The letter, dated March 24, 2025, is a formal communication addressed to Dr. Matthew Memoli, Acting Director of the National Institutes of Health (NIH), from the leadership of the American Society for Microbiology (ASM), the Association for Biosafety and Biosecurity International (ABSA), and the Council on Governmental Relations (COGR). The organizations collectively express concerns regarding the impending implementation of the U.S. Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP), particularly the lack of clear guidance and required documentation as the May 6, 2025, compliance deadline approaches. They note that many researchers and institutions they represent will be affected by the policy but remain uncertain how to fulfill its requirements due to incomplete direction from NIH, especially after recent leadership changes and administrative turnover.
The signatories formally request a meeting with relevant NIH officials to seek clarification on policy implementation, including the process for obtaining and maintaining NIH assurances, and to offer their support in disseminating necessary compliance information to the broader research community. Additionally, they urge NIH and the Office of Science and Technology Policy (OSTP) to work together to promptly provide detailed compliance documentation, establish clear points of contact for further inquiries, and involve biosafety and biosecurity experts in future policy development. The organizations reiterate their willingness to collaborate with NIH to facilitate smooth and effective implementation of these important regulatory frameworks.
