Division Title
Safety

Select Agent Program

Select one of the links below for more information:

About the Select Agent Program

What is a Select Agent?

How Do I Enroll in the Select Agent Program?

How Do I Remove Myself or Another Individual from the Select Agent Program?

How Do I Inform The Select Agent Program of a Name Change?

Select Agent Program Training 

pdf documentAnnual Notice: Possession of Select Agents

About the Select Agent Program

The Select Agent Program (SAP) at the NIH manages a range of functions to facilitate research with select agents.  It registers participants in the SAP and provides initial and annual SAP training as well as any additional training needed related to a specific agent/toxin or biohazard level.  The program maintains the records necessary for Centers for Disease Control and Prevention (CDC) Registration.  SAP coordinates the receipt of select agents, movement between NIH laboratories as well as shipping these highly regulated substances.  In addition, the NIH SAP performs a variety of regulatory functions to remain in compliance with federal select agent regulations.  The NIH must comply with the regulations and requirements of 42 CFR Part 73 External Website, 7 CFR Part 331 External Website and 9 CFR Part 121 External Website

 

Anyone planning to work with select agents/toxins must enroll in the SAP and receive approval prior to the possession, use and transfer of select agents/toxins.  If you require unescorted access to areas containing select agents or areas associated with the biocontainment of select agents, you must enroll in the SAP.

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What is a Select Agent? 

Biological agents and toxins that the Federal Select Agent Program (HHS and USDA) has determined to pose a severe threat to both human and animal health, to plant health, or to animal and plant products are known as Select Agents/Toxins. Any microorganism or toxin capable of harming living organisms or the environment, regardless of its origin (naturally occurring, engineered or synthesized) can be classified as a select agent.  For further information, refer to 42 CFR Part 73 External Website7 CFR Part 331 External Website, and 9 CFR Part 21 External Website or the Annual Select Agent Notice External Website.     

 

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How Do I Enroll in the Select Agent Program?

To begin the enrollment process, the Principal Investigator or Supervisor must email a completed Enrollment Request Form Download Free Adobe Acrobat Reader. to the NIH Select Agent Program (SAP).  The form may be filled out electronically and e-signed. Additional requirements must be met before an individual is fully enrolled in the SAP and is granted access to registered spaces.  A Select Agent Program staff member will contact the enrollee (or Supervisor for enrollees without an email) with further instructions to complete the FD-961 Form and to sign-up for training.  NOTE: Submit your enrollment form using either encrypted email or the NIH Secure Email and File Transfer (SEFT)External Website service.

 

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How Can I Remove Myself or Another Individual from the Select Agent Program?

To begin the removal process, the Principal Investigator or Supervisor must complete the Removal Request Form Download Free Adobe Acrobat Reader. and email it to the Select Agent Program (SAP).  The form may be filled out electronically and e-signed. Additional requirements must be met before an individual is fully removed from the program.  A Select Agent Program staff member will contact the Principal Investigator, Supervisor and/or the individual with further instructions.  NOTE: Submit your removal request form using either encrypted email or the NIH Secure Email and File Transfer (SEFT)External Website  service.

 

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How Do I Inform the Select Agent Program of a Name Change?

The Select Agent Program must be informed of any name changes as soon as it occurs. This will assist the program in updating the participant’s records with the Federal Select Agent Program immediately. The individual must complete the Name Change Form Download Free Adobe Acrobat Reader.and email it to the SAP.  The form may be filled out electronically and e-signed. A Select Agent Program staff member will contact the individual if additional information is required.  NOTE: Submit your name change request using either encrypted email or the NIH Secure Email and File Transfer (SEFT)External Website  service.


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Select Agent Program Training

The Select Agent Program (SAP) provides initial and annual training as well as any additional training related to a specific agent/toxin or biohazard level.  To find out how to register for SAP training, email the Select Agent Program. When an enrollment request is submitted, new enrollees or their Supervisors will be contacted by the SAP with further instructions to register for training.