75N91024Q00095_PreSol Notice.pdf

Title: Validation and Calibration Services for a Government-owned Rees Scientific Environmental Monitoring-Alarm System

Document Type: Pre-solicitation Notice of Intent to Sole Source Reference Number: 75N91024Q00095 Posted Date: 07/22/2024 Response Date: 07/29/2024 by 12:00pm EST

Classification Code: J066 – Maintenance, Repair, and Rebuilding of Equipment – Instruments and Laboratory Equipment NAICS Code: 8811210 – Electronic and Precision Equipment Repair and Maintenance

Issued By:

National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions (OA)

Description:

The Surgery Branch at the Center for Cancer Research (CCR) at the National Cancer Institute (NCI) of the National Institutes of Health (NIH) requires validation and calibration services for a Government-owned Rees Scientific Environmental Monitoring-Alarm System.

The Office of Acquisitions (OA) plans to procure, on a sole source basis, this specialized device from:

Rees Scientific Corporation 1007 Whitehead Road Ext. Ste. 1 Ewing, NJ 08638

SAM UEI: NCRKL9YLY2X4

The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 and will be made pursuant to the authority in FAR 13.106-1(b)(2) and, in accordance with FAR 13, is exempt from requirements in FAR Part 6. The North American Industry Classification System (NAICS) code is 8811210 – Electronic and Precision Equipment Repair and Maintenance; and the small business size standard is $34 million.

The Surgery Branch (SB) has several current Good Manufacturing Practices (cGMP) manufacturing facilities involved in the production of cellular therapies for infusion into patients enrolled in clinical trials at the NIH for which a monitoring system is required. A Rees Scientific T30 environmental monitoring-alarm system is currently installed at NIH. To ensure the safety and integrity of the products and to meet cGMP requirements, equipment used in manufacturing processes must be monitored for performance to ensure the processes have not been compromised. The facilities and equipment in all aseptic processing and cGMP facilities use the REES monitoring system to achieve compliance. Therefore, proper maintenance and responsive emergency service is essential for this critical environmental monitoring system.

The operating system, secure server databases, and software are integral to the function of the monitoring system. All of these components are proprietary to Rees Scientific Corporation. Only Rees engineers are authorized to perform maintenance on their proprietary system and software. Rees does not license third party technicians to perform maintenance on its monitoring systems. In addition, Rees is the sole-source for replacement parts and software.

Given the clinical use of the Surgery Branch’s cell-based therapeutic biological products, it is critical that the manufacturing processes are monitored to ensure nothing is compromised. Continued maintenance of the government-owned Rees environmental monitoring system ensures that the system will be calibrated and maintained according to the manufacturer’s specifications. Any deviation from the specifications could jeopardize the safety and integrity of the manufacturing process. This would cause delays in patient treatment, which is unacceptable.

To NCI’s knowledge the manufacturer, Rees Scientific Corporation, is the only provider that can meet the Government’s needs at this time.

This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received no later than 12:00PM EST, July 29, 2024. All responses and questions must be in writing and emailed to Lena Lee, Contract Specialist, via electronic mail at lena.lee@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: 75N91024Q00095 on all correspondence.

***Please reference the attached Statement of Work for more details pertaining to the nature of the requirement.***

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use the information provided by respondents for any purpose deemed necessary and legally appropriate.

Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

mailto:lena.lee@nih.gov