Sending on behalf of Valerie Parkison, Director, Office of Animal Care and Institutional Biosafety

NIH Issues Agency Implementation Information on U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential

NIH intends to implement the DURC/PEPP Policy effective May 6, 2025. Please carefully review the NOT-OD-25-061 from January 10, 2025.

NIH will provide additional details and requirements, including applicable grant and cooperative agreement activity codes, specific implementation timelines, and information regarding implementation for other NIH funding mechanisms, (e.g., contracts, Other Transactions), in future Guide Notices.

Applicability

The DURC/PEPP Policy requirements apply to all NIH-funded research, including grants and cooperative agreements, Research and Development (R&D) contracts, NIH intramural research projects, and other funding agreements (e.g., Other Transactions).

For competing grant and cooperative agreement applications, NIH will request applicable DURC/PEPP materials to be provided as part of Just-in-Time (JIT) materials submitted on or after May 6, 2025. DURC/PEPP materials must be submitted by the Authorized Organizational Representative (AOR).

For active grants and cooperative agreements, NIH will request applicable DURC/PEPP materials to be provided as part of any non-competing applications, including Research Performance Progress Reports (RPPRs), due on or after May 6, 2025. Non-competing applications that include DURC/PEPP materials must be submitted by an AOR.

Definitions of Category 1 Research and Category 2 Research can be found in the DURC/PEPP Policy and examples of such research can be found in the Implementation Guidance.

NIH strongly encourages researchers and research institutions to become familiar with the DURC/PEPP Policy, associated Implementation Guidance, and the Administration for Preparedness and Response (ASPR) S3 website and FAQs.

NIH will continue to provide updates as additional implementation details are finalized. OVCR and the Institutional Biosafety Committee will continue to provide institutional updates as details are finalized.