Foreign organizations must comply with Federal/NIH biosafety and biosecurity regulations. 

Grantees who conduct research involving Select Agents must complete registration with the U.S. Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) or the U.S. Department of Agriculture (USDA), depending on the agent, before using NIH funds. HHS and USDA Select Agents and Toxins are listed at: http://www.selectagents.gov/) Regulatory requirements are at 42 CFR 73, 7 CFR 331 and 9 CFR 121. In addition, research involving both Select Agents and recombinant DNA is subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules.

Select Agents – Direct to Foreign Awards

Awardees who conduct research involving Select Agents (see 42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens) must provide information satisfactory to the 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 the 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 Agents - Awards to U.S. Institutions with Foreign Subcomponents

Awardees who conduct research involving Select Agents (see 42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens) 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 the 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 the 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.

For more general information about NIH’s Select Agents Policy see: http://grants.nih.gov/grants/policy/select_agent/

Additional information is on the NIAID Webpages at http://www.niaid.nih.gov/ncn/grants/sagrantsproc.htm and http://www.niaid.nih.gov/ncn/clinical/default_biodefense.htm.

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