Attachment

o Delineates the roles and responsibilities of principal investigators, research institutions, and Federal departments and agencies that conduct, fund, or oversee research within the scope of the policy. • The Administration also strongly believes in the importance of ensuring the highest level of integrity in scientific and technological processes, and has supported the establishment and enforcement of policies that maintain integrity in the conduct of scientific research and in the collection of scientific or technological data. In support of this, the Administration published a report on Protecting the Integrity of Government Science in January 2022. • The bill seems to create redundancies with some reforms recently introduced by the DURC/PEPP policy, which was developed following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. • The bill retains a number of problematic details that could negatively impact innovation and the U.S. competitive edge in life sciences research, including our ability to attract and retain the best scientists. • However, HHSthe Administration welcomes efforts from Congress to further strengthen biosafety and biosecurity in the life sciences. o For example, we would welcome discussions on how the risk-based oversight processes established in the DURC policy for federally funded research could be extended to non-federally funded research. • We recognize that biosafety and biosecurity oversight responsibilities are currently shared across many different departments and agencies and welcome discussions on appropriate entities for oversight of the highest risk research. o Some Scope/Definitions • While steps have been made toward harmonization of the scope of the Board's oversight with the new United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (2024 OSTP DURC/PEPP Policy), some of the listed experiments in the "dual use research of concern" definition do not match those in the policy, and other articulated in-scope research in the bill including the "gain of function research" term continues to be in conflict with USG policy. These definition differences will be challenging to deconflict for the research community. Many of the USG definitions were determined following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. We recommend that the definitions and scope of review be fully harmonized with the DURC/PEPP policy and not include a separate list of pathogens. Many of the definitions of research that is subject to requirements of this proposed legislation are very broad and not all are in line with existing policies, which is likely to cause confusion in the research community. o This could result in delays to critical biosurveillance efforts such as COVID-19 testing, H5N1 monitoring, and detection of emerging outbreaks of Ebola and other diseases. It could also result in delays for development of vaccines, therapeutics, and biomedical, agricultural, and other life sciences research writ large (including research that is not associated with pathogens or toxins and raises no identified national security threats, such as cancer research).