PreSolicitation_Notice_NOI-FDA-131696.pdf

ALP: CDER-2026-131696

Notice ID: NOI-FDA-131696 | Page 1 of 4

PRESOLICITATION NOTICE

Notice ID: NOI-FDA-131696

Subject: Portable Control Stand for Coperion K-Tron KCM/K-Vision, Installation of Integration Platform, and Installation of Continuous Powder Feeders

SECTION 1 – IDENTIFICATION AND CLASSIFICATION CODES

Contracting Office: U.S. Food and Drug Administration, Office of Acquisitions and Grants Services (OAGS), CDER Acquisition Branch

Contracting Officer: Sarah Hussain

Address: 11601 Landsdown St. 13th floor, North Bethesda, MD 20852

CO Email: Sarah.Hussain@fda.hhs.gov

NAICS Code: 333248 – All Other Industrial Machinery Manufacturing

Product Service Code (PSC): J065 (Maintenance/Repair of Equipment)

SECTION 2 – SET-ASIDE STATUS

A determination has been made by the Contracting Officer that competition to the maximum extent practicable is not feasible because only one source is reasonably available, consistent with RFO 12.201-1(c) and RFO 13.101(b). The intended award is single-source to Coperion Process Solutions, LLC, as the original equipment manufacturer (OEM).

All responsible sources that believe they can fully satisfy this requirement are invited to submit a capability statement. See Section 5 for details.

SECTION 3 – DESCRIPTION OF REQUIREMENT

Per RFO 5.101(c)(4)(i), the following description is provided to allow prospective sources to make an informed business judgment about this requirement.

Item 1 – Portable Control Stand for KCMs and K-Vision

The FDA CDER Office of Pharmaceutical Quality Research (OPQR) currently possesses five Coperion K-Tron continuous powder feeders: three QT20 feeders, one KT20 feeder, and one MT12 feeder. These feeders are to be integrated into a continuous manufacturing (CM) line using an integration platform located at FDA's facility in Beltsville, Maryland. The integration platform currently lacks mounting space for the Human Machine Interface (HMI) controllers (Coperion K- Tron Control Modules, or "KCMs") associated with each feeder, and for the K-Vision operator interface used to control all five feeders from a single location.

The required portable control stand shall:

• Be constructed from stainless steel with casters and brakes.

• Provide mounting provisions for six KCMs (five active, one spare position) and one existing K-Vision unit.

• Enable electronic communication with all five existing continuous powder feeders.

• Include cables (minimum 25 ft) with quick disconnects to connect each feeder's junction box to its associated KCM.

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• Include power supply cables (minimum 25 ft) with quick disconnects for all six KCM mounting provisions and from the K-Vision to the power supply, with appropriate plugs for the three QT20 feeders.

• Include wiring between the five KCMs and the K-Vision (one direct connection from one KCM; one daisy-chained connection from the remaining KCMs).

• Not restrict or inhibit any existing operational capabilities of the feeders, KCMs, or K-Vision.

• Include all hardware, cable, and materials required for on-site installation.

• Include a one-year parts and labor warranty from date of service.

Item 2 – Delivery, On-Site Installation, Commissioning, and Training

The vendor shall provide, at no additional cost to the Government:

• Packaging, delivery, and disposal of packaging materials.

• On-site installation, commissioning, and qualification of the portable control stand including all five KCMs and the K-Vision.

• On-site installation and commissioning of the five previously delivered continuous powder feeders and the integration platform.

• On-site operator training for the feeders, KCMs, K-Vision, and the complete assembled skid.

• Updated qualification documents, instruction manuals, drawings/diagrams, and related equipment documentation for the KCMs and K-Vision.

SECTION 4 – INTENDED SOURCE AND BASIS FOR NONCOMPETITIVE ACTION

Pursuant to RFO 5.101(c)(4)(vii), the following identifies the intended source and explains why competition is not practicable for this requirement.

Intended Contractor:

Coperion Process Solutions, LLC

590 Woodbury Glassboro Road, Pitman, NJ 08080

CAGE Code: 1WXR3

The basis for limiting this solicitation to a single source is that only one source is reasonably available, consistent with RFO 13.101(b) and the single-source standard at RFO 12.201-1(c).

Coperion Process Solutions, LLC is the original equipment manufacturer (OEM) of the five continuous powder feeders currently owned and operated by FDA CDER/OPQR. The portable control stand and all associated installation work require direct integration with proprietary mechanical, electrical, and communication interfaces unique to Coperion K-Tron equipment.

Specifically:

(a) The integration platform and feeder fleet were custom-built by Coperion to comply with spatial and electrical constraints specific to FDA's facility. No third-party vendor possesses the design specifications, drawings, or interface documentation required to develop and install a compatible control stand.

(b) The KCM-to-K-Vision communication architecture and daisy-chain wiring configuration are proprietary to Coperion K-Tron. The installation requires direct modification of live electrical connections between proprietary components. Only a Coperion-authorized engineer with

Notice ID: NOI-FDA-131696 | Page 3 of 4 system-specific training can perform this work safely and in compliance with applicable safety standards.

(c) Market research conducted by the Technical Point of Contact confirmed that no third-party vendors were willing or able to assume responsibility for modifications to this proprietary system. Prior acquisitions of Coperion equipment were placed under PO Nos.

HHSF223201710135P, 75F40121P00139, and 75F40122P00260.

A written single-source justification has been prepared and approved in accordance with RFO 12.201-1(c) and RFO 13.101(b).

SECTION 5 – CONTRACT TYPE AND AWARD PROCEDURES

Per RFO 5.101(c)(4)(ii), the following describes the award procedures and anticipated award date for this action, which is valued above $25,000 but at or below the Simplified Acquisition Threshold

(SAT).

Contract Type: Firm-Fixed-Price (FFP) Purchase Order

Procedures: Simplified acquisition procedures per RFO 12.201-1

Anticipated Solicitation Issuance: June 23. 2026

Anticipated Award Date: On or before July 30, 2026

Documentation: Award will be documented in accordance with RFO 12.204

SECTION 6 – SOURCES SOUGHT / CAPABILITY STATEMENTS

Pursuant to RFO 5.101(c)(4)(vi), all responsible sources that believe they can fully satisfy this requirement are invited to submit a capability statement or expression of interest.

Response Deadline: June 20, 2026, 10:00 AM Eastern Time

Submit to: Contracting Officer, Sarah Hussain at Sarah.Hussain@fda.hhs.gov

Capability statements must address, at a minimum:

• Demonstrated experience performing installation, commissioning, and qualification of Coperion K-Tron continuous powder feeder systems, or functionally equivalent OEM-proprietary feeder systems, including evidence of access to required interface specifications and drawings.

• Authorization status with respect to Coperion K-Tron equipment modification and qualification documentation issuance.

• Business size under NAICS 333249 (or the applicable code confirmed by the CO).

• Relevant prior contract performance: contract numbers, agency points of contact, dollar values, and period of performance.

Responses will be used solely to assess whether a competitive procurement is practicable. The Government will consider all capability statements received by the response deadline. A determination not to compete based on information received is solely within the discretion of the Government.

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Capability statements submitted in response to this notice are not offers and cannot be accepted to form a binding contract. The Government is not obligated to issue a solicitation or award a contract as a result of this notice.

No phone calls will be accepted. All inquiries must be submitted in writing to the contracting officer.

SECTION 7 – QUALIFICATION REQUIREMENTS

Per RFO 5.101(c)(4)(viii), offerors are advised that award of a contract under this requirement is conditioned on the contractor's ability to demonstrate authorization from Coperion K-Tron to perform modifications, installation, commissioning, and qualification of the subject equipment. Offerors lacking such authorization will not be considered responsible sources for this requirement.