Select Agent Awards

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

Select agents, toxins, and overlap select agents and toxins are identified in the Federal Register:

• HHS and USDA Select Agents and Toxins List
• Possession, Use, and Transfer of Select Agents and Toxins; Final Rule, 42 CFR Part 73.3 Section 73.3 and 73.4. For the entire rule in one file, visit 42 CFR Parts 72 and 73 (PDF).
• Agricultural Bioterrorism Protecton Act of 2002; Possession, Use, and Transfer of Select Agents and Toxins; Final Rule, 7 CFR Part 331.3 or 9 CFR Part 121.3 and 121.4.

Grant Applicants

• Describe select agent use in the research plan. See Will Your Research Have Special Requirements? in the NIH Grant Cycle: Application to Renewal.
• Note if the agent is exempt or excluded. See the following lists:
  • CDC-excluded select agents
  • APHIS-excluded select agents
  • HHS-exempt or -excluded select agents in Section 73.3(d), 73.4(d), and 73.5
  • USDA-exempt or -excluded select agents and toxins in 7 CFR Part 331 Section 331.3(d) and 331.5 and 9 CFR Part 121 Section 121.3(d), 121.4(d), and 121.5

Offerors

• Describe select agent use in the technical proposal.

Grantees and Contractors

• Both domestic and foreign institutions using select agents or toxins are subject to a Select Agent Terms of Award for NIAID Grants or Select Agent Language for NIAID Contracts and RFPs stating the grantee's or contractor's responsibility to comply with NIAID's select agent policy for the possession, use, and/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. The list is updated periodically. For example, some forms of the 1918 influenza virus are now classified as select agents.
• Assign a responsible official to control and ensure compliance with regulations involving restricting access, security, biosafety, restricted experiments, incident response, training, transfer, records, notification of incidents, and penalties.

Domestic Institutions

• All domestic institutions must register with either CDC or APHIS if planning to use select agents, toxins, or overlap select agents or toxins.
• You are prohibited from using NIH funds for select agent work before registering with the CDC or APHIS. If the grants or contracting officer requests a copy of the registration, send it.

Foreign Institutions

• Foreign institutions must provide information satisfactory to NIAID that safety, security, and training standards comparable to those described in 42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121 are in place.
• All foreign institutions that are either primary awardees, subcomponents, or subcontractors must:
  • Provide information required by the NIAID select agent policy for foreign institutions.
  • Have an NIAID representative inspect laboratories where NIAID-funded research involves select agents.
    • An authorized NIH-chaired Federal Employees committee will review the inspection reports, institutional policies, and other submitted information.
    • The results will be presented to the DEA director for review and approval.
    • You are prohibited from using NIH funds for select agent work if the approval is denied.
    • For details, see the following:
      • Select Agent Research Review and Approval for Procedure for New and Continuing Grants That Include Foreign Institutions
      • Select Agent Review and Approval Procedures for New and Existing Contracts That Include Foreign Institutions
      • NIAID Select Agent Policy for Foreign Institutions questions and answers

Program Staff

• On the program officer checklist, identify applications with foreign components and select agents, including excluded or exempt select agents. See the following lists of excluded or exempt select agents:
  • CDC-excluded select agents
  • APHIS-excluded select agents
  • HHS-exempt or -excluded select agents in Section 73.3(d), 73.4(d), and 73.5
  • USDA-exempt or -excluded select agents and toxins in 7 CFR Part 331 Section 331.3(d) and 331.5 and 9 CFR Part 121 Section 121.3(d), 121.4(d), and 121.5
• Make sure the select agent radio buttons are present and completed on the program officer checklist; otherwise GMP will return it to you.
• Specify the Select Agents Terms of Award to be applied. Research involving excluded or exempt select agents does not need Select Agents Terms of Award.

Grants Management DMID Division Coordinator

• Participate in Interagency Select Agent Review Group (ISARG) meetings.

Grants Specialist

• Place the appropriate select agent term as specified by program staff on relevant Notice of Awards to ensure that the grantee is aware of NIAID's select agents policy.
• For more responsibilities, see GMP's Select Agents SOP.

Contracts Staff

• If a contract will involve select agents, include the Select Agent Language for NIAID Contracts and RFPs in the RFP and contract.
• For domestic awards, contracts staff should:
  • 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, contracts staff should:
  • During negotiations or immediately after award as appropriate, notify the OIEA select agent coordinator if select agent use is anticipated by either a prime or subcontractor. When this occurs during contract performance, notify OIEA immediately.
  • Upon receipt of conflict of interest forms from OIEA, provide copies of the award, original proposal, and final proposal revision to the OIEA select agent coordinator.
  • If information is not in the proposal, send the contractor a copy of APHIS/CDC 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, and/or transfer of select agents and toxins. Forward the form and documents to OIEA.
  • 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.
  • Attend the meeting of the Interagency Select Agents Review Group.
  • After the DEA director's approval and receipt of memo from OIEA, send notice of approval to the contractor using the Select Agent Approval Letter to Contractor Template.
  • Send a copy of the Select Agent Approval Letter to Contactor Template to the OIEA select agent coordinator.
  • 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 International Extramural Activities 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.
• For sites that require inspection, coordinate site visits by the NIAID inspection representatives.
• Administer review panel for the NIAID ISARG. Present review results to the DEA director for approval on waiving the restriction on using funds for select agent work.
• Update the incidence report spreadsheet with instances of contamination or a grantee failing to meet safety standards.

Interagency Select Agent Review Group

• Recommend to retain or waive award restrictions that include select agents.
• Send recommendation to the DEA director.

DEA Director

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

Contacts

OIEA director -- Paula Strickland, pstricklan@niaid.nih.gov, 301-435-8563

OIEA select agent coordinator -- Arunsri Brown, acbrown@niaid.nih.gov, 301-451-2614

Grantees with questions should contact the appropriate program officer or grants management specialist listed on their Notice of Award. For more information, see Contact Staff for Help.

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

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

Responding to Reports of Potential Incidents Involving Breaches of Biocontainment or Biosecurity SOP

Biosafety in Microbiological and Biomedical Laboratories

CDC Select Agent Program Web site

Flowchart and Procedures for NIAID Select Agent Research Awards (PowerPoint)

Program Officer Checklist SOP

USDA Web site

Will Your Research Have Special Requirements? in the NIH Grant Cycle: Application to Renewal