For more on this topic, see the Biodefense and Select Agents section of NIAID Research Funding.
All U.S. institutions and individuals that possess, use,
and/or transfer select
agents and toxins are required to adhere to 42
CFR Part 73. This policy also extends to research involving the select
agents and toxins identified in HHS and USDA Select Agents and Toxins List or 7
CFR Part 331 and 9
CFR Part 121 as posing a severe threat to human
and/or animal health, plant health, or animal and plant products. These
regulations establish requirements regarding registration, security risk
assessments, safety plans, security plans, emergency response plans, training,
transfers, record keeping, inspections, and notifications. NIH has established
a new policy regarding the use of NIH funds for research involving select
agents. This policy is being implemented using Terms
of Award that are to be included in any grant, cooperative
agreement, or contract in
which select agents are or will be used. The terms and conditions of award
are in the accompanying document.
Awards to U.S. Institutions. Awards to U.S. institutions for research involving select agents will contain a Term of Award requiring registration with the U.S. Centers for Disease Control and Prevention (CDC), or the United States Department of Agriculture, depending on the agent, prior to using NIH funds for such research.
Awards to non-U.S. (Foreign) Institutions. Awards to non-U.S. institutions for research involving select agents will contain a Term of Award requiring U.S. review and approval of safety and security measures/practices prior to use of NIH funds for such research. An NIH-chaired committee of U.S. federal employees (including representatives of NIH grants and scientific program management, CDC, Department of Justice and other federal intelligence agencies, and Department of State) will assess the policies and procedures for comparability to the U.S. requirements described in 42 CFR Part 73. Toward this end, awardee institutions must be willing to provide key information delineating any laws, regulations, policies, and procedures applicable to the institution for the safe and secure possession, use, and transfer of select agents. This includes concise summaries of safety, security, and training plans, and applicable laws, regulations, and policies. For the purpose of security risk assessments, awardee institutions must be willing to provide the names of all individuals who will have access to the select agents and procedures for ensuring that only approved/appropriate individuals have access to select agents that are the subject of the NIH award.
Awards to U.S. Institutions with Foreign Components. Awards to U.S. institutions with non-U.S. components for research involving select agents will contain a Term of Award (or a Special Contract Requirements Clause under Section H in the case of contract awards) requiring U.S. review and approval of safety and security measures/practices prior to use of NIH funds for such research. An NIH-chaired committee of U.S. federal employees (including representatives of NIH grants and scientific program management, CDC, Department of Justice and other federal intelligence agencies, and Department of State) will assess the policies and procedures for comparability to the U.S. requirements described in 42 CFR Part 73. Toward this end, the U.S. awardee institution must be willing to provide key information delineating any laws, regulations, policies, and procedures applicable to the foreign institution for the safe and secure possession, use, and transfer of select agents. This includes concise summaries of safety, security, and training plans, and applicable laws, regulations and policies. For the purpose of security risk assessments, awardee institutions must be willing to provide the names of all individuals at the foreign institution who will have access to the select agents and procedures for ensuring that only approved/appropriate individuals have access to select agents that are the subject of the NIH award.
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. |
