Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Subject: Fixed Price (FFP) Contract Type for the Procurement of Four (4) Powder Feeders and Integration Platform as a sole source procurement to Coperion K-Tron Pitman, Inc., under Request for Quote FDA-RFQ-2021-1237650.

Notice of Intent to Sole Source to: Coperion K-Tron Pitman, Inc.

Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, (there is only one responsible source and no other supplies or services will satisfy agency requirements), the Food and Drug Administration (FDA) intends to award a Sole Source Fixed Price (FFP) Contract Type purchase order to Coperion K-Tron Pitman, Inc., located at:

Coperion K-Tron Pitman, Inc.

590 Woodbury Glassboro Road Sewell, NJ 08080, USA Email: info.cus@coperion.com Tel.: +1 856-256-3175 Fax: +1 856-256-3159

POC: Jerry Spross EPI Technical Sales /REPRESENTING: COPERION KTRON 545 Beckett Road, Suite 103 Logan Township, NJ 08085 Email: jerry@episales.net

OFC: 856-214-3621

FAX: 856-975-6324

CELL: 610-656-8197

FDA has a requirement to procure Four (4) Powder Feeders and Integration Platform as a sole source acquisition to Coperion K-Tron Pitman, Inc., under Request for Quote FDA-RFQ-2021-1237650. FDA is requesting four loss-in-weight powder feeders along with an integration platform for proactive research on continuous manufacturing. The J & A provided, states that: Only Vne vendor (Coperion K- Tron Pitman, Inc.) is capable of designing and constructing the platform required to integrate blender with new and existing feeders necessary for associated project due to compatibility issues. The supplier is the manufacturer of the feeders being integrated and uniquely capable of designing integration platform specifically suited for their equipment. No other source meets both compatibility and integration requirements. The system requested include a custom engineered solution of feeders as well as components and support structures for continuous processing. The system is also comprised of an integrated system that includes specialized development and technical requirements for continuous processing applications in the pharmaceutical industry. In addition, all technical support and services will be provided solely by Coperion K-Tron Salina, Inc., and they reflect its expertise and design knowledge which is critical to the optimized and correct operation of this system. Coperion K-Tron Salina, Inc., asserts that the components of the system are designed for the specific use of US FDA, and any separate quotes from a third party will not incorporate the specific composition of this scope. In short, the requested system constitutes a unique offering of Coperion K-Tron Salina, Inc.’s proprietary feeding equipment, support structure and technical services that is not available from any other source.

Given that this instrument is proprietary in nature and that the manufacturer does not allow third party resellers, FDA will sole source this requirement to Coperion K-Tron Salina, Inc.

The associated NAICS Code is: 334516 - Analytical Laboratory Instrument Manufacturing.

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to Coperion K-Tron Salina, Inc., within approximately fifteen (15) days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 12:00 p.m. EST 04/30/2021. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov