FDA ORA Regulatory Business Information Services
Investment ID: 009-000005316
Overview
Program Title
FDA ORA Regulatory Business Information Services
Description
The Regulatory Business Information Services (RBIS) program mission is to provide data management, reporting, business intelligence, analytics, and predictive analysis to support ORA and Centers regulatory enforcement operations, work planning activities, evaluate accomplishments, risk assessments and similar activities. RBIS investment addresses three main business needs: 1) Master Data Management of ORA Firm Inventory through FDA Inventory Data Assets (FIDA); 2) Data Warehouse and Business Intelligence capabilities provided through Online Reporting Analysis Decision Support (ORADSS); 3) Big Data Analytics and Predictive Analysis capabilities provided through Online Search and Retrieval (OSAR) / Firm360, Center Views (CV) and Resource Library (RL). Additionally, the RBIS investment houses FDA's ORA Dashboard and Health Fraud Surveillance efforts. The RBIS investment is also aligning its efforts to FDA IT Modernization by aligning ORA priorities to ODT's Strategic Priorities.
Type of Program
Major IT Investments
Multi-Agency Category
Not Applicable
Associated Websites
https://datadashboard.fda.gov/ora/index.htm
Investment Detail
Centers utilize RBIS applications to obtain establishment and ORA field operations data in order to implement workforce planning, establish food safety policies, and enforce compliance programs on regulated products. RBIS identifies and removes duplicate firms from ORA's inspection location inventory, thereby improving ORA's operations. RBIS provides web services to validate addresses and match firms within the establishment inventory. Multiple applications used by ORA, CFSAN, CDER, CTP and CDRH benefit from these services, evidenced by the services receiving over 100,000 calls per month.
RBIS provides a fast and easy to use search capability to view structured and unstructured data including: Field Accomplishment Computerized Tracking System (FACTS) inspection data, establishment inspection Reports, FDA 483 Observations report, firm details and history data, and recall information. RBIS includes a critical 24/7 application supporting field entry reviewers in the admissibility decisions of import operations. RBIS has over 25 Business Intelligence Universes for ad-hoc reporting, 1,000 pre-defined reports and over 70,000 user-defined reports supporting a wide variety of functions across FDA.
Over the span of 7 years, RBIS will have an estimated cost avoidance total of $150.380M with the following breakdown: $63.063M cost avoidance in productivity improvements, $9.8M in lives saved, $34.591M in avoided cost to industry, $20.5M health care costs, and $22.426M in staffing.
RBIS provides a fast and easy to use search capability to view structured and unstructured data including: Field Accomplishment Computerized Tracking System (FACTS) inspection data, establishment inspection Reports, FDA 483 Observations report, firm details and history data, and recall information. RBIS includes a critical 24/7 application supporting field entry reviewers in the admissibility decisions of import operations. RBIS has over 25 Business Intelligence Universes for ad-hoc reporting, 1,000 pre-defined reports and over 70,000 user-defined reports supporting a wide variety of functions across FDA.
Over the span of 7 years, RBIS will have an estimated cost avoidance total of $150.380M with the following breakdown: $63.063M cost avoidance in productivity improvements, $9.8M in lives saved, $34.591M in avoided cost to industry, $20.5M health care costs, and $22.426M in staffing.