Refresher on Select Agents Research Policy and Federal Law

Funding News Edition: September 15, 2021
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NIAID-funded research often includes pathogens that the U.S. Federal Select Agent Program, co-managed by HHS and USDA, designates as select agents. These biological select agents and toxins pose a significant public health risk and require additional safety precautions to ensure public health safety. The steps you need to take are outlined on the Federal Select Agent Program (FSAP) and NIAID Research Using Select Agents websites.

Updates on Select Agent Designations and Exemptions 

Before submitting grant applications or contract proposals, you should check for updates to select agent designations and select agent exemptions on the FSAP website. For more information on select agent regulations, read the FSAP FAQ: Select Agents & Toxins.

Current select agent regulations designate the SARS-CoV virus as a select agent, but not the SARS-CoV-2 virus. While it is possible that the designation will change, and the SARS-CoV-2 virus will be classified as a select agent, absent a status change the select agent regulations do not apply to SARS-CoV-2. Additionally, in accordance with recent FSAP announcements, there are new exemptions of certain African Swine Fever viruses and the Brucella abortus strain.

Sign up for the FSAP newsletter Select Agent (SA) Grams to receive updates directly from the U.S. Federal Select Agent Program.

Step 1: Check the Regulations 

Familiarize yourself with the Select Agents and Toxins List for your planned research materials. In addition, check the Select Agents and Toxins Exclusions list to see if your agent is exempt. You’ll also want to reference the HHS select agents and toxins regulations (42 CFR Part 73), which contains a list of agents, toxins by quantity, and regulated molecular sequences.

Remember, if your proposed research includes a select agent not on the exclusions list, your domestic institution needs to be registered with the CDC or USDA depending on the agent. Complete the Registration for Possession, Use, and Transfer of Select Agents and Toxins form and submit it to FSAP. If you are conducting restricted experiments with select agents, you must submit a Request to Conduct a Restricted Experiment in addition to the form linked above; see Restricted Experiment Guidance Document for more information.

Non-U.S. institutions do not submit these forms to FSAP but instead will work with the Office of Extramural Research Policy and Operations (OERPO) within NIAID’s Division of Extramural Activities to complete select agent approval processes both before and during the award.

Step 2: Complete Your Application

If your research includes a select agent, you will need to describe how and where you will use the agent in the Research Strategy section of your application. You will also need to complete the Select Agent Research attachment Other Research Plan Section to the PHS 398 Research Plan form and describe biocontainment resources at each performance site in the Facilities and Other Resources section of the Other Project Information form.

Step 3: If a Grant or Contract Award Is Likely

NIAID awards will include the appropriate Select Agent Terms of Award for NIAID Grants or Select Agent Language for Solicitations and Contracts. Your program officer or contracting officer representative will be aware that your proposed research includes select agents not on the exclusions list and monitor compliance. Remember, you cannot use research funds involving select agents until your institution obtains final Registration for Possession, Use, and Transfer of Select Agents and Toxins certification from CDC. Your grants management specialist or contracting officer may request a copy of the registration.

As per a special NIAID Term of Award, a separate review and approval process must occur before an awardee can use NIH funds for select agent research that will occur at a non-U.S. institution. For questions about foreign select agent Terms of Award and policy compliance, contact OERPO.

Step 4: Research

Upon completing NIAID’s administrative requirements for select agent or toxin research, you can begin your research. Keep in mind that you are responsible for following U.S. Regulations 7 CFR Part 3319 CFR Part 121, and 42 CFR Part 73.

Be aware that people defined as “restricted” under the USA Patriot Act cannot work with pathogens or toxins that are potential bioterrorism agents. Read the Foreign Workers on NIH Awards SOP for the Patriot Act definition of restricted persons.

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