NIH, with the Southeastern Biological Safety Association and the Carolinas Biological Safety Association, will be hosting the second in a series of public listening sessions to obtain stakeholder feedback on NIH’s effort to modernize and strengthen biosafety oversight.

Priority for this meeting will be given to stakeholders located in: Virginia, Kentucky, Tennessee, North Carolina, South Carolina, Georgia, Florida, Alabama, and Missouri, and Puerto Rico.

NIH Videocast

https://videocast.nih.gov/

Draft Agenda

Listening Session 2 Draft Agenda

Meeting Flyer

Listening Session 2 Flyer

Introductory Slides

Coming Soon

Public Comments

NIH encourages 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, and feedback on the following topics is particularly encouraged.

1. NIH is interested in hearing individual opinions regarding an appropriate scope for its biosafety policy. NIH is interested in hearing feedback on biomedical biohazards that may require oversight action due to higher potential risks:
   • Options for Wild type agents that could require institutional and/or NIH oversight:
     • All microbes that cause disease or are infectious in humans
     • RG2, 3 and 4 agents
     • RG3 and 4 agents
     • Other
   • Options for other biological agents/substances with higher biorisks that could require institutional and/or NIH oversight
     • Proteins that may be included
       • Prions
       • Toxins
       • Factors that influence immunity or expression
   •   Any other biohazardous research that may require institutional and/or NIH oversight

NIH welcomes individuals to offer additional options for the scope of the policy, as well.

2. NIH is equally interested in hearing individual opinions on the types of research that may require less local or NIH oversight based on accrued safety data or due to oversight by other federal authorities.  Examples of this type of research may include:
   • Non-biomedical research with plants, agricultural animals, or certain microbes under the purview of other federal agencies such as USDA or EPA
   • Clinical research under the purview of the FDA
   • Other research that, based on accrued safety data, may be lower risk (e.g., RG1 agents, some transgenic organisms, some expression plasmids or toxins)

NIH welcomes individuals to offer additional examples of research that may require less oversight, as well.

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.