Combined Synopsis Solicitation.pdf

HFP-2026-133240

MALDI-TOF Biotyper Sirius RFQ No.: 75F40126R00030 Attachment 1

The Food and Drug Administration’s (FDA), Moffett Laboratory requires the purchase of one (1) Bruker MALDI-TOF Biotyper Sirius one GP system, including associated software, computer workstation, peripherals, on-site installation, training, and warranty, to support Endopep-MS neurotoxin detection and microbial identification, in Bedford Park, IL.

1. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation.

Offers are being requested, and a separate written solicitation will not be issued.

Solicitation number 75F40126R00030 is issued as a Request for Quotation (RFQ) for MALDI-TOF Biotyper Sirius.

This acquisition is not set-aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov.

2. The following list of line items:

Product Description Part No.: Quantity Unit

Price/Rate Total Price Bruker MALDI-TOF Biotyper Sirius one

GP

1890221 1

Application Training, 2 Days Onsite DAL00909 1

MBT Compass HT Industry Software Package

1868405 1

UPS Powervar

ABCE602-11

120VAC

8605553 1

Bruker Standard Laser Printer, 115V Color 1902007 1

Freight / Shipping Costs 1

Tariff / Customs Surcharge 1

RFQ No.: 75F40126R00030 Attachment 1

3. Description of requirement. Please refer to the attached Statement of Work (SOW) for the complete technical requirements.

4. Delivery information.

The anticipated Period of Performance (POP) for this requirement shall consist of a one (1) year base period.

Delivery Schedule: The contractor shall complete delivery, installation, operational qualification, and training within 60 days of contract award, with the warranty and support services extending for one year from acceptance.

5. A list of solicitation provisions that apply to the acquisition (see 12.205(a)).

The provision at 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services, applies to this acquisition. Addenda to the provision is provided.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 90 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

m. QUESTION DEADLINE: Submit all procurement-related questions in writing via email to the Contracting Officer and Contract Specialist listed in Section 1. Questions must be received by April 7, 2026, at 12:00PM ET, to be considered.

n. QUOTATION DEADLINE: Quotations are due by the date and time listed in SAM.gov.

o. The Contractor shall submit a firm-fixed-price quote, including details of all costs supporting the price for the required deliverables. Quotes shall be for all the deliverables requested.

p. The Contractor shall include and complete the attached pricing schedule. Pricing shall include all applicable fees; any charges presented after contract award shall not be considered/acceptable.

q. Submit two separate volumes:

1. Volume I – Technical: Must exclude pricing. Include specifications, work schedule, warranty, delivery timeline. Page limit: 10.

2. Volume II – Price: Include completed pricing schedule and cost breakdown.

RFQ No.: 75F40126R00030

r. Quotes shall clearly reference the RFQ number and include:

1. Date of quotation

2. Company Name

3. Company Point of Contact name, email address and phone number

4. Contractor’s GSA schedule contract number

5. System for Award Management Unique Entity ID (UEI)

6. Quotation validity of at least 90 days after RFQ due date and time

s. The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.

Offerors shall include a completed copy of the provision at FAR 52.212-3 (with its Alternate I), Offeror Representations with its offer

52.212-2, Evaluation-Commercial Products and Commercial Services (Nov 2021)

(a) Evaluation factors. The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

1. Technical

2. Price

Technical and price, when combined, are approximately equal in importance.

All non-price factors when combined are approximately equal to price.

(b) Options – N/A

(c) Notice of Award. A written notice of award or acceptance of an offer furnished to the successful Offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

Addendum to FAR 52.212-2

Fator 1: Technical Approach

The Government will evaluate the technical quotation to determine the offeror’s ability to meet the requirements of the Statement of Work (SOW), including scope of work, safety needs (snap-

RFQ No.: 75F40126R00030 Attachment 1 front, fluid-resistant lab coats), and bi-weekly service expectations. Clear and feasible plan for managing sizing sessions, inventory control, laundry logistics, and contingency plans for volume fluctuations.

Confirmation that proposed lab coats meet the snap-front closure and fluid-resistant material requirements. Specification sheets or product descriptions demonstrating compliance with required dimensions and features (e.g., towel sizes, fabric composition).

Realistic delivery timeline for initial fitting, sizing, and first round of lab coats post-award.

Confirmation of ability to meet bi-weekly collection and delivery schedule.

The Government will assess narrative response for completeness, logic, feasibility, and alignment with the SOW. The Government will evaluate the quoter’s technical approach for completeness, feasibility, and alignment with the requirements of the Statement of Work.44. Review proposed timeline in light of required 30-day delivery post-award and ongoing performance expectations.

Factor 2: Price

Price will be evaluated to determine whether the quotation includes a complete and itemized price breakdown and whether the proposed price is fair and reasonable for the supplies and services required under the RFQ.

The total evaluated price will be the sum of all items included in the pricing schedule.

The Government will evaluate price using one or more price analysis techniques in accordance with FAR 13.106-3.

The Government intends to make award without discussions; therefore, quoters are encouraged to submit their best technical quotation and price in response to this RFQ.

(End of provision)

RFQ No.: 75F40126R00030 Attachment 1

Statement of Work

1. Background

The select agent laboratory at Moffett participates in the Laboratory Response Network (LRN) for detecting botulinum neurotoxins (BoNTs). Traditional mouse bioassays, though the gold standard, are costly, slow, and raise ethical concerns. Previously, DIG-ELISA kits were used for high-throughput screening to reduce animal use, but these kits are being phased out in favor of the Endopep-MS (Endopeptidase–Mass Spectrometry) assay.

Developed over 10 years by CDC’s Biological Mass Spectrometry Laboratory, the Endopep-MS assay detects BoNT activity on peptide substrates that mimic the toxin’s natural targets. This method eliminates animal testing and allows high-throughput analysis, supporting rapid response in large-scale events.

The FDA requires one (1) Bruker MALDI-TOF Biotyper Sirius one GP system to replace an obsolete instrument. The system must support Endopep-MS assays for detection, differentiation, and characterization of Clostridium botulinum neurotoxins, maintaining operational capability critical to mission readiness and public health protection.

2. Objective

Acquire, install, and validate one (1) FDA-approved benchtop MALDI-TOF mass spectrometer with associated software, workstation, peripherals, training, and warranty to ensure uninterrupted capability for neurotoxin detection and microbial identification.

3. Scope of Work

The Contractor shall provide:

• One (1) Bruker MALDI-TOF Biotyper Sirius one GP system

• Required software and reference libraries

• Dedicated computer workstation meeting specifications

• Associated peripherals and accessories

• On-site installation and operational qualification

• Two (2) days of on-site application training

• Warranty and technical support

• Freight and delivery

All components shall be new, current production models, and fully supported by the manufacturer.

4. Required Equipment and Deliverables

Item No. Description Quantity Unit 1 MALDI-TOF Biotyper Sirius one GP 1 Each

RFQ No.: 75F40126R00030 Attachment 1

Item No. Description Quantity Unit 2 On-site Application Training (2 Days) 1 Each 3 MBT Compass HT Industry Software Package 1 Each 4 UPS Powervar ABCE602-11 120VAC 1 Each 5 Bruker Standard Laser Printer, 115V Color 1 Each 6 Freight (Intercontinental, if applicable) 1 Lot

5. Technical Requirements

Instrument Requirements:

• FDA-approved benchtop MALDI-TOF mass spectrometer

• Small footprint for standard benchtop installation

• 60 Hz N₂ cartridge laser with variable power attenuator and UV optics

• Supports Endopep-MS assay for C. botulinum neurotoxin detection

• Microorganism identification and classification using MALDI-TOF MS profiles

• Automated processing from raw spectra to peak lists and reference spectra

• Validated, current microorganism reference library

Computer Workstation:

• 2.66 GHz single CPU quad-core processor (or current equivalent)

• Minimum 12 GB RAM

• Minimum 2 TB hard drive

• DVD +/- RW drive

• At least one Ethernet port

• LCD monitor

• Pre-installed, fully licensed OS compatible with instrument software

Software Requirements:

• MS data acquisition and processing

• Automated data analysis

• Microorganism identification and classification

• Reference library access

• Audit trail capability

• Compliance with FDA IT and security policies

6. Delivery and Place of Performance

Delivery Location:

FDA Moffett Laboratory 6502 S. Archer Rd., Bedford Park, IL 60501 Delivery Timeline: Within 60 days of contract award

RFQ No.: 75F40126R00030

Shipping:

• Equipment shall be securely packaged

• Contractor shall coordinate delivery with laboratory point of contact

• Freight included in total price

7. Installation and Acceptance

Installation:

• On-site setup and configuration

• Electrical compatibility verification

• UPS integration

• Software and reference library installation

Operational Qualification:

• System calibration and performance verification

• Demonstration of proper operation

• Documentation of installation and operational verification

Acceptance Criteria:

• All components delivered and installed

• Instrument meets manufacturer’s specifications

• Software operates as specified

• Endopep-MS assay capability demonstrated

• Training completed

• Documentation received

8. Training

• Two (2) consecutive days of on-site training

• Instruction on instrument operation, routine maintenance, data acquisition and analysis, and troubleshooting

• Training materials and user documentation provided

9. Warranty and Support

• Minimum one (1) year full warranty from acceptance, including parts, labor, and travel

• Technical support via phone and email, with 48-hour response time

• Software updates included during warranty

• Optional extended warranty pricing may be provided separately

10. Quality Assurance

RFQ No.: 75F40126R00030

• System meets manufacturer specifications

• New and free of defects

• Documentation certifying regulatory compliance included

• Government may inspect and test upon delivery

11. Security Requirements

If connected to FDA networks:

• Must comply with FDA IT security policies

• Support secure user authentication and maintain audit logs

• Contractor personnel must coordinate access with laboratory management

12. Compliance

Contractor shall comply with all applicable:

• FDA laboratory safety requirements

• Electrical and environmental standards

• Federal, state, and local regulations