…ers the effects of predicted Level A harassment, duration of Level B harassment events, and impacts to marine mammal habitat, which respectively were not integrated into or included in the risk ratings. These components of the full analysis, along with any germane species or stoc…

…ot enforced requirements related to registration and listing, reporting adverse events to FDA, current good manufacturing practices (CGMPs), or premarket review of an IVD by FDA prior to use of the LDT in patient care, among other requirements. The rationale for this approach was…