Combo Synopsis-Solicitation Biorad sam.doc

75F40126Q00195

Combination Synopsis-Solicitation:

75F40126Q00195

BioRad QX200 Droplet Digital PCR System Combination Synopsis-Solicitation for Commercial Purchases Under SAT

1. Solicitation Number: 75F40126Q00195

2. Title: BioRad QX200 Droplet Digital PCR System

3. Classification Code: 6630

4. NAICS Code: 334516

5. Response Date: 06/08/2026 by 3:00 PM Eastern Time (ET) due via email to the Primary Point of Contact listed in the SAM.gov webpage for this combined synopsis-solicitation.

6. Description: This action is for one (1) BioRad QX200 Droplet Digital PCR System, along with all required deliverables, as specified in the Statement of Work (SOW). Delivery, installation, and operational verification shall be completed within 30 calendar days after award.

Disclaimer: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

This acquisition is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2026-01.

7. For purposes of this acquisition, the associated NAICS code is 334516

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

The Food and Drug Administration intends to issue a Firm-Fixed Price, Brand Name Purchase Order for the following:

PART 3 - DESCRIPTION OF REQUIREMENTS

See attached Statement of Work

Part 4 – CONTRACT ADMINISTRATION DATA The Contracting Officer Representative (COR) is:

Name: Kristen McLaughlin Email: Kristen McLaughlin@fda.hhs.gov

The Technical Point of Contact (TPOC)

Name: Michael Kulka Email: Michael.Kulka@fda.hhs.gov The Contracting Officer is:

Name: Jennifer Mun Email: Jennifer.Mun@fda.hhs.gov The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to direct or negotiate any changes in the task order, including modifying or extending the period of performance, changing the delivery schedule, and authorizing reimbursement to the Contractor for any costs incurred during the performance of their contracts.

PART 5 - FAR and HHSAR Clauses

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. While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

References: FAR clauses can be viewed in full text at: FAR: https://www.acquisition.gov/ FAR 52.204-13 – System for Award Management Maintenance (Oct 2018)

FAR 52.204-18 – Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services (Nov 2023) FAR 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (Mar 2026)

(a) The Contractor shall comply with the following FAR clauses incorporated in FAR 52.212-5(a):

52.203-19 52.204-23 52.204-25 52.209-10 52.232-40 52.233-3 52.233-4

(b) The Contractor shall comply with the FAR clauses in paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference:

_xx_ 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) _xx_ 52.204-27 Prohibition on a ByteDance Covered Application (Jun 2023) _xx_ 52.209-6 Protecting the Government’s Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (Jan 2025) _xx_ 52.222-3 Convict Labor (Jun 2003) _xx_ 52.222-19 Child Labor—Cooperation with Authorities and Remedies (Mar 2026) _xx_ 52.222-21 Prohibition of Segregated Facilities (Apr 2015) _xx_ 52.222-26 Equal Opportunity (Sep 2016) _xx_ 52.222-50 Combating Trafficking in Persons (Oct 2025) _xx_ 52.223-23 Sustainable Products and Services (May 2024) _xx_ 52.225-1 Buy American—Supplies (Oct 2022) _xx_ 52.225-13 Restrictions on Certain Foreign Purchases (Feb 2021) _xx_ 52.232-33 Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) _xx_ 52.240-1 Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by American Security Drone Act-Covered Foreign Entities (Nov 2024)

(End of clause)

HHSAR Clauses HHSAR 352.203-70 – Anti-Lobbying (Dec 2015)

HHSAR 352.222-70 – Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

HHSAR 352.239-74 Electronic and Information Technology Accessibility. (December 18, 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (a lso referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508- standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see

FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are: Must meet 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)

· 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 http://508.hhs.gov/, 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 should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Based on what is being procured you will also need to provide the following appropriate scoping and technical requirements from chapters A and C which are as follows:

Appropriate Scoping Requirement from Appendix A

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

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: ( http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

HHSAR Provisions:

HHSAR Clauses can be viewed in full text at: https://www.acquisition.gov/hhsar HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice. (December 18, 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508- standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website http://www.hhs.gov/web/508.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

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 Products and Commercial Services included in commercial products and commercial services 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.

· 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, General and Administrative, 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 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;

· 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, i.e., 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, the following information for contract administration and reconciliation purposes:

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

(c) 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 task 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.

Part 6 – INSTRUCTIONS TO OFFERORS / BASIS FOR AWARD

This acquisition is restricted to the Bio-Rad QX200 Droplet Digital PCR System in accordance with FAR 11.105. The Government's minimum needs require compatibility with ongoing validated research workflows and existing assay development activities. The Government has determined that only the specified brand name product will satisfy its minimum needs. The Government intends to award a firm-fixed-price purchase order to responsible offeror submitting the lowest-priced technically acceptable quotation meeting the requirements of the solicitation. A quotation will be considered technically acceptable when it demonstrates that the offered product is the Bio-Rad QX200 Droplet Digital PCR System and includes all required components, software, installation, training, warranty coverage, and other requirements identified in the Statement of Work. The Government intends to evaluate the total price of Contract Line Item 0001 and 0002 for award purposes.

Responses received by the closing date of this notice will be considered.

Quotes shall be submitted electronically to Jennifer Mun at Jennifer.Mun@fda.hhs.gov no later 3:00 PM ET June 08, 2026. Late submissions will not be considered. Offerors shall provide sufficient information to demonstrate that the quoted product is the Bio-Rad QX200 Droplet Digital PCR System and meets all requirements of the Statement of Work.

The quoted system shall include a minimum one (1) year manufacturer warranty. The warranty shall include all labor, travel, replacement parts, technical support, and corrective maintenance necessary to maintain the instrument in accordance with Original Equipment Manufacturer (OEM) specifications.

Any maintenance, repairs, or replacement of components performed under the warranty shall be conducted by OEM-trained or OEM-authorized personnel using OEM-approved parts. Following any repair or maintenance activity, the Contractor shall verify and document that the instrument has been restored to and is operating within OEM specifications.

Offerors shall provide documentation describing the warranty coverage included with the system.

In addition, Offerors shall provide separate pricing for an option one (1) year extended warranty/service plan to be provided following expiration of the manufacturer warranty. The optional extended warranty/service plan may be exercised by the Government, subject to the availability of funding. The extended warranty/service plan shall provide the same level of support necessary to maintain the instrument in accordance with OEM specifications.