Select Agent Review and Approval Procedure for New and Existing Contracts That Include Foreign Institutions

For more on this topic, see the Biodefense and Select Agents section of NIAID Research Funding.

Preparing the Acquisition Plan and RFP

• Project officers identify projects that will involve select agents in acquisition plans.
• All RFPs will contain information for offerors about select agent regulations and state the evaluation process for foreign primes and foreign subcontracts. See Select Agent Language for NIAID Contracts and RFPs for more information.

Institute review

• During negotiations, the contracting officer will request the following information for the foreign institution:

1. An acknowledgement to complete Form 1 Application for Laboratory Registration from APHIS and CDC Forms within 30 days after request from the Office of International Extramural Activities (OIEA), in the Division of Extramural Activities (DEA).
2. Information about policies for possession, use, and/or transfer of select agents, and assurance from the institutional responsible official that a process (comparable to that described in 42 CFR 73, 7 CFR 331, and/or 9 CFR 121 for US institutions) is in place and will be administered on behalf of all select agent work sponsored by NIH funds.
• Institutions that currently do not have a policy equivalent to 42 CFR 73 must provide information delineating any laws, regulations, policies, and procedures applicable to the institution for the safe and secure possession, use, and/or transfer of select agents. If needed, an NIAID contractor can assist in gathering and submitting information.
3. Certification by the institutional responsible official and the alternate responsible official that facilities meet their institution's requirements to work safely with select agent(s), that only authorized personnel have access to select agents, and the institution keeps records of select agents transferred to and from their facilities.

• When selected for award, the contracting officer will provide the contract number, organization name, and address to OIEA in DEA along with, if available, the information obtained during negotiations. (Items a-c from above.)
• OIEA requests the completed Form 1 Application for Laboratory Registration from APHIS and CDC Forms be submitted for the foreign institution. Because the form will not be used for registration with CDC Select Agent Program, completed forms must be sent to NIAID, not to CDC or USDA as indicated in the application form instruction. Information provided on Form 1 will be reviewed during the laboratory inspection. Every foreign laboratory will be inspected.
• OIEA coordinates foreign laboratory inspections by CDC or USDA and provides reports for review by the Interagency Select Agent Review Group (ISARG).
• For institutions without a process similar to that described in 42 CFR 73, if needed, an NIAID contractor can assist in gathering and submitting information about any laws, regulations, and policies for possession, use, and transfer of select agents applicable to the foreign institution.
• The ISARG reviews laboratory inspection reports, foreign institution policies, institutional certification, and NIAID contractor data, and then recommends to DEA director whether approval will be granted.
• The DEA director will make final determination and notify the contracting officer whether approval is granted.

Potential outcomes of NIAID review

• No restrictions on the contract. ISARG completes its review before award, and the DEA director approves the release of funds for select agent research at foreign institutions.
• Restriction on the contract. ISARG is unable to complete its review before award. The contract contains language restricting the use of NIH funds for research involving select agents until the ISARG review is complete and approval is granted by the DEA director.

More information

If your research involves select agents, see our biodefense information, including our Flowchart for Select Agent Awards. If your research involves human subjects, read our human subjects information.

Return to the main R&D Contracts Web page.