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In September 2023, informed by recommendations from the National Science Advisory Board for Biosecurity, public comment, and other expert input, the White House Office of Science and Technology Policy issued a Federal Register Notice soliciting feedback on potential changes to high consequence research oversight policies.
Following this notice, a new policy and implementation guidance for research involving Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) was released in May 2024. This new U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential will supersede the 2012 and 2014 DURC Policies and the 2017 HHS P3CO Framework, beginning on May 6, 2025.
The new policy is a unified federal oversight framework for the oversight of certain types of federally funded life sciences research involving biological agents and toxins. This policy addresses oversight of research on biological agents and toxins that, when enhanced, have the potential to pose risks to public health, agriculture, food security, economic security, or national security.
The White House Office of Science and Technology Policy posted an email address, ASPRBIO@hhs.gov, to collect feedback from stakeholders on interpreting and/or implementing this policy. The U.S. government has considered this email feedback and prepared a Frequently Asked Questions list to clarify certain issues. These may be updated as additional questions are received.