Restricted Experiments Guidance: Request to Generate Intermediate Variants
The RO must submit the request to conduct restricted experiments that involve the use of intermediate selection markers to generate intermediate variants to the FSAP. Describe the methods used for selection (e.g. recombinant or passive selection), including all potential drug resistant traits and intermediate selection markers not retained in the final construct in the request.
As a general rule, long term storage materials include select agents and toxins (including viral genetic elements, recombinant and/or synthetic nucleic acids, recombinant and/or synthetic organisms, and products resulting from restricted experiments) which are not part of an ongoing experiment or have not been accessed for a significant period of time (e.g., 30 calendar days). All intermediate variants that contain restricted selection markers in long term storage must be added to the select agent inventory and managed in accordance with the select agent regulations. Please refer to the Guidance on the Inventory Requirements for Select Agents and Toxins for more information.