Summary

In response to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) automated Import Support and Information System (ISIS) to determine whether FDA: (1) complied with government standards and regulations in developing ISIS; (2) ensured that ISIS would interface with the Customs Service's automated systems; (3) plans to use ISIS to collect data on imports FDA regulates; and (4) ensured that ISIS would be compatible with existing management systems.

GAO found that FDA: (1) failed to follow government standards requiring competitive procurement of computer systems, system design, and interface requirements; (2) did not identify alternative system designs for management consideration; (3) postponed identifying interface requirements until after the system becomes operational; (4) plans to use ISIS to collect data only for those imports examined at the port of entry; and (5) believes that ISIS will be compatible with existing automated systems, such as the Laboratory Management System. GAO noted that, if FDA fails to identify and plan for its interface requirements, ISIS may be unable to interface with Customs' systems.