FDA-SSN-75F40126Q00243.pdf

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA) is conducting market research to support, the Office of

Pharmaceutical Quality and Research (OPQR), which requires software license renewals, software maintenance and support, targeted software development improvements, and on-site hardware preventative maintenance services to sustain and enhance the operational capabilities of the Integrated Digital Asset

System (IDAS).

The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of providing services of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The associated North American Industry Classification System (NAICS) Code is 541519 – Other Computer

Related Services, Small Business Size Standard is $34.0 million.

The FDA/OPQR requires (A) RFID Label Printing Software Licensing and Maintenance, (B) Asset

Management Software Licensing and Maintenance, (C) Asset Management Software Development and

Enhancements, and (D) On-Site Hardware Preventative Maintenance and Technical Support for a 12-Month

Period of Performance.

Schedule of Supplies or Services and Price/Costs

Item No. Description Qty. Unit Unit Price Subtotal

BarTender Enterprise: Printer License Reactivation

8 12 Months $ $

BarTender Enterprise: Application License

Reactivation 1 12 Months $ $

BarTender Enterprise: Additional Printer

License 2 12 Months $ $

BarTender Enterprise: Printer License

Annual Maintenance Renewal 14 12 Months $ $

ItemAware: Licensing and Maintenance up to 10,000 laboratory assets and up to

100 networked IP/Edge devices 1 12 Months $ $

ItemWare: Development and

Enhancements. Batch Tag Printing; Batch

Archiving; Report Improvements; and

Item Count Display

1 12 Months $ $

On-Site Hardware Preventive Maintenance and Technical Support 1 12 Months $ $

Optional Task (if exercised): ItemWare

Software Support Hours; up to 50 hours 50 12 Months $ $

Period of Performance (12-Months): as outlined in each item description.

The contractor shall be required to meet the following Maintenance and Technical Support

Requirements:

A. RFID Label Printing Software — Licensing and Maintenance (BarTender Enterprise)

IDAS relies on RFID label printers to generate and apply identification tags to laboratory assets. These printers operate in conjunction with BarTender Enterprise software, which enables laboratory staff to produce accurate, consistently formatted RFID labels for equipment, supplies, chemicals, and other assets tracked within IDAS. FDA/OPQR has custom-designed label templates within BarTender Enterprise to meet the specific identification and traceability requirements of its laboratory environment.

The contractor shall provide the following BarTender Enterprise licensing and maintenance services:

1. License Reactivation — Printer and Application Licenses: The contractor shall reactivate the previously expired BarTender Enterprise printer license and application license, restoring

FDA/OPQR's ability to generate and print compliant, standardized RFID labels within IDAS.

Reactivation shall include reinstatement of Standard Maintenance and Support coverage for the reactivation period. Without an active license, labeling functionality would be unavailable, disrupting day-to-day laboratory operations and the program's ability to maintain proper asset identification and traceability.

2. Addition of Printer Licenses: The contractor shall provide two (2) additional BarTender

Enterprise printer licenses to expand the licensed printer count, aligning the printer license with the application license term and supporting the full complement of RFID label printers currently deployed across OPQR laboratory sites.

3. Annual Maintenance Renewal — 14-Printer License: The contractor shall provide one (1) year of

Standard Maintenance and Support renewal for the BarTender Enterprise application license and all fourteen (14) printer licenses. This maintenance coverage ensures the software remains current, secure, and fully functional throughout the contract period of performance, and provides

FDA/OPQR with access to software updates, patches, and vendor technical assistance essential to sustaining reliable, uninterrupted system performance in a regulated laboratory environment.

B. Asset Management Software — Licensing and Maintenance (ItemAware)

ItemAware serves as the core asset management platform within IDAS, enabling real-time searching, tracking, and monitoring of laboratory assets by location and quantity across all OPQR laboratory sites.

ItemAware was collaboratively customized by OPQR and the vendor to meet the unique operational needs of FDA laboratory environments, and is integrated with OPQR's electronic laboratory notebook (ELN) system to support seamless, workflow-aligned asset management.

The contractor shall provide perpetual software license annual maintenance fees for ItemAware, supporting up to 10,000 laboratory assets and up to 100 networked IP/edge devices across the OPQR laboratory environment. This fee ensures continued access to software updates, technical support, and system stability necessary for managing laboratory instruments, equipment, supplies, and other assets in a reliable and compliant manner.

Maintaining this license is essential to FDA/OPQR's ability to track, monitor, and manage laboratory assets without interruption. Without active annual maintenance coverage, the program would risk losing access to critical software updates and vendor support, potentially disrupting laboratory operations and compromising data integrity.

C. Asset Management Software — Development and Enhancements (ItemAware)

Through more than twelve (12) months of hands-on operational experience with ItemAware across OPQR laboratory sites, OPQR has identified specific functional areas where targeted software enhancements would significantly improve operational efficiency, data quality, and staff productivity. The contractor shall ensure that all software modifications implemented under this section maintain full compatibility with the existing integration between ItemAware and the OPQR electronic laboratory notebook (ELN) system, SciNote, so that automated inventory consumption updates and workflow-aligned asset tracking functions are not disrupted. The contractor shall implement the following software modifications and provide associated technical assistance to sustain each enhancement within the IDAS environment:

1. Batch Tag Printing: The contractor shall implement functionality enabling program staff to generate and print multiple asset identification tags simultaneously, rather than processing them individually. This capability is essential for FDA laboratory operations where large volumes of assets must be accurately labeled and tracked to ensure regulatory compliance and operational efficiency.

2. Batch Archiving: The contractor shall implement functionality enabling program staff to retire and archive multiple asset records simultaneously, rather than processing them on an individual basis.

This capability is critical for maintaining an organized and current asset inventory, supporting accurate recordkeeping, audit readiness, and long-term data integrity.

3. Report Improvements: The contractor shall implement enhancements to the reporting capabilities within ItemAware, enabling program staff to generate more comprehensive, accurate, and user-friendly reports on laboratory assets and inventory. Improved reporting functionality is essential for supporting data-driven decision-making, resource planning, and compliance with agency recordkeeping requirements.

4. Item Count Display: The contractor shall implement functionality to display the total number of items within any given asset list or inventory view, providing program staff with immediate visibility into the size and scope of asset collections without the need for manual counting or additional queries. This capability supports efficient workflow management and accurate inventory reporting.

D. On-Site Hardware Preventative Maintenance and Technical Support

The IDAS hardware infrastructure — including ceiling-mounted RFID antennas, reader zones, and RFID label printers deployed across OPQR laboratory sites — requires regular preventative maintenance to ensure continued system reliability and optimal performance. Hardware issues such as antenna misalignment, signal interference, and printer calibration drift can affect the accuracy of asset location reads and the quality of printed RFID labels.

The contractor shall provide on-site labor and technical support services to perform scheduled preventative maintenance on IDAS hardware components across all OPQR laboratory sites. Contractor personnel shall conduct on-site visits to inspect, service, calibrate, and address identified hardware issues before they escalate into larger operational disruptions. Preventative maintenance activities shall include, but are not limited to, antenna alignment verification, reader zone performance assessment, printer calibration, and general hardware inspection and repair as needed. The contractor shall perform a minimum of one (1) on-site preventative maintenance visit per laboratory site per year, covering all four OPQR locations identified in Section 6. Additional visits may be scheduled as needed and as directed by the COR.

Optional Task – ItemAware Software Support Hours

The Government reserves the right to exercise this optional task, which provides for up to fifty (50) hours of

ItemAware software support and programming services during the base period of performance. These hours may be utilized for additional software modifications, system enhancements, troubleshooting, or other technical support activities as directed by the Contracting Officer's Representative (COR). Hours under this optional task shall be exercised at the unit rate established in the contract and are intended to provide the

Government with flexible, on-demand technical support capacity to address evolving operational needs within the IDAS environment.

Item No. Description of Deliverable

001/002

License Reactivation Confirmation: Documentation confirming reactivation of BarTender Enterprise printer and application licenses

License Activation Confirmation: Additional BarTender

Enterprise Printer Licenses

004/005

Annual Maintenance Confirmation: Documentation confirming annual maintenance renewal for all BarTender and ItemAware licenses

Software Enhancement Completion Reports: Written confirmation and demonstration of each ItemAware software enhancement upon completion

Preventative Maintenance Report: Written summary of on-site preventative maintenance activities performed, findings, and any corrective actions taken

Optional Task Hours Log (if exercised): Monthly log of support hours utilized, activities performed, and remaining hours balance

The COR may approve any changes to the delivery schedule by mutual agreement of the parties.

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above

Though the target audience is small business manufacturers or small businesses capable of supplying a U.S.

made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name, Unique Entity ID, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm);

• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.

• Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.

• If a large business, identify the subcontracting opportunities that would exist for small business concerns;

• Standard commercial warranty and payment terms; and

• Though this is not a request for quote, informational pricing is encouraged.

The government is not responsible for locating or securing any information, not identified in the response.

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements by email to Contract Specialist (CS) /

Terina.Hicks@fda.hhs.gov on June , 2026, by 1:00PM Washington, DC Local Time or sooner. Reference FDA-

SSN-75F40126Q00243. For information regarding this Sources Sought, please contact Terina Hicks (CS) by

June , 2026, by 1:00PM Washington, DC Local Time.

Notice of Intent

Responses to this Sources Sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procured through sole-source acquisition procedures.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The

Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

mailto:Terina.Hicks@fda.hhs.gov