This page provides the NIH awards process for research involving infectious agents and select agents, including submissions, awards, monitoring and oversight. This page also clarifies the processes and responsibilities for investigations of laboratory accidents, research-related illnesses and potential Biosafety violations.

The role of the Inter-Agency Task Force on Select Agents:

• Delineate the process for NIH grants for research with infectious/select agents (SA), including:
• Submission
• Award
• Monitoring
• Oversight
• Clarify the process for investigations of:
• Laboratory Accidents
• Research-related illness
• Potential Biosafety violations
• Determine if changes in NIH policies and procedures need to be made

Task Force Member Contact List, December 2, 2005 (MS Word - 42 KB)

• HR 3448: Public Health Security and Bioterrorism Preparedness and Response Act, January 23, 2002 (PDF - 971 KB)
• USA Patriot Act of 2001, October 26, 2001 (PDF - 908 KB)
• Code of Federal Regulations:
  

  7 CFR Part 331 and 9 CFR Part 121	USDA Possession Use and Transfer of Select Agents and Toxins	PDF - 33 KB
  29 CFR Part 1910-1030	Bloodborne Pathogens	HTML PDF - 808 KB
  29 CFR Part 1910-1450	Occupational Exposure to Hazardous Chemicals in Laboratories	HTML PDF - 516 KB
  42 CFR Part 72	Additional Requirements for Facilities Transferring or Receiving Select Agents	PDF - 200 KB
  42 CFR Part 73 and 42 CFR Part 1003	HHS Possession Use and Transfer of Select Agents and Toxins	PDF - 255 KB
  49 CFR Part 171	DOT Hazardous Materials – Revision to Standards for Infectious Substances	PDF - 231 KB
  49 CFR Part 171.15	Immediate Notice of Certain Hazardous Materials Incidents	PDF - 78 KB

• U.S. Code:
  

  18 USC Part 175	Prohibitions with respect to Biological Weapons	HTML
  18 USC Part 175a	Requests for Military Assistance to Enforce Prohibition in Certain Emergencies	HTML
  18 USC Part 175b	Possession by Restricted Persons	HTML
  18 USC Part 2332a	Use of Weapons of Mass Destruction	HTML
  42 USC Part 262a	Enhanced Control of Dangerous Biological Agents and Toxins	HTML
  42 USC Part 4321-4347	National Environmental Policy Act	HTML

  
  
• CDC Select Agent List (PDF - 57 KB)
• NIH Grants Policy Statement: Select Agent Requirements, December 2003 (HTML) or (PDF - 99 KB)

• Interim CDC-NIH Recommendation for Raising the Biosafety Level for Laboratory Work Involving Noncontemporary Human Influenza Viruses
• NIH Guidelines for Research Involving Recombinant DNA Molecules (PDF - 1.16 MB)
• Select Agent Language for NIAID Contracts and RFPs
• NIAID: Select Agent Research Review & Approval Procedure for Grants that include Foreign Institutions
• NIAID: Select Agent Review & Approval Procedure for Contracts that include Foreign Institutions
• Select Agent Terms of Award for NIAID Grants

• Submission, Review and Monitoring of NIH-Funded Awards Involving Research with Infectious Agents or Select Agents, March 31, 2005 (MS Word - 36 KB)
• Oversight and Regulatory Authorities for NIH-Funded Awards Involving Research with Infectious Agents or Select Agents, March 31, 2005 (MS Word - 34 KB)
• Responsibilities of Organizations/Agencies for Monitoring and Oversight of NIH-Funded Research with Select Agents (MS Word - 34 KB)

• Processes for Investigations of Accidents, Research-related Illnesses and Potential Biosafety Violations Involving Infectious or Select Agents (MS Word - 32 KB)

• CDC: http://www.cdc.gov/od/sap/index.htm
• USDA: http://www.aphis.usda.gov/programs/ag_selectagent/index.html

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