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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 12 million/year -- up by 50% in since 1999) 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 5,200 importers agents' PCs within minutes after their shipment data is transmitted electronically to FDA. With OASIS, 85% of the shipments are cleared without any paper submission by the importers, versus the previous requirement for paper documentation submission for all shipments. OASIS assists in targeting likely problem areas and, ultimately, in identifying and stopping 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 480 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 the metaframe server that houses the application to access a national centralized database that maintains the data. The OASIS database is managed by ORACLE software. A small percentage of remote (no direct access to metaframe server) users have the application software installed on their PCs 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

Prior to the implementation of the Bioterrorism (BT) Act of 2002, OASIS worked closely with U.S. Customs and Border Protection’s (CBP) Automated Commercial System (ACS) to process entries from the import industry and obtain the information needed to make decisions regarding all food articles entering the United States. With the implementation of the BT Act, OASIS now receives this information from both ACS and the FDA’s Prior Notice System Interface (PNSI). PNSI is a free Internet application which allows facilities to provide information regarding expected U.S. imports. As a result, OASIS now further serves industry by providing a low cost alternative for small businesses and others to provide required information regarding imported items.

OASIS was designed to minimize the amount of time an importer or importer’s agent spends waiting for review results. OASIS retains and utilizes product historical data to reduce the system workload, decrease review time and increase efficiency. Product historical data is used to sort the imported items into different risk categories, from high to low. Low-risk imports are subject to regular review while high-risk imports are subject to a more stringent review process.
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Increased Agency Efficiency

OASIS improves the effectiveness and productivity of the over 500 FDA import personnel 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.

OASIS has improved its effectiveness and service to industry by generating timely correspondence in PDF format. This allows the FDA to promptly respond to a filer’s request for duplicate correspondence via email.

OASIS is linked to strategic systems in the agency which allows import personnel to make sound and informed decisions about the products allowed into the country quickly and efficiently. During the process of reviewing imported products, the OASIS reviewers can leverage the resources of other government agencies (for example, United States Department of Agriculture (USDA)) to render expert import decisions. Increasing communication and interconnection between the government agencies fosters cohesiveness, increases efficiency and ensures that all government agencies are working together to protect the public and enforce the BT Act.

FDA has optimized its ability to address the fluctuating workload between the U.S. ports of entry and ensure timely review by allowing employees to designate alternative reviewers within the office or district. In addition, the work of an entire office may be assigned and assessed by another office in times of high capacity. This innovation greatly enhances and improves communications between the various offices, further ensuring public safety and enabling the FDA to support and enforce the BT effort.
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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 within 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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