ZFDA CFSAN Food Applications Regulatory Management System (FARM)
Investment ID: 009-000005336
Overview
Program Title
ZFDA CFSAN Food Applications Regulatory Management System (FARM)
Description
FARM is a comprehensive end to end information management system with electronic document content management searching workflows tracking and reporting that provides efficient receipt of applications expedited safety reviews and safety decisions and maximizes productivity
Type of Program
Non-major IT Investments
Multi-Agency Category
Not Applicable
Investment Detail
FARM, initiated in 1995, has been reengineered using modernized technology, enterprise content management system, workflows, searching and reporting capabilities. The DME project will develop a frontend interface using an eSubmission tool accessible by industry to complete, update and submit their applications in a standardized format. FARM will process online submissions and store them in the database. The DME will also normalize current and legacy datasets in the content management system for enhanced searching and reporting of administrative data. This includes identification and correction of erroneous data, formatting and exporting data to the Chemical Evaluation and Risk Estimation System (CERES), and exporting and registering substances in the FDA's Global Substance Registration System (G-SRS) to implement the FDA Data Standards. The DME will enhance regulatory reviewer access to submissions to analyze the chemical, toxicological, and environmental information, and respond to correspondence and FOI requests to meet the statutory deadlines. The FARM DME project supports CFSAN goals by reducing the duration of the scientific review, safety evaluation and approval process, to allow FDA to continue meeting statutory deadlines and responding more efficiently to risks associated with new food ingredient applications.