An official website of the United States government
Scope Note
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.
Laws and Policies
- HR 3448: Public Health Security and Bioterrorism Preparedness and Response Act, January 23, 2002 (971 KB)
- USA Patriot Act of 2001, October 26, 2001 (908 KB)
Code of Federal Regulations
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7 CFR Part 331 and 9 CFR Part 121
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USDA Possession Use and Transfer of Select Agents and Toxins
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PDF - 333 KB
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| 29 CFR Part 1910-1030 | Bloodborne Pathogens | HTML - 808 KB |
| 29 CFR Part 1910-1450 | Occupational Exposure to Hazardous Chemicals in Laboratories |
HTML |
| 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 | HTML |
| 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 |
- HHS Select Agents and Toxins Page (including the list of select agents and toxins and information about additions or deletions to the list)
- NIH Grants Policy Statement: Select Agent Requirements
Monitoring and Oversight for NIH Awards
- 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)
Investigations
- Processes for Investigations of Accidents, Research-related Illnesses and Potential Biosafety Violations Involving Infectious or Select Agents (MS Word - 32 KB)