Federal Register #2026-18646

NIH Request for Information: Draft Biosafety Policy for Research Involving Biohazards

The National Institutes of Health (NIH), part of the Department of Health and Human Services, is seeking public feedback on a draft biosafety policy for biomedical research involving biohazards. - Government Buyer: - Department of Health and Human Services (HHS) - National Institutes of Health (NIH) - Scope: - Applies to all biomedical research involving biohazards, including genetically modified organisms, toxins, prions, infectious agents, and cells or organisms containing these elements - Covers both NIH-supported research and non-NIH funded research at institutions receiving NIH funding - Purpose: - Modernize and strengthen biosafety practices - Replace the current NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules - Notable Requirements: - Expanded oversight of biosafety practices - Strengthened roles for Institutional Biosafety Committees - Enhanced transparency and accountability in biosafety management - No OEMs or vendors are specified, as this is a policy solicitation and not a procurement of products or services - The NIH is requesting information and feedback from the public and stakeholders to inform the final policy

Description

The National Institutes of Health (NIH) is proposing a new comprehensive biosafety policy to modernize and strengthen biosafety practices in biomedical research involving biohazards. This policy aims to replace the current NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and ensure oversight keeps pace with evolving risks. The policy covers all biomedical research involving biohazards, including genetically modified organisms, toxins, and infectious agents, and applies to NIH-supported research as well as non-NIH funded research conducted at institutions receiving NIH funding. NIH is requesting public input on this draft policy, with comments due by October 19, 2026.

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