RFQ_WD-XRF_Spectrometer_Combined_Synopsis_Solicitation Final.docx

ALP: OC-2026-134665

WD-XRF Spectrometer

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 RFQ-FDA-134655 is issued as a/an [☒ RFQ ☐ RFP ☐ IFB] for the purchase, delivery, installation, on-site training, and warranty/service support of one (1) new wavelength-dispersive X-ray fluorescence (WD-XRF) spectrometer system for the U.S. Food and Drug Administration (FDA), Office of Cosmetics and Colors, Division of Color Certification and Technology, Color Certification Branch, College Park, Maryland.

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 (Analytical Laboratory Instrument Manufacturing) 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 ☐ bid ☐ proposal], which will be considered by the agency.

2. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance: U.S. Food and Drug Administration, University Station (CPK2), Room 1098, 4300 River Road, College Park, MD 20740 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 Delivery, Warranty, and Option Periods for Preventative Maintenance / Extended Warranty Delivery shall be completed within twenty-five (25) weeks 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.

The base period covers delivery, installation, training (if applicable), and the warranty period. Option periods for preventative maintenance / extended warranty begin the day after the warranty period ends, with no gap between periods.

Following Government acceptance, the Contracting Officer will issue an administrative modification under RFO 43.203(b)(1) and 43.201 to memorialize the period of performance dates, anchored to the Government acceptance date. The modification does not change scope, price, or any other substantive term. The Contractor's written confirmation of the installation completion date supports inspection and acceptance scheduling; it does not establish the period of performance.

Base Period: [CONTRACT AWARD DATE] through [12 MONTHS AFTER GOVERNMENT ACCEPTANCE] Option Period 1: [DAY 1 AFTER WARRANTY END DATE] through [12 MONTHS] Option Period 2: [DAY 1 AFTER OP1 END DATE] through [12 MONTHS] Option Period 3: [DAY 1 AFTER OP2 END DATE] through [12 MONTHS] Option Period 4: [DAY 1 AFTER OP3 END DATE] through [12 MONTHS]

3. CONTRACT LINE ITEMS (CLINs)

Note to offerors: Prices shall be inclusive of all freight, insurance, duties, and tariffs. The Government intends to award a single firm-fixed-price contract for all CLINs listed above. Option CLINs will be evaluated for award purposes but exercise is at the sole discretion of the Government.

4. POINTS OF CONTACT

Contracting Officer:

Name: David Seid Email: David.Seid@FDA.HHS.Gov Phone: (301) 796-3941

5. CONTRACT CLAUSES

5A. Clauses Incorporated by Reference

Jun 2026

Apr 2026

Legend: REQ = required by regulation for this acquisition; APPL = applicable and incorporated; TBD = applicability to be confirmed by the Contracting Officer before issuance; N/A = not applicable to this acquisition.

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)

52.217-8, Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor at any time before contract completion.

(End of clause)

52.217-9, Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor any time prior to contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at any time before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

sixty (60) months.

(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

The Contractor shall provide one (1) new wavelength-dispersive X-ray fluorescence (WD-XRF) spectrometer system with all supplies and accessories necessary for installation, training, and operational performance of the analytical instrumentation, together with delivery, on-site installation, on-site training, and warranty and service support as described below. Used or remanufactured instrumentation shall not be considered.

Background and Purpose The Color Certification Branch (CCB), Division of Color Certification and Technology (DCCT), Office of Cosmetics and Colors (OCAC), requires a WD-XRF spectrometer capable of determining trace levels of arsenic (As), lead (Pb), mercury (Hg), and other elements in certifiable color additives. Batch certification of color additives is a regulatory premarket enforcement function. CCB conducts laboratory testing of color additives to determine whether a batch submitted for certification meets the specifications described in 21 CFR Parts 74 and 82.

WD-XRF is the primary technique used to determine trace levels of heavy metals in certifiable color additives in the range of 1–1000 ppm, and results are used to certify or reject batches of color additives for elements with limiting specifications listed in 21 CFR Part 74. Guaranteed service support for the incumbent instrument has expired and is not renewable; replacement is required to sustain continuity of the Color Certification Program.

Objectives The instrument will be used for high-throughput sample determinations of elemental impurities in certifiable color additives to support the certification or rejection of those additives as required under 21 CFR Part 74; for research in developing new methods for the Color Certification Program; and for the analysis of regulatory samples of unknown elemental composition. Guaranteed service support providing timely maintenance and repair is required.

Salient Characteristics / Minimum Requirements The Contractor shall provide a WD-XRF system that meets or exceeds each of the requirements below. Quotations that do not meet every requirement will be determined technically unacceptable.

1. Sensitivity and precision

a. The Contractor shall provide an instrument capable of determining As, Pb, and Hg in the calibration range of 0.5–20 parts per million (ppm).

b. The Contractor shall demonstrate that the instrument can achieve a minimum limit of detection (LOD) of 0.5 ppm for As, Pb, or Hg in light element matrices.

c. The Contractor shall demonstrate that the instrument can achieve precision for As, Pb, and Hg in light element matrices of 0.2 ppm or lower in the calibration ranges.

d. The Contractor shall demonstrate that the instrument can quantify As and Pb in color additive samples containing bromine (Br).

i. The Contractor shall demonstrate that the instrument can achieve a minimum LOD of 1 ppm or lower for As and Pb in heavy element matrices.

ii. The Contractor shall demonstrate that the instrument can achieve precision of 0.5 ppm or lower for As and Pb in heavy element matrices in the calibration ranges.

e. Full analyte coverage from beryllium (Be; Z=4) to uranium (U; Z=92), with general quantitation levels ranging from sub-ppm levels to high percent by weight.

2. Sample changer / autosampler

a. The instrument must demonstrate that the sensitivity and precision requirements can be met while allowing for continuous sample throughput. To this end, the Contractor shall demonstrate that the instrument provides:

i. Capability for both system-automated and manual loading of samples.

ii. Capability to load samples externally during system operation.

iii. Capability to recognize sample types including solid, liquid, and powder.

iv. Capability to measure multiple applications in one run from the same sample changer tray.

b. The instrument must be capable of holding and running at minimum 50 sample cups from the sample changer tray(s).

3. X-ray tube

a. The instrument must have a primary excitation X-ray tube (rhodium anode) with no less than 2.4 kW power supply to achieve the excitation needed for the sensitivity and precision requirements stated in paragraph 1.

b. The X-ray tube end window shall be no thicker than 75 µm.

c. The X-ray tube shall be able to operate between 20–60 kV and 10–160 mA.

4. Primary beam and optical path

a. The instrument must contain components capable of modifying the spectral composition of the primary X-ray beam to reduce background noise and enhance sensitivity for specified target elements (filters or equal).

b. The instrument must contain components capable of automatically controlling the divergence of the X-ray beam (collimators or equal) into fine, medium, and coarse spot sizes for controlled analysis of light, medium, and heavy elements.

5. Goniometer and analyzing crystals

a. The included goniometer shall include multiple high-quality analyzer crystals suitable for WD-XRF spectrometry applications to improve the sensitivity of elemental measurements.

b. The instrument shall include the following types of crystals:

i. LiF 220 crystal for enhanced resolution (V – Am).

ii. LiF 200 crystal (K – Am).

iii. Synthetic crystal for Al – Cl.

iv. Synthetic crystal for O – Mg.

v. Synthetic crystal for P – Cl.

6. Detection and counting electronics

a. The instrument shall include at a minimum two detectors capable of prioritizing the detection of light and heavy elements.

b. The instrument shall include a flow proportional counter and a scintillation counter type of detector.

c. The detectors shall be capable of measuring high count rates in millions of counts per second (Mcps) to deliver high detector linearity and the lowest detection limits.

d. The instrument shall include the added capability to perform energy-dispersive X-ray fluorescence (ED-XRF) through a separate channel in addition to WD-XRF, able to generate a spectrum for the energy range of 1–40 keV and capable of detecting elements with a characteristic line in this region.

7. Computer and software

a. The instrument operating software must be fully compatible with the Windows 11 operating system.

b. The software must be in accordance with FDA information technology guidelines.

c. The instrument shall include software capable of the following:

i. Ability to define spectral peaks above background noise, predict element identity, and resolve complex peak overlaps through deconvolution.

ii. Both standardless analysis and quantitative analysis.

iii. Qualitative data acquisition for the WD scan modes.

iv. Calibration and quantitation for the WD scan modes.

v. Standardless analysis capable of semi-quantitative measurements.

vi. Monitoring for instrument drift and application of corrections.

vii. Measurement of Compton scattering to correct measurements for matrix effects.

viii. Use of fundamental parameters (FP) methods to estimate quantitation of elements without standards.

ix. Updating of instrument calibrations per application.

x. Processing of data to generate full spectrum reports and/or quantitative data reports.

8. Service and support

a. The Contractor shall offer a warranty on the WD-XRF, including full coverage for labor, parts, on-site service with travel and housing, phone support, and on-line support.

b. The warranty shall include unlimited on-site visits, repairs, and phone calls.

c. The Contractor shall offer at least one additional option year of extended service warranty beyond the standard first-year warranty.

d. The Contractor shall cover parts, labor, and travel for repairs and defects within the service agreements at no cost to CCB or the Government.

e. The service agreement shall include one preventative maintenance and unlimited repairs as needed. The Contractor shall provide service and application support within 24 hours and on-site repairs within 3–5 days of the initial contact.

f. Service must be performed by engineers/technicians trained and certified in accordance with the manufacturer specifications.

g. Any travel expenses incurred by the visiting engineer/technician shall be covered by the Contractor.

h. Certified parts (original equipment manufacturer parts) shall be used to restore the WD-XRF to optimal operational specifications.

i. At least one annual preventative maintenance (PM) shall be performed by the Contractor.

j. Unlimited telephone and on-line support for hardware and software shall be provided by trained service engineers/technicians.

k. On-demand service shall be available during normal business hours, Monday through Friday, 8:00 a.m. to 5:00 p.m. (excluding Federal holidays).

9. Training and installation

a. The Contractor shall provide on-site installation and training for up to two (2) trainees.

b. The complete system, including instrumentation, associated software, and all hardware, must include full training for a minimum of two employees, conducted on-site.

c. The instrument shall be delivered with all necessary supplies and accessories required for installation and training.

10. General specifications

a. The system, if a floor-standing unit, shall be designed with integrated support structures.

b. The system shall not exceed the following footprint: 85 cm width, 110 cm depth, 155 cm height.

c. The system shall operate within ambient room temperature laboratory conditions.

d. The Contractor shall provide the entire system, including all supplies and accessories, for immediate start-up and installation at the designated laboratory delivery location.

e. Necessary peripherals (e.g., chiller/heat exchangers) required for instrument installation shall be provided by the Contractor.

Contractor-Provided Special Material Requirements The Contractor shall supply the necessary tools required to perform the instrument installation, maintenance service, and repairs.

Security The equipment is to be installed in a Government-secured building. Visiting engineers/technicians will adhere to security screening upon arrival and will be escorted into the building by personnel from OCAC. Additional security requirements will be communicated to visiting engineers/technicians upon scheduling.

Place of Performance Installation, maintenance, any necessary repairs of the equipment, and all training will be performed at the FDA site where the equipment is located:

U.S. Food and Drug Administration University Station (CPK2), Room 1098 4300 River Road, College Park, MD 20740 Work shall be conducted Monday through Friday, 8:00 a.m. to 5:00 p.m., excluding Federal holidays. Scheduling is to be coordinated through the Contracting Officer’s Representative (COR). Other times of performance shall be discussed and scheduled with the COR.

Post-award technical coordination will be through the COR and Project Officer identified at award. All pre-award questions shall be directed only to the Contracting Officer and Contract Specialist identified in Section 4 and in the SAM.gov notice.

Inspection and Acceptance Inspection will be performed by the technical personnel designated by the Project Officer. Acceptance of the system will be made by the COR at the place of delivery in accordance with 52.212-4.

Holidays and Government Closures The Contractor is not required to provide on-site services on the following days that are Federal holidays or on 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; Juneteenth National Independence Day; Independence Day; Labor Day; Columbus Day; Veterans Day; Thanksgiving Day; and 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, as a minimum, directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather, unless otherwise specified in the contract.

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center, or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work. The Contractor may not bill the Government for any hours that contractor employees did not work due to any Government closure.

A. SOLICITATION PROVISIONS

A1. Provisions Incorporated by Reference

Basis for Award Lowest Price Technically Acceptable (LPTA). Award will be made to the lowest-priced quoter whose quotation is determined technically acceptable. Technical acceptability will be determined on a pass/fail basis against the salient characteristics and minimum requirements in Section 6. Quotations 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.

Evaluation of options: The Government will evaluate quotations for award purposes by adding the total price for all option CLINs to the total price for the basic requirement. Evaluation of options shall not obligate the Government to exercise them.

A2. Addenda to 52.212-1

Offer Acceptance Period (if applicable):

Paragraph (b) of the provision is hereby amended to extend the period for acceptance of offers from 60 calendar days to 120 calendar days from the date specified for receipt of offers.

B. OFFER SUBMISSION

Questions Due: Questions regarding this solicitation shall be submitted in writing to the Primary POC identified in the SAM.gov notice no later than five (5) business days after solicitation posting date. Questions and answers may be posted as an amendment to this solicitation on SAM.gov.

Offers Due: As listed on the SAM.gov notice.

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. Past performance information: not required for this acquisition.

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 (52.225-5, Trade Agreements, applies to this acquisition)

1. Documented performance data (e.g., manufacturer specifications, validation or demonstration reports) substantiating each demonstration requirement in Section 6, paragraphs 1 and 2; a completed CLIN pricing schedule; and the manufacturer’s standard and extended service agreement terms.

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.

Attachments (if applicable):

Attachment 1 — Statement of Work / Requirements Document (WD-XRF Spectrometer).

Trade Agreements Statements (conditional — 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.

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