CSS__Amendment01__CVM-2026-133678.docx

Amendment00001

ALP: CVM-2026-133678

Short Description: Automated Liquid Handling Robot

COMBINED SYNOPSIS/SOLICITATION

1. GENERAL INFORMATION

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

Solicitation number 75F40126Q00158 is issued as a/an ☒ RFQ ☐ RFP ☐ IFB for This requirement is for the purchase of a Robotic Liquid Handling System that is capable of completing the bead washing steps involved in the library preparation for the sequencing of long reads. This requirement will be acquired using a Firm-Fixed-Price (FFP) contract for the purchase, delivery, installation, training, and warranty of the robotic liquid handling system.

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

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

NAICS Code: 334516 Small Business Size Standard: 1000 employees This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at: https://acquisition.gov/ | https://acquisition.gov/far-overhaul | https://acquisition.gov/hhsar

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

2. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance:

FDA CVM Laboratory Facility Bldg. MOD2 8401 Muirkirk Rd Laurel, MD 20708

Note: Loading dock delivery is acceptable. Installation shall be performed by a manufacturer-certified technician

FOB Point: ☒ Destination ☐ Origin Inspection and Acceptance: Inspection and acceptance shall be performed at the delivery location in accordance with the terms of clause 52.212-4.

Period of Performance Supplies: Delivery Timeframe + Warranty Delivery shall be completed within 60 days of award. The delivered items shall include a [one (1)] year warranty. The warranty period begins on the date of Government acceptance under the inspection and acceptance clause(s) of this contract.

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

3. CONTRACT LINE ITEMS (CLINs)

4. POINTS OF CONTACT

Contracting Officer:

Name: Iris Johnson Email: Iris.Johnson@fda.hhs.gov Phone: 301-796-3353 Contract Specialist:

Name: Reagan Davis Email: Reagan.Davis@fda.hhs.gov Phone: 301-792-0910

5. CONTRACT CLAUSES

5A. Clauses Incorporated by Reference

5B. Clauses Incorporated by Full Text

52.252-2, Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://acquisition.gov https://acquisition.gov/far-overhaul https://acquisition.gov/hhsar (End of clause)

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:

(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.

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.

f. 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.

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)

6. SPECIFICATIONS

This requirement is for the robotic liquid handling system that is capable of completing the bead washing steps involved in the library preparation for the sequencing of long reads.

References to compatibility with Pacific Biosciences instrumentation are intended to identify required interoperability and performance outcomes necessary to support existing Government-owned equipment and validated laboratory workflows.

This requirement is being acquired as a brand-name-or-equal procurement. Equal products meeting all stated salient characteristics, interoperability requirements, performance standards, and workflow compatibility requirements will be considered.

The system shall be new, unused, and not previously used for demonstration purposes. Refurbished or remanufactured equipment will not be accepted.

Reference to the PacBio Sequel IIe system is for compatibility purposes only and does not restrict competition to a single manufacturer.

Minimum Required Salient Characteristics:

i) Liquid handling system shall provide automatic processing for DNA shearing, to average size of 10,000 bp, up to 96 samples in a 96-well plate format. It shall provide subsequential AMPure bead clean up steps.

ii) To support interoperability with existing Government-owned Pacific Biosciences sequencing instrumentation, including the PacBio Sequel IIe sequencing environment currently operated by CVM, the system shall support automated long-read sequencing library preparation workflows involving DNA shearing and AMPure bead cleanup processes compatible with existing validated laboratory workflows.

iii) The system shall allow users to create, edit, and manage at least two additional custom pipetting workflows..

iv) Unit shall be able to handle a pipetting range of 1- 1000 ul with high precision (with manufacturer-specified precision of ≤5% coefficient of variation across the operating range.

v) System shall be compatible with the following plates and reservoirs at the minimum:

(1) 96-well plates

(2) 384-well plates

(3) reagent reservoirs

(4) 96-well magnet

vi) The instrument shall be capable of pipetting and transferring liquid between 96-well PCR plates and tube racks with different sizes, such as 12 x 8 and 16 x 5 tube racks at the minimum.

vii) The system shall include a safety measure to stop the pipetting and any other movement when crashing happens under unexpected conditions, such as unexpected error or door opening during the run.

viii) The instrument shall use a standard 110 voltage plug. Due to available laboratory bench space and workflow layout limitations within the existing CVM laboratory environment, System footprint shall not exceed approximately 30 inches wide by 25 inches deep due to existing laboratory space, workflow configuration, operator clearance, and safety-spacing limitations.

ix) Due to lab space restrictions, footprint of the base shall be less than W30 x D25 inches.

x) Shall include enough consumables to run 200 samples in 96-well plate format.

b) Other Considerations:

· The quoted price shall include all costs for shipping, delivery, installation, training, warranty, and any other services required for full performance.

· New Equipment: Shall be newly manufactured unit, not used or refurbished, or previously used for demonstration.

· Site Preparation Information: Offerors shall include in their proposal any, and all site-preparation information required for proper system operation and maintenance, including physical space and ventilation.

· Section 508 Requirement: If software, web-based interfaces, electronic manuals, or electronic reporting tools are provided, the contractor shall provide a completed VPAT or equivalent Section 508 conformance documentation

c) Safety Requirements:

· The Contractor shall ensure all equipment complies with applicable laboratory safety standards and manufacturer safety requirements.

· All installation activities shall be performed in accordance with applicable Federal, state, and local safety regulations to prevent hazards to personnel and facilities.

A. SOLICITATION PROVISIONS

A1. Provisions Incorporated by Reference

Basis for Award 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. Offers that do not meet all salient characteristics will be determined technically unacceptable and will not be considered for award. Price will be evaluated for reasonableness.

A2. Addenda to 52.212-1

Offer Acceptance Period (if applicable):

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

B. OFFER SUBMISSION

Questions Due: Questions regarding this solicitation shall be submitted in writing to the Primary POC identified in the SAM.gov notice Hard Date: August 12, 2026. 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 Country of Origin: Offerors shall identify the country of origin for each proposed end product. If the proposed end product is not a domestic end product as defined in FAR 52.225-1, the offeror shall clearly identify the country of origin on its quotation.

Offerors Shall Submit:

1. Technical quotation

1. Price quotation

1. Warranty terms (if applicable)

1. UEI and confirmation of active SAM.gov registration

1. Lead time for delivery

1. Offerors shall clearly identify how their proposed product meets each salient characteristic

1. Manufacturer technical literature/specifications demonstrating compliance with all salient characteristics

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

C. ADDITIONAL INFORMATION

Amendments:

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

FDA OAGS | Supplies | Page 1 FSB Version 2.1 (June 14, 2026)