FDA OC Unified Registration and Listing System
Investment ID: 009-000005314
Overview
Program Title
FDA OC Unified Registration and Listing System
Description
The FDA OC Unified Registration and Listing System (FURLS) is a portfolio of registration, listing, export certification, reporting, and user authentication applications across the FDA.
Type of Program
Non-major IT Investments
Multi-Agency Category
Not Applicable
Associated Websites
https://www.access.fda.gov/
Investment Detail
FURLS supports the FDA's effort to make registration and listing systems electronic. Feedback from clients from surveys, governance boards, and ad hoc commentary has been very satisfactory. FURLS supports for following FDA Strategic Objectives:
Objective 2.4 - Prepare for and respond to public health emergencies FURLS allows FDA to maintain the list of regulated entities and products and able to detect unregistered firms and potential harmful products in respond to public health emergencies.
Objective 4.1 - Improve surveillance, epidemiology, and laboratory services FURLS enables FDA Centers to enforce federal regulations stemming from the Food, Drug, and Cosmetic Act (FDCA) of all regulated entities and products such as manufacturers and distributors of food, medical devices and tobacco products.
Objective 4.2 - Expand the capacity of the scientific workforce and infrastructure to support innovative research FURLS provides users from across the FDA the ability to share regulated products information such as registered firms, inspections and listing of products to make regulatory decisions, in addition to having consolidated views of data to further advance researches and other programmatic initiatives.
Objective 5.3 - Optimize information technology investments to improve process efficiency and enable innovation to advance program mission goals FURLS leverages existing external and internal services (i.e. investments) to validate data, to exchange data, and to promote sharing of business processes across FDA Centers.
Objective 5.4 - Protect the safety and integrity of our human, physical, and digital assets FURLS complies with, and utilizes all, applicable security standards and records management, on both extranet and intranet environment, to facilitate user's submissions and maintenance of digital assets.
Objective 2.4 - Prepare for and respond to public health emergencies FURLS allows FDA to maintain the list of regulated entities and products and able to detect unregistered firms and potential harmful products in respond to public health emergencies.
Objective 4.1 - Improve surveillance, epidemiology, and laboratory services FURLS enables FDA Centers to enforce federal regulations stemming from the Food, Drug, and Cosmetic Act (FDCA) of all regulated entities and products such as manufacturers and distributors of food, medical devices and tobacco products.
Objective 4.2 - Expand the capacity of the scientific workforce and infrastructure to support innovative research FURLS provides users from across the FDA the ability to share regulated products information such as registered firms, inspections and listing of products to make regulatory decisions, in addition to having consolidated views of data to further advance researches and other programmatic initiatives.
Objective 5.3 - Optimize information technology investments to improve process efficiency and enable innovation to advance program mission goals FURLS leverages existing external and internal services (i.e. investments) to validate data, to exchange data, and to promote sharing of business processes across FDA Centers.
Objective 5.4 - Protect the safety and integrity of our human, physical, and digital assets FURLS complies with, and utilizes all, applicable security standards and records management, on both extranet and intranet environment, to facilitate user's submissions and maintenance of digital assets.