NIH, with the Southern Biosafety Association will be hosting the fourth in a series of public listening sessions to obtain stakeholder feedback on NIH’s effort to modernize and strengthen biosafety oversight.

Priority for providing oral comments at this meeting will be given to stakeholders located in: New Mexico, Texas, Oklahoma, Arkansas, Mississippi, and Louisiana.

NIH Videocast

https://videocast.nih.gov/

Draft Agenda

Listening Session 4 Draft Agenda

Meeting Flyer

Listening Session 4 Flyer

Introductory Slides

Listening Session 4 Slides

Public Comments

NIH and its partners encourage any interested individual to sign up to provide oral comments during the listening session.  All comments offered at the listening session are welcome and will be considered, including on topics covered at previous sessions. Feedback on the following topics is particularly encouraged.  

1. The utility of agent risk groups (RGs) as a starting point in determining appropriate containment for specific experiments
2. There are different levels of NIH or IBC oversight that could be required under a biosafety policy, which would be tiered based on the risk of the research. NIH is interested in hearing individual opinions regarding what levels of oversight should be required under the policy and what categories of research should fall under those levels based on risk and safety data. As a starting point, NIH is interested in hearing feedback on these potential options:  
   
   
   • NIH review and approval required before initiation  
     • Lowering containment for research involving wild type or genetically modified RG3 or RG4 agents (e.g., experiments with attenuated or replication defective constructs)  
     • Research involving emerging or zoonotic agents for which the RG classification or containment level in the BMBL is not available  
     • Other higher risk research  
   • IBC review and approval required before initiation, including potential expedited review  
     • Research involving RG2, 3, or 4 wild type agents  
     • Research involving genetically modified organisms, cells or viruses (e.g., certain vectors, replicons, gene editing, gene drives, transgenic animals)  
     • Research involving other biohazards (e.g., prions, toxins, other bioactive proteins, certain emerging technology products)  
     • Other  
   • IBC notification simultaneous with initiation  
     • Research involving RG1 or RG1 and RG2 wild type agents  
     • Research involving reporter constructs or other low risk expression vectors  
     • Research involving certain transgenic organisms 
     • Other  
   • No IBC oversight  
     • Research with RG1 wild type agents, or BL1 transgenic animals  
     • Research involving reporter constructs or other low risk expression vectors (e.g., RG1 or RG1/2 vectors/replicons with lower risk modifications)  
     • Other
       
       
3. Please discuss opportunities, including situations, if any, where expedited review (e.g., chair/less than full committee, BSO) would be appropriate and what types of research would fall into such a level. 

Registration

The listening session is open to the public and there is no cost to attend. Registration is required, using the form below, if you are planning to make an oral statement at the listening session.  Those planning to only view the listening session are kindly requested, but not required, to register below.