Biodefense Research Questions and Answers

Table of Contents

What is a select agent or toxin?

Select agent and/or toxin means unless otherwise specified, all of the biological agents or toxins listed in 42 CFR 73.3 and 73.4. These biological agents and toxins have been determined to have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products.

How do I know if a biological agent in my research is considered to be a select agent or toxin?

Check the HHS and USDA Select Agents and Toxins List. Be sure to also check Select Agent Exclusions for specific strains.

Do I need to follow rules for select agent research if I use only a killed select agent?

No, you do not need to follow select agent rules for a killed select agent.

What should I do if the biological agent in my research is a select agent or toxin?

Describe your select agent use in your Research Plan, including how and where the select agent will be used.

If applying electronically, complete the Select Agent Research attachment to the PHS 398 Research Plan form in the grant application and describe biocontainment resources at each performance site in the Facilities and Other Resources section of the Research and Related Other Project Information form.

Domestic institutions 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. Foreign institutions must provide information satisfactory to NIAID that safety, security, and training standards are comparable to those described for U.S. institutions in 42 CFR Part 73 (go to Federal Select Agent Program).

See the Flowchart for NIAID Select Agent Research Awards (PowerPoint) for an overview of the approval process for both foreign and domestic awards, including those that plan restricted experiments.

For more information, see the Select Agents Awards SOP.

For rDNA research, is there a list of restricted agents?

Yes. See Section V-L under Section V. Footnotes and References of Sections I through IV in the NIH Guidelines For Research Involving Recombinant DNA Molecules. NIAID does not keep a separate list.

Do foreign applications involving select agent research have a special review and approval process?

Go to NIAID Select Agent Research Review and Approval Procedure for Grants That Include Foreign Institutions.

Who is responsible for notifying NIAID program staff that the proposed research includes a restricted experiment with a select agent?

If an application is selected for funding, the applicant must notify his or her program officer that the proposed research includes restricted experiments as defined in any of these resources:

Are foreign institutions eligible to receive money for alterations and renovations?

See Foreign or International Applications.

Where can I find information on biodefense and select agents?

Check out Research Using Select Agents as well as NIAID's Biodefense and Related Programs Web site. You may also want to read the Select Agent Awards SOP.

Foreign applicants should see the Select Agent Review Grants the Include Foreign Institutions.

What if my question wasn't answered here, or I'd like to suggest a question?

Email with the title of this page or its URL and your question or comment. We answer questions by email and post them here. Thanks for helping us clarify and expand our knowledge base.

Content last reviewed on January 15, 2016