Sources sought notice HFP-2026-133524.docx

SOURCES SOUGHT NOTICE

Maxwell RSC 48 DNA Extraction Systems Notice ID: HFP-2026-133524

1. PURPOSE

This is a SOURCES SOUGHT NOTICE ONLY for market research and planning purposes. This is NOT a solicitation announcement for proposals, quotes, or bids. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification relative to the North American Industry Classification System (NAICS) code specified herein.

The U.S. Food and Drug Administration (FDA), Office of Acquisition and Grant Services (OAGS), on behalf of the Office of Laboratory Operations and Applied Science (OLOAS), Office of Regulatory Testing and Surveillance (ORTS), is conducting market research to identify potential sources capable of providing Maxwell RSC 48 DNA Extraction Systems over a five-year contract period.

Responses to this notice are not considered adequate responses to solicitation and will not be accepted in lieu of responses to any future solicitation.

2. BACKGROUND

The mission of the Food and Drug Administration, Office of Laboratory Operations and Applied Science, Office of Regulatory Testing and Surveillance, Human and Animal Food Laboratories (OLOAS/ORTS/HAFL), is to protect the public health by providing analytical approaches encompassing the use of rapid methodology and expert scientific evaluations in support of investigations involving the safety of foods and other FDA regulated products.

The Microbiology Branches of OLOAS/ORTS/HAF laboratories use validated rapid, highly sensitive molecular methods and instrumentation for recovery, detection, and quantification of enteric bacterial pathogens and their related toxins isolated from foods and cosmetics as well as related food processing and farm production environments. Molecular methods rely on having high quality nucleic acid (DNA) for rapid and reliable test results from 24-hour enriched food samples.

3. REQUIREMENT DESCRIPTION

3.1 Overview

The FDA requires the acquisition of Promega Maxwell RSC 48 DNA Extraction Systems to support regulatory molecular detection methods practiced by FDA field laboratories. The Maxwell RSC 48 is an automated DNA extraction system that has been validated for use in regulatory molecular detection methods and allows for high-quality DNA purification for up to forty-eight (48) samples with minimal steps and less hands-on time.

BRAND NAME REQUIREMENT: This acquisition is for the Promega Maxwell RSC 48 DNA Extraction System specifically. No alternative or substitute products will be accepted. The competition is limited to vendors capable of providing the Promega Maxwell RSC 48 DNA extraction system, including the manufacturer and its authorized resellers.

3.2 Scope of Work

Base Year (Year 1):

- Seven (7) Maxwell RSC 48 systems to be delivered to FDA Human and Animal Food Laboratories located in:

- Irvine, CA

- Jefferson, AR

- Atlanta, GA

- Alameda, CA

- Jamaica, NY

- Denver, CO

- Bothell, WA Option Years 1-4:

- One (1) to Two (2) systems per year

- Destinations to be determined at time of order

3.3 Required Components

Each Maxwell RSC 48 system shall include the following components:

Maxwell RSC 48 Instrument Tablet PC preloaded with Maxwell RSC Application Software USB Cable for connection of the Maxwell RSC Instrument to the Tablet PC Power Cable for Maxwell RSC Instrument Power Cord for Tablet PC Pair of Maxwell RSC/CSC Deck Trays UV bulb (installed) Tablet PC Holder Quantus Fluorometer and accessories Quick Start Guide Set-up Guide 2 Additional front deck and back deck trays

3.4 Key Requirements

Equipment Specifications:

- Systems must be newly manufactured units (not used, refurbished, or demonstration units)

- Must include all necessary supplies and accessories for installation and start-up

- Minimum one (1) year warranty from date of installation Delivery Requirements:

- Delivery within 90 days of award/order

- FOB Destination (inside delivery to facility loading dock)

- Delivery hours: Monday-Friday, 8:00 AM - 4:00 PM (excluding Federal holidays) Installation Services:

- Installation by qualified field system engineer within 14 days of delivery

- Move equipment from loading dock to final point of use

- Install unit in designated room

- Ensure operational functionality Training Services:

- On-site training by qualified field application specialist

- Training for up to three (3) users per laboratory

- Training within 14 days of delivery

- Training materials and consumables provided Warranty Services:

- Minimum one (1) year warranty on all non-consumable items and parts

- Coverage includes parts and labor

- Unlimited telephone/email support for operational questions

4. NAICS CODE AND BUSINESS SIZE STANDARD

NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing

5. ANTICIPATED CONTRACT INFORMATION

5.1 Contract Type

Blanket Purchase Agreement (BPA) with firm-fixed pricing Base period: 12 months Four (4) additional 12-month option periods

5.2 Anticipated Acquisition Method

This acquisition is anticipated to be conducted as a limited competition for a brand-named commercial item in accordance with FAR 13.501(a)(1)(ii). The competition is limited to vendors capable of providing the Promega Maxwell RSC 48 DNA extraction system, including the manufacturer and its authorized resellers.

5.3 GSA Federal Supply Schedule (FSS)

The Government is interested in determining whether this requirement can be satisfied through the GSA Federal Supply Schedule (FSS) program.

Interested parties are requested to indicate:

Whether they hold a current GSA FSS contract If yes, provide GSA contract number and schedule Whether the Promega Maxwell RSC 48 DNA Extraction System and associated services (delivery, installation, training, warranty) are available on their GSA schedule If not currently on GSA schedule, whether the vendor would be willing to add these items/services to an existing schedule or obtain a GSA schedule contract

6. SMALL BUSINESS CONSIDERATIONS

The Government is conducting market research to determine the appropriate small business set-aside strategy for this acquisition. The Government is particularly interested in responses from:

Small Businesses (including those with GSA FSS contracts) Small Disadvantaged Businesses (SDB) Women-Owned Small Businesses (WOSB) Service-Disabled Veteran-Owned Small Businesses (SDVOSB) Veteran-Owned Small Businesses (VOSB) HUBZone Small Businesses 8(a) Business Development Program Participants 2 | Page