A Metis Customer Success Story: FDA Leverages Enterprise Architecture to Make Faster, Better Business and IT Budget Decisions.

SEATTLE -- The U.S. Food and Drug Administration protects the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the nation's food supply, cosmetics, and products that emit radiation. As such, the FDA plays a central role in managing today's most urgent health issues, including toxins in the food supply such as mercury in fish, food-borne illnesses such as BSE ("mad cow disease"), harmful agents such as the Ephedra dietary supplement, the safety of imported drugs, etc. The FDA even figures prominently in counterterrorism efforts by working with food safety agencies at federal, state and local levels to strengthen the nation's food safety system across the entire distribution chain, from the farm to the table.

To successfully fulfill these and other critical responsibilities, the FDA is continually refining and improving its business processes and its supporting Information Technology infrastructure. To that end, the agency has embarked on creating an Enterprise Architecture (EA) that provides:

--A planning framework for ensuring that every FDA organization's use of and investment in information resources and technologies align with and support its business needs.

--A means of looking at an entire enterprise, across barriers that have developed over time in many organizations (functional, programmatic, or organizational stovepipes).

--A view of the current environment (baseline), a vision for the future (target), and a plan for moving from the baseline to the target environment (implementation, migration, or transition plan).

--A key interlocking piece of a broader planning framework that includes strategic planning, capital planning and investment control, budgeting, systems development/acquisition life cycle management, and other key processes.

The Enterprise Architecture effort at the FDA, a top priority set by Chief Information Officer James J. Rinaldi, began in September 2002. Since then, the EA - which spans over 200 applications running on more than 500 servers and 10,000 desktops at FDA sites nationwide - has made solid progress on several fronts. Baseline architectures in most of the FDA's eight Centers and Offices(a) have been developed, and efforts on target architectures - which will be synchronized in a single unified architecture - are underway. An especially important area of development focuses on a component-based architecture, incorporating new technology standards for the electronic submission of documents and data throughout the review and approval processes for new drugs and biologic products. Groundbreaking work has also been done on integrating EA models into the FDA's Capital Planning and Investment Control (CPIC) process, a strategy with important benefits for the creation of "Exhibit 300" Business Case documents that must accompany requests to the Office of Management and Budget (OMB) for major project and program funding.

Tasked with driving the EA effort is Gary Washington, the FDA's chief architect. At the outset in the Winter of 2002, Washington realized the need for an EA modeling tool, and conducted a technology evaluation of EA tools available on the market. The tool chosen - the Metis(R) Enterprise visual modeling toolset from Computas NA - is now the standard across the FDA. Says Washington, "We store everything in our EA tool's repository, and the users have access to the tool based on their authorization. At their convenience, they can view the architecture as it applies to them, see the relationships between the different layers, drill down to deeper layers of detail, and generate reports based on what they've found. All of this is invaluable in giving them greater insight and understanding in their decision-making."

Key Benefits of the Enterprise Architecture include Security, Business Alignment

The FDA's EA crosses organizational boundaries, presenting an Agency-wide view of business operations and their associated technologies. By providing a visual structure for this complex information, the EA is providing many benefits, such as:

--Alignment - ensuring that implementation of reengineering and new information technology reflects management's intent.

--Integration - ensuring that interfaces and information flows are standardized, and that technology supports enhanced connectivity and interoperability across the Agency.

--Change management - identifying opportunities, then facilitating and managing change in all aspects of the Agency (e.g., process reengineering, organizational realignment, and incorporation of new technologies).

--Streamline development - reducing systems development and modernization timeframes and the resources required by these efforts.

--Convergence - realizing the IT product portfolio envisioned in the Agency's Technical Reference Model (TRM) as defined in the Federal Enterprise Architecture (FEA).

Washington notes that the EA is central to the FDA's efforts to address the government-wide objectives of legislation and directives such as the Clinger-Cohen Act, the Government Performance and Results Act (GPRA) and OMB Circular A-130. "These not only mandate an EA but also require processes and mechanisms that can only be effectively resolved by an EA," he says. "Moreover, in light of the events of September 11, 2001, our EA facilitates the flow of information and communication within the FDA and with other Agencies to prevent and counter bioterrorism attacks in our nation."

The FDA's EA tool also supports the Agency's emphasis on internal security, Washington says. "Our security is set up based on user roles, and the EA tool allows us to provide appropriate levels of functionality for each role - ranging from simple Web browsing to the use of a 'metamodel' template in actually developing new models. Within roles, there are granular security features for allowing users to view different layers, limiting them to particular layers and excluding them from others. The security functionality of the EA tool is centralized, ensuring that we can control each user's access individually."

EA Supports Capital Planning Process

An important recent development leveraging the EA has been its integration into the FDA's CPIC process. This capability leverages the EA tool's use of XML (eXtensible Markup Language) for data exchange between applications over the Internet. The EA tool allows automated importing of baseline Capital Asset Planning artifacts in XML format - such as the FEA Reference Models, existing Exhibit 300's, etc. Once an EA model is populated with this data, it can be updated with any proposed changes, and analytics can be performed to assist in creating documentation such as Exhibit 300's submitted to OMB. The result will be more effective decision-making as well as reduced time and effort to create or update the Exhibit 300 Business Cases.

The benefits of the EA are pervasive in the FDA, Washington says. "Every business user in the Program Areas is our customer, and they often request us to show the status of their infrastructure and how it relates to their data and applications. With our EA tool, we have empowered them to generate their own reports containing the information on which they can perform analysis in order to understand the impact of consolidating hardware and software, migrating to new platforms, etc. Likewise, they can know what would happen if a business process or organization disappeared. By supporting our customers in the background with our EA, we are enabling them to make faster, better business and IT budget decisions."

(a)The eight FDA Centers and Offices that FDA IT serves are: Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM), National Center for Toxicological Research (NCTR), Office of the Commissioner (OC), and the Office of Regulatory Affairs (ORA). A majority of FDA's IT resources are in the Washington, D.C., metropolitan area; NCTR is in Jefferson, Arkansas.