ALP: OC-2026-132529

Whole Genome Sequencing Instrument for IRVLMP

FDA OAGS — Supplies | Page 1

COMBINED SYNOPSIS/SOLICITATION

1. INTRODUCTION

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

Solicitation number 75F40126Q22123 is issued as a/an ☒ RFQ for one (1) Whole Genome Sequencing Instrument for IRVLMP

This acquisition ☒ is not set-aside for small business concerns.

Set-Aside: ☒ None ☐ Total Small Business ☐ WOSB ☐ SDVOSB ☐ 8(a) ☐ HUBZone ☐ Other:

NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing. Small Business Size Standard: 1,000 employees

This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at: https://acquisition.gov/ | https://acquisition.gov/far-overhaul | https://acquisition.gov/hhsar

All responsible sources may submit a quotation, which will be considered by the agency.

2. DESCRIPTION OF REQUIREMENTS

The Food and Drug Administration (FDA), Irvine Medical Products Laboratory (IRVLMP), requires the purchase of one (1) Whole Genome Sequencing system to perform whole genome sequencing of microorganisms obtained from regulatory pharmaceutical samples.

The Contractor shall provide one (1) Illumina MiSeq i100 System in accordance with the requirements identified Attachment 1 - Statement of Work. All equipment shall be new, not used or refurbished.

3. LINE ITEMS

CLIN Description Qty Unit Unit Price Total Price

0001 Whole Genome Sequencing Instrument (Illumina MiSeq i100 System), including onboard software, monitor, and control computer in accordance with the

SOW

1 EA $ $

0002 Delivery and Installation to FDA IRVLMP, Irvine, CA

1 Lot $ $ https://acquisition.gov/ https://acquisition.gov/far-https://acquisition.gov/far-https://acquisition.gov/hhsar

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CLIN Description Qty Unit Unit Price Total Price

0003 Training and system familiarization for up to three (3) personnel, to be provided upon installation and prior to Government acceptance

1 Lot $ $

0004 One (1) Year Manufacturer Warranty (included – no additional cost)

1 Lot $0.00 $0.00

TOTAL $ $

Offerors shall provide firm-fixed pricing for all required items. Shipping/inside delivery shall be included in the quoted price. FOB Destination applies.

4. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance: FDA/IRVLMP, 19701 Fairchild, Irvine, CA 92612.

FOB Point: ☒ Destination

Inspection and Acceptance: Inspection and acceptance shall be performed at the delivery location in accordance with the terms of clause 52.212-4. Upon arrival, the shipping container(s) will be inspected for damage. If significant damage is observed, the delivery may be rejected.

Final acceptance will be made by the Government after inspection and confirmation that the equipment meets contract requirements.

Period of Performance Supplies: Specific Delivery Date

Delivery Timeframe + Warranty: Delivery shall be completed within sixty (60) days after award unless the Government approves a different delivery schedule. Delivery will be accepted during regular business hours, Monday through Friday, 8:00 AM to 4:00 PM local time, excluding Federal holidays. The equipment delivered shall include a one (1) year manufacturer’s warranty.

The warranty period begins on the date of Government final receipt and acceptance.

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5. CONTRACT CLAUSES

5A. Clauses Incorporated by Reference

Appl. Clause/Prov.

No.

Title Date

X 52.212-4 Terms and Conditions—Commercial Products and Commercial Services

Nov 2025

X 52.203-17 Contractor Employee Whistleblower Rights Nov 2023 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 52.204-13 System for Award Management—Maintenance Nov 2025 X 52.209-6 Protecting the Government's Interest When

Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

Nov 2025

X 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations

Nov 2025

X 52.219-8 Utilization of Small Business Concerns Nov 2025

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Title Date

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 (or with

Alt I) Nov 2025

X 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

X 52.223-23 Sustainable Products and Services Nov 2025 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 (or with Alt I) Nov 2025 X 52.240-93 Basic Safeguarding of Covered Contractor Information

Systems Nov 2025

X 52.244-6 Subcontracts for Commercial Products and Commercial Services

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Title Date

X 52.225-1 Buy American—Supplies (or with Alt I) Nov 2025

X 52.217-8 Option to Extend Services Nov 1999

X HHSAR

352.232-71

Electronic Submission of Payment Requests Feb 2022

5B. Clauses Incorporated by Full Text

52.252-2, Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

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

(End of clause)

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

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

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FDA Electronic Invoicing and Payment Requirements — Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

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

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

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

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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4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

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

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

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

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

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

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

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the Delivery Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301- 827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

(End of clause) mailto:ERIC@fda.hhs.gov

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6. SOLICITATION PROVISIONS

6A. Provisions Incorporated by Reference

Title Date

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

X 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services

Nov 2025

X 52.212-2 Evaluation—Commercial Products and Commercial Services (if applicable)

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 52.209-12 Certification Regarding Tax Matters Oct 2025 X 52.222-18 Certification Regarding Knowledge of Child Labor for

Listed End Products

X

52.222-56 Certification Regarding Trafficking in Persons Compliance Plan

Nov 2025

X 52.223-4 Recovered Material Certification May 2008

X 52.225-2 Buy American Certificate Oct 2022

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Title Date

X 52.240-90 Security Prohibitions and Exclusions—Representations and Certifications

Basis for Award Lowest Price Technically Acceptable (LPTA): Award will be made to the lowest-priced offeror whose quotation is determined technically acceptable. Technical acceptability will be determined on a pass/fail basis against the salient characteristics and minimum requirements stated in the SOW. Quotations that do not meet all salient characteristics, and minimum requirements will be determined technically unacceptable and will not be considered for award.

Price will be evaluated for reasonableness.

6B. Addenda to 52.212-1

Offer Acceptance Period: Offerors shall hold prices firm 60 calendar days from the date specified for receipt of quotations, unless otherwise stated in the SAM.gov notice.

7. OFFER SUBMISSION AND POINTS OF CONTACT

Questions Due: Questions regarding this solicitation shall be submitted in writing to the Primary POC identified in the SAM.gov notice no later than May 18, 2026, at 10:30 am Eastern Time (ET). Questions and answers may be posted as an amendment to this solicitation on SAM.gov.

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

Submission Method: Email to the POCs listed in the SAM.gov posting.

Preferred File Format: Searchable PDF and Excel

Page Limit (if applicable): N/A

Offerors Shall Submit:

• Technical quotation describing how the quoted equipment meets or exceeds each SOW requirement/salient characteristic.

• Price quotation with firm-fixed pricing for all CLINs, including shipping/inside delivery.

• Warranty terms.

• UEI and confirmation of active SAM.gov registration.

• Lead time for delivery.

• Country of origin for all items.

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• Any assumptions, exceptions, or deviations.

Points of Contact As listed on the SAM.gov notice.

8. ADDITIONAL INFORMATION

Amendments:

Any amendments to this solicitation will be posted to SAM.gov. It is the offeror's responsibility to monitor SAM.gov for any amendments.

Attachments: Attachment 1 – Statement of Work, Purchase of one (1) Whole Genome Sequencing Instrument for IRVLMP.

Attachment 1 Summary - Salient Characteristics Uses sequencing by synthesis next-generation sequencing techniques.

Supports single-read and paired-end libraries.

Output range of up to 25 Gigabytes.

Up to 50 million paired-end reads per run.

Maximum read length of at least 2 x 300 base pairs.

Quality score greater than or equal to 85% of bases higher than Q30 when using a 2 x 300bp flow cell type.

RFID or equivalent technology for tracking consumables.

Kit reagents should require room-temperature storage.

Data collection software included for instrument control and onboard sequence alignment.

Monitor and computer included to run instrument control software.

Benchtop model with footprint no larger than 16 inches x 18 inches x 26 inches (WxDxH).

One-year manufacturer warranty for equipment parts and operational services.

All equipment new, not used or refurbished.