NOT-OD-23-162: Notice of Availability: Proposed Amendments to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

Notice of Availability: Proposed Amendments to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

Notice Number:

NOT-OD-23-162

Key Dates

Release Date:

August 10, 2023

Related Announcements

None

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

NIH is seeking public input on a proposal to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. These amendments include specific considerations and requirements for conducting NIH-supported research involving gene drive modified organisms (GDMOs) in contained research settings. With respect to GDMOs, NIH proposes to:

clarify minimum containment requirements for research involving GDMOs;
articulate considerations for risk assessment; and
define additional institutional responsibilities regarding Institutional Biosafety Committees and Biosafety Officers.

The proposed changes detailed above are consistent with the recommendations contained in the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) report, Gene Drives in Biomedical Research.

In addition, NIH is proposing to:

replace the term “helper viruses” with the broader term “helper systems”; and
reclassify West Nile Virus (WNV) and Saint Louis Encephalitis Virus (SLEV) as risk group 2 agents for consistency with containment guidance provided in Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6^th edition.

Complete details on these proposed revisions may be found in the Federal Register. https://www.federalregister.gov/d/2023-17178

NIH will accept comments on the proposal until October 10, 2023. Comments must be submitted electronically at: https://osp.od.nih.gov/proposed-amendments-to-the-nih-guidelines-for-research-involving-recombinant-or-synthetic-nucleic-acid-molecules-nih-guidelines/

Comments may be submitted anonymously. You may also voluntarily include your name and contact information with the response. Other than name and contact information, please do not include in the response 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 response. After the Office of Science Policy (OSP) has finished reviewing the responses, the responses may be posted to the OSP website without redaction.

Inquiries

Please direct all inquiries to:

NIH Office of Science Policy

SciencePolicy@od.nih.gov