See the Glossary for more terms.
For more on this topic, see the Biodefense and Select Agents section of NIAID Research Funding.
Contracting officer's representatives 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.
During negotiations, the contracting officer will request the following information for the foreign institution:
When selected for award, the contracting officer provides the contract number, organization name, and address to OIEA in DEA along with, if available, information obtained during negotiations. (Items 1 through 3 from above.)
OIEA requests that completed Form 1 be submitted for the foreign institution. Because the form will not be used to register with CDC's Select Agent Program, send completed forms to NIAID, not to CDC or APHIS as indicated in the instructions. Information provided on Form 1 will be reviewed during the laboratory inspection. Every foreign laboratory will be inspected.
For every foreign laboratory, ORTSP coordinates select agency laboratory site visits 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, submit information about any laws, regulations, and policies for possession, use, and transfer of select agents applicable to the foreign institution, if needed.
The ISARG reviews laboratory site visit reports, foreign institutional policies, and institutional certification and makes a recommendation to NIAID. ISARG members are federal employees with experience in select agent research or policies.
The DEA director decides whether to approve or not and notifies the contracting officer of that decision.
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 approved by the DEA director.
If your research involves select agents, find more information in NIAID's Biodefense and Biosecurity portal.
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Last Updated May 13, 2015
Last Reviewed July 28, 2015