NATIONAL INSTITUTES OF HEALTH (NIH)
The Federal Government is issuing a new National Policy for Nucleic Acid Synthesis Screening pursuant to Section 4 of Executive Order 14292. NIH is working with the Administration and its Interagency partners to fully implement this new National Policy, which requires all recipients of Federal life sciences funding to procure synthetic nucleic acids and benchtop synthesis equipment exclusively from Adherent Suppliers that verify the legitimacy of Customers and sequences ordered.
Implementation Guidance
Per the Policy, Customers will be required to procure all synthetic nucleic acids through Adherent Suppliers no later than July 13, 2027, and will be required to procure all Benchtop Equipment through Adherent Suppliers no later than October 11, 2027. Policy requirements will be incorporated into federal assistance terms and conditions in a fashion aligned with implementation of the U.S. Government Policy for Stopping High-Risk Life Sciences Research. Federal funding agencies must require individuals to keep records regarding any procurement, receipt, or exchange of sequences of concern (SOCs) or Benchtop Equipment. Researchers must execute such procurement, receipt, or exchange through a contractual or transactional agreement (e.g., a material transfer agreement).
On the date of full implementation outlined in this Policy, this Policy supersedes the 2024 Framework for Nucleic Acid Synthesis Screening, as well as any conflicting or inconsistent nucleic acid synthesis screening policy. Until that date, (1) parties should continue to draw from the relevant portions of the 2023 Health and Human Services (HHS) Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids and (2) NOT-OD-25-012 remains in effect.
Please direct all inquiries to:
NIH Office of Science Policy