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ADP Systems: FDA Can Reduce Development Risks for Its Import Information System

IMTEC-88-42 Published: Sep 30, 1988. Publicly Released: Oct 19, 1988.
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Highlights

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.

Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services The Secretary of Health and Human Services should take steps to ensure that FDA complies with department requirements to identify and specify FDA computer hardware and software requirements for ISIS in functional terms, rather than specifying vendor-specific computer hardware and software.
Closed – Implemented
In order to comply with this recommendation, FDA withdrew an earlier agency procurement request and submitted a new agency procurement request for ISIS in functional terms timed to coordinate the equipment acquisition with completion of the pilot test, which began October 1, 1990.
Department of Health and Human Services The Secretary of Health and Human Services should take steps to ensure that FDA complies with department requirements to identify FDA requirements for an ISIS automated interface with Customs, and obtain an agreement on a plan to implement the automated interface.
Closed – Implemented
On October 19, 1992, FDA and Customs implemented the pilot automated interface project with the initial testing of the Seattle Electronics Entry Project. FDA indicated that it would not make any further reports on this recommendation.
Department of Health and Human Services The Secretary of Health and Human Services should take steps to ensure that FDA complies with department requirements to explore feasible alternative system designs to meet the functional requirements of ISIS.
Closed – Implemented
The FDA contractor delivered a cost-benefit analysis that addressed four alternative hardware configurations for ISIS. The Associate Commissioner for Regulatory Affairs selected one alternative and issued a decision in June 1989 to support the system with decentralized mini-computers in each region. Office automation and access to the primary data systems will be achieved.

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Topics

IT acquisitionsAgency missionsSoftwareFederal procurementImport regulationInformation systemsIrregular procurementSystems compatibilitySystems designProcurement