Federal Bureau of Investigation/Criminal Justice Information Service/Bioterrorism Risk Assessment Group (BRAG):

A revised FD-961 form has been approved by the Office of Management and Budget (OMB) (OMB No. 1110-0039 [Exp. 07-31-2024]) and should now be used when submitting security risk assessments.  BRAG will continue to accept the expired form, FD-961 (OMB No. 1110-0039 [Exp. 4-30-2021]), until December 4, 2021.  Previous versions of the FD-961 will not be accepted after this date and will result in return of the form to the submitter. This could result in the delay of processing an individual’s security risk assessment.

A link to the revised FD-961 form is also available on the FSAP websiteexternal icon.

If you have any questions regarding the FD-961 form, please contact BRAG at 304-625-4900.

Page last reviewed: November 18, 2021, 08:46 AM