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

2. 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. 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 ORTSP sends ISATTAC’s recommendation with a routing slip to the NIAID division director and the PO or COR. Restricted Experiment Review Process for Non-U.S. Awardees PO or COR informs NIAID’s Office of Research Training and Special Programsof restricted experiments prior to award or after awardee notification.Office of Research Training and Special Programs PO or COR informs NIAID’s Office of Research Training and Special Programsof restricted experiments prior to award or after awardee notification.Office of Research Training and Special Programs 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.Office of Research Training and Special Programs 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.Office of Research Training and Special Programs 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. Select Agent Awards For acronyms, see below. ISATTAC reviews the proposed restricted experiment and makes a recommendation to NIAID’s DSAT representative. 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. DSAT representative relays the ISATTAC recommendation to NIAID ORTSP. Did ISATTAC have concerns? NoYes Restricted experiment is not allowed. Restricted experiment is allowed. ORTSP informs awardee, PO or COR, and the grants management specialist or contracting officer. ORTSP forwards the awardee’s response to NIAID’s DSAT representative and PO or COR.