Strengthening and Modernizing Biosafety Oversight: Region 2 Listening Session

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/watch=57156

Draft Agenda

Listening Session 2 Draft Agenda

Meeting Flyer

Listening Session 2 Flyer

Introductory Slides

Listening Session 2 Slides

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.

  1. 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


Registration for this event is now closed

Strengthening and Modernizing Biosafety Oversight: Region 1 Listening Session

NIH, in partnership with the New England Biological Safety Association, the Northeast Biological Safety Association, the Mid-Atlantic Biological Safety Association and the Chesapeake Area Biological Safety Association, will be holding the first 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: ME, NH, VT, MA, CT, RI, NY, PA, NJ, DE, WV, MD, and Washington DC.

NIH Videocast

https://videocast.nih.gov/watch=57067

Agenda

Listening Session 1 Draft Agenda

Meeting Flyer

Listening Session 1 Flyer

Introductory Slides

Introduction and Context 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, and feedback on the following topics are particularly encouraged.

  1. NIH is interested in hearing individual opinions regarding an appropriate scope for its biosafety policy. As a starting point, NIH is interested in hearing feedback on these potential options:
  • Current scope of recombinant or synthetic nucleic acids plus research with other biohazards to possibly include wild type biological agents, proteins (e.g., toxins, prions), etc.
  • Research with infectious microbes and hazardous biological materials
  • Life sciences research

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

  1. 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 low risk (e.g., RG1 agents, some transgenic organisms, some expression plasmids)

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

Novel and Exceptional Technology and Research Advisory Committee Meeting

The Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) will hold a virtual meeting to discuss the draft report of the Engaging the Public as Partners in Clinical Research (ENGAGE) Working Group

NIH Videocast

https://videocast.nih.gov/

Agenda

NExTRAC Meeting Agenda Final

Additional Meeting Materials

Draft Report of the Engaging the Public as Partners in Clinical Research (ENGAGE) Working Group

NExTRAC Meeting Engage Slides Final

Public Comments

Public Comments

Final Report

Engaging the Public as Partners in Clinical Research Report