75F40126Q00072_Amendment 03 - SIRCE II.pdf

Request for Information: 75F40126Q00072 Amendment 03 Title: Systems for Inspection & Imports, Recalls Compliance, and Enforcement (SIRCE) II Amendment Date: February 24, 2026 Response Due Date: March 6, 2026 @ 12pm Eastern Time

Introduction 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.

Summary Contemplated Magnitude

FDA anticipates that the SIRCE II effort will have a five (5) year period of performance with a value up to $300M. The quantity of task orders awarded each year is estimated to be from 2-4.

FDA anticipates that the awardee will have fifteen (15) business days to respond to each task order and will be responsible for fully staffing each effort within fifteen (15) business days of award.

Purpose and Scope This RFI seeks to understand the marketplace's ability to deliver modern, scalable IT solutions that support FDA's mission-critical operations. The initiative encompasses comprehensive technology services including cloud infrastructure management, software development, artificial intelligence implementation, cybersecurity, and operations and maintenance across hybrid cloud environments.

The FDA is particularly interested in vendors who demonstrate:

• Proven experience with large-scale, complex IT modernization efforts

• Expertise in implementing and managing hybrid cloud environments (AWS, Azure, Google Cloud)

• Advanced capabilities in artificial intelligence and machine learning technologies

• Strong track record in DevSecOps methodologies and automated deployment pipelines

• Ability to rapidly scale teams and respond to concurrent task order solicitations

Market Research Objectives Through this RFI, the FDA aims to:

1. Assess Market Capabilities: Evaluate industry capacity to meet the technical and operational requirements outlined in the draft Statement of Work

2. Gather Industry Feedback: Collect recommendations for improving the solicitation approach, evaluation criteria, and technical requirements

3. Understand Pricing Approaches: Gain insights into cost structures and performance optimization strategies

4. Identify Innovation Opportunities: Explore emerging technologies and best practices that could enhance program outcomes

This market research will inform the development of the formal solicitation and help ensure that the SIRCE II program leverages the most effective industry capabilities and innovative approaches available in the marketplace.

Important Note: This RFI is for market research purposes only and does not constitute a solicitation for proposals. No contract will be awarded based on responses to this RFI, and the FDA is not obligated to issue a subsequent solicitation.

Information Request The FDA is looking for input on its draft critical SOW Task Areas and Technology Stack provided in Attachments 1 and 2. In addition, FDA is looking for responses on the questions below.

Technical Expertise

1. Discuss and provide examples of how your company has been able to keep pace in implementing modern technology and retiring legacy/unsupported systems.

2. Provide examples of how your company has implemented and/or supported automation efforts; i.e. automated system provisioning and deployments, writing scripts to automate routine tasks, etc.

3. Discuss and provide examples of how your company has minimized the failure rate of mission critical systems; i.e. appropriate level of logging and awareness, high availability, redundancy, fail-over capability, etc.

4. Describe how your company ensures that the system resources being requested and provisioned (i.e. servers, storage, databases, platform (web) services, etc.) are right sized to the performance of the application/product.

5. Describe your company’s success in implementing and managing hybrid cloud environments; internal (RHEV, VMWare, Citrix) & external (AWS, Google, Azure).

6. Describe your company’s success in meeting the Security standards of today and your approach toward risk mitigation and patching of systems.

7. How do you ensure new team members are quickly brought up to speed on technology that is considered custom, legacy and unsupported.

8. How does your company ensure that critical Operations and Maintenance procedures and support plans are maintained and kept up to date.

9. How does your company navigate and plan for Operations and Maintenance activities in the evenings and weekends (outside of business hours?) that have the potential to impact multiple systems.

10. What are the key discriminators that the Government should consider as evaluation criteria?

11. Based on your experience with IT application development contracts, what cost, Quality Assurance (QA), and performance optimizations would you recommend including in the solicitation to effectively manage governance, quality, and cost? Please provide sample language.

12. Provide an explanation of any additional technologies and/or best practices that should be considered for inclusion within the SOW and why?

13. Are there any sections in the SOW where the intent of the government is unclear?

14. What information is needed for you to accurately price the contract?

15. What type of specialized certifications should be required for developers assigned to support specific technologies such as AWS, Appian, Salesforce, AI/ML capabilities?

16. What emerging technologies should the government consider for inclusion as optional tasks?

17. How would you approach software development lifecycle management, including methodologies (Agile, DevSecOps, etc.) and quality assurance processes?

Artificial Intelligence (AI) Integration and Innovation

1. Provide examples or suggestions to accelerate the product delivery life cycle using AI-enabled tools. How have acceleration and cost savings been realized?

2. Given the rapid evolution of AI, how can agencies structure contracts to allow for incremental adoption of AI capabilities without triggering full recompetes or major contract modifications?

3. What are examples of successful AI pilots or phased implementations that respected federal acquisition constraints?

4. What experience do you have in applying AI within a software development environment? Please specify which AI tools and how you applied them.

Program Management

1. How has your company responded to multiple, concurrent task order solicitations with responses due in 10 business days, without sacrificing quality?

2. How has your company proposed to, and on-boarded up to 100 resources? Please include the timeframe from onboarding.

3. Propose an organizational structure including team size, recommended labor categories, to support an effort such as described in the draft SOW.

4. What key performance indicators (KPIs) do you use to measure success?

5. What is your project management methodology for a program of this size? How do you handle scope changes, risk management, stakeholder communication?

6. What personnel, skillsets and qualifications would you consider key to successful delivery (aka Key Personnel)

7. What metrics do you propose to monitor program health?

Response Section Responses are to be submitted to Noah Padilla, Contract Specialist. Email is preferred. Please include the RFI number in the response. Do not send information that requires a non-disclosure agreement or sensitive business information. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Interested companies must submit a Capability Statement limited to 10 pages that provides responses to the following requested information. Capability statements will not be returned and will not be accepted after the due date.

Note that FDA reserves the right to contact one or more of the respondents if additional information is required or to request demonstrations of available systems.

• RFI number: 75F40126Q00072

• RFI release date: February 19, 2026

• RFI response date: March 6, 2026

• Point of Contact email: Noah.Padilla@fda.hhs.gov

Interested parties shall respond with following information:

• Company Name

• Company Address

• Company Point of Contact, phone number, and email address.

• Type of company under NAICS, as validated via the System for Award Management

(SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp.

• Small Business Socioeconomic program, if applicable

• Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.)

• Current GSA Schedules appropriate to this Sources Sought

• Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the response.

• A SOLICITATION IS NOT CURRENTLY AVAILABLE. The Government is not obligated and will not pay for any information received from potential sources as a result of this RFI.

• For any questions regarding this RFI, please note the question(s) in the response, however FDA will not respond to any questions at this time. The purpose of providing questions, is for FDA to consider them in developing its requirement.

• For purposes of the RFI, the capabilities statement shall not exceed 10 pages of text;

graphics, tables and diagrams do not count toward the page limit. The document(s) shall be prepared using Times New Roman 12-point font style for printing on 8.5 X 11-inch paper. Each page shall identify the submitting respondent and page number. Page Margins shall be no less than 0.5” on all sides. A complete response to the RFI should include answers to all the information requested. Responses should demonstrate capability, not merely affirm the respondent’s capability (i.e. the response must go beyond the statement that, “XYZ company can provide O&M support”).

http://www.sam.gov/index.asp