Combo Synopsis Solicitation 0814.docx

75F40126Q00339

COMBINED SYNOPSIS/SOLICITATION

1. GENERAL INFORMATION

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 75F40126Q00339 is issued as a/an Request for Quote (RFQ) for two (2) Agilent Gas Chromatograph with mass selective detector systems that meets the requirements in the attached Statement of Work.

This acquisition [☐ is / ☒ is not] set-aside for small business concerns.

Set-Aside: ☐ None ☐ Total Small Business ☐ WOSB ☐ SDVOSB ☐ 8(a) ☐ HUBZone ☐ Other: [specify]

NAICS Code: 334516 Small Business Size Standard: 1,000 employees This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at: https://acquisition.gov/ | https://acquisition.gov/far-overhaul | https://acquisition.gov/hhsar

All responsible sources may submit a [☒ quotation, which will be considered by the agency.

2. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance: U.S. Food and Drug Administration, Cincinnati, OH 45237 FOB Point: [☒ Destination ☐ Origin] Inspection and Acceptance: Inspection and acceptance shall be performed at the delivery location in accordance with the terms of clause 52.212-4.

Period of Performance

Supplies: Delivery Timeframe + Warranty Delivery shall be completed no later than 90 of award. The delivered items shall include a one (1)] year warranty. The warranty period begins on the date of Government acceptance under the inspection and acceptance clause(s) of this contract.

Base Period: 09/01/2026 through 12/01/2027

3. CONTRACT LINE ITEMS (CLINs)

4. POINTS OF CONTACT

Contracting Officer:

Name: Jennifer Mun Email: Jennifer.mun@fda.hhs.gov

5. CONTRACT CLAUSES

5A. Clauses Incorporated by Reference

5B. Clauses Incorporated by Full Text

52.252-2, Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://acquisition.gov https://acquisition.gov/far-overhaul https://acquisition.gov/hhsar (End of clause)

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. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

3. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

(2) total amount of all payments received to date under the subject contract or order

(3) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the Delivery Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

(End of clause)

6. SPECIFICATIONS

REQUIREMENT TITLE

Two (2) Agilent Gas Chromatograph with mass selective detector (GC/MSD) Systems

BACKGROUND

The National Forensic Chemistry Center (NFCC) in the Office of the Chief Scientist, Office of Specialty Laboratories and Enforcement Support, requires the purchase of two (2) Agilent Gas Chromatograph with mass selective detector systems including auto injectors and updated mass spectral libraries in its continued support of the FDA’s mission to protect the public health and support criminal and regulatory investigations involving foods, drugs, dietary supplements, and medical products. The systems will replace two older, Agilent systems and provide enhanced capabilities for the continued work of non-targeted identification of small molecules, particularly approved and counterfeit drugs, misbranded/adulterated dietary supplements, synthetic cannabinoids and designer drugs.

PURPOSE

NFCC regularly provides support to CDER, CBER, and various offices within the Office of Inspections and Investigations, such as the Office of Criminal Investigations and the Office of Import Operations, as well as other agencies outside of the FDA in the analysis of foods, drugs, dietary supplements, and medical products suspected of being harmful to consumers. Additionally, this type of system is required to support forensic laboratory sample analysis from an increase in package inspections for opioid products and drugs at International Mail Facilities (IMFs) and Express Courier Hubs (ECHs). GC-MS is one of the primary screening and identification techniques used at the NFCC for analysis of forensic samples. Maintaining the capability these systems provide is required to identify potentially hazardous products in a timely and accurate manner. Furthermore, the Food Emergency Response Network (FERN) GC-MS Counter Terrorism (CT) screen is performed using this type of instrument and it will provide support for future CT events. The enhanced sensitivity of the new instruments will also allow detection and identification of trace-level drugs and contaminants, a capability that is especially useful in tampering/theft cases where scheduled drugs are removed and replaced/diluted. These new instruments will allow for simultaneous full scan and single ion monitoring (SIM), a functionality the older system does not possess. Additionally, the new instruments will possess faster electronics, a faster GC oven, and an updated mass spectral library with over 950K spectra, a critical tool for the work done at NFCC. Additional analytes such as new fentanyl analogs, synthetic cannabinoids, and designer drug analogs can be easily added to the library.

Order Type

FDA intends to award a Brand name or equal for the items described below.

SCOPE

The National Forensic Chemistry Center (OC/OCS/OSLES/NFCC) requires two (2) Agilent gas chromatograph/mass selective detector (GC/MSD) systems including auto-injector, and updated mass spectral libraries.

Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the NFCC prior to purchase.

The systems must meet or exceed the following requirements:

I. Minimum Performance Requirements/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 NFCC prior to purchase.

General Requirements

· The systems must include a capillary gas chromatograph with mass selective detector, auto-sampler, data system, and updated mass spectral library software.

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

· The delivered systems shall include one set of installation and service manuals; and preloaded computer software required to operate and control the GC, the MSD, the auto-injector, and the NIST and Wiley Libraries.

Gas Chromatograph (GC):

· The GC shall be equipped with a capillary split/splitless inlet.

· The system must include electronic pneumatic control.

· The GC oven shall be able to operate at a temperature range of 4 °C above ambient to 450 °C.

· The GC oven must be capable of an oven ramp up to 120 °C/minute and a pressure range of 0 to 100 psi.

· The GC must have a flip-top or turn-top inlet sealing system built in for easily changing injector liners.

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

· GC oven shall be able to compensate for barometric pressure and ambient temperature changes. This reduces the influence of environmental factors retention time repeatability. Methods remain stable when atmospheric pressure changes.

Mass Spectrometer Detector (MSD):

· System must be able to perform synchronous SIM / full scan operation.

· System must have the capability of automatically converting a full scan method to a SIM or SIM/Scan method with auto-configuration.

· System must be able to analyze up to maximum mass of 1090 Daltons.

· System must have an electronic scan rate of up to 20,000 Daltons / second.

· System must exhibit an EI SIM instrument detection limit (IDL) of 10 fg OFN using a 1 µL injection with the capability of reaching 1.5 fg

· System or ion source must be capable of being upgraded to allow the use of alternative carrier gases other than helium. Such as hydrogen or nitrogen.

· EI sensitivity in scan mode: signal-to-noise specification is 3500:1 for 1 pg OFN when using helium as a carrier gas and 1500:1 for 1 pg OFN when using hydrogen as a carrier gas and minimum scan range of 50-300 Daltons

· System must use an ion source constructed of inert material (not-coated or stainless-steel construction) with turbo-molecular pump capable of handling flows up to 4 mL/min.

· System must be capable of automated source cleaning without venting the system.

· System must include an independently heated quadrupole mass filter with user-selected temperature from 100-200 C.

· Ion source temperature must be controllable up to 350 C.

· System shall come with an oil-free roughing pump to provide an environmentally friendly alternative as well as to reduce the cost associated with oil disposal from required maintenance.

Autosampler:

· Auto injector must be fully compatible with the GC-MSD system, including the GC-MSD control software.

· The autosampler shall hold 150 vials or greater (2- mL vials)

· Syringe size 10 µL

Data System:

· System must include the Wiley23 with NIST23 or latest mass spectral libraries with AMDIS program included.

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

· System must include single instrument software and computer sufficient to control and process data for all components of GC-MSD system provided. Vendor shall supply software and license to allow control of GC-MSD system, data acquisition, and data processing. Shall include PC and monitor suitable for use with software

· System must be able to combine results with NIST library and AMDIS software search for target compounds into a single report.

· System must have a sleep/wake mode for power and gas saving which allows for user entered clock times for entering standby mode and “ready” mode.

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

· System software must have a retention time locking feature for analyzing target compounds in complex matrices.

· The systems computer shall have not less than 4 USB ports and a CD/DVD player/recorder and shall come with a 24” flat screen color monitor and a laser printer.

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

· Deconvolution reporting software shall be available for the system to accurately identify and quantify trace components that co-elute with other analytes.

· The data system shall be able to reprocess data files from existing GCMS Chemstation systems in the laboratory.

· The data system must be capable of controlling two GC-MSD systems simultaneously.

· Backup of the data, and sequence lists must be possible by copying the individual sample files or folders and must not be stored in a database only.

II. Trade and Service Specifications

· The systems must be a complete, newly manufactured unit, not used and refurbished or previously used for demonstration. The Government must be able to expect routine customer service and technical support to be available from the vendor during its lifecycle.

· The systems must include at least a one (1) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, computer, monitor, printer, unlimited site service visits with a maximum 72-hour on-site response time, factory-certified replacement parts, engineer labor and travel costs, software updates and notifications.

· Systems must include analyst familiarization at installation and one year of phone assistance.

Shipping Destination

Two (2) systems to be shipped to the following laboratory:

US Food & Drug Administration National Forensic Chemistry Center Cincinnati, OH 45237 POC Name: Determined at award

Period of Performance

Equipment shall be delivered no later than 90 days after contract award. The Period of Performance begins on the date of formal government acceptance and continues through the end of the manufacturer’s warranty period.

A. SOLICITATION PROVISIONS

A1. Provisions Incorporated by Reference

Basis for Award Lowest Price Technically Acceptable (LPTA): Award will be made to the lowest-priced offeror whose offer is determined technically acceptable. Technical acceptability will be determined on a pass/fail basis against the salient characteristics and minimum requirements of the requirement. Offers that do not meet all salient characteristics will be determined technically unacceptable and will not be considered for award. Price will be evaluated for reasonableness.]

B. OFFER SUBMISSION

Offers Due Date: All quotes shall be submitted via email to Jennifer.mun@fda.hhs.gov no later than 08/21/2026, 2:00 PM, ET, with the subject line 75F40126Q00339. No questions are accepted for this RFQ.

Submission Method: Email to the POCs listed in the SAM.gov posting.

Preferred File Format: Searchable PDF and Excel Page Limit (if applicable): N/A

Offerors Shall Submit:

1. Technical quotation

1. Price quotation

1. Warranty terms (if applicable)

1. UEI and confirmation of active SAM.gov registration

1. Lead time for delivery

1. Country of origin for all items Points of Contact As listed on the SAM.gov notice.

C. ADDITIONAL INFORMATION

Amendments:

Any amendments to this solicitation will be posted to SAM.gov. It is the offeror's responsibility to monitor SAM.gov for any amendments.

Trade Agreements Statements (per RFO FAR 5.101(c)(4)(iii)):

One or more of the items under this acquisition is subject to the World Trade Organization Government Procurement Agreement and Free Trade Agreements.

FDA OAGS | Supplies | Page 1 FSB Version 2.1 (June 14, 2026)