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

Draft Agenda

Listening Session 1 Draft Agenda

Meeting Flyer

Listening Session 1 Flyer

Draft Introductory Slides

Draft 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.

Registration

The listening session is open to the public and there is no cost to attend.  Pre-registration is required through the submission below.  When registering, please indicate whether you would like to provide oral comments.  Requests to make oral comments must be received by September 29, 2025 (Speaking slots for this listening session are full as of 9/30/25)

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

National Science Advisory Board for Biosecurity (NSABB) Meeting

Virtual Meeting

Federal Register Notice

Webcast

Agenda

Minutes

Additional Files

Public Comments

To sign up to make an oral public comment at the meeting, please send an email to [email protected] at least one business day prior to the meeting date. Once all time slots are filled, only written comments will be accepted. Any interested person may file written comments by forwarding the statement to [email protected] at least one business day prior to the meeting date. The statement should include the name, address, telephone number and, when applicable, the business or professional affiliation of the interested person. Other than name and contact information, please do not include any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your comments. Please note that any written comments NIH receives may be posted unredacted to the Office of Science Policy website.

Public Comments

Novel and Exceptional Technology and Research Advisory Committee

Federal Register Notice

NIH Videocast

The Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) will hold a virtual meeting to hear an update from the Working Group on Data Science and Emerging Technology on its work to address the charge the Committee received in June 2021.

Registration is not required to view the webcast.

Agenda

Minutes

Progress on Phase 1 of Current Charge

Additional Meeting Materials

Public Comments