Frequently Asked Questions

Yes, while Federal Select Agent Program regulatory oversight may not apply [42 CFR 73.3(d)(7)] research involving any quantity of a toxin on the Biological Select Agents and Toxins list is subject to review under the Policy. Category 1 oversight considers the anticipated experimental outcomes described in Section 4.1.2 of the Policy, regardless of the amount of toxin involved.

As Category 1 includes all non-exempted agents from the Risk Group 3 list in the NIH Guidelines, experiments with transmissible spongiform encephalopathy (TSE) agents (i.e., Creutzfeldt-Jacob disease and kuru agents) are included in consideration for this oversight. Research involving prions not explicitly specified in the NIH Guidelines that have been noted as causing Creutzfeldt-Jacob disease in humans, such as prions associated with bovine spongiform encephalopathy (BSE), should be assessed for the experimental outcomes described in Section 4.1.2 of the Policy to determine whether it requires Category 1 oversight. The Policy also encourages investigators and research institutions to review any research for anticipated Category 1 and/or Category 2 experimental outcomes, regardless of agent and funding source.

Investigators and institutions with existing awards that may be subject to the Policy are encouraged to consult with the federal funding agency to determine next steps. The Policy is applicable to all research funded or sponsored by grants, contracts, cooperative agreements, and other agreements and transactions issued on or after the effective date of May 6, 2025, and requirements will be reflected in the terms and conditions of the awards. Investigators and institutions are encouraged to consult with their federal funding agency whenever Category 1 and/or Category 2 scopes and experimental outcomes are identified in any research.

There is no general requirement to report non-USG funded research. However, as appropriate, and subject to available authorities, as discussed in Section 5.4 of the Policy, individual funding agencies may establish, as a condition of funding, that they require notification of non-federally funded research that meets the definitions for oversight under the Policy. In those cases, institutions should report to the funding agency issuing that requirement.

Institutions have flexibility to establish internal policies and processes to meet the requirements of the Policy, including mechanisms to ensure appropriate communication with federal funding agencies. Institutions conducting research covered by either Category 1 or 2 oversight requirements are required to designate an Institutional Contact for Dual Use Research (ICDUR) to serve as an internal resource for application of the Policy as well as the liaison – as necessary – between the institution and the relevant federal funding agency. However, institutions may communicate with funding agencies through whichever internal mechanism is preferred and are encouraged to copy the ICDUR on those communications with funding agencies.

Institutions should consult with their federal funding agencies regarding how the annual assurance should be provided.

Federal funding agencies will implement the Policy based on their individual structure and program mechanisms. Institutions should consult with the funding agency regarding the timing for submission of required materials.

Notification that an application or proposal has passed scientific merit review does not guarantee it will be funded. Under the Policy, the funding agency and funding agency-level review entity (for Category 1 and Category 2 research) and the departmental-level review entity (for Category 2 research) must review and approve the risk-benefit assessments and risk mitigation plans, as well as address any disagreements prior to making funding decisions. Once all concerns have been addressed, the funding agency will notify the research institution and investigator whether it will fund the research identified as Category 1 or Category 2 research.