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Biodefense Research

Questions and Answers

Table of Contents

What is a select agent or toxin?

It is an agent or toxin that is a potential threat to public health and safety.

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. See the select agent glossary term and other related terms in the Look it Up section on the right.

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 package 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 National Select Agent Registry Regulations).

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 Do foreign applications involving select agent research have a special review and approval process? on the NIAID Select Agent Policy for Foreign Institutions questions and answers page.

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

Where can I find information on biodefense and select agents?

Check out the Biodefense and Select Agents portal of the Research Funding Web site 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 NIAID Select Agent Policy for Foreign Institutions questions and answers page.

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

Email deaweb@niaid.nih.gov 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.

Last Updated January 15, 2013

Last Reviewed January 15, 2013