Summary of Regulatory Changes

4/21/10: OMB-approved FD-961 form

This is a reminder that on June 1, 2010, the FBI, Criminal Justice Information Services (CJIS) will only be accepting the OMB approved FD-961 form (OMB No. 1110-0039; expiration date 10/31/2012) required to evaluate an individual’s suitability to access, possess, use, receive, or transfer select agents  The form is available at: http://www.selectagents.gov/sra.html. The use of an expired form after June 1, 2010 will result in return of the form to the submitter and a delay in the processing of an individual’s security risk assessment (SRA).

12/16/09: Diagnostic Laboratories

Guidance regarding transferring identified select agents or toxins from clinical/diagnostic specimens being sent for susceptibility testing. The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs are providing clarification related to the shipment of select agents and toxins. Effective today, the Select Agent Programs will require prior authorization for any transfers that involve the transfer of select agent(s) for the purpose of susceptibility testing.
The Select Agent Programs have developed the below FAQ that will be posted on the Select Agent Program website at: http://www.selectagents.gov/resources/Report%20of%20Identification%20of%20Select%20Agents%20and%20Toxins%20FAQ%202008-12-23.pdf.

Question: Is the APHIS/CDC Form 2 required to transfer select agents identified from clinical/diagnostic specimens being sent to a registered laboratory for susceptibility testing?
Answer: Yes, APHIS/CDC Form 2 is required to request prior authorization for the transfer of the identified select agent(s). For further guidance regarding requesting a transfer of a select agent or toxins, please refer to: http://www.selectagents.gov/TransferForm.html.