Grant: NIAID recommended for funding Contract: Offeror in competitive range

1. Flowchart for NIAID Select Agent Research Awards Grant: NIAID recommended for funding Contract: Offeror in competitive range Updated November 23, 2012 For a text description of this flowchart, see the related SOP: Select Agent Awards. No need for Select Agent Terms of Award for NIAID Grants or Select Agent Language for Solicitations and Contracts. End. Program officer:Does research involve select agents? No Yes Award needs Select Agent Terms of Award for NIAID Grants or Select Agent Language for Solicitations and Contracts. Foreign – For select agents research with restricted experiments, even those previously approved, also see the next slide. No Yes Any foreign involvement? U.S.-Only Institution Foreign Institution or U.S. Institution With Foreign Component NIAID applies Select Agent Terms of Award for NIAID Grants or Select Agent Language for Solicitations and Contracts. PI and institution’s responsible official (RO) apply for CDC registration. NIAID requests information, including foreign policies and regulations. NIAID applies Select Agent Terms of Award for NIAID Grants orSelect Agent Language for Solicitations and Contracts. PI and institution’s responsible official (RO) respond. For restricted experiments, even those previously approved, also see the next slide. PI and institution’s responsible official follow U.S. regulations 42 CFR 73 including requirements for restricted experiment with a select agent. NIAID coordinates with CDC to visit foreign laboratory and revisit every three years while the award is active. PI and institution’s responsible official must register with CDC before using funds for select agent research. ISARG* reviews visit report, policies, and makes recommendations to NIAID. * ISARG – Interagency Select Agent Review Group; government employees with various experience in select agents research or policies. NIAID DEA director approves use of funds for select agent research. PI may use funds for select agent research.

2. Restricted Experiment Review Process for Non-U.S. Awardees PO or COR informs NIAID’s Office of Research Training and Special Programsofrestricted experiments prior to award or after awardee notification. Awardee directly informs NIAID’s Office of Research Training and Special Programs. ORTSP confirms that the PO or COR is aware of the restricted experiments. OR ORTSP sends a letter to the awardee requesting additional information about the restricted experiment. For a text description of this flowchart, see the related SOP: Select Agent Awards. For acronyms, see below. ORTSP forwards the awardee’s response to NIAID’s DSAT representative and PO or COR. DSAT representative reviews the response and requests additional information from the awardee or ORTSP as needed. DSAT representative presents final information to ISATTAC for review. ISATTAC reviews the proposed restricted experiment and makes a recommendation to NIAID’s DSAT representative. DSAT representative relays the ISATTAC recommendation to NIAID ORTSP. ORTSP sends ISATTAC’s recommendation with a routing slip to the NIAID division director and the PO or COR. DSAT representative’s team performs a foreign site visit unless the restricted experiment is not funded and is the only select agent research proposed. End. Did ISATTAChave concerns? Yes No Acronyms COR: Contracting Officer's Representative DSAT: CDC Division of Select Agents and Toxins ISATTAC: Interagency Select Agent and Toxin Technical Advisory Committee ORTSP: Office of Research Training and Special Programs, DEA PO: NIAID Program Officer Restricted experiment is not allowed. Restricted experiment is allowed. ORTSP informs awardee, PO or COR, and the grants management specialist or contracting officer.