Questions and Answers Table of Contents
How do I know if the biological agent in my research is considered a select agent or toxin (threat to public health and safety)?
Check the HHS and USDA Select Agents and Toxins List. Be sure to also check Notification of Exclusion for specific strains. See the select agent glossary term.
What if the biological agent in my research is a select agent or toxin?
Applicants need to describe their select agent use in their research plan, including how and where it 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 either CDC for human pathogens or APHIS for plant and animal pathogens if using select agents, toxins, or overlap select agents or toxins.
U.S. investigators are prohibited from using NIH funds for select agent work before receiving a registration certification from CDC or APHIS as well as written approval from the contracting officer. The Flowchart for NIAID Select Agents Research Awards gives an overview of the process.
Foreign institutions have a different select agent approval process. See the question below.
For more information, see the Select Agents Awards SOP and Will Your Research Have Special Requirements? in the NIH Grant Cycle: Application to Renewal.
Do foreign applications involving select agent research have a special review and approval process?
Yes. Foreign institutions are required to have NIAID representatives inspect laboratories that conduct NIH-funded select agent research. They must provide information satisfactory to NIAID that safety, security, incident response, personnel security risk assessment, records, and training comparable to those described in 42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121 are in place.
For more details, read the Procedure for New and Continuing Grants that Include Foreign Institutions and the Procedure for New and Existing Contracts that Include Foreign Institutions. Also see the NIAID Select Agent Policy for Foreign Institutions questions and answers page.
What are the key provisions of the Patriot Act?
The Patriot Act states that people defined as "restricted" cannot work with pathogens or toxins that are potential bioterrorism agents.
NIAID does not require assurances from PIs; the investigator's institution is responsible for enforcing the law. Violations can be punished with a $10,000 fine, 10 years imprisonment, or both.
If the Patriot Act affects you, call your institutional business office for advice.
Who does the Patriot Act define as restricted?
The Patriot Act applies to grantees, contractors, trainees, and graduate students who are paid by a government award.
For more information, see our Foreign Workers on NIH Awards SOP.
Are foreign institutions eligible to receive money for alterations and renovations?
See Are foreign institutions eligible to receive money for alterations and renovations?
Can a Pakistani national work in a U.S. lab with Category A or B agents?
Yes. Pakistan is not defined in the Patriot Act as a "restricted" country, so an investigator from there can work in a U.S. lab with Category A or B agents. For a list of restricted countries, see the Foreign Workers on NIH Awards SOP.
Where can I find information on biodefense and select agents?
Check out the Biodefense Research and Development page 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.
Where can I find biodefense research funding opportunities?
Go to Current NIAID Biodefense Research Funding Opportunities.
Why did the biodefense funding level increase?
The terrorist attacks of September 11, 2001, and the spreading of anthrax spores through the mail prompted the administration to increase spending on biodefense research to develop countermeasures to protect the public against agents of bioterror. See NIAID's Open Letter in Science Regarding NIH Biodefense Funding.
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. |
