Attachment 1 - SOW Critical Task Areas.pdf

Request for Information: 75F40126Q00072 Title: Systems for Inspection & Imports, Recalls Compliance, and Enforcement (SIRCE) II Sent Date: February 19, 2026 Response Due Date: March 6, 2026 @ 12pm Eastern Time

Attachment – 1 SOW Critical Task Areas

Systems Integration and Engineering Services Systems integration and Systems engineering services encompasses the necessary tasks to develop integration and interoperability strategies for evolving systems, phasing out legacy systems, and phasing in new systems by collaborating with other organizations as needed. Recommend strategies to address business/mission needs, and integration, interface, and interoperability challenges within and across environments.

Architecture Support Services Encompasses the necessary tasks to provide the full range of architecture support services to develop and minimize the cost of developing and maintaining integrated, end-to-end automated systems that provide enhanced IT capabilities necessary to support business and mission processes. These architectural services provided should support a more intuitive workflow and reduce the amount of time required for users to complete their tasks. This stable evolutionary progression from an organization’s current state to its envisioned future state shall be achieved by developing software following modern architecture and design principles and identifying tools and technologies using full cycle benefit analyses that work together to satisfy the needs or changing business needs of users.

Artificial Intelligence Encompasses the necessary tasks to provide comprehensive AI adoption and implementation support services to enhance capabilities through the strategic integration of artificial intelligence technologies. This includes both enhancement of existing systems with AI capabilities and development of standalone AI-driven solutions to support FDA's regulatory mission. The Contractor shall support the full spectrum of AI technologies including traditional machine learning, generative AI, and emerging AI capabilities to improve operational efficiency, decision-making, and regulatory effectiveness.

Representative tasks under this task area include, but are not limited to:

AI Strategy and Planning Develop AI adoption roadmaps and implementation strategies aligned with business objectives and FDA's regulatory mission;

Conduct AI readiness assessments for existing systems and business processes to identify optimal AI integration opportunities;

Perform feasibility studies and cost-benefit analyses for proposed AI solutions;

Create AI governance frameworks that ensure ethical AI development and deployment while maintaining compliance with FDA standards;

Develop AI use case identification and prioritization methodologies to maximize business value and regulatory impact.

AI Solution Development and Integration Design, develop, and implement AI and machine learning models for various regulatory processes and program/project management tasks, including automated risk scoring, pattern recognition, predictive modeling algorithms, project reporting, data calls, and knowledge management;

Create natural language processing solutions for document analysis, text classification, information extraction, and automated content review across diverse regulatory materials;

Develop computer vision systems for image analysis, object detection, quality assessment, and visual inspection processes;

Implement AI-powered rules engines for automated decision support, workflow optimization, and intelligent routing systems;

Build predictive analytics models for forecasting, trend analysis, anomaly detection, and resource optimization across operational domains;

Develop generative AI solutions for content creation, automated reporting, summarization, and intelligent assistance capabilities;

Create intelligent automation workflows that integrate AI capabilities with existing business processes to enhance efficiency and decision-making;

Implement recommendation systems for process optimization, resource allocation, and decision support across various operational areas;

Develop AI-powered data analysis tools for pattern discovery, correlation analysis, and insight generation from complex datasets.