Sol_CDER-2026-133237.docx

ALP: CDER-2026-133237

Short Description: Triple-Stack Incubator Shaker System 2

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 75F40126Q00086 is issued as a/an ☒ RFQ ☐ RFP ☐ IFB for one (1) Infors HT Multitron Triple-Stack Shaker System, or Equal, to support mammalian cell culture at the Advanced Manufacturing Research Facility (AMRF). Equal products shall meet or exceed the minimum salient characteristics identified in Section 6, Specifications.

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 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:

Advanced Manufacturing Research Facility (AMRF) 5901 Ammendale Road, Suite D Beltsville, MD 20705

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.

Delivery and Period of Performance Supplies: Delivery Timeframe + Warranty Delivery shall be completed within 90 calendar days after contract award. The Contractor shall provide a minimum one-year (1) year original equipment manufacturer (OEM) warranty covering parts and labor. The warranty period shall begin upon Government acceptance of the complete system.

The Government will inspect and accept the equipment after successful delivery, installation, completion of Installation Qualification (IQ) and Operational Qualification (OQ), completion of on-site training, and receipt of all required documentation. Acceptance will be performed by the Contracting Officer's Representative (COR) or designated Government representative.

Installation shall be completed within ten (10) calendar days following delivery. Installation shall include equipment assembly, triple-stack configuration, connection of required utilities, verification that the equipment operates in accordance with the manufacturer's specifications, and confirmation that all system functions are operational.

Installation Qualification (IQ) and Operational Qualification (OQ) shall be completed within five (5) calendar days following completion of installation. The Contractor shall provide complete IQ/OQ documentation suitable for use in a regulated laboratory environment.

On-site training for one (1) to three (3) Government personnel shall be completed within five (5) calendar days following completion of IQ/OQ. Training shall include system operation, routine maintenance, safety procedures, and basic troubleshooting sufficient to enable Government personnel to safely and effectively operate the equipment.

3. CONTRACT LINE ITEMS (CLINs)

4. POINTS OF CONTACT

Name: Iris Johnson Email: Iris.Johnson1@fda.hhs.gov Phone: 301-796-3353 Contract Specialist:

Name: Reagan Davis Email: Reagan.Davis@fda.hhs.gov Phone: 301-796-0910

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.

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

The U.S. Food and Drug Administration (FDA), Division of Product Quality Research (DPQR), requires a laboratory incubator shaker system to support mammalian cell culture operations at the Advanced Manufacturing Research Facility (AMRF).

The Contractor shall furnish a complete, commercially available incubator shaker system capable of supporting mammalian cell culture at production-relevant working volumes under controlled environmental and agitation conditions.

At a minimum, the proposed system shall:

· Be compatible with the Government's existing Chinese hamster ovary (CHO) suspension culture processes.

· Maintain homogeneous mammalian cell suspension cultures at production-relevant working volumes.

· Support simultaneous cultivation under multiple independent operating conditions.

· Provide sufficient capacity and operational flexibility for upstream bioprocessing activities.

· Operate reliably within a regulated laboratory environment.

· Be fully operational upon completion of installation and qualification.

The Contractor shall provide all equipment, accessories, hardware, software (if applicable), cables, utilities, documentation, and ancillary components necessary to furnish a complete, fully functional system.

This requirement includes only the equipment and associated contractor services necessary for delivery, installation, qualification, and training. It does not include process development, modification of existing laboratory protocols, or Government facility upgrades beyond those necessary for normal installation.

Offerors shall clearly demonstrate within their quotation how the proposed system meets or exceeds each salient characteristic identified below.

Salient Characteristics This acquisition is conducted on a Brand Name or Equal basis. The Government will consider offers of the referenced brand-name product or an equal product that meets or exceeds the minimum salient characteristics identified below. Offerors proposing an equal product shall clearly demonstrate how the proposed product satisfies each salient characteristic.

· Triple-stack incubator shaker configuration

· Independent control of temperature, CO₂, humidity, and orbital shaking for each module

· Compatibility with 5-liter Erlenmeyer shake flasks

· Adjustable orbital shaking drive

· Integrated humidity control

· Integrated CO₂ control

· UV sterilization capability

· Dark observation window

· Cable passthrough capability

· IQ/OQ documentation

· On-site installation

· On-site training

· UL certification or equivalent

Quotation Requirements Offerors shall submit sufficient technical documentation to demonstrate compliance with each salient characteristic identified in this solicitation. At a minimum, quotations shall include:

· Manufacturer's product literature or technical specifications.

· A completed Salient Characteristics Compliance Matrix identifying where each salient characteristic is addressed within the supporting technical documentation.

· Documentation identifying the proposed manufacturer and model number.

· Delivery lead time.

· Warranty information.

· For offerors proposing an equal product, descriptive literature, specifications, drawings, or other technical documentation sufficient to enable the Government to determine whether the proposed product meets or exceeds each salient characteristic identified in this solicitation.

· Any additional documentation necessary to demonstrate compliance with the requirements of this solicitation.

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.

Factor 1 – Technical Acceptability Pass/Fail based upon:

• Compliance with all salient characteristics

• Delivery schedule

• Installation approach

• IQ/OQ capability

• Training capability

• Warranty compliance with the solicitation requirement for a minimum one-year OEM warranty covering parts and labor

· Functional equivalency and compatibility with the Government’s existing CHO suspension culture processes.

· Demonstration that the proposed system will not require redevelopment or modification of established seed-train processes.

Factor 2 – Price Price 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: July XX, 2026, EST. 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:

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. Completed Salient Characteristics Compliance Matrix identifying the proposed manufacturer and model number, providing a point-by-point response to each salient characteristic, and identifying the page, section, specification sheet, or other location within the supporting technical documentation demonstrating compliance.

1. Country of origin for all items required if Buy American (52.225-1) or Trade Agreements (52.225-5) clause applies.

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 FSB Version 2.1 (June 14, 2026)