FDA Import Automation: Serious Management and Systems Development Problems Persist

Highlights

Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) progress in implementing its Operational and Administrative System for Import Support (OASIS), focusing on systems development areas that need improvement.

Recommendations

Recommendations for Executive Action

Agency Affected	Recommendation	Status
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Assistant Secretary for Management and Budget and the Commissioner, FDA, to ensure that continuous top management oversight and systems expertise are provided to FDA as it proceeds with its import automation effort.	Closed – Implemented FDA's Office of Regulatory Affairs (ORA) and Office of Information Resources Management (OIRM) have signed a memorandum of agreement to ensure that OASIS project development proceeds in a manner consistent with good system development practices. Further, HHS' Assistant Secretary for Management and Budget (ASMB) and the Commissioner of Food and Drugs have taken steps to ensure continuous oversight through briefings on the progress of the import automation project. In addition, FDA has assigned a person with systems development expertise to the OASIS project team and a multi-disciplined team to oversee the OASIS development and implementation.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Assistant Secretary for Management and Budget and the Commissioner, FDA, to ensure that FDA develops and maintains reliable cost and performance information.	Closed – Implemented HHS concurred with this recommendation. FDA maintains a system that captures all expenditures associated with OASIS. This system was reviewed by the agency's financial management office to ensure that it fully meets the purpose for which it is intended. FDA also has developed and maintains system and performance data for monitoring purposes.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Assistant Secretary for Management and Budget and the Commissioner, FDA, to ensure that FDA follows sound systems development practices, including validating systems software, conducting user acceptance testing, developing a security plan, and conducting a cost-benefit analysis that includes an assessment of alternative systems.	Closed – Implemented HHS partially concurred with this recommendation. It reported that it employed Booz-Allen & Hamilton for development of OASIS. A team of FDA technical and program specialists oversaw the contractor's activities to ensure that sound system development practices were followed, and FDA requirements were met. FDA conducted user testing and developed a security plan.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Assistant Secretary for Management and Budget and the Commissioner, FDA, to clearly define how FDA plans to reengineer its import operations. At a minimum, FDA should: (1) identify and analyze existing business processes and work flows; (2) obtain the necessary technical assistance and training to support its reengineering efforts; and (3) determine new information needs, application system requirements, and technology requirements necessary to support the new business processes.	Closed – Implemented According to FDA, it has reengineered the traditional manual business process utilized for conducting its import operational work. For example, brokers and filers were previously required to complete and submit a special multipart shipment form, along with copies of invoices and other hard copy documents. OASIS has eliminated the special form and no paper is required for automated clearance consideration if shipment data is submitted electronically.

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