Sirce II

Closed Pre-Solicitation Posted

Solicitation number
75F40126Q00072
Agency
FDA Office of Acquisition and Grant Services Food and Drug Administration, Department of Health and Human Services
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
541512 Computer Systems Design Services
PSC
DA01 It And Telecom - Business Application/Application Development Support Services (Labor)
Place of performance
Rockville, Maryland, United States
Points of contact

Notice details come from SAM.gov. Updated .

About this opportunity

The U.S. Food and Drug Administration (FDA) is conducting market research through a Request for Information (RFI) to identify qualified vendors capable of supporting the Systems for Inspection & Imports, Recalls Compliance, and Enforcement (SIRCE) II initiative, which encompasses comprehensive IT modernization and support services including cloud infrastructure management, software development, artificial intelligence implementation, cybersecurity, and operations and maintenance across hybrid cloud environments. The RFI, issued February 19, 2026, seeks to assess industry capabilities and innovative approaches for delivering these services. Interested vendors must submit a capability statement limited to 10 pages of text addressing 28 detailed questions across three categories: Technical Expertise (17 questions), Artificial Intelligence Integration and Innovation (4 questions), and Program Management (7 questions). The FDA is evaluating responses based on demonstrated experience with large-scale IT modernization, hybrid cloud environments (AWS, Azure, Google Cloud), advanced AI and machine learning capabilities, DevSecOps methodologies, rapid team scaling, and the ability to handle concurrent task orders with 15-business-day response and staffing timelines. Submissions must be emailed to Noah.Padilla@fda.hhs.gov by March 6, 2026, at 12:00 PM Eastern Time, and should include company information, NAICS code validation via the System for Award Management (SAM), current GSA schedules, and verification points of contact, with responses emphasizing specific examples of capability rather than general affirmations.

This is a pre-solicitation notice with no set-aside designation, and the FDA explicitly states that no contract will be awarded based on RFI responses and the agency is not obligated to issue a subsequent solicitation. The anticipated contract value is up to $300 million over a five-year period of performance, with an estimated 2-4 task orders awarded annually to selected vendors. Awardees must be capable of responding to each task order within 15 business days and fully staffing efforts within 15 business days of award, demonstrating organizational capacity to handle multiple concurrent task orders. The RFI encompasses three critical task areas: Systems Integration and Engineering Services for developing integration strategies and managing legacy system phase-outs; Architecture Support Services providing full-range support for integrated, end-to-end automated systems using modern design principles; and Artificial Intelligence services including AI strategy, planning, solution development, and implementation of machine learning, natural language processing, computer vision, predictive analytics, and generative AI solutions. Vendors should be familiar with or capable of supporting a representative technology stack including AWS EC2 as the primary cloud platform, Azure and Google Cloud as secondary platforms, DevSecOps tools (Jenkins, Git/GitLab, SonarQube), AI platforms (Amazon SageMaker and Bedrock, Azure AI with OpenAI, Google Vertex AI), and multiple programming languages and frameworks including Java, Python, .NET, and Spring Boot.

Notice text

4 versions

Update #4 · Latest ·

The purpose of Amendment 03 is to increase the page limit to 10 pages.

The purpose of Amendment 02 is to remove this statement formerly located in the last paragraph, " Please note that a respondent’s failure to provide a complete response to the information requested in this Section 7, will be interpreted to mean that it does not understand what information is being requested and does not demonstrate the capability to provide services required." 

The purpose of Amendment 01 is to correct the estimated ceiling from $400,000,000 to $300,000,000.

The U.S. Food and Drug Administration (FDA) is conducting market research to identify qualified vendors capable of supporting the OII Systems for Inspection & Imports, Recalls Compliance, and Enforcement (SIRCE) II initiative. This Request for Information (RFI) is issued solely for market research purposes to assess industry capabilities, capacity, and innovative approaches for delivering comprehensive IT modernization and support services.

Update #3 ·

The purpose of Amendment 02 is to remove this statement formerly located in the last paragraph, " Please note that a respondent’s failure to provide a complete response to the information requested in this Section 7, will be interpreted to mean that it does not understand what information is being requested and does not demonstrate the capability to provide services required." 

The purpose of Amendment 01 is to correct the estimated ceiling from $400,000,000 to $300,000,000.

The U.S. Food and Drug Administration (FDA) is conducting market research to identify qualified vendors capable of supporting the OII Systems for Inspection & Imports, Recalls Compliance, and Enforcement (SIRCE) II initiative. This Request for Information (RFI) is issued solely for market research purposes to assess industry capabilities, capacity, and innovative approaches for delivering comprehensive IT modernization and support services.

Update #2 ·

The purpose of Amendment 01 is to correct the estimated ceiling from $400,000,000 to $300,000,000.

The U.S. Food and Drug Administration (FDA) is conducting market research to identify qualified vendors capable of supporting the OII Systems for Inspection & Imports, Recalls Compliance, and Enforcement (SIRCE) II initiative. This Request for Information (RFI) is issued solely for market research purposes to assess industry capabilities, capacity, and innovative approaches for delivering comprehensive IT modernization and support services.

Update #1 ·

The U.S. Food and Drug Administration (FDA) is conducting market research to identify qualified vendors capable of supporting the OII Systems for Inspection & Imports, Recalls Compliance, and Enforcement (SIRCE) II initiative. This Request for Information (RFI) is issued solely for market research purposes to assess industry capabilities, capacity, and innovative approaches for delivering comprehensive IT modernization and support services.

Attachments

Files attached to this notice, newest first
File Type Posted
75F40126Q00072_Amendment 03 - SIRCE II.pdf PDF
75F40126Q00072_Amendment 02 - SIRCE II.pdf PDF
75F40126Q00072_Amendment 01 - SIRCE II.pdf PDF
Attachment 1 - SOW Critical Task Areas.pdf PDF
Attachment 2 - Representative Technology Stack.pdf PDF
75F40126Q00072 - SIRCE II.pdf PDF

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