RFQ - 75F40126Q00143 08.21.2026.pdf

CDRH-2026-134082

RFQ - 75F40126Q00143

Particle tracking setup

FSB Version 2.0 (June 8, 2026)

Request for Quotation (Supplies)

Section 1 General Information & Summary of Requirement

This is a Request for Quotation (RFQ) for commercial products prepared in accordance with the commercial acquisition procedures of RFO Part 12.

The Solicitation number is 75F40126Q00143.

The NAICS Code for this requirement is 334516 – Analytical Laboratory Instrument Manufacturing.

This acquisition is not set aside for small business concerns.

Set-Aside: None (unrestricted competition).

The small business size standard for this NAICS code is 1000 employees. The full table of size standards is available at: https://www.sba.gov/document/support-table-size-standards.

Description of Requirement: The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), has a requirement for one complete 3D Particle Tracking Velocimetry (PTV) system, including hardware and software, as outlined in the attached Requirements Document.

Section 2 Period of Performance / Delivery

Delivery of the complete system, including all hardware, software, and documentation, shall be made within 90 days after contract award. Delivery shall be FOB Destination to the FDA White Oak Campus in Silver Spring, Maryland, in accordance with the Requirements Document.

Section 3 Contract Line Items (CLINs)

CLIN / Description Spec/Part No.

Quantity Unit of

Issue

Unit Price Extended Price

0001 – 3D Particle Tracking Velocimetry (PTV) System -complete hardware, software, optics, calibration components, mounting hardware, accessories, cabling, interfaces, documentation, and ancillary items required by the Requirements Document (one complete system under the offered technical approach)

1 EA

0002 – Shipping / Delivery (FOB 1 LOT https://www.sba.gov/document/support-table-size-standards

CLIN / Description Spec/Part No.

Quantity Unit of

Issue

Unit Price Extended Price

Destination), if not included in CLIN

TOTAL

Section 4 Points of Contact

Contracting Officer:

Name: Linda Finan Email: Linda.Finan@fda.hhs.gov

Contract Specialist:

Name: Erika Crawford Email: Erika.Crawford@fda.hhs.gov

Contracting Officer's Representative (COR):

TBD

mailto:Linda.Finan@fda.hhs.gov mailto:Erika.Crawford@fda.hhs.gov

Section 5 Contract Clauses

Clauses Incorporated by Reference The following clauses apply:

Buy American applies to this acquisition. Any award of a foreign end product is subject to an approved nonavailability determination/waiver, as applicable, before award.

Appl. Clause No. Clause Title Date

X 52.212-4 Terms and Conditions—Commercial Products and Commercial Services (use Alt I for T&M/LH)

Nov 2025

52.203-6 w/Alt I

Restrictions on Subcontractor Sales to the Government Nov 2021

52.203-13 Contractor Code of Business Ethics and Conduct Nov 2021

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

52.204-9 Personal Identity Verification of Contractor Personnel Nov 2025

X 52.204-13 System for Award Management—Maintenance Nov 2025

X 52.204-91 Contractor Identification Nov 2025

52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

Nov 2025

52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters

Nov 2025

X 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations

Nov 2025

52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns

Nov 2025

52.219-6 Notice of Total Small Business Set-Aside Nov 2025

52.219-6 w/Alt I

Notice of Total Small Business Set-Aside, with Alternate I Nov 2025

52.219-8 Utilization of Small Business Concerns Nov 2025

52.219-9 Small Business Subcontracting Plan Nov 2025

52.219-9 w/Alt I

Small Business Subcontracting Plan, with Alternate I Nov 2025

52.219-9 w/Alt II

Small Business Subcontracting Plan, with Alternate II Nov 2025

52.219-9 w/Alt III

Small Business Subcontracting Plan, with Alternate III Nov 2025

Appl. Clause No. Clause Title Date

52.219-9 w/Alt IV

Small Business Subcontracting Plan, with Alternate IV Nov 2025

52.219-14 Limitations on Subcontracting Nov 2025

52.219-16 Liquidated Damages—Subcontracting Plan Nov 2025

52.219-33 Nonmanufacturer Rule Nov 2025

X 52.222-3 Convict Labor Nov 2025

X 52.222-19 Child Labor—Cooperation with Authorities and Remedies Nov 2025

52.222-35 Equal Opportunity for Veterans Nov 2025

52.222-35 w/Alt I

Equal Opportunity for Veterans, with Alternate I Nov 2025

52.222-36 Equal Opportunity for Workers with Disabilities Nov 2025

52.222-36 w/Alt I

Equal Opportunity for Workers with Disabilities, with Alternate I

Nov 2025

52.222-37 Employment Reports on Veterans Nov 2025

52.222-40 Notification of Employee Rights Under the National Labor Relations Act

Nov 2025

X 52.222-50 Combating Trafficking in Persons Nov 2025

52.222-50 w/Alt I

Combating Trafficking in Persons, with Alternate I Nov 2025

52.222-54 Employment Eligibility Verification Nov 2025

X 52.222-90 Addressing DEI Discrimination by Federal Contractors Apr 2026

52.223-9 Estimate of Percentage of Recovered Material Content for EPA-Designated Items

May 2008

52.223-9 w/Alt I

Estimate of Percentage of Recovered Material Content for EPA-Designated Items, with Alternate I

May 2008

X 52.223-23 Sustainable Products and Services Nov 2025

52.224-3 Privacy Training Nov 2025

52.224-3 w/Alt I

Privacy Training, with Alternate I Nov 2025

52.225-1 Buy American—Supplies Nov 2025

52.225-1 w/Alt I

Buy American—Supplies, with Alternate I Nov 2025

52.225-3 Buy American—Free Trade Agreements—Israeli Trade Act

Nov 2025

X 52.225-3 w/Alt II

Buy American—Free Trade Agreements—Israeli Trade Act, with Alternate II

Nov 2025

Appl. Clause No. Clause Title Date

52.225-3 w/Alt III

Buy American—Free Trade Agreements—Israeli Trade Act, with Alternate III

Nov 2025

52.225-3 w/Alt IV

Buy American—Free Trade Agreements—Israeli Trade Act, with Alternate IV

Nov 2025

52.225-5 Trade Agreements Nov 2023

X 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving

May 2024

X 52.232-33 Payment by Electronic Funds Transfer—System for Award Management

Oct 2018

X 52.232-40 Providing Accelerated Payments to Small Business Subcontractors

Mar 2023

X 52.233-3 Protest After Award Nov 2025

X 52.233-4 Applicable Law for Breach of Contract Claim Nov 2025

X 52.240-91 Security Prohibitions and Exclusions Nov 2025

52.240-91 w/Alt I

Security Prohibitions and Exclusions, with Alternate I Nov 2025

52.240-92 Security Requirements Nov 2025

52.240-92 w/Alt II

Security Requirements with Alternate II Nov 2025

52.240-93 Basic Safeguarding of Covered Contractor Information Systems

Nov 2025

X 52.244-6 Subcontracts for Commercial Products and Commercial Services

Nov 2025

52.247-64 Preference for Privately Owned U.S.-Flag Commercial Vessels

Nov 2025

52.247-64 w/Alt I

Preference for Privately Owned U.S.-Flag Commercial Vessels, with Alternate I

Nov 2025

52.247-64 w/Alt II

Preference for Privately Owned U.S.-Flag Commercial Vessels, with Alternate II

Nov 2025

X HHSAR

352.232-71

Electronic Submission of Payment Requests Apr 2026

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 RFO 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 Products and Commercial Services included in commercial item contracts. The IPP website address is: https://www.ipp.gov

c. The Agency will enroll 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 a Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3–5 business days of contract award for new contracts or date of modification for existing contracts.

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.

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 the first, contains a temporary password. You must log in with the temporary password within 30 days.

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

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-hour 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 and contract cumulative amounts. At a minimum, the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred:

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;

Indirect Costs (i.e., Fringe Benefits, Overhead, G&A, Other Indirects) – show rate, base, and total amount;

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

Travel – include for each trip the name of the traveler, date, destination, transportation costs (including ground transportation separately), and per diem costs;

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

Other Direct Costs – include a listing of all other direct charges to the contract (e.g., office supplies, telephone, duplication, postage); and 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: (1) a list of all invoices submitted to date under the subject award, including invoice number, amount, and date submitted, as well as corresponding payment amount and date received; (2) total amount of all payments received to date under the subject contract or order; and (3) 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 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 the U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, 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. When emailing, please include the contract number, invoice number and date, your name, phone number, and a detailed description of the issue.

Section A Solicitation Provisions

Provisions Incorporated by Reference The following provisions apply:

Appl. Provision

No.

Provision Title Date

X 52.212-2 Evaluation—Commercial Products and Commercial Services (*Required for RFO 12.201-2; optional for 12.201-1 simplified procedures)

Nov 2025

52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions

Sep 2024

52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements—Representation

Jan 2017

X 52.204-7 System for Award Management—Registration Nov 2025

52.204-7 w/Alt I

System for Award Management—Registration, with Alternate I

Nov 2025

52.204-90 Offeror Identification (use in lieu of 52.204-7 if SAM registration not required; see RFO 12.205(a)(4))

Nov 2025

52.207-6 Solicitation of Offers from Small Business Concerns and Small Business Teaming Arrangements or Joint Ventures (Multiple-Award Contracts)

Aug 2024

52.209-12 Certification Regarding Tax Matters Oct 2025

X 52.219-2 Equal Low Bids Nov 2025

52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products

Nov 2025

52.222-48 Exemption from Application of the Service Contract Labor Standards for Maintenance, Calibration, or Repair of Certain Equipment—Certification

Nov 2025

52.222-52 Exemption from Application of the Service Contract Labor Standards for Certain Services—Certification

Nov 2025

52.222-56 Certification Regarding Trafficking in Persons Compliance Plan

Nov 2025

52.223-4 Recovered Material Certification Nov 2025

52.225-2 Buy American Certificate Oct 2022

52.225-4 Buy American—Free Trade Agreements—Israeli Trade Act Certificate

Nov 2025

X 52.225-4 w/Alt II

Buy American—Free Trade Agreements—Israeli Trade Act Certificate, with Alternate II

Appl. Provision No.

Provision Title Date

52.225-6 Trade Agreements—Certificate Feb 2021

52.226-3 Disaster or Emergency Area Representation Nov 2025

52.229-11 Tax on Certain Foreign Procurements—Notice and Representation

Nov 2025

X 52.240-90 Security Prohibitions and Exclusions Representations and Certifications

Provisions Incorporated by Full Text 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer.

Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://acquisition.gov https://acquisition.gov/far-overhaul https://acquisition.gov/hhsar

(End of provision)

Section B Evaluation

Basis for Award Award will be made to the quoter whose quote represents the best value to the Government, considering technical merit and price. Technical Approach and Past Performance, when combined, are more important than Price.

Section C Instructions to Offerors

52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (NOV 2025)

(a) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. As a minimum, offers shall include—

(1) The solicitation number;

(2) The name, address, telephone number of the Offeror;

(3) The Offeror's Unique Entity Identifier (UEI) and, if applicable, Electronic Funds Transfer (EFT) indicator;

(4) Information necessary to evaluate the factors contained in the provision at 52.212-2 or as described in the solicitation;

(5) Responses to provisions that require Offeror completion of information, representations, and certifications (other than those collected via the System for Award Management (SAM)); and

(6) A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and any solicitation amendments.

(b) Period for acceptance of offers. The Offeror agrees to hold the prices in its offer firm for 60 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(c) Late submissions, modifications, revisions, and withdrawals of offers.

(1) Offerors are responsible for submitting offers and any modifications or revisions to the Government office designated in the solicitation by the time specified in the solicitation.

(2) Any offer, modification, or revision received after the time specified for receipt of offers is "late" and will not be considered unless it is received before award is made and the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition. However, a late modification of an otherwise successful offer that makes its terms more favorable to the Government will be considered at any time it is received and may be accepted.

(3) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(4) Offerors may withdraw their offers by written notice to the Government received at any time before award.

(d) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with Offerors. Therefore, the Offeror's initial offer should contain the Offeror's best terms. However, the Government reserves the right to conduct discussions, if necessary. The Government may reject any or all offers if such action is in the public interest, accept other than the lowest offer, and waive informalities and minor irregularities in offers received.

(e) Debriefings. If a postaward debriefing is given to requesting Offerors, the Government will disclose the following information, if applicable:

(1) The agency's evaluation of the significant weak or deficient factors in the debriefed Offeror's offer.

(2) The overall evaluated cost or price and technical rating of the successful Offeror and the debriefed Offeror and past performance information on the debriefed Offeror.

(3) The overall ranking of all Offerors when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award.

(5) For acquisitions of commercial products, the make and model of the product to be delivered by the successful Offeror.

(6) Reasonable responses to relevant questions posed by the debriefed Offeror as to whether the agency followed source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities.

(End of provision)

Addendum to RFO 52.212-1

(b) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 90 calendar days from the date specified for receipt of offers.

(f) Question Deadline. August 27, 2026, by noon EST. Submit all procurement-related questions in writing via email to the Contracting Officer and Contract Specialist identified in Section 4. Questions must be received by the deadline above to be considered.

(g) Quotation Deadline. Quotations are due by the date and time listed in the SAM.gov system and must be submitted via email to the Contracting Officer and Contract Specialist identified in Section 4.

(h) Quote Format and Submission Requirements.

The Quoter shall submit a firm-fixed-price quotation for the complete system offered under one of the two technical approaches in the Requirements Document. The quotation shall include sufficient detail to support the proposed price for all required deliverables. Discounts or other concessions are encouraged. Quotations shall use standard 8.5 x 11-inch pages, 1-inch margins, and a minimum 11-point font. Illegible or materially non-conforming submissions may be rejected without evaluation.

(i) Quote Content Requirements. Quotes shall clearly reference the RFQ number and include:

• Date of quotation

• Company name

• Company Point of Contact name, email address, and phone number

• System for Award Management (SAM) Unique Entity Identifier (UEI)

• Quotation validity of at least 90 days after RFQ due date and time

• Identification of Technical Approach 1 (Integrated System) or Technical Approach 2 (Standalone System)

• Manufacturer, make/model, part number, and country of origin for each offered end item/component

• Completed Buy American Certificate and identification of any foreign end products

• Technical literature/crosswalk demonstrating compliance with each applicable Requirements Document minimum requirement

• Delivery schedule confirming delivery within 90 days after award

• Standard manufacturer warranty information

(End of provision)