The Food and Drug Administration (FDA) has issued an 8(a) set-aside solicitation for a single-award IDIQ supporting the Human Foods Program’s Food Applications Regulatory Management (FARM) platform and related IT systems. The opportunity combines long-term operations and maintenance with application development to support the regulatory review of food chemicals, dietary supplements, food additives, and other human foods submissions.
FARM is the primary system used by FDA scientific reviewers to manage regulatory submissions, conduct chemical and toxicological reviews, process correspondence, respond to Freedom of Information requests, and maintain historical regulatory records. The platform supports multiple FDA organizations and interfaces with CERES, TRAM, STARI, WILEE, and other Human Foods Program systems. The contractor will be expected to support this multi-system environment while maintaining system availability and supporting evolving program requirements.
The scope includes project management, enterprise application operations and maintenance, database administration, release management, help desk services, infrastructure support, system administration, user training, security compliance, workflow automation, reporting, content management, online submission processing, and integration support. The contractor will also perform development, modernization, and enhancement activities, including new application development, workflow improvements, system integrations, and enhancements to search, reporting, and data management capabilities.
The solicitation also includes work to enhance Appian workflows, improve integration across FDA systems, expand regulatory data search capabilities, and support implementation of AI-enabled regulatory review workflows using FDA-approved tools, including Elsa and MARS. Additional development activities include enhancements to the Centralized Online Submission Module (COSM), integration with FDA Identity, Credential, and Access Management capabilities, and improved interoperability across Human Foods Program systems.
Task Order 1 focuses on maintaining the current FARM 13.x production environment while supporting future releases. The contractor will provide 24/7 operational support for the mission-critical platform, manage software releases, perform database and application maintenance, operate the FARM Helpdesk, support cloud and on-premises environments, coordinate with FDA modernization initiatives, and maintain system documentation and Enterprise Performance Lifecycle artifacts throughout the contract.
This opportunity is best suited for 8(a) systems integrators and federal IT contractors with experience supporting enterprise business applications, Appian development, Java enterprise environments, Oracle database administration, cloud operations, enterprise system integration, application operations and maintenance, and FDA or other federal regulatory IT environments.
Read more here.
Solicitation Number: 75F40126R00042 – FDA-RFI-75F40125R00031
