FDA ORA Imports
Investment ID: 009-000353235
Overview
Program Title
FDA ORA Imports
Description
Imports Systems enables the ORA staff to predict risk and screen import of FDA-regulated products and conduct sampling and examination of products offered for import. Imports include both 801a and 801m responsibilities, to ensure imports that do not meet regulations are not admitted into commerce and to protect against possible bioterrorism threats. The work includes all the stages of import review, including the steps needed to review PNs, make admissibility decisions, and address imports that are detained or refused entry.
Type of Program
Major IT Investments
Multi-Agency Category
Not Applicable
Investment Detail
IMPORTS benefits the public by enabling import functions that ensure product safety in the supply chain. IMPORTS expands ORA's ability to share data with other public health organizations improving the nation's ability to detect, identify, and respond to health emergencies. IMPORTS' internal benefits include improved user interface, data management, and communication systems that increase productivity.
The benefits for enhanced Imports set of applications are the resulting cost avoidance by the ORA staff being more efficient in executing their tasks. This results in each employee able to carry out more inspections, import entry review of exceptions, etc. Examples of this are: 1. Reduced time spent on tracking compliance actions & holds. 2. The system targeting shipments to inspect. 3. Reduced time spent on filed inspection/investigation and label exams, and sample collection administrative tasks. 4. Industry Help Desk efficiency. 5. Entry review integration to the Compliance Management System. 6. The expansion of self-service by the imports industry to check information on inspection status.
These six benefits are estimated to exceed $35M per year in cost avoidance to ORA staff and Industry/Trade participants.
The benefits for enhanced Imports set of applications are the resulting cost avoidance by the ORA staff being more efficient in executing their tasks. This results in each employee able to carry out more inspections, import entry review of exceptions, etc. Examples of this are: 1. Reduced time spent on tracking compliance actions & holds. 2. The system targeting shipments to inspect. 3. Reduced time spent on filed inspection/investigation and label exams, and sample collection administrative tasks. 4. Industry Help Desk efficiency. 5. Entry review integration to the Compliance Management System. 6. The expansion of self-service by the imports industry to check information on inspection status.
These six benefits are estimated to exceed $35M per year in cost avoidance to ORA staff and Industry/Trade participants.