The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) has been conducting a pilot evaluation program to evaluate the use of an automated system for the submission of biologics license applications (BLA), BLA supplements (BLS), and annual reports for blood and blood components. The pilot program is intended to provide both industry and CBER regulatory review staff the opportunity to evaluate the eSubmitter system and determine if it facilitates the BLA/BLS submission process. During this program, FDA will describe the eSubmitter system, its intended use, and lessons learned to date from the pilot program. One of the blood centers participating in the pilot program will share its experiences using this software program.