Submitted Electronically to: RE: Response to Advance Notice of Proposed Rulemaking – “Provisions Regarding Access to Americans’ Bulk Sensitive Personal Data and Government-Related Data by

Food and Drug Administration (FDA) and the Chinese National Medicines and Pharmaceutical Administration (NMPA) in 2023 and citing the FDA’s approval of the Chinese innovative drug toripalimab as the “first FDA-approved drug for the treatment of nasopharyngeal cancer”). [...] We urge the DOJ to work with FDA, NIH, and other federal agencies involved in the conduct of clinical research to identify appropriate bulk threshold levels for genomic and personal health data that would permit the conduct of international clinical trials that include study sites in CoCs. [...] Sensitive Personal and Government-Related Data 7 States to gain approval for the drugs/devices in multiple countries.12 As previously noted, study sponsors require access to study data to provide oversight for the study, and they obtain subjects’ consent to collect and share data and specimens. [...] Restricting the transfer of genetic materials among the researchers participating in the study would substantially reduce the impact of the study through loss of the Chinese collaborator. [...] Participants in this research generally provide written informed consent and authorization to the sharing of their data and/or biospecimens, so they are aware of and agree to how, why, and with whom this information will be shared,23 and much of this information can be shared in a deidentified or anonymized fashion.