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OASIS Project Logo

OASIS is an automated FDA system for processing and making admissibility determinations for shipments of foreign-origin FDA-regulated products seeking to enter domestic commerce.

Project Description Improvements Provided by the Project Technically Speaking Improved Service to the Public Increased Agency Efficiency Cost Savings Innovation Awards/

Project Description

OASIS automated the re-engineered business processes the FDA utilizes for making its admissibility determinations to ensure the safety, efficacy and quality of the foreign-origin products for which FDA has regulatory responsibility under the Federal Food, Drug and Cosmetic Act. OASIS enables FDA to handle more efficiently and effectively the burgeoning volume of shipments (now over 8 million/year -- up by 50% in the last four years) of imported products, despite decreasing agency resources.
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Improvements Provided by the Project

OASIS has significantly speeded up the time within which FDA makes its admissibility determinations for imported products. Under the legacy manual system, FDA's review processes took days; OASIS routes electronic admissibility decisions to 2200 importers agents' PCs within minutes after their shipment data is transmitted electronically to FDA. With OASIS, 85% of the shipments are cleared without any submission of paper by the importers, versus the previous requirement for submission of paper documentation for all shipments. OASIS assists in targeting probable problem areas and, ultimately, in the identification and stoppage of violative goods. Automated screening functions enhance FDA's ability to detect problems, thereby keeping violative products from entering the country and safeguarding the public. OASIS brings consistency to FDA enforcement decisions at the 350 U.S. ports of entry nationwide, where FDA-regulated products arrive, to an extent that was not possible with the manual system. System security controls protect the confidentiality of the proprietary trade information involved in these government-industry electronic transactions. FDA's goals of protecting the health of the American consumer, conducting business in an efficient, cost effective manner, and providing optimum service to industry are all enhanced by OASIS.
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Technically Speaking

Within FDA, OASIS utilizes a two-layer client-server architecture, with graphical user interface (GUI) clients connecting to LAN file servers that house the application, and a national centralized database that maintains the data. The OASIS database is managed by ORACLE software. Remote (no direct access to file servers) users have the application software installed on their PC and connect to the FDA WAN through a PPP connection. The intranet is used for downloading the OASIS software to file servers for networked and remote site users.
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How the project has improved service to the public

OASIS serves two publics, industry and consumers. OASIS improves service to the import community, whose products FDA regulates, by greatly speeding up the government's process for making admissibility determinations for shipments seeking to enter the U.S. Demurrage is reduced by allowing shipments to clear much faster; just-in-time inventory planning can be employed by the industry; product spoilage is reduced; uniformity in decision making is enhanced at FDA's widely dispersed entry clearance sites. OASIS serves the American public by more effectively screening foreign-origin shipments seeking to enter the country, thus better ensuring product safety, efficacy, and quality. OASIS also serves the public by reducing the costs for bringing in foreign products -- hopefully these savings are passed on to consumers.
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Increased Agency Efficiency

OASIS improves the effectiveness and productivity of the 350 FDA employees responsible for processing shipments that are candidates for importation, enabling them to handle an ever-increasing workload that could not be efficiently managed under the legacy manual system. FDA employees doing this work are dispersed nationwide -- a modern automated processing system is essential for consistency in FDA's enforcement decision-making.
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Cost Savings

A benefit/cost analysis study conducted by a contractor (Booz-Allen & Hamilton) conservatively projected savings to the import industry from OASIS to be $1.2 billion over a seven-year period. These savings calculations were based on the projected volume of shipments requiring FDA admissibility determinations and the reduced time for clearing those shipments, compared to the times and costs for the pre-OASIS legacy manual system. The actual volume of shipments has proved to be greater than what was foreseen when the benefit/cost study was conducted, due to international agreements that have resulted in greatly increased international trade, so the actual savings to the industry undoubtedly exceeds the projected $1.2 billion.
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OASIS is the first automated system in the FDA to utilize GUI client-server technology to solve the problems inherent to a manual, widely dispersed, high volume, paper-intensive operating process that could no longer keep up with the needs for regulating an ever-increasing foreign trade workload. The technology being utilized, and the way it is applied, solves operational and program management problems that had been overwhelming FDA in regulation of imported products for a number of years.
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