NIAID Select Agent Research Awards Process

NIAID staff and awardees use this process in conjunction with the related Select Agent Awards SOP.

Follow the steps shown in the sections below:

• Confirm Select Agent Involvement
• Next Steps for U.S.-Only Institutions
• Next Steps for Foreign Institution or U.S. Institution with Foreign Component
• Restricted Experiment Review Process for Non-U.S. Awardees

Confirm Select Agent Involvement

When an NIAID grant or cooperative agreement is recommended for funding or a contract offeror is in the competitive range, the NIAID program officer (PO) or contracting officer’s representative (COR) confirms whether the research involves a select agent or toxin. 

If it does, the award needs the Select Agent Terms of Award for NIAID Grants or Select Agent Language for Solicitations and Contracts.

For awards with foreign involvement, skip down to Next Steps for Foreign Institution or U.S. Institution with Foreign Component. For U.S.-only institutions, continue reading here.

Next Steps for U.S.-Only Institutions

1. The principal investigator (PI) and institution’s responsible official (RO) must apply to register with the Centers for Disease Control and Prevention (CDC) of HHS and/or Animal and Plant Health Inspection Service (APHIS) of USDA, depending on the agent.
2. NIAID applies the Select Agent Terms of Award for NIAID Grants or Select Agent Language for Solicitations and Contracts.
3. PI and institution’s responsible official (RO) follow U.S. Select Agents Regulations including requirements for Restricted Experiments with a select agent.
4. Once the PI and institution’s RO complete registration and obtain a certificate from CDC or APHIS, they may begin using funds for select agent research.

Next Steps for Foreign Institution or U.S. Institution with Foreign Component

1. NIAID applies the Select Agent Terms of Award for NIAID Grants or Select Agent Language for Solicitations and Contracts.
2. NIAID requests information from the awardee, including foreign policies and regulations. 
3. The PI and institution’s responsible official (RO) respond. If restricted experiments are planned, even types that have been previously approved, the PI and RO must complete special procedures before proceeding to the next steps in this section. Check the Restricted Experiment Review Process for Non-U.S. Awardees section below for other prerequisite requirements. 
4. NIAID coordinates with CDC to conduct an initial assessment of the foreign laboratory and a re-assessment every 3 years while the award is active.
5. The Interagency Select Agent Review Group (ISARG) members are U.S. government employees with experience in select agents research or policies. ISARG evaluates the review report and foreign institution’s regulations, policies, and procedures before making recommendations to NIAID. 
6. The NIAID Division of Extramural Activities (DEA) Director approves use of funds for select agent research.
7. PI may use funds for select agent research.

Restricted Experiment Review Process for Non-U.S. Awardees 

1. The NIAID PO or COR should inform Contact for NIAID Staff in the Office of Extramural Research Policy and Operations (OERPO) about any restricted experiment prior to award or after awardee notification. If the awardee directly informs OERPO instead, OERPO will confirm that the PO or COR is aware of the restricted experiment.
2. OERPO sends a letter to the awardee requesting additional information about the restricted experiment.
3. OERPO forwards the awardee’s response to the PO or COR and NIAID’s representative from the CDC Division of Regulatory Science and Compliance (DRSC).
4. The DRSC representative reviews the response and requests additional information from the awardee or OERPO as needed. 
5. The DRSC representative presents final information to the CDC’s Interagency Select Agent and Toxin Technical Advisory Committee (ISATTAC) for review.
6. The ISATTAC reviews the proposed restricted experiment and makes a recommendation to NIAID’s DRSC representative.
7. The DRSC representative relays the ISATTAC recommendation to Contact for NIAID Staff in NIAID OERPO.
8. OERPO sends ISATTAC’s recommendation to the NIAID DEA Director and the PO or COR.
   • If ISATTAC had concerns, the restricted experiment is not allowed. 
   • If ISATTAC had no concerns, the restricted experiment is allowed. 
9. For either ISATTAC recommendation outcome, OERPO informs the awardee, PO or COR, and the grants management specialist or contracting officer. 
10. Following the ISATTAC recommendation:
    • If the only select agent research planned was the restricted experiment that is not allowed, the process ends.
    • Otherwise, proceed with Steps 4 through 7 in the Next Steps for Foreign Institution or U.S. Institution with Foreign Component above.

More Information

Find more detail in the Select Agent Awards SOP.