FDA's responsibilities to protect the public health are broad, complex, and necessary because the products we regulate are in every American home and used every day. To continue to meet our mission and increasing responsibilities we need more effective and efficient business processes, increased capabilities to better use our data, and more coordinated development of the information technology systems designed to support these activities. FDA is advancing an agency-wide enterprise approach to business process, data, and technology management that will allow us to work more efficiently and optimize use of the vast amount of data that is the foundation of our work.  

This Enterprise Modernization Action Plan (EMAP) describes our plans to shape FDA’s future by delivering successful cross-agency efforts that optimize common and essential business processes. These efforts will improve operational efficiency and use of our data, while strengthening the alignment between agency-wide strategic objectives and investments. The EMAP is the next installment pf the FDA’s stronger data and technology foundational approach started with the Technology Modernization Action Plan (TMAP) and Data Modernization Action Plan (DMAP) that are in action today.

Enterprise Modernization Action Plan (EMAP)

The three components of the EMAP include:

1. Create the Infrastructure to Support Change: The Enterprise Transformation Operation (ETO) team was created within the Office of the Commissioner and strategically reviews enterprise-wide challenges and implements optimized business processes. The ETO is governed by a committee of the Agency's senior leadership charged with prioritizing the most pressing priorities and change opportunities.

2. Develop a Common Operational Approach: The ETO will employ a standardized approach to analyze, recommend, and implement agreed-upon enterprise business programs that solve shared, cross-agency issues by optimizing business processes and use of data across multiple Centers/Offices.

3. Ensure Strategic Alignment: Improving alignment between agency-wide strategic objectives and program activities will help us effectively manage funding to increase return on investment and improve operational and employee effectiveness and efficiency. 

The EMAP focuses our modernization efforts on optimizing our processes to support the people at the forefront of these efforts and more effectively achieve our public health mission. These efforts are aimed at the business of the organization as we focus on common problems affecting more than one FDA organization to best use our financial resources, improve operational efficiency, and improve use of our data. These efforts will enhance decision-making by improving availability of information and knowledge across the FDA. We see this as an investment in our mission-driven staff, who are the collective stewards of our data, and will enable us to meet increasing demands.

Modernization at the FDA is an ongoing, continuous journey, requiring a comprehensive, flexible strategy, supported by a change mindset at all levels of the agency. It requires that we break down barriers and eliminate silos – both structural and behavioral. With the EMAP, TMAP, and DMAP, the FDA has a solid framework to drive the modernization that will improve business outcomes. This comprehensive and integrated approach ensures that we operate as a single agency, with our employees, technology, and budget all optimized to meet our public health mission.