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THIS IS A PRE-SOLICITATION NOTICE OF INTENT TO AWARD ON A SOLE SOURCE BASIS. THIS IS NOT A REQUEST FOR QUOTE/PROPOSALS. On behalf of the National Institute of Neurological Disorders and Stroke (NINDS)... THIS IS A PRE-SOLICITATION NOTICE OF INTENT TO AWARD ON A SOLE SOURCE BASIS. THIS IS NOT A REQUEST FOR QUOTE/PROPOSALS. On behalf of the National Institute of Neurological Disorders and Stroke (NINDS), the Office of Acquisitions Contracts Management Branch Red, NINDS Section of the National Institute on Drug Abuse (NIDA), intends to solicit on a sole-source basis by a request for quotation to Spectrydne, LLC to acquire the Spectradyne nCS1 equipment on or around January 27, 2022 with an award issued on or around February 24, 2022. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 334516 with a Size Standard of 1,000 employees. This acquisition is NOT set aside for small businesses, but rather is a sole-source acquisition to Spectradyne, LLC. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1 (b) Soliciting from a single source. BACKGROUND, PURPOSE AND OBJECTIVES OF REQUIREMENT The mission of the INSS lab is to study the Neuropathogenesis of HIV infection. The lab is trying to understand HIV-Tat role in HIV pathogenesis and they show that the HIV-Tat protein is produced in the brain despite adequate antiretroviral therapy. The INSS has an established track record of quantifying the Tat protein from CSF via enzyme-linked immunosorbent assay (ELISA), however this assay does not work with serum. Recent work has demonstrated that Tat is secreted in EVs and the lab developed a serum-based Tat ELISA assay which requires the purification and quantification of EVs. In order to successfully apply this assay to samples the INSS require a Spectradyne nCS1 system to quantify EVs. Currently, the lab does not have access to a Spectradyne that is permitted to have potentially infectious materials applied to the system, nor is there one available within NINDS. Therefore, this purchase will allow for the analysis of EVs from patients and model organisms/systems with known viral infections that impact the CNS. In addition to HIV, the INSS lab is investigating the role of EVs in the development of amyotrophic lateral sclerosis (ALS) via viral-like transmission of endogenous retroviruses. In this line of inquiry, EVs are characterized on both physical and functional aspects. Additional ongoing studies include investigating the RNA-protein complexes encapsulated in EVs that may facilitate evasion of the immune system. Use of a Spectradyne system to aid in the measurement of EVs will be an integral part of the workflow to normalize functional assays as well as allow for comparison of profiles amongst individuals with ALS healthy volunteers. In addition to the outlined projects, this instrument will be made available to the Undiagnosed Diseases Program and other PIs from NINDS who develop future studies which require the quantification or characterization of EVs. Analysis of EV content in bodily fluids could help identify biomarkers and develop minimally invasive techniques for diagnostics. Such profiling and identification of potential vesicular biomarkers will be performed for neurological diseases such as Multiple Sclerosis, Alzheimer’s Disease, Parkinson’s Disease, neurodegenerative viral infections, and gliomas and is important for the NINDS mission, to reduce the burden of neurological diseases. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION Spectradyne, LLC, located at 2501 Cherry Ave., Suite 140, Signal Hill, CA, 90755, is the sole manufacturer and distributor of the Spectradyne nCS1 nanoparticle characterization instrument. The Spectradyne nCS1 is the only instrument on the market which characterizes nanoparticles using microfluidic resistive pulse sensing. This approach is more sensitive and accurate compared to similar nanoparticle characterization instruments (Nanoparticle tracking analysis; NTA, or Dynamic Light Scattering, DLS) on the market which utilize Brownian motion measurement to quantitate and measure nanoparticles. Recent evidence (Arab et al. J Extracell Vesicles, “Characterization of extracellular vesicles and synthetic nanoparticles with four orthogonal single?particle analysis platforms”, 2021) has shown that the measurement of nanoparticles using microfluidic resistive pulse sensing technology can detect distinct size populations of nanoparticles at the level necessary for the research being conducted in the NINDS INSS lab. Given the variation in cargo and function of distinct subpopulations of vesicles, it is essential for INSS lab applications to have the ability to examine subpopulation distribution and abundance to better explore the nature of these particles and their contribution to human disease. In accordance with FAR part 10, extensive market research was conducted to reach this determination. Specifically, contact with knowledgeable individuals both in industry and Government, as well as reviews of available product literature, revealed no other sources. A review of the GSA Advantage, Dynamic Small Business Search, and previous Government acquisitions returned no results that meet all requirements. A letter from the OEM confirmed that Spectradyne, LLC is the only provider for this equipment. Therefore, only Spectradyne, LLC is found to be capable of meeting the needs of this requirement. The intended source is: Spectradyne, LLC. 2501 Cherry Ave., Suite 140 Signal Hill, CA, 90755 Salient characteristics: The Contractor shall provide a Spectradyne nCS1 nanoparticle characterization instrument including: Software upgrades (non-custom) Laptop computer (Instrument controller) Air compressor kit for nCS1 Remote installation & training Extra cartridges, exact mix TBD The nCS1 System Specifications are as follows: Capable of measuring particle sizes (spherical diameters) from 50 nm to 10 micrometers. Detection system uses resistive pulse sensing (electrical signal) exclusively (no optical detection). Sample volume required is 3 microliters or smaller. Particle detection rate maximum is ? 10,000 particles/second. Nano-constriction is achieved using disposable cartridges to eliminate cleaning and prevent cross-contamination. Nano-constriction cartridges have on-board filtering to prevent clogging by removing particles that are larger than the nano-constriction. Nano-constriction cartridges are factory calibrated for size and concentration measurements to ensure reproducible results between cartridges; no user calibration is required. Size measurement accuracy is ±10% or better. Concentration measurement accuracy is ±30% or better. Size measurement reproducibility is ±5% or better. Concentration measurement reproducibility is ±20% or better. Particle size measurement is based on particle’s volume, independent of its shape or material make-up. Particle size and concentration meets specs even for mixtures of different sized particles (for instance, a mixture of 100 nm, 150 nm and 200 nm particles Sample concentration range: 107 particles/mL to 1011 particles/mL (for d = 50 nm to 400 nm). Typical sample collection times needed: 5 minutes to 10 minutes. System software provides an automated method for unclogging the nano-constriction aperture and sending the clogging analyte to waste to prevent reclogging Laptop PC with Windows 10 OS for instrument-control, data acquisition and analysis with preloaded and tested instrument software included. Compressed air system included. System power to be 115 V, 60 Hz. Operation and maintenance manual included. Estimated Delivery Date: 30-60 days after receipt of order Place of Performance: National Institutes of Health 10 Center Dr., Building 10, Room 7C103 MSC 1414, Bethesda, MD 20892-1414 Contract Type: A firm-fixed price type contract with option periods is planned for this acquisition, consistent with commercial practices. CLOSING STATEMENT THIS NOTICE OF INTENT TO AWARD ON A SOLE-SOURCE BASIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must provide evidence that they can provide equipment that meets all of the requirements in this announcement. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N95022Q00066. Responses must be submitted electronically to Samson Shifaraw, Contract Specialist, Contracts Management Branch – Red, NINDS Section, NIDA, at Samson.Shifaraw@nih.gov. U.S. Mail and Fax responses will not be accepted.