Unisys Launches Web-based Notification System

Unisys Corporation (www.unisys.com) created a Web-based notification system that allows the Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) to more quickly and efficiently receive and process applications to approve new drugs for animals. 

The innovative system, which Unisys implemented in less than three months, administers user fee submissions - the amount a customer pays to have his/her application reviewed - in accordance with the Animal Drug User Fee Act (ADUFA). 

The system fully integrates and automates all activities, including processing the customer's notification (i.e., intent to apply) and accompanying fee. 

The ADUFA legislation, passed in December 2003, created user fees that pharmaceutical companies pay when submitting an animal drug application.  It also established performance standards for the CVM that are designed to reduce delays in product approvals. 

The ADUFA user fee system is part of the FDA's strategic initiative to modernize its financial systems, which includes converting to Oracle Federal Financials (www.oracle.com). 

This e-government system, according to the FDA, brings the agency into the 21st century in terms of business modernization and efficiency. 
The FDA plans to leverage its ADUFA success by converting other programs' user fees into the new system in the coming months.

An FDA customer - for example, a pharmaceutical company seeking animal drug approval from the FDA - logs in through the ADUFA Web site and enters the required information.

CVM then reviews the submission and makes any necessary changes.  The request remains in "hold" status until payment is received from a lockbox and CVM acknowledges receipt through its tracking systems.