Key Dates

Related Announcements

None

Issued by

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

Purpose

The purpose of this notice is to outline the National Institutes of Health’s expectations for the safe, secure, and responsible procurement of synthetic nucleic acids, including but not limited to DNA and RNA, whether single- or double-stranded, as well as whole organism genomes (e.g., viruses, bacteria), or benchtop equipment capable of synthesizing nucleic acids. NIH is implementing new requirements for the research community consistent with these expectations.

Background

Advances in nucleic acid synthesis technology and the open-source availability of genetic sequence data have significantly contributed to discovery and innovation in areas such as health and agriculture research and development. However, there are concerns among the scientific community, the nucleic acid synthesis industry, the U.S. government, and the public that individuals with ill intent could exploit biotechnology for harmful purposes. The U.S. government is taking steps to ensure that synthetic nucleic acid procurement for the conduct of life-sciences research is conducted through providers of synthetic nucleic acids and manufacturers of benchtop nucleic acid synthesis equipment that adhere to a set of security and access procedures enacted to minimize biorisks.

In April 2024, pursuant to Section 4.4(b)(i) of Executive Order 14110, the White House Office of Science and Technology Policy (OSTP) released the Framework for Nucleic Acid Synthesis Screening (Framework) outlining a unified process for screening purchases of synthetic nucleic acids and benchtop nucleic acid synthesis equipment. In accordance with the Executive Order, the Framework outlines expectations for providers and manufacturers to implement responsible synthetic nucleic acid procurement sequence and customer screening practices. Additionally, agencies that fund life sciences research are to issue requirements of funding for synthetic nucleic acid procurement to be conducted through providers or manufacturers that adhere to the framework, such as through an attestation from the provider or manufacturer.

Expectations

It is NIH’s expectation that all NIH awardees adhere to the OSTP Framework for Nucleic Acid Synthesis Screening. NIH funds may only be used to procure synthetic nucleic acids or benchtop nucleic acid synthesis equipment from sources adhering to the OSTP Framework for Nucleic Acid Synthesis Screening.  Adherence may be demonstrated either through written attestation from the provider or manufacturer to the recipient, awardee or contractor, or by attesting publicly on the provider or manufacturer website. NIH requires awardees and contractors to maintain appropriate documentation at the time of procurement in accordance with record retention requirements (See 2 CFR 200.334). Supporting documentation must be made available to NIH upon request, in accordance with 2 CFR 200.337. For more information on provider and manufacturer expectations, please see the OSTP Framework. Further guidance can be found in the Department of Health and Human Services 2023 Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids and Companion Guide.

NIH-funded research involving synthetic nucleic acids must be conducted in compliance with all applicable federal, state, and local laws, regulations, and policies. The policy applies to all NIH-funded grant awards, cooperative agreements, and R&D contracts issued and will take effect on April 26, 2025.  

Inquiries

Please direct all inquiries to:

For questions regarding a specific application or award, please contact the assigned NIH grants management specialist.

For questions regarding a specific contract proposal or award, please contact the assigned NIH contracting officer.

For general questions related to this policy, please contact:

National Institutes of Health
Office of Science Policy
[email protected]