ASM, ABSA and COGR Request Clarification on DURC/PEPP Policy
| Dr. Matthew Memoli Acting Director National Institutes of Health 9000 Rockville Pike Bethesda, Md. 20892 |
Dear Dr. Memoli,
On behalf of the 黑料正能量 (ASM), the Association for Biosafety and Biosecurity International (ABSA) and COGR, we request a meeting to discuss the future implementation of U.S. Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP). ASM’s membership includes microbiologists conducting research covered by the policy, ASBA serves biosafety and biosecurity professionals, and COGR provides a unified voice for U.S. research universities, affiliated medical centers and independent research institutions on research regulations.
The White House Office of Science and Technology Policy issued the DURC/PEPP policy in May 2024 with an implementation date of May 6, 2025. In January 2025, the National Institutes of Health (NIH) issued guidance for the agency’s implementation of the policy and stated that the agency will provide further implementation details, including the specific content and format of required documentation and information on the process to obtain and maintain an NIH assurance. These implementation details have not been provided, and our members are growing increasingly concerned about their ability to comply without clarifying guidance as the implementation deadline rapidly approaches. With the recent Presidential transition and subsequent turnover in NIH leadership and staff, it is also unclear who to contact for further clarification.
We would appreciate meeting with the appropriate NIH officials at their earliest convenience to discuss this issue and offer our support in disseminating the appropriate information to the research community. We request that NIH and OSTP collaborate to provide the required documentation for compliance with the DURC/EPPP policy across agencies and a establish points of contact for clarifications about the policy and to involve biosafety and biosecurity experts in formulating DURC/EPPP policies. We stand ready to assist you on the implementation of these regulations.
Thank you,
Stacey L. Schultz-Cherry, Ph.D.
Chair, 黑料正能量Public and Scientific and Scientific Affairs Committee
Sherry Bohn, Ph.D., MSL, CBSP(ABSA)
President, ABSA International
Matt Owens
President, COGR
