Research Rules & Policies

Select Agent Awards SOP

This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.

Purpose

To ensure that all grants, cooperative agreements, and contracts that possess, use, or transfer select agents comply with the NIAID select agent policy as described at Research Using Select Agents.

Procedure

Find links for the regulations that govern select agent activities at Federal Select Agent Program.

Use the NIAID Select Agent Research Awards Process in conjunction with this document. It walks you through the approval process for research using select agents, then describes the restricted experiment review process for non-U.S. awardees. Both domestic and foreign institutions using select agents or toxins are subject to the Select Agent Terms of Award for NIAID Grants or Select Agent Language for Solicitations and Contracts stating the recipient's or contractor's responsibility to comply with NIAID's select agent policy for the possession, use, or transfer of select agents.

Everyone involved with select agents or toxins must be familiar with the latest HHS and USDA Select Agents and Toxins list, which is updated continually. Some have been added and others removed, so checking the list is important for researchers in this area.

The institution assigns a responsible official to oversee and ensure compliance with regulations involving restricting access, security, biosafety, restricted experiments, incident response and notification, training, transfer, records, and penalties. Read the Guidance Documents on Federal Select Agent Program for details and information about restricted experiments.

The institution is also responsible for its subcomponent's or subcontractor's compliance with the NIAID select agent policy.

For every foreign laboratory, NIAID Office of Extramural Research Policy and Operations (OERPO) staff coordinate with CDC Division of Select Agents and Toxins (DSAT) partners to conduct select agent laboratory site reviews. OERPO convenes and leads the Interagency Select Agent Review Group (ISARG) review panels where the site visit reports are discussed.

Grant Applicants

  • See if you are working with a select agent or toxin. Use the up-to-date list of select agents, toxins, and overlap select agents and toxins list at HHS and USDA Select Agents and Toxins. Also see if your agent is exempt or excluded at Select Agents and Toxins Exclusions.
  • Describe select agent use including restricted experiments in the Research Plan. For details and information, refer to the Restricted Experiments Guidance.
  • In the Select Agents Research section of the application, describe in detail:
  • Select agent(s) to be used. 
  • Registration status of all relevant organizations where the select agent(s) will be used and indicate any foreign institutions. 
  • All facilities where the select agent(s) will be used including procedures to monitor possession, use and transfer of the select agents. 
  • Plans for appropriate biosafety, biocontainment, and security of the select agents.

Offerors

  • See if you are working with a select agent or toxin. Use the up-to-date list of select agents, toxins, and overlap select agents and toxins list at HHS and USDA Select Agents and Toxins. Also see if your agent is exempt or excluded at Select Agents and Toxins Exclusions.
  • Describe select agent use, including restricted experiments, in the technical proposal as directed in the Technical Evaluation Criteria.

Recipients and Contractors

Domestic Institutions

  • Register with the Centers for Disease Control and Prevention (CDC) of HHS or Animal and Plant Health Inspection Service (APHIS) of USDA, depending on the agent. Check the Federal Select Agent Program to learn more.
  • Do not use NIH funds for select agent work before registering and obtaining a certificate from the CDC or APHIS. If the grants management or contracting officer requests a copy of the registration, send it.
  • If a project involves restricted experiments with a select agent, contact CDC for approval before conducting the experiments and notify your program officer when you get approval. Read Restricted Experiments Guidance for details and information. 

Foreign Institutions

  • Provide information satisfactory to NIAID that safety, security, and training standards are comparable to those described in 42 CFR Part 73 (go to Federal Select Agent Program) for U.S. institutions.
  • Before conducting experiments with select agents or toxins, and every 3 years thereafter, all foreign institutions must take the following steps whether they are primary awardees, subcomponents, or subcontractors:

Program Staff

  • Before or immediately after award notification, notify OERPO’s policy officer of any grants or contracts in which non-U.S. institutions will be doing select agent research or restricted experiments with select agents. When this occurs during contract performance, notify OERPO immediately.
  • On the Program Officer Checklist, identify applications with foreign components and select agents or toxins, including excluded or exempt select agents. Find exempt or excluded select agents at Select Agents and Toxins Exclusions.
  • Make sure the select agent “Yes” radio button form control is present and selected correctly on the Program Officer Checklist; otherwise, the Grants Management Program (GMP) will return it to you. Note that for research involving excluded or exempt select agents, you do not need to select the “Yes” radio button for select agents.
  • Work with OERPO’s policy officer and your grants management specialist to apply select agent terms of award. Note that research involving excluded or exempt select agents does not need a select agent term of award.
  • Provide an overview of the planned foreign select agent research to DSAT partners before they conduct the site visit.
  • Upon receipt from OERPO, complete your conflict of interest forms. Return the forms to the OERPO policy officer in advance of the ISARG review meeting.
  • Participate in ISARG meetings.

Grants Management DMID Division Coordinator

  • Upon receipt from OERPO, complete your conflict of interest forms. Return the forms to the OERPO policy officer in advance of the ISARG review meeting.
  • Participate in ISARG meetings.

Grants Management Specialists

  • Place the appropriate select agent term as specified by program staff on relevant Notices of Award to ensure that the recipient is aware of NIAID's select agent policy.
  • Save the DEA Director funding approval letter and OERPO funding decision memo in the grants folder.

Contracts Staff

  • If a contract will involve select agents, include the Select Agent Language for Solicitations and Contracts in the solicitation and contract.
  • For domestic awards, do the following:
    • Notify contractors that they are prohibited from using NIH funds for select agent work if they are denied a registration certification.
    • Confirm that domestic contractors and subcontractors register and obtain a CDC or APHIS certificate of registration.
    • Receive the contractor's notification of CDC recommendations from the U.S. Federal Select Agent Program.
    • Monitor contractor's progress toward resolving CDC recommendations, when applicable, and ensure that the contractor is making progress toward a final approval from CDC.
  • For foreign awards or domestic awards with foreign components, do the following:
    • During negotiations or immediately after award as appropriate, notify the OERPO policy officer if select agent use is anticipated by either a prime or subcontractor. When this occurs during contract performance, notify OERPO immediately.
    • Email copies of the award, original proposal, and final proposal revision to the OERPO policy officer.
    • As needed, assist the OERPO policy officer with sending the contractor a copy of APHIS/CDC Form 1 Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins and NIAID Attachment A: Non-U.S. Institution’s Procedure for Personnel Security Risk Assessment.
    • Ensure that foreign institutions, prime and subcontractors, using select agents follow the Select Agent Review and Approval Procedure for New and Existing Contracts That Include Foreign Institutions.
    • Inform the contractor that all foreign laboratories are reviewed every 3 years or sooner after the initial review.
    • Upon receipt from OERPO, complete conflict of interest forms. Return the forms to the OERPO policy officer in advance of the ISARG review meeting. 
    • Participate in ISARG meetings.
    • After OERPO obtains the DEA Director's funding approval letter and sends its funding decision memo, send the funding decision memo to the contractor and all memo recipients.
    • Send confirmation that the contractor and the foreign institution received the funding decision memo to the OERPO policy officer.
    • Save the DEA Director funding approval letter and OERPO funding decision memo in the contract folder. 

Scientific Review Officers

  • Indicate the use of select agents in the Biohazard section header of the summary statement or, for contracts, the technical evaluation report. If a review committee raises issues about use of select agents, include these comments.
  • Note additional comments in the Scientific Review Officer's Administrative Notes section.

Office of Extramural Research Policy and Operations Staff

  • Track select agent awards.
  • Determine if the appropriate select agent term is applied. If the incorrect term is applied, discuss with the grants management specialist, contracting officer, and program staff.
  • Contact foreign awardees or awardees with foreign subcomponents or subcontractors for information required by NIAID's select agent policy and assist them through the entire process.
  • Keep NIAID’s program, grants management, and contract staff informed of all communication with the award recipient and/or foreign institution.
  • When planning to contact a foreign subcomponent or subcontractor, work with the domestic grant recipient or prime contractor. After that, keep the recipient or prime informed about any communication with a subcomponent or subcontractor.
  • For foreign sites that require a laboratory assessment, coordinate laboratory review with CDC DSAT.
  • Convene and run ISARG review meetings.
    • Provide conflict of interest forms as needed before the meeting.
    • ISARG discusses site visit reports and other information to provide a recommendation to the DEA Director on whether NIAID should approve or continue to approve the use of funds for the foreign select agent work.
  • Inform grant recipients, contractors, and the relevant NIAID staff (grants management, contract, or program) about the DEA Director's funding approval letter and OERPO funding decision memo.
  • If notified of restricted experiments, send a letter to awardee requesting additional information.
  • Forward an awardee's response to program or contracts staff and CDC DSAT.
    • After review, CDC DSAT will request additional information from either you or the awardee and present final information to the Interagency Select Agent and Toxin Technical Advisory Committee (ISATTAC) for review.
    • ISATTAC reviews proposed restricted experiment and makes a recommendation to the CDC DSAT representative, who relays ISATTAC's recommendation to OERPO.
    • CDC DSAT performs a site visit of the laboratory.
  • Send ISATTAC's recommendation to the appropriate NIAID division director and program or contracts staff.
  • Inform the awardee about whether the restricted experiment is allowed or not.

Interagency Select Agent Review Group Members

  • Upon receipt from OERPO, complete any necessary conflict of interest forms. Return the forms to the OERPO policy officer in advance of the ISARG review meeting. 
  • Attend the ISARG meeting.
  • Assess laboratory review reports and the foreign institution's policies on select agent safety and security. Assess whether they are comparable to 42 CFR Part 73.
  • Recommend whether NIAID should approve the use or continued use of funds for select agent work.
  • Complete the ISARG meeting forms from OERPO. Return the forms to the OERPO policy officer after the ISARG meeting.

DEA Director

  • Participate in the ISARG meeting.
  • Sign the DEA Director funding approval letter that OERPO develops based upon the ISARG recommendations. 

Contacts

OERPO—DEAPolicyShop@niaid.nih.gov

Contact for NIAID Staff—DEA Director

Grant recipients with questions should contact the grants management specialist or program officer listed in the eRA Commons. For more information, read Contacting Program Officers and Grants Management Specialists.

Offerors and contractors should see the Office of Acquisitions Contacts for the appropriate contract specialist.

Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.

Links

If your research involves select agents, find more information on NIAID's Research Using Select Agents.

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