The U.S Food and Drug Administration is establishing an Indefinite Delivery/Indefinite Quantity (IDIQ) contract to provide IT support services to support FDA’s goal for improved management of information across the agency by using the current or most appropriate E2B and Fast Healthcare Interoperability Resources (FHIR) based exchange standard.
The scope of this IDIQ contract includes all activities necessary to address the system development, system operation and maintenance support, and system enhancement of the FDA E2B/FHIR essential applications, which includes, but is not limited to:
- Specification
- Design, coding, system test, data migration, implementation
- Training and development of training artifacts
- Project Management following FDA standards
- Operations and Maintenance
- Requirements Analysis and Development
- Business Process Modeling
- Data Migration, Integration and Testing
- Purchasing/Upgrading of COTS Licenses
- Purchasing/Upgrading of Hardware
- Integration of Enterprise Projects
- Improving management of structured and unstructured data
For all tasks the Contractor shall:
- Provide all deliverables as indicated in each task order (TO).
- Conduct all software system development activities in a manner consistent with the HHS EPLC, unless a waiver is granted by the FDA COR (PO). In all cases where the Contractor seeks to pursue an alternative to the EPLC, the request shall be made in writing (email acceptable) to the FDA TO COR. In all cases, permission to substitute or omit EPLC artifacts or otherwise interpret the EPLC requirements for the FDA E2B and FHIR Data Exchange Service project shall be provided on behalf of the government by the FDA TO COR or his/her delegate.
- Utilize configuration management procedures approved by the FDA TO COR.
- Support the activities of the FDA Bioinformatics Board (the FDA Information Technology Investment Review Board), the Configuration Control Boards and the Technical Control Boards of the programs that will interface with the FDA E2B and FHIR Data Exchange Services, and assist in the development and documenting of problem/change requests.
- The Contractor shall design the solution to utilize existing and emerging CDER strategic capabilities to support data integration, technology consolidation, and reuse. Note some of the strategic capabilities are in development…
