Biodefense and Select Agents

If you are proposing or conducting research on select agents or highly pathogenic agents, follow the steps on this portal to learn how to comply with federal law and NIH policy and process requirements.

Action Items

1. Learn About Federalwide Select Agent Policies

• Federal Select Agent Program
  • Select Agents and Toxins
    • Select Agents and Toxins List
    • Select Agent and Toxins Exclusions list
  • Federal Select Agents Regulations
    • 42 CFR 73—HHS
    • 7 CFR 331—USDA
    • 9 CFR 121—USDA
• Public Health Security and Bioterrorism Preparedness and Response Act of 2002
• USA Patriot Act

2. Read NIAID Information on Select Agents

• Grants
  • Research Using Select Agents
  • Select Agent Awards SOP
  • Select Agent Terms of Award for NIAID Grants
  • Select Agent Research Review and Approval Procedure for Grants That Include Foreign Institutions
• Contracts
  • Research Using Select Agents
  • Select Agent Awards SOP
  • Select Agent Language for Solicitations and Contracts
  • Select Agent Research Review and Approval Procedure for New and Existing Contracts That Include Foreign Institutions
• NIAID Select Agent Research Awards Process
• NIAID Biodefense and Related Programs
  • Biodefense and Emerging Infectious Diseases
    • Biosafety Labs
    • Biocontainment Research Facilities
  • Radiation and Nuclear Countermeasures Program
  • Chemical Countermeasures Research Program

Reference Reading at NIAID

• NIAID Emerging Infectious Diseases/Pathogens
• Stay Informed About Policy Changes and News. Subscribe for news and alerts from NIAID and NIH.
• Research Rules & Policies

Links Beyond NIAID

• Find policy portals at NIH and CDC.
  • NIH Office of Science Policy
    • Biosafety and Biosecurity Policy
  • CDC Biosafety in Microbiological and Biomedical Laboratories
  • Federal Select Agent Program
• SF 424 Application Guide
• Find other useful links beyond NIH.
  • American Biological Safety Association
  • Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA

Questions? 

• For questions about NIAID's select agent policy, see the Contacts section of the Select Agent Awards SOP.
• For science questions, talk to a program officer. See Contacting Program Officers and Grants Management Specialists.
• For public inquiries, go to Office of Biodefense Research and Surety (OBRS) - Contacts.