Solicitation 75F40126Q00418 .docx

U.S. FOOD AND DRUG ADMINISTRATION

OFFICE OF ACQUISITIONS AND GRANTS SERVICES (OAGS)

REQUEST FOR QUOTATION (RFQ)

SOLICITATION FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

This is a combined synopsis solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This solicitation is issued as a Request for Quotation (RFQ) under the simplified acquisition procedures of FAR Part 12 (Commercial Products and Services). The Government contemplates award of a single, firm-fixed-price purchase order for the items listed below. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

SECTION 1 – SOLICITATION INFORMATION

Solicitation Number: 75F40126Q00418 Solicitation Issue Date: September 8, 2026 Response Due Date/Time: September 15, 2026, by 1:00 PM Eastern Time Solicitation Type: Request for Quotation (RFQ) Set-Aside: Small Business Set-Aside NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing Product Service Code (PSC): 6640 – Laboratory Equipment and Supplies Place of Performance: See Section 6 – Delivery Information

SECTION 2 – REQUIREMENT TITLE AND BACKGROUND

Requirement Title:

Two (2) Gas Chromatograph with Mass Selective Detector (GC/MSD) Systems Background:

The U.S. Food and Drug Administration (FDA), Division of Seafood Science and Technology (HFP/OLOAS/OAMT/DSST) requires one (1) GC/MSD system, and the Division of Food Processing Science and Technology (HFP/OLOAS/OAMT/DFPST) requires one (1) GC/MSD system, including auto-injectors and updated mass spectral libraries.

The addition of GC/MSD systems will restore laboratory capabilities lost through the retirement of older systems without replacement. The systems will enhance capabilities for non-targeted identification of small molecules, particularly seafood contaminants and toxins. These instruments are critical to developing methods that support the American seafood industry and ensure that imported products are safe and of the quality expected by American consumers.

Purpose:

The GC-MS systems will be used to compare samples, identify unknown compounds, and compare new methods to official methods as required for method validation. The instruments will also be used to discover new compounds of interest in imported seafood. The GC-MS will complement existing LC-MS instruments in the laboratories, enabling the detection of a larger number of compounds of interest, including those found in fin fish (e.g., tuna) and shrimp. The enhanced sensitivity will support detection and identification of trace-level contaminants and toxins, including seafood adulteration cases.

SECTION 3 – CONTRACT TYPE AND ORDER DETAILS

Order Type: Firm-Fixed-Price (FFP) Quantity: Two (2) complete GC/MSD systems FDA intends to award a single firm-fixed-price order for two (2) complete GC/MSD systems as described in this solicitation.

SECTION 4 – STATEMENT OF WORK / SALIENT CHARACTERISTICS

All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the DSST prior to purchase.

I. General Requirements The system must include a capillary gas chromatograph with mass selective detector (MSD), auto-sampler, data system, and updated mass spectral library software.

The system shall be delivered with all necessary supplies and accessories required for installation and start-up.

The delivered system shall include one set of installation and service manuals.

Preloaded computer software shall be required to operate and control the GC, MSD, auto-injector, and NIST and Wiley Libraries.

II. Gas Chromatograph (GC) Requirements The GC shall be equipped with a capillary split/splitless inlet with electronic pneumatic control.

GC oven temperature range: 4°C above ambient to 450°C.

GC oven ramp capability: up to 120°C/minute.

Pressure range: 0 to 100 psi.

The GC must have a flip-top or turn-top inlet sealing system for easy liner changes.

System must allow constant pressure and flow modes with programmable pressure and flow.

GC oven shall compensate for barometric pressure and ambient temperature changes to maintain retention time repeatability and method stability.

III. Mass Spectrometer Detector (MSD) Requirements System must perform synchronous SIM / full scan operation.

System must automatically convert a full scan method to SIM or SIM/Scan with auto-configuration.

Maximum mass: 1,050 Daltons.

Electronic scan rate: up to 20,000 Daltons/second.

EI SIM instrument detection limit (IDL): 10 fg OFN using a 1 µL injection.

System or ion source must be upgradeable to support alternative carrier gases (e.g., hydrogen or nitrogen).

EI sensitivity (scan mode): signal-to-noise of 5,000:1 for 1 pg OFN with helium; 2,500:1 for 1 pg OFN with hydrogen; minimum scan range of 50–300 Daltons.

Ion source must be constructed of inert material (non-coated or stainless steel) with a turbo-molecular pump capable of handling flows up to 4 mL/min.

System must support automated source cleaning without venting.

Independently heated quadrupole mass filter: user-selectable temperature from 100–200°C.

Ion source temperature: controllable up to 350°C.

System must include an oil-free roughing pump to reduce oil disposal costs and environmental impact.

IV. Autosampler Requirements Auto-injector must be fully compatible with the GC-MSD system and control software.

Autosampler capacity: minimum 50 vials (2-mL vials).

Syringe size: 10 µL.

V. Data System Requirements System must include the Wiley 12th Edition with NIST 2020 (or latest) mass spectral libraries with the AMDIS program included.

Deconvolution and reporting software with pesticide RTL database and spectral library of at least 900 compounds.

Single-instrument software and a computer sufficient to control and process data for all components of the GC-MSD system.

Software must support integration with Agilent OpenLab (3.6.4.0 / 3.6.4.1) to facilitate control and maintain data integrity by automatically exporting data to the Electronic Content Manager (ECM).

Vendor shall supply software and license to allow control of GC-MSD system using OpenLab software.

System shall include a PC and monitor suitable for use with the software, including a 24" flat-screen color monitor and a laser printer.

Computer shall include no fewer than 4 USB ports and a CD/DVD player/recorder.

System must combine results from NIST library and AMDIS software searches for target compounds into a single report.

System must have a sleep/wake mode for power and gas saving, including user-programmable standby and ready times.

MS tuning and sleep/wake mode must be programmable as part of a run sequence.

Software must include a retention time locking (RTL) feature for analyzing target compounds in complex matrices.

System must allow fast venting when a vent cycle is initiated to allow the MSD to cool rapidly.

Deconvolution reporting software must be capable of accurately identifying and quantifying trace components that co-elute with other analytes.

The data system must be able to reprocess existing GCMS ChemStation data files.

The data system must be capable of controlling two (2) GC-MSD systems simultaneously.

Data backup must be possible by copying individual sample files or folders; data must not be stored in a database only.

SECTION 5 – TRADE AND SERVICE SPECIFICATIONS

The system must be a complete, newly manufactured unit. Used, refurbished, or previously used demonstration units are not acceptable.

Warranty and Support Requirements:

Minimum one (1) year warranty covering all non-consumable items and parts, including the base instrument, computer, monitor, and printer.

Unlimited site service visits with a maximum 72-hour on-site response time.

Coverage shall include factory-certified replacement parts, engineer labor and travel costs, and software updates and notifications.

System must include analyst familiarization training at installation and one (1) year of phone support.

Detailed training by a specialist, including method development and specific application training, for a minimum of three (3) days.

Routine customer service and technical support must be available from the vendor throughout the system lifecycle.

SECTION 6 – DELIVERY INFORMATION

Required Delivery Date: No later than 90 calendar days after contract award Period of Performance: Begins on the date of formal Government acceptance and continues through the end of the manufacturer's warranty period.

Delivery Location 1 – DSST Laboratory:

Contracting Officer's Representative (COR):TBD Gulf Coast Seafood Lab 1 Iberville Drive Dauphin Island, AL 36528 Phone: 251-406-8135 Technical Point of Contact (TPOC): TBD Gulf Coast Seafood Lab 1 Iberville Drive Dauphin Island, AL 36528 Phone: 251-406-8142 | Cell: 240-454-4389

Delivery Location 2 – DFPST Laboratory:

Technical Point of Contact (TPOC):

Yang Chen

U.S. FDA HFP/OLOAS/OAMT

8301 Muirkirk Road Laurel, MD 20708 Cell: 708-924-0604 | Email: Yang.Chen@fda.hhs.gov

IMPORTANT: Delivery must be coordinated with the Point of Contact (POC) at least 72 hours in advance. The contractor shall contact the POC to schedule a delivery appointment before dispatching equipment. Unscheduled deliveries may be refused.

Federal Holidays and Government Closures The Contractor is not required to provide on-site services on the following Federal holidays or any other day designated as a Federal holiday for the Washington, DC area:

New Year's Day Martin Luther King Jr. Day Presidents' Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day In the event of inclement weather when the Federal Government is closed, the Contractor is not required to provide on-site service. The Contractor shall follow all directives issued by the U.S. Office of Personnel Management for late arrivals due to inclement weather unless otherwise specified in the contract.

SECTION 7 – CONTRACT CLAUSES AND PROVISIONS

This solicitation incorporates one or more solicitation clauses/provisions by reference, with the same force and effect as if they were given in full text. In lieu of submitting the full text of those clauses/provisions, the offeror may identify the clauses/provision by paragraph identifier and provide the appropriate information with its quotation or offer. Full text of any clause/provision may be accessed electronically at this address(es): https://www.acquisition.gov/far-overhaul

This acquisition is conducted under FAR Part 12 (Acquisition of Commercial Products and Commercial Services) as applicable. The following clauses and provisions apply:

FAR 52.212-1 – Instructions to Offerors—Commercial Products and Commercial Services FAR 52.212-2 – Evaluation—Commercial Products and Commercial Services (Evaluation criteria: [Lowest Price Technically Acceptable (LPTA)]) FAR 52.212-3 – Offeror Representations and Certifications—Commercial Products and Commercial Services (Offerors must complete annual representations and certifications via SAM.gov) FAR 52.212-4 – Contract Terms and Conditions—Commercial Products and Commercial Services FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Products and Commercial Services FAR 52.232-33 – Payment by Electronic Funds Transfer—System for Award Management FAR 52.204-7 – System for Award Management FAR 52.204-13 – System for Award Management Maintenance

HHSAR clauses (Incorporated by Reference) HHSAR 352.203-70 - Anti-Lobbying HHSAR 352.222-70 - Contractor Cooperation in Equal Employment Opportunity Investigations HHSAR 352.239-73 - Information and Communication Technology Accessibility Notice HHSAR 352.239-74 - Information and Communication Technology Accessibility Full text available at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

SECTION 8 – PRICING / SCHEDULE OF SUPPLIES AND SERVICES

Offerors shall provide firm-fixed unit pricing for each line item listed below. All prices shall include delivery, installation, and any applicable taxes or fees. Extended prices shall be calculated as Unit Price × Quantity. The Total Evaluated Price will be the sum of all line items.

Note: Unit prices must remain valid for a minimum of 90 calendar days from the quotation submission date.

Gas Chromatograph with Mass Selective Detector, capillary split/splitless inlet, electronic pneumatic control, and all hardware components. One (1) system to be delivered to DSST, Gulf Coast Seafood Lab, Dauphin Island, AL.

Gas Chromatograph with Mass Selective Detector, capillary split/splitless inlet, electronic pneumatic control, and all hardware components. One (1) system to be delivered to DFPST, Laurel, MD.

Coverage for all non-consumable items and parts (base instrument, computer, monitor, printer). Includes unlimited on-site service visits (max 72-hr response), factory-certified parts, engineer labor and travel, and software updates. Per system.

All costs associated with shipping, delivery, and freight to both laboratory locations (Dauphin Island, AL and Laurel, MD).

TOTAL EVALUATED PRICE (Sum of all CLINs)

* Offerors shall populate all unit price and extended price fields. Leave no line item blank. If a line item is included within the base system price, enter $0.00 and provide a notation in the Description column.

SECTION 9 – CONTRACT ADMINISTRATION DATA

The Contracting Officer (CO) is the only individual authorized to make changes to or modify this contract. Any changes made by any other individual are void.

Contracting Officer (CO): Janice Heard; email: Janice.Heard@fda.hhs.gov Contracting Officer's Representative (COR): TBD FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (JAN 2022)

a. All invoice submissions for goods and/or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. To constitute a proper invoice, the payment request must comply with FAR 32.905(b) and the applicable Payment clause. The IPP website address is: https://www.ipp.gov

c. The Agency will enroll Contractors new to IPP. The Contractor Government Business POC (as listed in SAM) will receive a Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3-5 business days of contract award. Registration emails are sent from ipp.noreply@mail.eroc.twai.gov. IPP Helpdesk: IPPCustomerSupport@fiscal.treasury.gov or (866) 973-3131. Temporary password must be used within 30 days of receipt.

d. Invoices that include time-and-materials or labor-hour line items must include supporting documentation to substantiate labor hours and material costs incurred.

e. Contractor is required to attach an invoice log addendum to each invoice which shall include: (1) list of all invoices submitted to date; (2) total payments received to date; and (3) for definitized contracts, total estimated amounts yet to be invoiced.

f. Payment will be made upon Government acceptance of the entire task or tangible product deliverable(s) invoiced, based on certification of satisfactory services.

g. If services are rejected for failure to conform to technical requirements, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

h. Questions regarding invoice payments should be directed to the FDA ERIC Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); email: ERIC@fda.hhs.gov.

INSTRUCTIONS TO OFFERORS:

Interested vendors are invited to submit a quotation in response to this combined synopsis/solicitation. Quotations must include the following:

1. Technical Approach / Product Specifications: A detailed description of the proposed GC/MSD system demonstrating that all minimum salient characteristics in Section 4 are met or exceeded. Any deviations from minimum requirements must be clearly identified and technically justified.

2. Completed Pricing Schedule: Section 8 Price Schedule with all CLINs fully populated (unit price and extended price). Pricing shall be firm-fixed and valid for a minimum of 90 calendar days from the quotation submission date.

3. Delivery Schedule: Confirmation that the system(s) can be delivered within 90 calendar days of contract award.

4. SAM.gov Registration: Vendor must be registered in the System for Award Management (SAM.gov) prior to award. UEI number must be provided.

Quotations shall be submitted electronically by the date and time specified on the cover page.

Submit Quotation To: Janice Heard; email: Janice.Heard@fda.hhs.gov Subject Line: Solicitation 75F40126Q00418