Office of Science and Technology Policy September 2023 – Federal Register Recent Federal Regulation Documents

Life sciences research is vital for improving health outcomes and protecting the Nation from infectious disease threats, but a small subset of this research could potentially pose risk of accidents or misuse that could harm human health. It is important to regularly evaluate and update biosafety and biosecurity oversight policies to keep pace with new technological developments and the evolving risk landscape. The Office of Science and Technology Policy (OSTP) invites comments on potential changes to the Policies for Federal and Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC) and Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO). These policies establish frameworks for review and oversight requirements for certain categories of life sciences research, namely research with certain pathogens and toxins, including at institutions that accept Federal funding for such research. These requirements are intended to complement activities under existing Federal regulations or guidelines such as the Federal Select Agent Program. OSTP requests comments on how potential changes to these research oversight policies could mitigate risks associated with DURC and research with enhanced potential pandemic pathogens (ePPP) while minimizing undue burden on institutions. The public input provided through this Request for Information (RFI) will inform policy evaluations and issuance of a revised policy (Revised Policy).