Intent to Sole Source Notice.doc

75F40126Q00297

Notice of Intent to Sole Source for Commercial Purchases Under SAT

1. Solicitation Number: 75F40126Q00297

2. Title: Distek Dissolution System and Autosampler Instrument

3. Classification Code: 6640

4. NAICS Code: 334516

5. Response Date: 07/20/2026 by 2:00 PM Eastern Time (ET). Capability Statements shall be submitted via email to the Contracting Officer identified in this notice. Interested parties believing they can satisfy the Government's requirement shall submit a Capability Statement demonstrating their ability to provide a product meeting all requirements identified in the attached Statement of Work. Capability Statements must be received by the response date identified in this notice.

6. Description: This action is for one (1) Distek Dissolution System and Autosampler Instrument with Accessories to support dissolution testing of extended-release dosage forms at the Irvine Medical Products Laboratory (IRVLMP), Irvine, CA. The requirements for this acquisition are specified in the Statement of Work (SOW) dated June 12, 2026. Delivery Date: 60 days after contract award.

7. Purpose:

NOTICE OF INTENT TO AWARD A SOLE SOURCE PURCHASE ORDER

The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b)(1)i. The Government intends to award a firm fixed price purchase order to: Distek, Inc., 121 North Center Dr., North Brunswick, NJ 08902.

This notice is not a request for competitive quotations, proposals, or bids. However, interested parties may submit capability statements demonstrating their ability to satisfy the Government’s requirements. Capability statements shall include sufficient technical documentation demonstrating the ability to meet all requirements identified in the attached Statement of Work. Responses received by the closing date of this notice will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed action based upon responses received to this notice is solely within the discretion of the Government. The Government will not be responsible for any costs incurred by interested parties in responding to this notice.

8. Rationale: Market research identified Distek, Inc., as the only known source that meets the Government’s minimum technical requirements for the required dissolution system and autosampler instrument. Specifically, the required system must utilizes syringe pumps and syringe filters and is equipped with interchangeable shafts that allow for the use of paddles or baskets. The autosampler must utilize syringe filters and not plate filters to allow for rapid, efficient changing of filters between samples and the USB and ethernet connections are required for data retrieval and archival requirements in alignment with ISO 17025 accreditation requirements.

PART 2 – SUPPLIES OR SERVICES

The Food and Drug Administration intends to issue a Firm-Fixed Price (FFP) type Purchase Order for the following:

PART 3 - DESCRIPTION OF REQUIREMENTS

See attached Statement of Work