Combined Synopsis Solicitation- OC-2026-134410-Final.pdf

Request for Quotation: FDA-RFQ-OC-2026-134410 Procurement of New Bench Top Single Quadrupole Inductively Coupled Plasma Mass Spectrometer (ICP-MS) System for Color Certification Program

- Brand Name or Equal

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Notice of Combined Synopsis/Solicitation. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

Part-A Fundamental Contract Information

The solicitation number is FDA-RFQ- OC-2026-134410 and is issued as a Request for Quotations (RFQ) for a new Bench Top Single Quadrupole Inductively Coupled Plasma Mass Spectrometer (ICP-MS) System for Color Certification Program-Brand Name and Equal (BNE). The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2026-01.

1. Contract Type - The Government intends to award a Firm Fixed-Price (FFP) Purchase Order to procure the requested items/system/services.

2. NAICS - This requirement is being solicited as an unrestricted, full and open competition requirement. Prospective offerors are responsible for downloading the corresponding solicitation and any amendments from SAM.gov. The Government reserves the right to award the consequential firm fixed price purchase order without discussion if the Contracting Officer determines that the initial offer provides the Best Value to the Government and discussions are not necessary.

a. The NAICS for this requirement is: 334516- Analytical Laboratory Instrument Manufacturing

b. The SB size standard for the NAICS code is: 1000 Employees or fewer.

The full table of size standards can be found at:

https://www.sba.gov/document/support-table-size-standards

3. Background: This request is for the Division of Color Certification and Technology

(DCCT), within the Office of Cosmetics and Colors, to acquire a new inductively coupled plasma mass spectrometer (ICP-MS). This system will replace an existing Agilent 7800 ICP-MS, which was purchased in May 2016 and will reach the end of its guaranteed support in October 2028. Timely replacement is necessary to ensure continuous service and to prevent any interruption in color certification activities. DCCT needs an instrument capable of determining element concentrations and accurate element ratios at low concentrations. In contrast to conventional quadrupole-based instruments, an instrument equipped with a kinetic energy discrimination-capable collision/reaction cell will provide the agency with the capability for achieving lower detection limits and higher accuracy in determining element concentrations in complex color additive and other matrices.

4. The instrument shall have a fully developed software package to allow the instrument to perform up to its design specifications and facilitate the transfer of existing methods. For seamless integration, the instrument software must be able to control all components of the ICP-MS system including autosampler, advanced diluting system, reaction system, plasma, mass analyzer, and torch. The software shall have comprehensive auto-tuning capabilities for plasma parameters, torch position, collision cell, lenses, mass analyzer, detector, and detector pulse/analog factors in one single step.

https://www.sba.gov/document/support-table-size-https://www.sba.gov/document/support-table-size-

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5. Purpose/Description of Work – The purpose of this Request for Quotation (RFQ) is to procure the proposed system is required to continue and expand the efforts of the FDA to protect the U.S. food supply and to respond to emergencies in a timely and accurate manner. DCCT staff will use the equipment for the following purposes:

• For analysis of color additives with regulatory limits of toxic and other elements

• For the development of new methods for quantification of low-level (parts per billion) heavy metals primary arsenic (As), cadmium (Cd), chromium (Cr), lead (Pb), manganese (Mn), and mercury (Hg) in various color additives

• For characterization of reference standard materials prepared in-house

• For the analysis of samples obtained during inspection

5.1 General Requirement Guidance for Salient Characteristics. - The Contractor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement. The Contractor shall demonstrate how the requested items or services, “MEET” or “DO NO MEET” the salient/functional characteristics and specifications listed here-below.

The Contractor shall annotate each salient/functional characteristics and specifications with the following: Meets (if it meets the specification) or Does not meet (if it fails to meet the specification).

5.2 Grey market or refurbished products will not be accepted.

5.3 The Vendor shall indicate if non-domestic items are included in the quote.

5.4 The Vendor shall meet all technical/salient/functional, operational characteristics and specifications listed, and if not the manufacturer, shall be able to provide the required service with OEM certified technicians and parts or show proof that they are an authorized third party re seller/provider.

5.5 Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine).

Document submissions required throughout the award period(s) shall not have macro-enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

Specifications/Salient Characteristics- This is a Brand Name or Equal requirement. Products other than the the aforementioned are acceptable but shall meet all the salient characteristics contained in the Minimum Technical Requirements below:

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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 DCCT prior to purchase:

1. General

The system shall be of a compact bench-top design to fit the space constraints of the laboratory and shall have an open architecture sample introduction area with external rotary pump(s) configured to fit under or behind the laboratory bench. The footprint for both the ICP-MS and the autosampler shall be smaller than height x width x dept: 35" x 45'' x 35”.

The components and/or equipment shall be new, not used or refurbished, or previously used for demonstration.

The system shall be a turn-key solution—the contractor shall be responsible for providing all hardware, components, instruments, and software that are otherwise required to meet these salient characteristics.

The contractor shall provide the entire system including all necessary supplies and accessories and fittings required for immediate start-up and installation on-site at the designated laboratory delivery location.

Instrument software must be able to control all components of the ICP-MS system (including autosampler, advanced diluting system, reaction system, plasma, mass analyzer, chiller, pump) with a single software program/package.

The ICP-MS software shall demonstrate exceptional consistency and operational simplicity through advanced system setup and comprehensive auto-tuning of plasma operating parameters, torch alignment, collision cell conditions, ion optics (lenses), mass analyzer settings, detector parameters, and percent abundance factors — all in one single step

All solutions, standards, and/or consumables required to perform initial instrument qualification are the responsibility of the offeror.

Single hyperbolic quadrupole for mass analysis, Agilent 7850 (G8422AA) or equal.

Sample Introduction system, Agilent SPS4 (G8415A) or equal.

Advanced dilution system, Agilent ADS 2 (M5172A) or equal.

Operating software and shall be Microsoft Windows based software Microsoft Office modules needed for data analysis and interpretation shall be included.

Color laser printer.

Heat exchanger/chiller for cooling the interface. The cooling water supply to the ICP-MS mainframe shall be supplied by a non-refrigerated heat exchanger to reduce maintenance cost.

Roughing pump with noise reduction (quiet) cover.

Gas regulator(s).

Perfluoroalkoxy alkanes inert sample introduction kit with 2.5 mm sapphire injector PFA concentric nebulizer.

The instrument installation and user familiarization training shall be included in price.

3-day on-site application consulting, routine operation and operator maintenance training A comprehensive spares kit, including nickel sample and skimmer cones, shall be supplied. An extra set of nickel sample and skimmer cones shall also be included.

Spectrometer must be covered under warranty for a period of 1 year after installation. The warranty shall include unlimited on-site visits for problem resolution.

The price proposal shall include optional service agreements for three additional years, covering all parts and labor for repairs or defects. This shall not obligate the FDA to purchase the service agreements. Optional service agreements shall not be exercised until expiration of the standard manufacturer's warranty.

2. Sample Introduction, Agilent SPS4 (G8415A) or equal An integrated, computer-controlled, high-precision peristaltic pump (pump speed 0.1 to 0.5 rps) with a minimum of three channels and ten rollers shall be provided for independent pumping of the sample, internal standard, and spray chamber drain.

The quartz spray chamber shall be thermoelectrically controlled and shall be fitted with a concentric micro-mist

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Temperature controlled spray chamber (-5 to 20 °C) Ultra-high matrix introduction capability shall be included, enabling reliable analysis of samples containing

≥5% total dissolved solids (TDS).

A high throughput autosampler is required with a minimum capacity of at least 42 50-mL and 120-15 mL sample vials as well as positions for tune and rinse bottles.

The autosampler shall come with a cover to prevent dust from entering sample containers during analysis.

Autosampler capable of automated monitoring of signal washout using computer software.

User selectable intelligent-automated monitoring of washout to the baseline and pre-emptive rinse routines for increased productivity.

It shall have pumped drain kit.

The sample introduction system shall be automatically tuned via the integrated software.

3. Advanced dilution system, Agilent ADS 2 (M5172A) or equal Capable of automatically preparing calibration standards from a single stock standard.

Preform fixed or predefined dilutions to cut down on manual pre-analysis dilutions, consumable usage, and laboratory waste.

Performs reactive dilution when a measured signal is over range, reducing the need for repeat analyses.

4. Gas flow controllers Instrument shall have computer-controlled gas flow controllers that precisely regulate the flow of gas in the instrument’s plasma and interface systems (plasma, torch, nebulizer).

One collision/reaction cell gas line shall be included as standard. The system shall be upgradable to three cell gas lines in total, to cover all possible applications. It is not acceptable to use an external gas manifold for the additional cell gas lines because it increases the dead volume and changeover cannot be automated within run.

5. Vacuum and Cooling system The instrument vacuum system shall consist of a single floor mounted external rotary pump, and single turbomolecular pump.

6. Plasma and ion optics

a. Torch One piece quartz torch with injector diameter of 2.5 mm for fast, easy replacement and high matrix tolerance.

Demountable torches that use O-ring seals or require alignment of the separate concentric tubes are not acceptable, as they increase maintenance time and possibly introduce sample contamination.

Torch position shall be fully computer controlled and fully auto tunable via the software in all three axes (horizontal and vertical position and sampling depth). The movement in each axis shall be independent of the other two. Torch position and reproducibility should be 0.1mm in all three axes. Computer readout of torch position is required for method and data audit purposes.

Solid state electronics in both plasma and quadrupole RF generators.

b. RF generator For tolerance of changes in sample matrix, the system shall include a high power-transfer efficiency and maintenance-free solid state digital drive 27 MHz RF generator with variable-frequency impedance matching.

Minimum RF Power Range from 1000 W to 1600 W The RF generator shall be able to tolerate change from volatile organic solvents to aqueous samples without affecting plasma stability.

c. Interface Shielded torch interface for precise ion energy control Shall come standard with nickel sampling (0.1mm) and skimmer (0.45mm) cones with option for use of

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d. Ion optics Conical extraction and off-axis focus lens for uniform mass response curve.

The main ion-lens assembly shall be located before the gate valve to reject neutrals and matrix components before they can enter the main high vacuum chamber.

The main ion-lens assembly shall ensure that only ions enter the high vacuum region.

An ion lens that incorporates a 90° ion deflection shall be the method of protecting the detector from stray photons and high-energy neutrals which would cause a raised background. However, due to the potential for ion energy, space charge and mass bias effects caused by high angles of deflection of the primary ion beam, the 90° deflection shall occur after mass separation—i.e., the deflection shall occur between the quadrupole mass analyzer and the detector.

The main ion-lens assembly shall be located outside the main vacuum system and allow for removal, cleaning and replacement without opening the main vacuum system.

7. Collision/reaction system To enable fast, stable and consistent interference removal, the cell shall be thermally-stabilized and operated with fixed RF amplitude for the full mass range.

The cell shall switch between gas modes and between gas and no gas mode in 3 seconds or less.

The ICP-MS shall be able to be used for semi-quantitative analysis in cell mode using helium cell gas. The cell shall operate effectively in collision mode using pure helium.

The instrument shall be able to be used for the multi-element analysis of unknown samples containing chloride

(Cl), sulfate (SO4), and organic content, without the need for polyatomic interference correction equations.

8. Quadrupole mass analyzer The system shall use a true hyperbolic quadrupole, operating at high (3 MHz) frequency with a mass range of 2

- 260 amu The system shall have mass scan speed >3000 amu/sec and variable mass resolution

<0.3 u to >1.0 u.

The system shall have mass stability of ≤0.05 u per day ≤0.1 u per six months The system shall be capable of a linear dynamic range of at least 9 orders of magnitude without the need to use increased resolution at the highest concentration point.

The detector dead time shall meet industry standard timing and be identical in both pulse and analog modes.

The sensitivity for low mass (>10), mid-range mass (59-115), and high mass range (205-238) shall be at least

50 Mcps/ppm when operating under normal (no cell gas) instrumental conditions.

The background at m/z 9 shall be less than 2 cps when operating under normal (no cell gas) instrumental conditions Oxide ratios measured using CeO+/Ce+ <2% when operating under normal (no cell gas) instrumental conditions.

Double charged ratios measured using Ce2+/Ce+ <3% when operating under normal (no cell gas) instrumental conditions.

Short-term signal precision measured under normal (no cell gas) instrumental conditions shall be <3% relative standard deviation over 20 minutes.

Long-term signal precision measured under normal (no cell gas) instrumental conditions shall be <4% relative standard deviation over two hours.

The detector shall offer a minimum dwell time of 3 msec in all modes (TRA and spectrum).

The system shall include a collision/reaction cell to eliminate or significantly reduce interferences from molecular species and allow for accurate multi-element analysis of elements such as chromium, arsenic, selenium, thallium, cadmium, lead, antimony, and mercury under the same experimental conditions.

The systems shall have the option of adding a 2nd and 3rd cell gas line to cover all possible applications, both current and future.

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The instrument shall be capable of eliminating interference at different masses, without the use of interference equations to correct for polyatomic interferences, in accurate determination of variable high matrix samples.

The collision/reaction cell shall be able to reduce polyatomic interferences in collision mode using pure helium, hydrogen, or oxygen.

9. Data system:

The instrument shall include software for data acquisition, processing and reporting.

The instrument shall include one-click plasma setting for simpler, more reproducible plasma optimization.

The instrument shall include the capability for remote monitoring of instrument status and run progress and support remote control of instrument and run processes using the ICP-MS vendor's software utility running on a smartphone or tablet.

The ICP-MS system shall include tutorial and standard operating procedures in electronic format for ease of operating and implementing software.

The instrument control software shall offer an automated method setup wizard to users to build a fully functional method by simply asking a few questions.

Pricing Schedule - Prices shall be inclusive of shipping and handling and shall be firm fixed through one (1) year after award for the contract line item (CLIN) below. Pricing shall include all applicable fees; any charges presented after contract award shall not be considered/acceptable:

Contract Line Item

(CLIN)

Description Quantit y

Unit Unit Price Extended Price

“Brand Name or Equal” Quadrupole Inductively Coupled Plasma Mass Spectrometer

(ICP-MS)

System

1 each

Autosampler

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Chiller

Advanced Dilution System

Installation and Training

ICP-MS Kits, Consumables, and Small

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Option Year 1

Option Year 2

Option Year 3

Option Year 4

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5.6 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, Government closure, or shutdown for the Washington, D.C. area:

New Year's Day January 1 Martin Luther King's Birthday Third Monday in January President's Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 19 American Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday in October Veteran's Day November 11 Thanksgiving Day Fourth Thursday in November Christmas Day December 25

5.7 Period of Performance (POP)- Performance begins on the date of formal government acceptance and continues through the end of the manufacturer's warranty period.

5.8 Points of Contact:

Contracting Officer /Contract Specialist:

Brandon Rafus Email: brandon.rafus@fda.hhs.gov

Contracting Officer’ Representative:

Name: Enio Miranda-Bermudez Email: enio.miranda-bermudez@fda.hhs.gov

6. Contracting Officer’s Authority

The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of the statement of work. In the event the Contractor effects any changes at the direction of any person other than the CO or the TPOC the changes shall be considered to have been made without authority, and no adjustment shall be made in the contract price to cover any increase in costs incurred as a result thereof. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract and modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds.

mailto:brandon.rafus@fda.hhs.gov mailto:enio.miranda-bermudez@fda.hhs.gov

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The Contracting Officer is the only person with authority to act as agent of the Government under the Contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of the Contract; or (5) otherwise change any terms and conditions of the Contract.

Part-B Contract Clauses

1. FAR 52.212-4 - Contract Terms and Conditions – Commercial – Items (Deviation NOV 2025).

2. FAR 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 these addresses:

https://www.acquisition.gov/far/part-52 https://www.acquisition.gov/far-overhaul https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

Required and applicable Clauses

Clause Number

Clause Title

X 52.203-6 w/Alt I

Restrictions on Subcontractor Sales to the Government (JUN 2020)

X 52.203-17 Contractor Employee Whistleblower Rights (NOV 2023) X 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

(JAN 2017)

X 52.204-9 Personal Identity Verification of Contractor Personnel (JAN 2011) X 52.204-91 Contractor Identification (NOV 2025) X 52.204-13 System for Award Management—Maintenance (DEVIATION) (RFO AUG 2025) X 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations (DEVIATION)

(RFO NOV 2025)

Required 52.212-4 Contract Terms and Conditions-Commercial Products and Commercial Services

(NOV 2023)

X 52.222-3 Convict Labor (NOV 2025) X 52.222-19 Child Labor—Cooperation with Authorities and Remedies (NOV 2025) X 52.222-36 Equal Opportunity for Workers with Disabilities (NOV 2025) X 52.222-50 Combating Trafficking in Persons (or with Alt I) (NOV 2025)

X 52.222-90 Addressing DEI Discrimination by Federal Contractors (DEVIATION) (RFO APR 2026)

X 52.223-23 Sustainable Products and Services (DEVIATION) (RFO Sep 2025)

X 52.225-1 Buy American—Supplies (or with Alt I) (NOV 2025) X 52.226-8 Encouraging Contractor Policies to Ban Text Messaging (MAY 2024) X 52.232-33 Payment by Electronic Funds Transfer- System of Award Management (Oct 2018) X 52.233.3 Protest After Award (DEVIATION) (RFO NOV 2025) X 52.244-6 Subcontracts for Commercial Products and Commercial Services (NOV 2025) X 52.243-1 52.243-1 Changes-Fixed-Price (DEVIATION) (RFO JUN 2025) X 52.233-4 Applicable Law for Breach of Contract Claim (DEVIATION) (RFO NOV 2025) X 52.240-91 Security Prohibitions and Exclusions (DEVIATION) (RFO AUG 2025)

X HHSAR

352.204.73 Contractor Personal Security and Agency Access (DEVIATION (FEB 2024

X HHSAR Electronic Submission of Payment Requests (APR 2026) (RFO DEVIATION) https://www.acquisition.gov/far/part-52 https://www.acquisition.gov/far-overhaul https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

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352.232-71

X HHSAR

352.239-79 Information and Communication Technology Accessibility (Feb 2024) (Deviation)

Health and Human Services Acquisition Regulation (HHSAR) Clauses can be viewed in full text at: https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-cont53ract-clauses/index.html

3.) 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) 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:

- invoice number, amount, & date submitted

- corresponding payment amount & date received

- total amount of all payments received to date under the subject contract or order

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

(e) 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.

https://www.hhs.gov/grants-contracts/contracts/contract-policies-https://www.hhs.gov/grants-contracts/contracts/contract-policies-http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

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(f) If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

(g) 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.

(h) 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.

(i) . 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)

4. FAR 52.252-6 Authorized Deviations in Clauses (Nov 2020)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any Health and Human Services Acquisition Regulation clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of clause)

Part C- Solicitation Provisions

1. FAR 52.252-1. Solicitation Provisions Incorporated by Reference (Feb 1998)

Required and applicable Clauses

Clause Number Clause Title

Required 52.204-7 System for Award Management--Registration (NOV 2025) Required 52.212-1 Instructions to Offerors—Commercial Products and Commercial

Services (NOV 2025) X 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain

Federal Transactions (SEP 2024) X 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal

Confidentiality Agreements—Representation (JAN 2017) X 52.219-2 Equal Low Bids (NOV 2025)

2. Inquiries and Notices:

All questions regarding this RFQ shall be submitted by 09/22/2026, in writing to Brandon.Rafus@fda.hhs.gov. Phone or fax inquiries will not receive a response.

mailto:ERIC@fda.hhs.gov mailto:Brandon.Rafus@fda.hhs.gov

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3. Response Dates and Time RFQ Due Date: All quotes shall be submitted electronically via email to Brandon.rafus@fda.hhs.gov by 4:00 pm Eastern Time on 09/23/2026.

4. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1 (f). Instructions to Offerors – Commercial Items (Nov 2021)

5. Proposal Preparation Instructions:

5.1 The vendor shall submit the following in their proposal:

a) The vendor should submit a proposal, which will be considered if received by the due date. The subject line shall read: Subject: Request for Quotations: Request for Quotation: RFQ-OC-2026-134410, and a statement from the Offeror verifying that they are SAM.gov, including the UEI Number.

b) The Offeror’s current address and UEI Number shall be included in the quote.

c) Offerors that fail to submit all required documentation, or do not complete the required representations and certifications, or reject the terms and conditions of the solicitation, shall be excluded from consideration.

d) Quotes must include all quantities listed; all or none.

o A complete quote must consist of: i) Cover Letter, ii) Technical Proposal (which, in accordance with FAR 52.212-1 (b) (4)) must be a technical description of the items or services being offered in sufficient detail to evaluate compliance with the requirements in this RFQ). This may include product literature, or other documents, if necessary. The quote must also include a Technical Capability Statement demonstrating how the proposed product meets or exceeds each salient characteristic listed above. The quote must also include itemized pricing for hardware, software licenses, calibration tools, and shipping. Lastly, the quote should include an adequate delivery timeline that includes the anticipated lead time after receipt of order (ARO).

e) Incomplete proposals shall be considered non- responsive and shall not be evaluated.

f) Digital Microsoft (MS) Word files and MS Excel files shall be compatible with MS

Office Windows 10.

g) Proposal shall not consist of any lock or password-protect files (e.g. *.docx, *.pptx, *.xlsx,*.txt,*.msg).

h) The Offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the Offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents, and the submission will be considered non-responsive to the solicitation. No additional time will be given to an Offeror or applicant to correct the document submission, and the Government will not inform the Offeror or applicant that their submission is non-responsive prior to award. It is the Offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

mailto:Brandon.rafus@fda.hhs.gov

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5.2. Period for Acceptance of Offers:

Addenda to 52.212-1 Quote Acceptance Period (if applicable)

Offer Acceptance Period (if applicable):

Paragraph (b) of the provision is hereby amended to extend the period for acceptance of quotes from 60 calendar days to 90 calendar days from the date specified for receipt of offers.

Preparation Costs ***Note that this solicitation does not commit the Government to pay any cost for the preparation and submission of a proposal. Until formal notice of award is issued, no communication by the Government, either written or oral, shall be interpreted as a promise that an award will be made.

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.

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items Deviation (RFO Aug 2025) The following addenda have been added to this provision:

Quoters shall provide sufficient technical information necessary for the government to conclusively determine that the offered service/equipment meets all the salient characteristics herein, to include descriptive material, literature, brochures and other information corresponding to each minimum technical requirement which demonstrates the capabilities of the offered system. The Government is not responsible for locating or securing any information which is not identified in the quote; however, the Government reserves the right to obtain information for use in the evaluation from any sources including sources outside of the Government. The Government reserves the right to request additional information at any time.

Technical Acceptability: Quoter must provide sufficient technical information for the Government to conclusively determine that the quoted product meets or exceeds the minimum salient characteristics identified above. In addition to identifying manufacturer, make, and model of quoted products, it is incumbent of quoters that they unequivocally demonstrate that quoted products meet the requirements herein through the submission of technical specifications, descriptive material, scientific literature, brochures, scientific publications where proposed solution has been used for same or similar purposes, and other information which demonstrates the capability of the quoted equipment. Quoters shall address the technical requirements identified above, as well as provide detailed information on the item(s) in the solicitation.

If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation.

1. To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must-

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• Meet the salient physical, functional, or performance characteristics specified in this solicitation;

• Clearly identify the item by-

• Brand name, if any; and

• Make or model number;

2. Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

3. Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.

Quoters who are authorized resellers of an item, and not the manufacturer, shall provide a copy of their letter of supply or other documentation substantiating their relationship as an authorized reseller of the proposed manufacturer’s product. The documentation shall be on the Original Equipment Manufacturer (OEM) letterhead and include contact information for the individual who has signed the letter.

6. Request for Pricing. The Vendor shall complete the chart below, including any fees and charges. Any charges after contract award shall not be accepted.

6.1 Pricing Chart

Contract Line Item

(CLIN)

Description Quantity Unit Price

1 “Brand Name or Equal” Quadrupole Inductively Coupled Plasma Mass Spectrometer (ICP- MS) System

1 $

2 Autosampler 1

3 Chiller 1

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4 Advanced Dilution System 1

5 Installation and Training 1

6 ICP-MS Kits, Consumables, and Small

7 Option Year 1

8 Option Year 2

9 Option Year 3

10 Option Year 4

Total: (All Items Free on Board Destination) $

The offer shall be on a firm-fixed-price basis and include all quantities/services listed; all or none. Offerors shall provide documentation that they are an authorized dealer/reseller of the product that is being proposed, if they are not the manufacturer.

The software and digital interfaces will be evaluated for Section 508 accessibility compliance.

Section 508 Compliance The Contractor shall be familiar with Section 508 requirements as described at http://www.section508.gov/ in order to ensure that documents generated as part of the tasks are fully Section 508-accessible using the available COTS tools. Each order will http://www.section508.gov/

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508 Accessibility The following standards must be met:

• WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/making-filesaccessible/ index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery shall be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

• E207 Software (Appendix A, Application and Scoping Requirements)

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

Integrating networked third-party software with medical devices requires strict adherence to the FDA Cybersecurity Guidance and Section 524B of the Federal Food, Drug and Cosmetic (FD&C)Act. The FDA treats cybersecurity as an essential pillar of device safety and quality management. Consequently, the vendor remains accountable for all inherited code and connected third-party environments.

PART D: Packing, Marking, Delivering, and Shipping- The Contractor shall deliver the item and quantities ordered within 60 days of award. The Contractor shall deliver the items and quantities ordered, all, or none. The deliverables required under this contract shall be packaged, marked, and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in immediate new, usable, and acceptable condition. All required materials shall be delivered in immediate new, usable, and acceptable condition, at the U.S. Food and Drug Administration (FDA) facility address listed below:

Shipment Destination-

FDA Campus Point of Entry Address:

https://www.hhs.gov/web/section-508/making-filesaccessible/ https://www.hhs.gov/web/section-508/additional-resources/section-508-https://www.hhs.gov/web/section-508/additional-resources/section-508-

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The prospective vendor should provide insured shipping of equipment to:

Attn: Nebebech Belai, HFS-106 U.S. Food and Drug Administration, CPK2 Office of Cosmetics and Colors, Room 1059 4300 River Road College Park, MD 20740

The User manual, documentation, testing and calibration information shall be provided upon delivery. Vendor support is expected for setup, integration, or training. Technical and business support should be provided during regular business hours.

PART E- Inspection and Acceptance: Inspection and Criteria- Delivery and installation of the instrument and all components specified above shall be coordinated through the FDA Project Officer. Inspection and acceptance shall be performed at the delivery location in accordance with the terms of FAR Clause 52.212-4.

The FDA’s Technical Point of Contact (TPOC) will approve all tasks and deliverables.

The delivery of services shall be performed during regular business hours (Monday- Friday) during the times of 8:00 AM – 4:00 PM Eastern, excluding holidays.

The TPOC/COR will be responsible for determining the acceptance of the work that is completed. The Vendor shall contact the TPOC/COR by email or phone to schedule delivery. Deliveries shall be coordinated with the TPOC/COR prior to shipment. No deliveries will be accepted without prior authorization from the TPOC/COR. To meet the purpose and objective of this requirement, a single Contractor shall provide a service contract comparable or equivalent to the Collaborative Robotic Arm and that meet the established delivery timeline. The vendor must contact the COR prior to shipping the items to ensure the shipments can be received and must provide tracking numbers for the shipments

All deliverables shall be marked as follows:

• Name and address of the Contractor,

• Contract Number

• Description of item contained therein; and

• Consignee’s name and address.

Travel and expenses shall be covered by the Contractor (in any manner causes an increase or decrease in the total contract price; or changes any of the expressed terms, conditions, or specifications of the contract.

A. All technical directions shall be issued in writing by the TPOC or shall be confirmed by him/her in writing within five (5) working days.

B. The Contractor shall proceed promptly with the performance of technical directions duly issued by the TPOC in the manner prescribed by this clause and within his/her authority under the provisions of this clause.

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C. If, in the opinion of the Contractor, any instruction or direction issued by the TPOC is within one of the categories as defined in B. (1) through B. (4) above, the Contractor shall not proceed but shall notify the Contracting Officer, in writing, within five (5) working days after the receipt of any such instruction or direction and shall request the Contracting Officer to modify the Contract accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor, in writing, that, in his/her opinion, the technical directions are within the scope of this clause and do not constitute a change under the "Changes" clause of the contract. The Contractor shall thereupon proceed immediately with the direction given.

Any failure of the parties to agree upon the nature of the instruction or direction, or upon the contract action to be taken with respect thereto, shall be subject to the provisions of the contract clause entitled "Disputes."

Part-F Evaluation of Commercial Items

FAR 52.212-2 Evaluation - Commercial Items (Nov 2021) applies to this acquisition.

The Government reserves the right to award a contract without discussions. Commercial Items (Oct 2014) applies to this acquisition. Only one award shall be made from this RFQ. The corresponding requirement will be awarded on the basis of identifying the quote deemed 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. Quotes that do not meet all salient characteristics will be determined technically unacceptable and will not be considered for award. Moreover, price will be evaluated for reasonableness.

Part-G Offeror Representations and Certifications

FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2024) (DEVIATION FEB 2025) applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision— "Covered telecommunications equipment or services" has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a https://www.sam.gov/

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Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following:

ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Reasonable inquiry has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174).