In response to the information request on January 19, 2016 for VPRIV NDS, control# 132604 for VPRIV stability out of specification results and commitment to provide summary of the Trend Evaluation, the following information is provided. Based on the fact that Drug Product Cellular Uptake Bioassay (CUB) releasing results of above mean trend was observed for DP CBI lots 2196-202 through 2196-210 and Vetter lots of TVNK12 through TVPI11, it was deemed that the scope of this evaluation would focus on