Select Agent Review and Approval Procedure for New and Existing Contracts That Include Foreign Institutions
Preparing the Acquisition Plan and Solicitation
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.
During negotiations, the contracting officer will request the following information for the foreign institution:
- 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 Research Training and Special Programs (ORTSP), in the Division of Extramural Activities (DEA).
- Information about policies for possession and use of select agents, and assurance from the institutional responsible official that a process comparable to that described in Federal Select Agent Program 42 CFR 73, 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 do not have a policy equivalent to 42 CFR 73 must provide information on any laws, regulations, policies, and procedures applicable to the institution for the safe and secure possession and use of select agents.
- Certification by the institutional business official and alternate responsible official that facilities meet their institution's requirements to work safely with select agents, only authorized personnel have access to select agents, and the institution keeps records of select agents transferred to and from its facilities.
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 the Centers for Disease Control and Prevention (CDC) Select Agent Program, send completed forms to NIAID, not to CDC or the Animal and Plant Health Inspection Service (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, the 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.
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 approved by the DEA director.