Office of Regulatory Affairs (ORA) Schema

Office of Regulatory Affairs (ORA) Schema

ORA Schema

The ORA Schema supports information sharing while enabling universal definitions to provide seamless exchange of regulatory, compliance, and enforcement data between ORA and various internal and external partners. These partners include State regulatory authorities, laboratories, foreign government agencies, and other federal agencies, among others.

What is a Schema?

A Schema describes the structure of a business entity and is a building block for information-sharing within a messaging platform.

What is the purpose of the ORA Schema?

The purpose of the ORA Schema is to provide uniform, system-independent structures that define entities and attributes, enabling sharing of data across various ORA business areas and external entities.

Why is the ORA Schema needed?

The ORA Schema enables the agency to share data across various internal and external partners by providing flexible universal data structure definitions. It enforces data standardization of the data exchange and does not restrict to any particular system, platform, or application. As such, the Schema provides flexibility for partners to build their system-specific data sharing features.

What is the underlying framework for the ORA Schema?

The ORA Logical Model is the basis for the key components of the ORA Schema. In certain instances, the existing physical database information is used for the convergence of the Logical Model with the current application at a high level. This is necessitated to enable the Data Access Service (DAS).

What is the ORA Logical Model and how does it relate to the ORA Schema?

The ORA Logical Model is a detailed representation of the organization’s data along with the entities and their relationships independent of any particular database, application, and storage technology. It describes the organization in business terms. The Logical Model is developed from the business requirements and is in synch with the ORA Schema.

What technology is used for the ORA Schema?

The ORA Schema is based on the XML Schema Definition (XSD) format. XSD-based structures allow FDA to remain technology and platform independent. XSDs are driven by industry standards (World Wide Web Consortium (W3C)) and promote flexibility and the foundation for a robust information exchange. XML-and XSD-based definitions allow compatibility with many applications/systems and can be seamlessly integrated within applications.

How often is the ORA Schema released?

Schema definition at ORA is consumer driven. The Schema is released periodically to meet project needs. It is similar to any software release in terms of major release, minor release, and patch.

Who is involved in the definition of the ORA Schema?

The project teams work very closely with the Schema development team as part of the ORA engagement model which includes processes related to the ORA Logical Model and Change and Release Management, along with the structural governance.

What is the current scope of the ORA Schema?

The current scope includes definitions for the initial Domestics and Imports data sharing capabilities. The National Food Safety Data Exchange (NFSDX) and ORA internal components such as DAS, Inspection Business Service (IBS), Imports Processing Business Service (IPBS), Mobile Application Framework (MAF), and Observation and Corrective Action Report (OCAR) currently use the ORA Schema.

What is the future scope of the ORA Schema?

In the future, every data sharing capability at FDA would use the ORA Schema. Potential data sharing tracks could include Produce Safety, Intelligent Questionnaire, and Preventive Controls.

Who do I contact for more information?