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For more on this topic, see the Biodefense and Select Agents section of NIAID Research Funding.
NIAID program
staff identifies grants using select agents. Based on this identification, grants
management adds a term to the Notice of Award of their renewals and noncompeting continuations:
Select Agent Term for U.S. Institutions
-
Awardees who conduct research involving select agents (see the HHS and USDA Select Agents and Toxins List) must complete registration with CDC (or USDA, depending
on the agent) before using NIH funds.
- No funds can be used for research
involving select agents if the final registration certificate is denied.
Select Agent Term for Foreign Awards
- Awardees who conduct research involving select agents (see the HHS and USDA Select Agents and Toxins List) must provide information satisfactory to NIH that
a process equivalent to that described in 42 CFR 73 for U.S. institutions
is in place and will be administered on behalf of all select agent work
sponsored by NIH funds before using these funds for any work directly involving
select agents.
- Awardees must be willing to address the following key elements
appropriate for their institutions: safety, security, training, procedures
for ensuring that only approved/appropriate individuals have access to
the select agents, and any applicable laws, regulations, and policies equivalent
to 42 CFR 73.
- If this work will not, in fact, involve select agents (e.g.,
excluded strains), and you provide documentation satisfactory to NIH
that your work does not now nor will it in the future (i.e., throughout
the life of the award) involve select agents, no further action will be
necessary.
Select Agent Term for U.S. Institutions With Foreign Subcomponents
- Awardees who conduct research involving select agents (see the HHS and USDA Select Agents and Toxins List) must complete registration with CDC (or USDA, depending
on the agent) before using NIH funds for any work directly involving
the select agent at the U.S. institution.
- No funds can be used for research
involving select agents if the final registration certificate is denied.
- Before using NIH funds for any work directly involving the select agents
at the foreign institution, the U.S. awardee must provide information from
the foreign institution satisfactory to NIH that a process equivalent
to that described in 42 CFR 73 for U.S. institutions is in place and will
be administered on behalf of all select agent work sponsored by these
funds.
- Awardees must be willing to address the following key elements
appropriate for the foreign institution: safety, security, training,
procedures for ensuring that only approved/appropriate individuals have
access to the select agents, and any applicable laws, regulations, and
policies equivalent to 42 CFR 73.
- If this work will not, in fact, involve
select agents (e.g., excluded strains), and you provide documentation
satisfactory to NIH that your work does not now nor will it in the
future (i.e., throughout the life of the award) involve select agents,
no further action will be necessary.
More Information
If your research involves select agents, see the Biodefense and Select Agents section of NIAID Research Funding. If your research involves human subjects, read our human subjects information. |
