Attachment

HHS Review of S.4667 Risky Research Review Act As amended by HSGAC on September 25, 2024 HHS appreciates the opportunity to review S. 4667, as amended by the Peters-Paul substitute amendment. Please note this is not formal Department TA or Administrations views. However, as there remain many similarities between the introduced bill and substitute amendment, we are also attaching the formal TA we shared with the committee in July. to the introduced bill, for reference. While some aspects of this bill related to scope are improved, there continue to be significant concerns about the impact on biomedical research. Topline points: • Strengthening biosafety and biosecurity oversight of life sciences research is a key priority of this Administration, as outlined in the National Biodefense Strategy. We believe the bill as drafted would significantly undermine life sciences research, and its oversight provisions fail to target the subset of research posing greatest risk. without commensurate security benefit. As such, we do not support this legislation. • As currently drafted, this legislation has the potential to negatively impact innovation and the U.S. competitive edge in life sciences research, including our ability to attract and retain the best scientists. While HHS continues to have serious concerns with this legislation as drafted, we remain committed to working with the Committee and Congress on biosafety and biosecurity. More detailed concerns are described below by category. Redundant with DURC/PEPP policy • The Administration has recently strengthened, streamlined, and expanded oversight of potentially high risk life science research in the May 2024 United States Government Policy for Oversight of Dual Use Research of Concern Pathogens with Enhanced Pandemic Potential ("DURC/PEPP policy"). This policy expands and strengthens a tiered system of oversight for all federally funded research that includes a requirement for research on pathogens with enhanced pandemic potential to undergo extra departmental review. The policy also: o Defines an expanded scope of pathogen and toxin research subject to additional oversight by the U.S. Government; o Provides a unified framework to support the consistent identification and oversight of research proposals that require enhanced oversight that accounts for safety, security, and ethical considerations; and