Table of Contents
- What is a select agent or toxin?
- How do I know if a biological agent in my research is considered to be a select agent or toxin?
- Do I need to follow rules for select agent research if I use only a killed select agent?
- What should I do if the biological agent in my research is a select agent or toxin?
- For rDNA research, is there a list of restricted agents?
- Do foreign applications involving select agent research have a special review and approval process?
- Who is responsible for notifying NIAID program staff that the proposed research includes a restricted experiment with a select agent?
- Are foreign institutions eligible to receive money for alterations and renovations?
- Where can I find information on biodefense and select agents?
- What if my question wasn't answered here, or I'd like to suggest a question?
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.
No, you do not need to follow select agent rules for a killed select agent.
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.
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.
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:
- Section 13b of 42 CFR Part 73
- Section 13 of 9 CFR Part 121
- Section 13 of 7 CFR Part 331
- List of restricted experiments on the Restricted Experiments page of the Federal Select Agent Program
Foreign applicants should see the Select Agent Review Grants the Include Foreign Institutions.
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