What is eFSAP?

Introduction to eFSAP

FSAP’s new secure information system, eFSAP, is used to submit select agent program information. For the first time, this two-way portal will be accessible by both FSAP and the regulated community. The new system will increase efficiency by greatly enhancing information exchange with FSAP and collaboration.

For users at registered entities, benefits of the system include reduced paperwork, increased ease of validating and submitting information (via use of the electronic portal), and reduced processing time for requests (as real-time information exchange will allow for increased responsiveness).

Access

To gain access to the system, all users are required to establish a SAMS (Secure Access Management Services) account, which protects the security of the information by requiring users to enter a user ID and password, or other secure credentials, before providing access to the system. Users with SAMS accounts will only have access to their own entity’s information. If you need assistance with this, please contact us.

Functionality

This form must be completed in order to apply to possess, use, or transfer select agents and toxins (as described in 7 CFR 331, 9 CFR 121, and 42 CFR 73). Information requested in this form includes: facility information; a list of select agents and/or toxins to be possessed, used, or transferred by the entity; a list of individuals who will have access, or potential access, to select agents and toxins; and information about the work to be performed.

This form is used by entities to request prior authorization of a transfer of select agent(s) or toxin(s) from the Federal Select Agent Program as required by regulations (7 CFR 331, 9 CFR 121, and 42 CFR 73).

This form is used by entities to report a theft, loss, or release of a select agent or toxin. The discovery of a theft, loss, or a release (occupational exposure or release of an agent or toxin outside of the primary barriers of the biocontainment area) of a select agent or toxin is required to be immediately reported.

This form is used by clinical or diagnostic laboratories and other entities to notify the Federal Select Agent Program of the identification of a select agent or toxin as the result of diagnosis, verification, or proficiency testing and of the final disposition of that identified agent or toxin.

This form is used by an entity to request an exemption from the select agent regulations for an investigational product. (Note: This feature is still under development.)

More information on these forms can be found here.

Page last reviewed: March 31, 2021

Content source: Division of Regulatory Science and Compliance