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Select Agent Terms of Award for NIAID Grants

NIAID program staff identify grants using select agents. Based on this identification, grants management staff add a term to the Notice of Award for renewals and noncompeting awards:

Select Agent Term for U.S. Institutions

  • Before using NIH funds, awardees who conduct research involving agents on the HHS and USDA Select Agents and Toxins list must register with the Centers for Disease Control and Prevention (CDC) of HHS or Animal and Plant Health Inspection Service (APHIS) of USDA, depending on the agent.
  • No funds can be used for research involving select agents if a final registration certificate is denied.
  • Before conducting a restricted experiment with a select agent or toxin, awardees must notify NIAID and must receive approval from CDC or APHIS.

Select Agent Term for Foreign Awards

  • Awardees who conduct research involving select agents must provide information satisfactory to NIH that a process equivalent to that described in 42 CFR Part 73 (National Select Agent Registry Regulations) for U.S. institutions is in place and will be administered on behalf of all select agent work sponsored by NIH funds before using these funds for any work directly involving select agents.
  • Awardees must be willing to do the following:
    • Address the following key elements appropriate for their institutions: safety, security, incident response plan, training, procedures for ensuring that only approved and appropriate individuals have access to the select agents, and any applicable laws, regulations, and policies equivalent to 42 CFR 73.
    • Allow a NIAID representative to enter and review the laboratories or facilities where select agent research is (or will be) conducted and the area(s) where NIAID-funded select agents and toxins are stored.
    • Allow site reviews every three years after the initial review.
  • If this work will not involve select agents (e.g., excluded strains), and you provide documentation satisfactory to NIH that your work does not now nor will it in the future (i.e., throughout the life of the award) involve select agents, no further action will be necessary. Find exempt or excluded select agents at Select Agent Exclusions.
  • Before conducting a restricted experiment with a select agent or toxin, awardees must notify NIAID and receive approval from NIAID.

Select Agent Term for U.S. Institutions With Foreign Subcomponents

  • Awardees who conduct research involving select agents on the HHS and USDA Select Agents and Toxins list must complete registration with CDC or APHIS (depending on the agent) before using NIH funds for any work directly involving the select agent at the U.S. institution.
  • No funds can be used for research involving select agents if the final registration certificate is denied.
  • Before using NIH funds for any work directly involving the select agents at the foreign institution, the U.S. awardee must provide information from the foreign institution satisfactory to NIH that a process equivalent to that described in 42 CFR Part 73 (National Select Agent Registry Regulations) for U.S. institutions is in place and will be administered on behalf of all select agent work sponsored by these funds.
  • Awardees must work with foreign institutions to ensure they understand the NIAID select agent policy and are willing to do the following:
    • Allow a NIAID representative to enter and review the laboratories or facilities where select agent research is (or will be) conducted and the area(s) where NIAID-funded select agents and toxins are stored.
    • Allow site reviews every three years after the initial review.
  • Awardees must be willing to address the following key elements appropriate for the foreign institution: safety, security, incident response plan, training, procedures for ensuring that only approved and appropriate individuals have access to the select agents, and any applicable laws, regulations, and policies equivalent to 42 CFR 73.
  • If this work will not involve select agents (e.g., excluded strains), and you provide documentation satisfactory to NIH that your work does not now nor will it in the future (i.e., throughout the life of the award) involve select agents, no further action will be necessary. Find exempt or excluded select agents at Select Agent Exclusions.
  • Before conducting a restricted experiment with a select agent or toxin, awardees must do the following:
    • For research at the U.S. institution, notify NIAID and receive approval from CDC or APHIS.
    • For research at the foreign institution, notify NIAID and receive approval from NIAID.

More Information

If your research involves select agents, find more information on NIAID's Biodefense and Select Agents portal.

Last Updated February 07, 2012

Last Reviewed November 17, 2011