FDA_RFI_EMS.pdf

REQUEST FOR INFORMATION #FDA-RFI-Emergency Management System (EMS)

*MARKET RESEARCH PURPOSES ONLY – NOT A REQUEST FOR PROPOSAL OR SOLICITATION*

FOR: Emergency Management System (EMS)

DEPT/AGENCY INFORMATION: Department of Health and Human Services U.S. Food and Drug Administration (FDA)

Requiring Offices: Office of Inspections and Investigations (OII) Office of Emergency Management (OER)

GENERAL INFORMATION

The U.S. Food and Drug Administration (FDA) is issuing this request for information (RFI) as a means of conducting market research, pursuant to FAR Part 10 Market Research, to identify potential parties from the marketplace capable of supporting a Commercially Available off-the-shelf (COTS) Emergency Management System (EMS) for the benefit of all existing Emergency Operations Network (EON) Incident Management System (IMS) users and COPS throughout the FDA and comply and adhere to all FDA security standards.

This is a REQUEST FOR INFORMATION ONLY, not a Request for Quote (RFQ) and does not commit the Government to award a contract now or in the future. The purpose of this sources sought is to identify sources with the capabilities to provide the services stated herein. Submission of any information in response to this market survey is purely voluntary and FDA welcomes responses from all interested parties;

the Government assumes no financial responsibility for any costs incurred. Small businesses are encouraged to submit a response.

The FDA will use the results of the market research to determine if sources capable of satisfying the agency's requirements exist based on its response to the objectives described in this notice. The FDA does not intend to make a selection decision or award a contract on the basis of responses.

Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

INSTRUCTIONS

Responses should not exceed 15 pages in length excluding the cover page. If a cover page is included it should be no longer than 2 pages in length. A complete response should include answers to all the questions below. Please note that a respondent's failure to provide a complete response to a question will be interpreted to mean that it does not understand the question and does not demonstrate the capability to provide services required. 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 technical support").

Respondents will not receive individualized feedback on any suggestions. No basis for claims against the United States government shall arise as a result of a response to this request for information or from the United States government's use of such information. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Federal Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

While the Government anticipates establishing a contract for EMS which requires contractual support, 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 sources sought.

Companies are encouraged to respond if they have the capability and capacity to provide the identified services. Interested small business potential Offerors are encouraged to respond to this notice.

However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required.

Responses should be emailed to Brian Wodzisz, Contract Specialist, at Brian.Wodzisz@fda.hhs.gov by 2pm ET, May 25th, 2026.

Responses should reference: “FDA-RFI-Emergency Management System (EMS)” in the subject line. No phone calls will be accepted for this notice.

BACKGROUND

The Office of Emergency Management (OER) is seeking a new and modernized system for all office emergencies. EMS will serve a variety of users, who work with a variety of issues, including emergencies and day‐to‐day issues. Users need a platform that operates on an issue management model and has strong search and reporting capabilities. The system needs to allow extensive data collection for the different issue types and must be able to maintain the relationships between issues. The system needs to be flexible so that users can provide new features quickly. This allows FDA users to adapt to real‐world situations and adopt new business practices faster. The current EMS will replace an aging system called FDA Emergency Operations Network (EON) Incident Management System (IMS). EON IMS was developed in 2002 and went live in 2004. It’s an old and antiquated system that needs to be modernized. The scope of EMS is approximately 50% of EON IMS.

TECHNICAL OVERVIEW

The Emergency Management System (EMS) will be a knowledge management system used to capture incidents regarding FDA regulated products that are, or may be responsible for causing injury, illness, or adverse events. They provide timely awareness of public health issues involving FDA regulated products to key agency officials through alerts/notifications. They also capture the large volume of information the response may generate including early investigational activities and analytical findings. They can be used to generate Geographic Information System (GIS) maps of incident location. They create a historical record of response related information.

EMS will provide the FDA with the tools they require to perform the tasks necessary to fulfill the requirements of their job efficiently and effectively. The FDA is responsible for facilitating communication among all parties involved in the resolution of an emergency and for providing guidance and direction as needed to bring about the rapid and effective end to situations where public health is threatened.

Efficient and effective management of communication among involved parties is essential to the ability of the FDA to meet their designated mission. The nature of each emergency—and the resulting response— is unique and demands a flexible set of tools to assist FDA users in their emergency response activities, and yet the toolsets should not hinder the users’ need for expediency.

OBJECTIVE

The objective of this RFI is to secure information on an Emergency Management System (EMS) for the benefit of all existing EON IMS users and FDA Center, Offices and Programs (COPS) throughout the FDA that comply and adhere to all FDA security and privacy standards. Mandatory salient characteristics are shown below:

• COTS

• Real-time situational awareness and common operating picture

• Incident tracking and status dashboards

• Capability for producing reports in PDF, MS Excel, and MS Word

• Resource management and tracking

• Internal coordination and information sharing (and multi-agency if possible)

• Customizable dashboards and workflows

• GIS mapping integration

• Data available for FOIA requests

• Communication options

• Pre-built forms, org charts, reports, checklists, including Incident Command System (ICS) forms

• Supports multi-agency/multi-location events

REQUESTED INFORMATION

Interested organizations are requested to provide information addressing the following areas.

1. CAPABILTY STATEMENTS

Interested, capable vendors (parties) shall submit a Capability Statement in response to this notice with the following information:

Contact information:

1) Company Name

2) Mailing Address

3) Name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives.

4) SAM UEI

5) Business size for NAICS 541512 – Computer System Design Services with size limitation standards of $34,000,000.00 and status, if qualified as an 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran Owned Small Business (must be listed in the VetBiz Vendor Information Pages).

6) Company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the SAM (www.sam.gov) to be considered as potential sources.

7) Any Governmentwide Acquisition contract number(s) with period of performance to include option periods.

8) Proposed NAICS for this effort

2. SECURITY & PRIVACY

Describe how your organization addresses security and privacy considerations, including:

• Data protection practices

• Compliance with relevant security standards (HIPAA, NIST, FISMA, etc.)

• Data governance approaches

• FedRAMP - High

• Authority to Operate (ATO)

• Personal Identifiable Information (PII)

3. RELEVANT EXPERIENCE

Provide examples of similar capabilities or implementations your organization has provided for:

• Federal agencies

• Healthcare Organizations

• Public Health surveillance initiatives

• Safety monitoring systems

4. ROUGH ORDER OF MAGNITUDE (ROM) COST INFORMATION

Respondents are requested to provide indicative pricing approaches for an EMS solution. The information being requested to support market research should include the following:

• Subscription or licensing models (e.g. per user, per incident, tiered, enterprise license)

• Transaction-based pricing models

• Volume-based pricing tiers and applicable discounts

• Implementation or integration costs

• Training costs

• Operation & Maintenance (O&M) costs

• Data storage costs

• Operational capabilities (analytics, dashboards, advanced reporting, or other add-on features

• Scalability, surge capability, and associated costs

• Expansion capability and associated costs

• Information on Government pricing programs (GSA MAS, CIO-SP4, etc.)

• Any assumption that materially affects pricing

5. Additional Questions

The FDA is interested in learning:

1) Are implementation/integration services available, how does that process work and what are the potential durations?

2) Is the recommended product a Cloud solution, on-premise, or hybrid?

3) Is Operations and Maintenance (O&M) support included?

4) How does your organization handle data migration?

5) Can your solution handle a surge capacity during major incidents?

6) What type of mobile capabilities are available?

7) Is training and support documentation included?

VENDOR DAY REGISTRATION

The FDA anticipates hosting a Vendor Day to provide industry with additional insight into the potential requirement.

This session is intended to:

• Clarify the Government’s objectives, scope, and constraints

• Provide an opportunity for vendors to present capabilities and approaches

• Facilitate industry feedback to refine acquisition strategy

Participation in Vendor Day is voluntary and not required to respond to this RFI or any future solicitation

Format & Logistics:

Vendor day is expected to be conducted in a virtual format (final details to be provided via amendment to this RFI or separate notice).

The event will include:

• General Overview session

• Individual vendor sessions

The Government reserves the right to:

• Adjust the format based on the number of respondents

• Limit attendance per organization

Tentative Agenda:

• Program overview and mission context

• EMS functional scope and high-level requirements

• Operational scenarios (steady state and surge response)

• Technical environment and integration considerations

• Security, compliance, and data management expectations

• Acquisition approach and anticipated timeline

• Questions and answers (Q&A)

A detailed agenda, schedule, and access information will be provided to registered participants in advance of the event.

Vendor Presentations & Demonstrations:

Respondents may be invited to participate in vendor-specific sessions, which may include presentations and/or system demonstrations.

Vendor sessions may be conducted as:

• Live virtual demonstrations

• Slide-based presentations

Vendors are encouraged to focus on capabilities relevant to EMS, including incident tracking, workflow management, reporting, scalability, and integration.

Time Allocation:

Each individual vendor session is anticipated to be 45-60 minutes total, which may include:

• 30-40 minutes: Vendor presentation and/or system demonstration

• 10-20 minutes: Government questions and discussion

The Government may adjust time allocations depending on the number of participating vendors.

Suggested Topics for Vendor Sessions:

Vendors are encouraged to address the following areas, as applicable:

• Overview of the proposed solution and architecture

• Demonstration of incident management workflows

• Scalability and surge response capabilities

• Data management, reporting, and analytics features

• Security and compliance with federal requirements

• Implementation and/or integration approach and estimated timelines

• Pricing model overview (high-level)

Registration and Participation:

Organizations interested in participating in the Vendor Day should submit a registration request including the following information:

• Organization name and website

• Attendee name(s) and title(s)

• Email address

• Relevant capability areas

Registration requests should be submitted via email to: Brian Wodzisz – Brian.Wodzisz@fda.hhs.gov

Vendor Day Registration Deadline: May 25th, 2026, at 10:00AM mailto:Brian.Wodzisz@fda.hhs.gov

The Government will notify selected vendors of presentation opportunities and provide scheduling details.

Vendor Day is for information exchange purposes only. It does not constitute a formal solicitation, and participation will not be considered in the evaluation of any future procurement. The Government will not reimburse any costs associated with participation.