FDA’s overall mission is to protect the public from selected domestic or imported foods, drugs, cosmetics, biological products, and medical devices and from products that make fraudulent or misleading claims that might threaten public health and safety. On matters relating to its import operations, FDA’s Office of Regulatory Affairs provides guidance and systems support, and performs planning, budgeting, and reporting activities for 6 regional offices, 21 district offices, and about 130 resident inspection posts. Imported products can enter the United States at seaports, airports, courier hubs, and border crossings. The volume of import entries subject to FDA regulations has been increasing over the last 20 years from about 590,000 entries in 1975 to about 1.6 million entries currently, and is expected to reach 2 million entries by 2000. Products imported into the United States must be cleared first by Customs, whose responsibilities include assessing and collecting revenues from imports, enforcing customs and related laws, and assisting in the administration and enforcement of other provisions of laws and regulations on behalf of 60 federal agencies. Import brokers act as agents for importers and process the information required to bring products into the United States. Brokers can electronically transmit data on their products to Customs through an automated interface with Customs’ Automated Commercial System (ACS). If Customs determines that a product requires FDA approval before being released into the domestic market, such as for regulated food and drugs, the broker is to forward entry information to FDA for review. Under FDA’s manual entry and review process, brokers must submit entry documents (an FDA-701, invoice, and associated certifications) to FDA for each shipment. Using these documents, FDA inspectors at the port of entry decide whether to release the shipment for entry, examine the shipment by inspecting it there, perform paper or laboratory examination of it for possible refusal due to violations of laws and regulations, or detain it until the broker furnishes additional information. Entry documents can range from a few pages to as many as 40 pages depending on the type and volume of goods in a shipment. The time interval between when the broker submits the documents to FDA and when the broker receives a release or examination decision from FDA averages 2 days. As the volume of imports continued to grow, FDA recognized a need to automate and expedite its entry and review process. Also, FDA envisioned that an automated system would provide a method to capture and share historical data to bring uniformity to its enforcement decisions for detecting and preventing “port shopping” by importers. FDA found that because of its heavy workload or less interest in particular products at some ports, some importers tended to use the port of entry that provided them with the best opportunity for receiving FDA approval. In 1987, the FDA Commissioner formed a task force to develop a new automated system as recommended in a contractor-prepared feasibility study. This system, now known as OASIS, was intended to increase the efficiency and effectiveness of FDA’s program for monitoring imported products. In general, OASIS was expected to (1) increase the productivity of investigations personnel through automated interfaces with the laboratories, brokers and/or Customs, (2) improve screening of imports by providing suggestions for actions likely to result in discovery of violations, (3) provide faster turnaround for processing of importer’s entries and faster and more consistent responses, (4) provide national and district uniformity in processing of entries, and (5) maintain a base of information for generation of reports. OASIS was initially planned to be fully implemented in September 1989. We interviewed FDA and Customs officials in the Washington, D.C., area, and Seattle, Washington, to determine the operational objectives and timeframe for implementing OASIS. We also reviewed systems documentation provided by FDA, such as the system design, functional requirements, capacity analysis, risk assessment, regional contingency plan, implementation schedules, software support contracts, task orders, interagency agreement between FDA and Customs, and security and information resources management policies and procedures. We assessed FDA’s efforts to design, develop, and implement OASIS against GAO’s executive guide on the best practices of leading private and public organizations for strategic information management, and federal guidelines, such as the Federal Information Processing Standards Publications. In addition, we reviewed the 1994 joint self-assessment report on OASIS, the contractor’s cost-benefit analysis, and the System Design Review Committee’s report. To monitor the implementation of OASIS, we visited and interviewed officials in FDA district offices and ports of entry in Seattle (system pilot location); Miami, Florida; Buffalo and New York, New York; and Detroit, Michigan. We also conducted telephone interviews with FDA officials in several other district offices. Interviews with FDA import managers and inspectors at these sites provided us with observations and examples of entries processed both manually and electronically at major FDA air, sea, and border ports. We also interviewed Customs officials and import brokers at the sites visited to obtain their perspectives on how the system has improved the import process. Further, we interviewed officials at HHS, who were involved with the self-assessment and system design reviews. We also interviewed one of the prior software development contractors and the current contractor regarding their roles and responsibilities for the OASIS project. We performed our work from April 1994 through June 1995, in accordance with generally accepted government auditing standards. We requested official comments on a draft of this report from the Secretary of Health and Human Services on August 10, 1995. As of September 18, 1995, we had not received any comments to include in the final version of this report. The development of OASIS is taking considerably longer than FDA officials expected. As shown in figure 1, after 8 years and three software development contractors, FDA still does not have a fully functional automated import system. The original design, which was called the Import Support and Information System (ISIS), was for a large, nationwide, on-line, real-time, distributed FDA system. This system was modified following its 1991 pilot test and FDA’s agreement with Customs to include an automated interface with Customs’ ACS. As shown in figure 1, the modified system, known as OASIS, was pilot tested in Seattle, Washington, in 1992 and expanded to Portland, Oregon, and Blaine, Washington, in 1993. OASIS, as implemented in the Seattle District locations, provides FDA inspectors the ability to (1) receive import entry data electronically from import brokers through interface with ACS, (2) receive results of preliminary processing against FDA’s selectivity criteria screening file, which is installed on ACS, that the shipment “May Proceed,” must be “Detained” for sampling, or must be held for “FDA Review,” (3) be alerted to potential problem areas with each line item of an entry, make follow-up screening decisions, and transmit these electronically to the broker through interface with ACS, (4) track actions taken and maintain historical data on all electronic import entries, and (5) eliminate many of the paper transactions among FDA, Customs, and import brokers. In addition, import brokers who interface with ACS receive preliminary and subsequent screening decisions relating to their electronic entries simultaneously with FDA. However, software design problems experienced at the pilot locations made OASIS difficult to use. Such problems included slow response times when receiving and printing electronic data, moving from computer screen to computer screen, or going in and out of other systems while processing entries. These OASIS development problems prompted FDA to assemble a team of information resources management (IRM) representatives from HHS, PHS, and within FDA to pilot a self-assessment tool to analyze risks associated with the development of OASIS. In June 1994, as a result of the exit briefing by the self-assessment team on its results and pending actions under way by FDA to replace the expiring OASIS contract, FDA’s Director of the Office of Information Resources Management called for the termination of both the development and deployment of all but the front-end portion of OASIS known as the electronic entry processing system or EEPS. FDA decided to maintain and refine OASIS in the Seattle District. In its July 1994 report, the self-assessment team concluded that the OASIS project was at high risk for system failure due to the lack of senior-level management involvement, project planning, and basic development processes as well as system design flaws, an insufficient budget, and a skeleton staff lacking adequate system design and implementation expertise. In contrast to the OASIS functions described previously, EEPS allows FDA inspectors to receive the broker’s entry data from ACS, but only allows inspectors and brokers to receive the preliminary admissibility messages of either “May Proceed” or “FDA Review” for the entire entry. It is not capable of processing or transmitting any follow-up line-item decisions from FDA to the brokers. EEPS was deployed to 114 ports between March 1994 and June 1995, with 103 additional ports expected to be automated by the end of 1995. According to import brokers and FDA inspectors we interviewed, even EEPS’ limited capability provides them quicker notifications as to the admissibility of imported shipments and reduces the amount of paperwork required from brokers. For “May Proceed” decisions, paper entry documentation is generally eliminated. For example, during the month of June 1995, FDA reported that of 2,520 brokers who interfaced with Customs’ ACS in the Seattle District and EEPS ports, 1,585, or 63 percent, used electronic filing for 178,412 FDA entries, and that 78 percent of the 1,585 electronic filers were not required to submit entry documentation for “May Proceed” entries. Table 1 below compares the traditional manual entry process to EEPS.