Practical Considerations for Navigating Withdrawal from the Federal Select Agent Program.

ABSTRACT

Introduction: Clear guidance is provided by the Federal Select Agent Program (FSAP) to assist registered entities in nearly all facets of compliance with the Federal select agent regulations (7 CFR Part 331; 9 CFR Part 121; 42 CFR Part 73). If a registered entity chooses to discontinue its registration, detailed instructions for registration withdrawal are deeply embedded within a document entitled "eFSAP Form 1 Amendment Instructions," which is found on the FSAP website within the electronic Federal Select Agent Program (eFSAP) Resource Center. Methods: Using the information found within the eFSAP Form 1 Amendment Instructions, as well as extensive written and verbal guidance provided by the lead assigned entity point of contact at the FSAP, we completed the FSAP withdrawal process during a 12-month period between 2022 and 2023. Discussion: This commentary shares our recent professional experiences navigating the FSAP withdrawal process at the University of Texas Health Science Center at Houston (UTHealth Houston). Successes, challenges, and lessons learned are shared so that others planning or considering withdrawing may benefit from our experience. Conclusion: The resources provided for withdrawal within the eFSAP Form 1 Amendment Instructions are relatively basic, and additional details are not currently found in other FSAP guidance documents. Therefore, direct communication and support from the FSAP to the entity Responsible Officials are imperative to ensure a safe, secure, and compliant withdrawal.