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 grantee'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 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.
  • 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.

Grantees 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.
  • Do not use NIH funds for select agent work before registering and obtaining a certificate from the CDC or APHIS. If the grants 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 three years thereafter, all foreign institutions that are primary awardees, subcomponents, or subcontractors must:

Program Staff

  • Before or immediately after award notification as appropriate, 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.
  • Upon receipt from OERPO, complete conflict of interest forms. Return the forms to the OERPO policy officer in advance of the Interagency Select Agent Review Group (ISARG) review meeting.
  • Participate in ISARG meetings.

Grants Management DMID Division Coordinator

  • Upon receipt from OERPO, complete conflict of interest forms. Return the forms to the OERPO policy officer in advance of the Interagency Select Agent Review Group (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 grantee is aware of NIAID's select agent policy.
  • Save the OERPO memo of DEA director approval letter 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. 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.
    • Send 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.
    • Receive the completed Form 1 and Attachment A. Forward these documents to the OERPO policy officer.
    • 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 three years after the initial review.
    • Attend the meeting of the Interagency Select Agents Review Group (ISARG).
    • After the DEA director's approval and receipt of memo from OERPO, send notice of approval to the contractor using the Select Agent or Toxin Approval Letter for Contractors.
    • Send confirmation that the contractor received the approval memo to the OERPO policy officer.
    • Place copies of all documentation in the contract file.

Scientific Review Officers

  • Indicate the use of select agents in the Biohazard section header of your 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

  • Keep track of select agent awards.
  • Determine if appropriate select agent term is applied. If incorrect, discuss with the grants management specialist and program officer.
  • 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 program and grants staff informed of all communication with the grantee. Work with contracts staff to communicate with contractors.
  • When planning to contact a foreign subcomponent or subcontractor, work with the domestic grantee or prime contractor. After that, keep the grantee or prime informed about any communication with a subcomponent or subcontractor.
  • For sites that require a laboratory assessment for biosafety, coordinate laboratory reviews by NIAID CDC Division of Select Agents and Toxins (DSAT) representatives.
  • Convene and run ISARG review panels. The panels discuss site visit reports, leading to a recommendation to the DEA director for approval on waiving the restriction on using funds for select agent work.
  • Inform grantees, contractors, and NIAID staff in GMP, Office of Acquisitions (OA), and program officers about the DEA director's decision memo.
  • If notified of restricted experiments, send a letter to awardee requesting additional information.
    • Forward awardee's response to program or contracts staff and NIAID's representative on CDC's Division of Select Agents and Toxins (DSAT).
    • After review, NIAID's DSAT partner 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 NIAID's DSAT representative, who relays ISATTAC's recommendation to OERPO.
    • DSAT representative's team performs a site visit of the laboratory and sends OERPO the ISATTAC's recommendation.
    • OERPO sends ISATTAC's recommendation to the appropriate division director and program or contracts staff.
    • OERPO will inform awardee, program or contracts staff, and GMP or OA whether the restricted experiment is allowed or not.

Interagency Select Agent Review Group Members

  • Upon receipt from OERPO, complete conflict of interest forms. Return the forms to the OERPO policy officer in advance of the Interagency Select Agent Review Group (ISARG) review meeting. 
  • Attend the meeting of the Interagency Select Agents Review Group (ISARG).
  • 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 to retain or waive award restrictions that include select agents.
  • Send recommendation to the DEA director.

DEA Director

  • Receive ISARG's recommendation.
  • Sign the decision memo based upon the recommendation to either allow or restrict the award funds and return to OERPO. 

Contacts

OERPO—DEAPolicyShop@niaid.nih.gov

Grantees 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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