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

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

Preparing the Acquisition Plan and Solicitation

• Project officers identify projects that will involve select agents in acquisition plans.
• All solicitations 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 Solicitations and Contracts 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 for Possession, Use, and Transfer of Select Agents and Toxins within 30 days after a 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 and 7 CFR 331 and 9 CFR 121 for U.S. 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 business official and alternate responsible official that facilities meet their institution's requirements to work safely with select agents, 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 that the completed Form 1 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 APHIS as indicated in the 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 APHIS 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 institutional policies, and institutional certification and then recommends to DEA director whether approval will be granted. ISARG members are federal employees with experience in select agent research or policies.
• The DEA director will make a 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, find more information in NIAID's Biodefense and Biosecurity portal.

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