NOTICE OF INTENT FOR A SOLE SOURCE AWARD.pdf

NOTICE OF INTENT FOR A SOLE SOURCE AWARD

Posted on SAM.gov pursuant to RFO FAR 5.101 and 6.302-1

Notice Type: Special Notice — Intent to Sole Source / Restrict Competition

Posted Date: 7/29/2026

Response Date and time: 08/13/2026, 3PM Eastern Time

SECTION 1 — CONTRACTING OFFICE INFORMATION

Field Information

Contracting Activity U.S. Food and Drug Administration (FDA), OƯice of Acquisitions and Grants Services (OAGS)

Solicitation Number 75F40126Q00337

Contracting OƯicer Min Jie Zeng

Point of Contact Minjie.Zeng@fda.hhs.gov

SECTION 2 — ACQUISITION INFORMATION

Product Service Code (PSC) 6640 — Laboratory Equipment and Supplies

NAICS Code 334516 — Analytical Laboratory Instrument Manufacturing

Small Business Size Standard 1,000 Employees

Contract Type Firm-Fixed-Price (FFP) Purchase Order

Acquisition Procedure FAR Part 12 — Commercial Products and Commercial Services (RFO)

Set-Aside None — Sole Source

Period of Performance 12 months

Place of Delivery [Insert Delivery Location, City, State, ZIP]

SECTION 3 — DESCRIPTION OF REQUIREMENT

The U.S. Food and Drug Administration (FDA), OƯice of Acquisitions and Grants Services (OAGS), intends to award a sole source, firm-fixed-price purchase order to Z-Spec, Inc. for the acquisition of the following brand-name commercial items:

Item Quantity Unit Measure

Unit Price

Extended Price

Z-Spec Z-max Analyzer 1 Ea $ $

Z-Spec E-max PLUS Analyzer 1 Ea $ $

The Z-max Analyzer is a proprietary instrument specifically optimized for the detection and quantification of lead (Pb) and other heavy metals in food, food additives, and agricultural products using Z-Spec's patented High Definition X-ray Fluorescence (HDXRF®) technology. The E-max PLUS Analyzer is a proprietary instrument engineered for the rapid quantification of ultra-low levels of cadmium (Cd) and other heavy metals — including arsenic (As), lead (Pb), copper (Cu), nickel (Ni), and chromium (Cr) — in soil, food, and water matrices using Z-Spec's proprietary Monochromatic X-ray Fluorescence (MXRF) technology.

These instruments are required by the FDA, Human Food Program (HFP) to support rapid analytical testing of foods, dietary supplements, cosmetics, and spices for toxic elements including arsenic (As), cadmium (Cd), mercury (Hg) and lead (Pb) detection. The analytical capabilities may be extended to include additional elements as needed.

SECTION 4 — BASIS FOR RESTRICTING COMPETITION

The FDA intends to restrict competition and award on a sole source basis to Z-Spec, Inc. (15 Tech Valley Drive, Suite 110 East Greenbush, NY 12061) pursuant to the authority at:

RFO FAR 6.103-1 — Only one responsible source

The basis for this restriction is as follows:

1. Proprietary Technology. The Z-max and E-max PLUS Analyzers are proprietary instruments exclusively designed, developed, and manufactured by Z-Spec, Inc. The instruments employ patented HDXRF® and MXRF optical and detection architectures that are unique to Z-Spec, Inc. and are not available from any other source.

2. No Technically Equivalent Substitute. Market research conducted by the FDA has determined that no other commercially available XRF or elemental analysis instrument provides equivalent analytical sensitivity, detection limits, and methodology required to meet the Government's specific technical requirements. Conventional energy-dispersive XRF (EDXRF) instruments available from other manufacturers do not achieve the detection performance levels required as below:

Performance Specifications - Required Limits of Detection

Element LOD required (ug/g) As 0.03 Cd 0.04 Hg 0.06 Pb 0.06 Tl 0.06

3. Only One Responsible Source. Z-Spec, Inc. is the only responsible source capable of providing the Z-max and E-max PLUS Analyzers that can meet all the government’s needs.

No other vendor manufactures or supplies instruments of equivalent capability that would satisfy the Government's minimum needs in terms of fair market prices, quality, and delivery.

SECTION 5 — RESPONSE INSTRUCTIONS

This notice is being posted in accordance with FAR 5.101 and RFO: FAR 6.103-1(d) to provide all interested parties an opportunity to respond with information demonstrating their capability to meet the Government's requirements.

The Government will consider all capability statements or oƯers received within 15 calendar days of the date of this posting.

Any responsible source that believes it can provide the required items and meet all of the Government's requirements — including the specific technical performance characteristics described herein — may submit a capability statement or quote to the Contracting OƯicer identified below. Responses must be submitted in writing and must include, at a minimum:

1. Company name, address, SAM UEI, and SAM.gov registration status;

2. A detailed technical description of the proposed product, including manufacturer name, model number, and technical specifications demonstrating the ability to meet the Government's requirements stated on the attached Statement of Work;

3. Pricing information;

4. Delivery schedule; and

5. Evidence of past performance supplying equivalent analytical instrumentation to federal, state, or commercial customers.

Responses must be received no later than 08/13/2026, 3PM Eastern Time.

Responses shall be submitted electronically to:

Contracting OƯicer: Min Jie Zeng

Email: Minjie.Zeng@fda.hhs.gov

SECTION 6 — DISCLAIMER

This notice does not constitute a Request for Quotations (RFQ) or a commitment by the Government to issue a solicitation or award a contract. The Government is not obligated to acquire any supplies or services described herein. No reimbursement will be made for any costs associated with providing information in response to this notice.

If no capability statements or quotes are received that demonstrate the ability to meet the Government's requirements, the FDA intends to proceed with a sole source award to Z- Spec, Inc. without further notice.

All responsible sources that submit a timely and adequate capability statement or a quote will be considered. A determination by the Government not to compete this requirement based on responses to this notice is solely within the discretion of the Government.

SECTION 7 — ATTACHMENTS

Attachment 1 — Statement of Work

Point of Contact:

Min Jie Zeng

Contracting OƯicer

U.S. Food and Drug Administration

OƯice of Acquisitions and Grants Services

Minjie.Zeng@fda.hhs.gov

AƩachment - STATEMENT OF WORK 07/29/2026

1. Purpose The Office of Chemistry and Toxicology, Division of BioanalyƟcal Chemistry, Chemical Contaminants Branch requires the purchase of two portable Mono-ChromaƟc High DefiniƟon X-ray fluorescence spectrometers (mHD-XRF systems): the Z-max Analyzer and the E-max PLUS Analyzer. These systems will support rapid analyƟcal tesƟng of foods, dietary supplements, cosmeƟcs, and spices for toxic elements including arsenic (As), cadmium (Cd), mercury (Hg) and lead (Pb) detecƟon. The analyƟcal capabiliƟes may be extended to include addiƟonal elements as needed.

The proposed instruments are required to conƟnue and to expand the efforts of the FDA to protect the U.S. food supply and to respond to emergencies in a Ɵmely and accurate manner.

2. Background The Chemical Contaminants Branch within the Office of Chemistry and Toxicology, Division of BioanalyƟcal Chemistry requires the portable XRF spectrometers with low detecƟon limits. The requested instrumentaƟon will be used for several elemental analysis applicaƟons including, but not limited to:

1. QualitaƟve screening of toxic elements in foods, dietary supplements, and cosmeƟcs with special emphasis on spices

2. QuanƟtaƟve tesƟng of toxic elements in foods, dietary supplements, and cosmeƟcs with special emphasis on spices

3. Method development and validaƟon for such applicaƟons

4. New instrumentaƟon, including the proposed Z-max and E-max analyzers uƟlize proprietary doubly curved crystal technology that reduces spectral background to enable detecƟon limits 100-1000x lower than other XRF designs.

FDA requires this instrumentaƟon to offer highly accurate, cost-effecƟve tesƟng for toxic elements that do not require tradiƟonal wet chemistry analysis including microwave digesƟon and analysis. These applicaƟons are criƟcal to the FDA’s mission to ensure the safety of the naƟon’s food supply and reduce dietary exposure to chemical contaminants like toxic elements.

3. ObjecƟves The purchase of these mHD-XRF systems is necessary to support method development and validaƟon for toxic element tesƟng that is criƟcal to the FDA’s mission. The major components of the acquisiƟon plan are as follows:

Items Required:

o Z-Spec, Inc. Part number (106-01) Z-max Analyzer o Z-Spec, Inc. Part number (102-02) E-max PLUS Analyzer o Accessories, including sample cups, sample prep kit, transporting case, food/plant standards kit.

4. Technical SpecificaƟons

4.1. System

Detection Method: energy dispersive XRF

Optics: Doubly Curved Crystal (DCC) optics

Excitation: 17 keV excitation beam or greater

Power: compatible with standard U.S. 120V 60 Hz power Portability:

Field-portable design (<10 kg) combined with high analytical sensitivity, enabling both laboratory and on-site testing

4.2. Sample Preparation

Samples will be provided as dried powders, and purchase should include sample holders and/cup, along with XRF transparent film to hold powdered sample.

4.3. Performance Specifications - Required Limits of Detection o Must meet ultra-low limits of detecƟon for toxic elements (e.g., As, Cd, Hg, Pb, Tl) required for FDA regulatory and research applicaƟons.

Element LOD required (ug/g) As 0.03 Cd 0.04 Hg 0.06 Pb 0.06 Tl 0.06

4.4. Software and Data Management

Fundamental Parameters data model

Data Output: Integrated hardware/software architecture designed specifically for food safety and contaminant analysis workflows and data should be available for export in standard .txt or .csv formats

Connectivity: Ethernet, USB ports

5. Scope The major evaluaƟon factor for this solicitaƟon will be ability to meet technical requirements. The Government reserves the right to select the system that will offer best value, including consideraƟon features that may enhance the value of the instrument, such as addiƟonal soŌware, training, and extension of warranty periods. Cost will be considered only aŌer the technical and hardware requirements are met.

6. Delivery The vendor is responsible for delivery of the instrument and all components specified above to the FDA/HFP laboratory facility located at 5001 Campus Drive, College Park, MD 20740. The delivery should be made to the loading dock within 45 days aŌer award. The instrument will not be accepted unƟl performance specificaƟons have been met. The FDA project officer will perform inspecƟon and acceptance of the instrument. The enƟre system will be warranted for parts and labor for 12 months from date of installaƟon. Service must be provided by service engineers who are trained and cerƟfied by the original manufacturer of the instrument. Engineers should have access to the manufacturer’s latest technical developments, repair procedures, applicaƟon updates, diagnosƟc soŌware, and planned maintenance procedures. Work shall be conducted Monday through Friday, excluding federal holidays.

7. InstallaƟon and Set-up The vendor will be responsible for installaƟon and set-up, including iniƟal calibraƟons.

8. Training and DocumentaƟon InstallaƟon includes a one-day onsite training led by field applicaƟon scienƟst (FAS).

9. Warranty and Maintenance The instrument will be covered by a one-year Extended Warranty. The Standard Warranty covers all parts and labor with one preventaƟve maintenance. Subsequent PMs available separately.

10. Quality Assurance The system must be newly manufactured unit, not used or refurbished, or previously used for demonstraƟon. The instrument must meet all the technical requirement specified above in: 3. ObjecƟves and 4. Technical SpecificaƟons.

11. Place of Delivery FDA/HFP, 5001 Campus Drive, College Park, Maryland, 20740. Delivery and installaƟon should be coordinated through the HFP Project Officer. Work shall be conducted Monday through Friday, excluding federal holidays.

12. Period of Performance EsƟmate Period of Performance 09/30/2026-09/29/2027