Combo Synopsis Solicitation 0920261.docx

75F40126Q00172

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 75F40126Q00172 is issued as a Request for Quote (RFQ) for one (1) CARR® PowerFuge® Pilot Separation System that meets the requirements in the attached Requirements Document.

The Government is soliciting quotations from authorized distributors/resellers of CARR Biosystems for the products identified herein.

This solicitation supersedes the Government's previously published notice of intent to award this requirement on a sole-source basis. Subsequent market research identified additional authorized sources capable of satisfying the Government's requirement.

This acquisition is 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: 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. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance: U.S. Food and Drug Administration, Silver Spring, MD 20993 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 no later than 90 of award. The delivered items shall include a two (2) year warranty. The warranty period begins on the date of Government acceptance under the inspection and acceptance clause(s) of this contract.

Base Period: 09/01/2026 through 12/01/2027

3. CONTRACT LINE ITEMS (CLINs)

4. POINTS OF CONTACT

Contracting Officer/Contract Specialist:

Name: Jennifer Mun Email: Jennifer.mun@fda.hhs.gov

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. 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;

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)

6. SPECIFICATIONS

REQUIREMENTS DOCUMENT

1. System Description and Technical Specifications The Contractor shall provide one (1) CARR® PowerFuge® Pilot Separation System, Model C1015PLT, manufactured by CARR Biosystems, 14550 58th Street North, Clearwater, FL 33760. This is a sole-source requirement. No substitutions or equivalent models are authorized.

1.1 Minimum Technical Requirements

The CARR® PowerFuge® Pilot (Model C1015PLT) meets the following Government minimum technical requirements, which were established based on OPQR’s specific application of continuous E. coli cell harvest at pilot scale under temperature-controlled conditions consistent with DEVCOM CBC’s validated CFPS workflow. These specifications represent true minimum needs, not preferences:

1.2 Required Accessories

In addition to the main CARR® PowerFuge® Pilot Separation System (Model C1015PLT), the Contractor shall provide the following accessories. Note: Only the PowerFuge® Pilot system and the spare bowl are sole-source items. The peristaltic feed pump, portable cart, and 115V power transformer are commercially available goods; however, they are required to be supplied by the Contractor as part of this package to ensure compatibility and complete system delivery.

One (1) additional/spare solids collection bowl (Ti-6Al-4V titanium alloy, ≥ 1.0 L solids capacity), for a total of two (2) bowls. [SOLE SOURCE] One (1) peristaltic feed pump capable of matching the maximum process feed rate of the system (≥ 1.0 L/min). [COMMERCIAL] One (1) portable stainless-steel cart with lockable casters and electrical grounding, capable of supporting and safely maneuvering the system. [COMMERCIAL] One (1) 115V power transformer to enable safe operation from a standard 120V/60Hz US outlet. [COMMERCIAL] Extended one (1) year warranty, in addition to the standard one (1) year manufacturer warranty, for a total warranty coverage period of two (2) years from receipt.

Spare replacement parts sufficient to cover routine maintenance and care for approximately one (1) year of operation (to include, at minimum, O-rings, gaskets, drive belt, and air filter as applicable).

Installation and end-user training by a qualified CARR Biosystems-authorized representative (see Section 3.3 and 3.4).

1.3 Brand Name Basis for Specified System

The CARR® PowerFuge® Pilot (Model C1015PLT) is specified by brand name and model number because it is the only commercially available centrifuge system that satisfies all of the minimum technical requirements listed in Section 1.1. The basis for this determination is as follows:

Separation mechanism: The imperforate solid bowl design is uniquely required for E. coli cell harvest at the required solids density (up to 1.5 g/mL). Alternative centrifuge types reviewed during market research — including basket/filter centrifuges, disc-stack self-cleaning centrifuges, high-speed tubular centrifuges, and decanter centrifuges — use different mechanical separation principles that result in inadequate solids recovery, excessive shear damage to the cell pellet, or incompatibility with the required solids bulk density. See the J&A for complete technical details.

Centrifugal force: The 20,000 × g minimum is not achievable by any alternative pilot-scale continuous centrifuge system identified during market research. Disc-stack pilot centrifuges reviewed achieve a maximum of approximately 9,500 × g; basket centrifuges achieve far less. These g-forces are insufficient for reliable E. coli pelleting at the required feed rates.

Experimental continuity: DEVCOM CBC’s validated CFPS SOPs and baseline data were generated using the PowerFuge® Pilot (Model C1015PLT) at specific operating parameters. Use of any other centrifuge system would require full revalidation of the cell harvest step at OPQR, introducing unacceptable cost, schedule delay, and risk of data incomparability with the interagency research program under MOU No. 225-24-013.

2. Tasks and Deliverables

2.1 Delivery

The Contractor shall guarantee receipt of all equipment and accessories within ninety (90) calendar days after receipt of order (ARO), unless a later delivery date is mutually agreed upon in writing by the Contractor and the FDA. The Contractor shall provide shipping, handling, and inside delivery to the delivery location specified in Section 4.

2.2 Pre-Installation Planning Meeting

At least two (2) weeks prior to the anticipated delivery date, the Contractor shall coordinate and participate in a pre-installation planning meeting with FDA laboratory staff receiving the equipment and the Project Officer. This meeting shall be used to confirm tasks, deliverables, schedules, facility readiness requirements, and any utility or infrastructure needs (electrical, compressed air, cooling water connections) specific to the delivery site.

2.3 Installation

The Contractor shall provide professional installation of the CARR® PowerFuge® Pilot at the delivery location, including assembly, leveling, connection of utilities as required, and verification of proper system function prior to acceptance. Installation shall be performed by a qualified CARR Biosystems-authorized representative.

2.4 End-User Training

The Contractor shall provide end-user applications training, delivered at the time of installation by a qualified CARR Biosystems-authorized representative. Training shall cover, at minimum: system startup and shutdown procedures; HMI operation and parameter entry; separation cycle execution; bowl installation, removal, cleaning, and autoclaving; routine maintenance procedures; and safety practices as described in the Operator’s Manual (C1015PLT-OPMAN). Training shall not be unnecessarily delayed or postponed by the Contractor.

2.5 Field Service Reports

The Contractor shall, commensurate with the completion of each service call or preventive maintenance visit, provide the end-user of the equipment and the Project Officer with a copy of a field service report/ticket identifying:

Equipment name, manufacturer, model number, and serial number of the equipment being serviced or repaired.

Reason for the service call.

Detailed description of the work performed.

Test instruments or other equipment used to perform the repair or service.

Name(s) and contact information of the technician(s) who performed the work.

On-site hours expended and parts/components replaced (for informational purposes).

2.6 Compliance with FDA Security and Safety Requirements

All representatives of the Contractor must comply with mandatory FDA security procedures while on-site and must voluntarily provide required proof of identity prior to building or laboratory access. All Contractor representatives must comply with OPQR’s laboratory safety guidelines while working and/or servicing equipment within the laboratory space.

3. Warranty The Contractor shall provide, at minimum, the CARR Biosystems standard manufacturer’s warranty for the PowerFuge® Pilot system. Per the manufacturer’s standard warranty terms, this covers defects in material and workmanship for a period of one (1) year from receipt at the Government’s designated delivery point, or 2,000 hours of operation, whichever occurs first.

In addition to the standard warranty, the Contractor shall provide one (1) extended warranty year as specified in Section 1.2, for a total warranty coverage period of two (2) years from receipt. The extended warranty shall cover the same scope of defects as the standard warranty. Warranty service shall be performed by a CARR Biosystems-authorized technician. Only factory-authorized replacement parts shall be used during warranty service and maintenance.

4. Delivery Location The Contractor shall provide shipping, handling, and inside delivery to:

FDA White Oak Campus ATTN: disclosed at time of award Silver Spring, MD 20993

5. Period of Performance The period of performance for this requirement is Fiscal Year 2026 (base year only; no options). Delivery shall be guaranteed within ninety (90) calendar days ARO, unless otherwise mutually agreed in writing. Installation and training shall be completed within a reasonable period following delivery, as coordinated during the pre-installation planning meeting (Section 2.2).

6. Contractor Qualifications This is a brand name acquisition. The manufacturer is: CARR Biosystems, 14550 58th Street North, Clearwater, FL 33760, the exclusive manufacturer of the CARR® PowerFuge® Pilot (Model C1015PLT). All installation, training, and warranty service activities described in this Requirements Document shall be performed by, or under the direct supervision of, CARR Biosystems-authorized representatives or technicians. The Contractor shall maintain the capability to provide on-site technical support, field service, and spare parts for the system throughout the warranty period and beyond.

7. Special Notes The Government will provide access to the delivery location and laboratory space for purposes of pre-installation coordination, delivery, installation, and training. The Government will ensure that the delivery location meets the utility and infrastructure requirements specified by CARR Biosystems, including: 120V/60Hz electrical supply and a level surface capable of supporting up to 216 kilograms (476 pounds).

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.]

B. OFFER SUBMISSION

Offers Due Date: All quotes shall be submitted via email to Jennifer.mun@fda.hhs.gov no later than 09/14/2026, 3:00 PM, ET, with the subject line 75F40126Q00172 CARR PowerFuge System. No questions are accepted for this RFQ.

Submission Method: Email to the POC 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 and small business status

1. Lead time for delivery

1. Country of origin for all items 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)