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Select Agent Awards

Lock icon: This link will not work for public visitors.Some links will work for NIAID staff only.

Standard Operating Procedure Table of Contents

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 in the NIAID Select Agents Award Explanatory Statement.

Procedure

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 at HHS and USDA Select Agents and Toxins. Also see if your agent is exempt or excluded at Select Agent Exclusions.

Find links for the regulations that govern select agent activities at National Select Agent Registry Regulations.

Use the Flowchart for NIAID Select Agent Research Awards (PowerPoint) in conjunction with this document. It contains two flow charts:

  • Page 1: Flowchart for NIAID Select Agent Research Awards
  • Page 2: Restricted Experiment Review Process for Non-US Awardees

Grant Applicants

  • Describe select agent use including restricted experiments in the Research Plan.

Offerors

  • Describe select agent use including restricted experiments in the technical proposal.

Grantees and Contractors

  • 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.
  • 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 regulations on National Select Agent Registry Regulations for details and information about restricted experiments.
  • Institution is responsible for its subcomponent's or subcontractor's compliance with the NIAID select agent policy.

Domestic Institutions

  • You must 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.
  • You are prohibited from using 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 the guidance on Restricted Experiments for details and information. When you get approval, notify your program officer.

Foreign Institutions

Program Staff

  • On the Program Officer Checklist, identify applications with foreign components and select agents, including excluded or exempt select agents. Find exempt or excluded select agents at Select Agent Exclusions.
    • Make sure the select agent radio buttons are present and completed on the Program Officer Checklist; otherwise the Grants Management Program will return it to you.
    • Specify the select agent term of award to be applied. Research involving excluded or exempt select agents does not need a select agent term of award.
  • If a non-U.S. awardee does not do so directly, notify the Office of Research Training and Special Programs (ORTSP) at niaidforeignawards@niaid.nih.gov of restricted experiments before award or after awardee notification.

Grants Management DMID Division Coordinator

  • Participate in Interagency Select Agent Review Group (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.
  • For more responsibilities, GMP staff can see GMP's Lock icon: This link will not work for public visitors.Select Agents SOP.

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 ORTSP director if select agent use is anticipated by either a prime or subcontractor. When this occurs during contract performance, notify ORTSP immediately.
    • Upon receipt of conflict of interest forms from ORTSP, provide copies of the award, original proposal, and final proposal revision to the ORTSP director.
    • Send the contractor a copy of Form 1 Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins.
    • Receive the completed Form 1 with the contractor's institutional policies and procedures for possession, use, or transfer of select agents and toxins. Forward the form and documents to ORTSP.
    • Ensure that foreign institutions, prime and subcontractors, using select agents follow the Select Agent Review and Approval Procedures 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.
    • After the DEA director's approval and receipt of memo from ORTSP, send notice of approval to the contractor using the Select Agent or Toxin Approval Letter for Contractors.
    • Send a copy to the ORTSP director.
    • Place copies of all documentation in the contract file.
    • If awardee does not do so directly, notify the Office of Research Training and Special Programs (ORTSP) at niaidforeignawards@niaid.nih.gov of restricted experiments before award or after awardee notification.

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 Research Training and Special Programs 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, grants, and contract staff informed of all communication with the grantee or contractor.
    • When planning to contact a subcomponent or subcontractor, inform the grantee or contractor first. After that, keep the grantee or contractor informed about any communication with a subcomponent or subcontractor.
  • For sites that require a laboratory review for biosafety, coordinate laboratory visits by NIAID site visit representatives.
  • Administer review panel for the NIAID ISARG. Present review results as ISARG's 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, and program officers in the program divisions about the DEA director's approval.
  • 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, DSAT representative 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 you.
    • DSAT representative's team performs a site visit unless the restricted experiment is not funded and is the only select agent research proposed.
    • Send ISATTAC's recommendation with a routing slip to the appropriate division director and program or contracts staff.
    • Inform awardee, program or contracts staff, and Grants Management Program or Office of Acquisitions whether restricted experiment is allowed or not.

Interagency Select Agent Review Group

  • Review laboratory visit 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 ORTSP director.

DEA Director

  • Receive ISARG's recommendation.
  • Decide to waive or retain a restriction on award funds.

Contacts

Grantees with questions should contact the grants management specialist or program officer listed in the eRA Commons. For more information, read Communicating With NIAID—How to Get Help.

See the Office of Acquisitions staff listing for the appropriate contract specialist.

ORTSP—Paula Strickland

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Lock icon: This link will not work for public visitors. Responding to Reports of Potential Incidents Involving Breaches of Biocontainment or Biosecurity SOP

Program Officer Checklist SOP

More information

If your research involves select agents, find more information in NIAID's Biodefense and Select Agents portal.

Last Updated September 09, 2013

Last Reviewed September 09, 2013