Restricted Experiments Guidance: Transfer of a Product resulting from a Restricted Experiment
Depending on when the product was generated, the possession of a product resulting from a restricted experiment may require pre-approval from FSAP before a transfer request is approved. The potential receiver must submit the following documentation to FSAP for review prior to transfer:
- Synopsis of the proposed experiments and the intended objectives.
- Description of biosafety level including facility containment, equipment and special practices to be utilized for the proposed experiments.
- Synopsis of any planned animal or plant experiments (if applicable) or other relevant animal or plant work.
- Description of the transferor (e.g. entity, name of person initiating transfer, point of contact information, etc.).
- Description of occupational health and medical surveillance procedures (applicable to Tier 1 select agents as required in section 12 (d) and non-Tier 1 select agents as recommended in the BMBL (e.g., SARS-CoV)).
- Scientific references or supporting documentation, particularly with respect to the biosafety aspects of the proposed experimental product.
In addition, the APHIS/CDC Form 2, Request to Transfer Select Agents and Toxins, must be completed and submitted to the FSAP prior to transferring any select agent(s) or any toxin(s) over the exclusion amount as indicated in section 73.3 (d)(3). Please refer to the Form 2 instructions and guidance documents for more information. If approved, an amendment to the recipient entity’s select agent registration must be submitted to the FSAP.