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EZ2 Connect MDx System & QIAxcel Connect system

Waiver type - Procurement: Nonavailability

Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 08/15/2023

Procurement Summary

The mission of the Intramural Research Program (IRP) of the National Institute on Drug Abuse is to conduct state-of-the-art research on basic mechanisms that underlie drug abuse and addiction, and to develop new methods for the treatment of drug abuse and addiction. Research is supported at the molecular, genetic, cellular, animal, and clinical levels and is conceptually integrated, highly innovative, and focused on major problems in the field. The long-term goal of the research is to better understand the biological and behavioral factors contributing to initiation, maintenance, and elimination of drug abuse and addiction (and associated diseases), and to translate this knowledge into improved strategies for preventing, treating, and reducing the negative consequences for the individual and for society caused by drug abuse and addiction. The GEVVC provides molecular biology and genetic engineering tools for the NIH community to complete the NIH mission. The ability to rapidly and reliably isolate nucleic acids from biological tissues is an essential capacity for downstream quantification and/or sequencing endpoints. Over the past two years, GEVVC has delivered several training sessions to the NIDA IRP dealing with RNA isolation and gene expression analysis. In addition, GEVVC technology development projects have encountered bottlenecks related to the high opportunity cost and the long turnaround time associated with in house sample processing. There is an underserved need for sample processing within the NIDA IRP. GEVVC requires an automated nucleic acid isolation system to increase throughput and quality of DNA/RNA preparation, and a rapid capillary electrophoresis system to facilitate the analysis of DNA/RNA samples. This will allow GEVVC to offer additional services related to gene expression analysis (training and services for sample processing) and scheduled walk-up access for sharing the equipment with the NIDA IRP at large. Devices: 1) Processing device used to isolate nucleic acids (RNA and DNA) from animal tissue, which includes device hardware, controller hardware (computer), and controller software. 2) Analysis device used to characterize nucleic acids (nucleotide length and molar concentration), which includes device hardware, controller hardware (computer), and controller software.

Waiver Rationale Summary

Based on the information explained in the findings above, the feasibility of foregoing the requirement or providing a United States manufactured substitute has been considered and a domestically manufactured item meeting the Government’s need is not mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality.

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

Yes

Was a sources sought or Request for Information issued?

Yes

OMB Determination

Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Date Submitted

08/11/2023

Procurement Instrument Identifier (PIID)

Solicitation ID

N/A

Procurement Stage

Pre-solicitation

Expected Maximum Duration of the Proposed Waiver

Instant Delivery Only

Waiver Coverage

Individual Waiver

Funding Agency

NATIONAL INSTITUTES OF HEALTH