Attachment

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). o If the statute only provided the board the responsibility to review federally-funded research involving DURC and PEPP, as defined in the DURC/PEPP policy, it would ensure oversight resources are used most efficiently to assess and mitigate risks to the public while avoiding unintended negative consequences for the nation's biomedical enterprise. We believe this is the intent of the bill but as written the definitions are not harmonized. o A large amount of scientific research involves gain or loss of function; it's a fundamental process in science. For example, some types of immune therapy cause the immune system to gain function to fight against a disease. Unfortunately, the term "gain of function" has often being misconstrued to suggest all research that causes a gain of function is highly risky, which is inaccurate. In fact, most research involving a GOF does not confer significant additional risk or require additional oversight. NIH does not define the term GOF and current federal policy does not define or operationalize the term. The research that requires strict oversight involves enhancing the transmissibility and/or