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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/ Accolades |
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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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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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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1998 Government Technology Leadership Award, Government Executive magazine
1998 Laureate, Smithsonian Institution's Innovation
Collection, Computer World magazine
1998 FDA Group Recognition Award for implementation and training teams,
Food and Drug Administration
1998 Selected as a Best IT Practice in the Federal Government, Chief
Information Officers Council and the Industry Advisory Council
1997 Intergovernmental Open System Solutions (IOSS) Award, Federation of
Government Information Processing Councils (FGIPC)
This page was last updated on: 05/25/99 .
