GDIT awarded $48M FDA OneNexus Program Support contract

This new 5-year contract was not competed and was awarded as a follow-on action following initial competitive action

Awardee Name: GENERAL DYNAMICS INFORMATION TECHNOLOGY, INC.
Unique Entity ID: SMNWM6HN79X5
Total Contract Value: $47,962,832.95
Action Obligation: $15,735,879.05
Department Name: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Funding Agency: FOOD AND DRUG ADMINISTRATION
Number of Bidders: 1
Award ID: 75F40125F80027
Referenced IDV ID: GS35F393CA
Contract Vehicle: GSA MAS
NAICS: 541511
Award Type: Delivery Order
Start Date: 2025-03-14
Ultimate Completion Date: 2028-03-23

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Notice ID 75F40125Q00083

The purpose of this acquisition is to allow CDER to retain IT services for planning, development, and maintenance of OneNexus, an enterprise-wide workflow and knowledge management platform. The platform is necessary to allow CDER to meet obligations under several pieces of legislation, including PDUFA, GDUFA, BsUFA, OMUFA, CARES, 21st Century Cures, and others. The acquisition will serve as a logical follow-on to the existing Order 75F40121A00008/75F40122F19004.

This acquisition will allow CDER to retain IT services for planning, development, and maintenance of OneNexus, an enterprise-wide workflow and knowledge management platform. The platform is necessary to allow CDER to meet obligations under several pieces of legislation, including PDUFA, GDUFA, BsUFA, OMUFA, CARES, 21st Century Cures, and others.

In 2018 the Center for Drug Evaluation Research (CDER) began a multi-year effort to modernize its Workflow Management (WFM} systems. The Center’s goal was to take advantage of improved technology, thus enhancing business processes and knowledge management that support its ability to protect the health and safety of the American public. Improved informatics for workflow and knowledge management is needed to support the modernization of regulatory review processes in CDER so the Center can meet the increasing demands it faces. While this need is of the utmost importance in and of itself, there’s an additional imperative for speedy delivery of a modernized system due to the time-critical requirement to retire two legacy systems that have outgrown their useful life: Panorama and DARRTS. These systems not only lack the capability to deliver modern solutions to CDER’s business needs but are the source of unacceptable cybersecurity and financial risks to FDA and the U.S. government.

In 2022 the OneNexus program was established by CDER’s Director to address the urgent needs mentioned above. Over the past 18 months General Dynamics Information Technology (GDIT} has transitioned into the key contract support role and has been

instrumental in setting overall strategy, developing strategic and tactical roadmaps, and initiating requirements gathering and software development efforts. While OneNexus program goals are aggressive, by executing an efficient roadmap with a team of experts who have been heavily involved in foundational efforts over the past 2 years, CDER is confident the program can be successful. However, for CDER to meet its goals within the deadlines dictated by the Center Director, it’s imperative that continuity be maintained by ensuring GDIT remains in place during this crucial and extremely risky phase of the program. Key achievements that have occurred to this point with vital cooperation between GDIT and government staff include:

• Collaborative development of program strategies and
• Project planning, prioritization, segmentation, and other detailed project documentation. These are based on GDIT’s assessments of technical complexity and dependencies, and reliant on expertise established by GDIT personnel through extensive time and effort working with government personnel on this novel
• Delivery of testable proof of concept covering the filing review process for marketing This was developed by GDIT using the Appian low-code platform, CDEROne, and other supporting technologies.
• Requirements gathering with 8 separate Integrated Project Teams (IPT} staffed with key business personnel, OBI staff, and GDIT analysts and developers.
• Partial development of several “common components,” which are reusable software modules that will form the basis of OneNexus platform

At the time of award of the new Order, the program roadmap calls for significant additional development to have occurred. By April 2025, GDIT analysts, developers, and architects will be in the midst of complex software development involving dozens of integrated components, supported by multiple cross-functional teams.

This acquisition will ensure retention of experienced personnel to develop sustainable and scalable end-to-end platforms built using common software components, based on a unified enterprise data model and harmonized user interface. Common components are complex software modules built in such a way that they can be re-used across many use cases, and still meet critical business needs for stakeholders across the agency. Key scope for the OneNexus program includes the following:

1. Unified enterprise data model: To allow for consistency in data management, informatics solutions should be built on a CDER-wide common data model. The contractor will assess legacy applications to identify gaps in the enterprise data model and recommend For each new implementation, a data architecture assessment shall be completed to align with the unified enterprise data model.

2. Common and modular components: To maximize efficiency and speed of delivery, common components based on CDER-wide common processes should be developed and used across applications. The contractor will assess CDER business processes, make recommendations following CDER’s informatics architecture principles as to which ones should be prioritized, and develop common components for re-use.
3. Unified and harmonized user experience: To ensure a consistent user experience and efficient scalability, a unified and harmonized user interface should be implemented across applications. The contractor will work with government personnel to assess existing applications and recommend designs for such an interface. The contractor will develop and implement the unified interface according to government direction.
4. Governance: To allow for continuous improvement of common components and interfaces while ensuring proper controls, a well-defined governance model will be established. The contractor will collaborate with the Development and Operations team to establish governance mechanisms to manage common components and interfaces across system stakeholder groups. The contractor will participate in governance strategic planning and development/maintenance activities.

• The current Order was originally awarded using a competitive acquisition under the Workflow Management Broad Purchase Agreement (BPA}. The following 7 contractors

were selected to compete for workflow management modernization contracts under the BPA: Booz Allen Hamilton, Deloitte, GDIT, TSPI, Groundswell, Ignyte Group, and REI Systems. In response to the RFQ, five quotes were received. After a rigorous selection process that included written quotes and oral presentations, GDIT was awarded the Order without protest. The Order included a base year and two options years, for a total of 3 years. This gave sufficient opportunity for GDIT to establish their team, develop necessary knowledge, and make significant headway in planning and development. The next Order represents logical follow-on work that relates directly to the efforts undertaken by GDIT since being awarded this Order in 2022, and whose timely success is reliant on the expertise and knowledge present within the program, which has been established through significant contractual investment. The work requires a deep understanding of the strategic and technical intricacies of the program and cannot be logically separated from the previous work at this phase of the program without increasing schedule, cost, and technical risk to an insurmountable level. While there are other vendors who can do this type of work, to attempt a change in vendor one third of the way through a complex software project would raise the risk to such a degree, that likelihood of successful on-time and on-budget delivery would be near zero. A change in contractor at this point would result in irrecoverable loss of economy and efficiency that would impose unacceptable risk to the program schedule and delivery quality. The loss of economy and efficiency would result in near certain realization of risk that would lead to failure of the program to meet critical goals in a timely fashion. Further, due to the time limitations, security vulnerabilities, and legislative mandates, an inability to meet timelines does not simply represent a delay in delivery, but instead would constitute a complete failure of the program.

In addition to the issues stated above, it is well understood that new contractors on a program of this magnitude experience a challenging learning curve. They would lack a current knowledge base, previous subject matter expertise will have been lost, and FDA employees would be required to fill many gaps. Engagement with a new contractor would result in substantial duplication of resources, time, and money already invested in gaining knowledge and insight required for the program to be executed successfully. This further exacerbates the loss of economy and efficiency and creates and untenable burden on government employees. Due to the complex, enterprise-wide nature of the program. The loss of economy and efficiency would be substantially higher than what would be tolerable, to the point that the program would be highly unlikely to overcome the losses and deliver successfully. The planning and development completed to date touches all critical software systems used by CDER to complete its mission. The program is entering a critical development phase with significant technical risk, and this phase has followed immediately from the detailed planning phase. At the time of award, the most challenging aspects of development will be well underway, with no reasonable expectation that it could simply be handed to a new team and continue without calamitous negative effects.

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