Inactive Total Small Business Set-Aside (FAR 19.5)

THIS IS A Sources Sought Notice ONLY. The U.S. Government desires to procure Ultra-High Performance Liquid Chromatography - Ion Trap Mass Spectrometer System as a small business set-aside, provided 2 ... THIS IS A Sources Sought Notice ONLY. The U.S. Government desires to procure Ultra-High Performance Liquid Chromatography - Ion Trap Mass Spectrometer System as a small business set-aside, provided 2 or more qualified small businesses respond to this sources sought synopsis with information sufficient to support a set-aside. Be advised that the U.S. Government will not be able to set aside this requirement if 2 or more small businesses do not respond with information to support the set-aside. We encourage all small businesses, in all socioeconomic categories (including, 8(a) Business Development Program, Small Disadvantage Business, Historically Underutilized Business Zone, Service-Disabled Veteran-Owned, Women-Owned Small Business concerns), to identify their capabilities in meeting the requirement at a fair market price. This notice is issued solely for information and planning purposes – it does not constitute a Request for Quote (RFQ)/Invitation for Bid (IFB)/Request for Proposal (RFP) or a promise to issue an RFQ, IFB or RFP in the future. This notice does not commit the U.S. Government to contract for any supply or service. Further, the U.S. Government is not seeking quotes, bids or proposals at this time and will not accept unsolicited proposals in response to this sources sought notice. The U.S. Government will not pay for any information or administrative costs incurred in response to this notice. Submittals will not be returned to the responder. Not responding to this notice does not preclude participation in any future RFQ or IFB or RFP, if any is issued. If a solicitation is released, it will be synopsized on the Governmentwide Point of Entry. It is the responsibility of potential offerors to monitor the Governmentwide Point of Entry for additional information pertaining to this requirement. The anticipated NAICS code is 334516 - Analytical Laboratory Instrument Manufacturing, with small business size standard of 1,000 employees. I. Minimum Performance Requirements/Salient Characteristics All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the FCC prior to purchase. General Requirements • The system shall include a benchtop, ion trap mass spectrometer (MSn) interfaced with an ultra-high pressure liquid chromatography (U(H)PLC) system to form a complete LC-MSn system. • The system shall include a PC-based data system/instrument controller including operating system, instrument control/data acquisition/data analysis software, monitor, and laser printer. • The system shall include electrospray ionization (ESI), atmospheric pressure chemical ionization (APCI) ionization sources, and a direct probe for analysis of solid samples. Ion Trap Mass Spectrometer • The ionization sources shall be capable of supporting ESI, APCI, and a direct probe for the analysis of solid samples and shall have an option for upgrading/adding atmospheric pressure photo-ionization (APPI). O The ionization sources shall be able to be changed without breaking the vacuum of the mass spectrometer. • The transfer ion optics shall be designed for high stability and ion transmission efficiency and must include an ion funnel, stacked ring ion guide, or similar mechanism to provide efficient ion delivery to the mass analyzer. • The vacuum system must include a low maintenance split flow drag pump and software-integrated pressure gauges. • The MSn system shall have a minimum mass range of m/z 15-2000. • The MSn system shall have capability for high-resolution scan to resolve isotopic envelopes, of ions of at least 8+ charge state at a peak width of <0.1 Da from 15-2000 Da at a scan speed of at least 5200 Da/sec • The MSn system shall have the ability to perform polarity switching experiments to detect positive and negative ions in a single LC-MS analysis. O Polarity switching must be possible at a 20 Hz rate or faster. • The MSn system shall be an ion trap and shall be capable of isolation and fragmentation experiments including the following: O Perform up to 5 stages of MSn automatically (1 ? n ? 5) O Perform manual MSn for n=1 through 11 O Isolate monoisotopic precursor ions up to m/z 1000 (doubly charged) and up to m/z 2000 (singly charged). • The MSn system shall have the ability to determine the ion injection time into the ion trap without carrying out a pre-scan event to increase the instrument scan speed/decrease the instrument cycle time. • The MSn system shall have capability to temporarily exclude an ion while allowing acquisition of MS/MS or MSn spectra; increases the selectivity of co-eluting compounds, and enhances the signal of a selected compound. • The MSn system shall have capability to perform experiments for automated 3-stage data-dependent experiments for charge state determination and structural elucidation of multiply charged ions. • The MSn system shall have the ability to exclude background ions on a list and include a list of precursor ions for MSn data acquisition. • The MSn system shall have a feature which eliminates the low mass cutoff which is inherent with all ion trap mass spectrometers to observe low masses in MSn scans. • The MSn system shall have an integrated syringe to allow for automated infusion under data system control. • The system shall be capable of MS and MS/MS mass accuracy of not worse than ± 0.15 Da within the calibrated mass range. • The system shall be capable of controlling HPLC systems from multiple vendors within the included MS software. • The system shall be capable of detecting 125 fg/µL (250 fg) Reserpine at S/N 500:1 in full scan MS/MS mode. • Manuals for the operation and maintenance of the system must be included. U(H)PLC System • The system shall include a binary pump with high pressure mixing, a solvent degasser, a thermostat controlled autosampler and trays capable of operating under ultra-high pressures, a thermostat controlled column compartment and appropriate cables and event boards for operation. • The system must have the capability of being configured for both UHPLC and conventional HPLC separations. • The binary pump shall have continuous and fully automatic solvent compressibility compensation. • The binary pump must have a configurable delay volume in order to support the use of LC columns 10 to 300 mm in length with internal diameters ranging from 1.0 to 4.6 mm and particle sizes ranging from <2 to 10 µm. • The binary pump must have typical pulsation of ? 1% amplitude (or < 5 bar, whichever is greater) when operated isocratically at 2 mL/min with conventional HPLC back pressures. • The maximum pressure requirement for the binary pump shall be at least 1300 bar. • The binary pump shall have a flow rate range of at least 0.001 to 5 mL/min and be adjustable in 1 µL/min increments. • The binary pump shall have a flow accuracy of ± 1% (or 10 µL/min, whichever is greater) or better. • The binary pump shall have a flow precision of ? 0.075% RSD or ? 0.005 min SD. • The autosampler shall be capable of injection volumes from 0.1 to 25 µL in 0.1 µL increments, without changing the injection loop and a total injection range of 0.1 to 5000 µL • The autosampler shall provide injection volume precision (RSD) of ? 1% for injection volumes of 1 µL or greater. • The autosampler shall provide injection volume accuracy of ± 0.5% or better for injection volumes of 10 µL. • The autosampler shall be thermostat controlled with a temperature range of at least 4ºC to 40ºC. • The thermostat controlled column compartment shall have a temperature stability of at least ± 0.1ºC. • The thermostat controlled column compartment shall have a temperature range of ambient +10ºC to 90ºC controllable in 1 degree increments. Data System • The system shall include single instrument computer and software sufficient to control, acquire data, process data, and export data for all components of the LC-MSn system provided. • The system shall include a PC, flat screen color monitor, and laser printer suitable for use with instrument software. • The system shall include all CD-ROMs needed to restore operation of the system in the event that the computer fails. • The software shall allow the user to upload raw data files and detect peaks via a library search. • The software shall allow the user to determine confirmation criteria including ion ratios, library searches, isotopic distributions, and defined fragmentation patterns to assist in identification. • The system must be capable of backing up the acquired data, methods, tune files, calibrations and all QA/QC information to a network device or server. • The computer system shall have all components necessary to operate the instrument with the following specifications: II. Trade and Service Specifications • The system must be a complete, newly manufactured unit, not used and refurbished or previously used for demonstration. The Government must be able to expect routine customer service and technical support to be available from the vendor during its lifecycle. • A minimum of one-year warranty is required with the purchase and shall include at a minimum: coverage on all non-consumable items and parts supplied including the base instrument and any sampling accessories. • FOB destination to include training. An on-site 3-day training class for up to four users will be provided within 60 days of delivery such that operators may independently operate the instrument and increase familiarity and proficiency. The training shall include manuals, hardcopy or electronic, to be used during training, and shall include instruction on any normal maintenance of the system. In response to this sources sought, please provide: 1. Name of the firm, point of contact, phone number, email address, DUNS number, CAGE code, a statement regarding small business status (including small business type(s)/certifications(s) such as SDB, 8(a), HUBZone, SDVOSB, WOSB, etc.) and the corresponding NAICS code. 2. Identify whether your firm is interested in competing for this requirement as a prime contractor or not. Identify subcontracting, joint ventures or teaming arrangement that will be pursued, if any. 3. Information in sufficient detail regarding previous experience (indicate whether as a prime contractor or subcontractor) on similar requirements (include size, scope, complexity, timeframe, government or commercial), pertinent certifications, etc., that will facilitate making a capability determination. 4. Information to help determine if the requirement of Ultra-High Performance Liquid Chromatography - Ion Trap Mass Spectrometer System is commercially available, including pricing information, basis for the pricing information (e.g., market pricing, catalog pricing), delivery schedules, customary terms and conditions, warranties, etc. 5. Identify how the FDA can best structure these contract requirements to facilitate competition by and among small business concerns. 6. Identify any GSA Schedules your company has available to fulfill this requirement. This is a request for information and shall not be construed as a solicitation or obligation on the part of the FDA for any future solicitation. Telephone inquiries will not be accepted. All interested parties shall submit their capability statements via email to be received by March 3, 2022, at 1:00 p.m Eastern Time, to the Contracting Office Address: Food and Drug Administration, Michael Gemmill, Contract Specialist, Michael.Gemmill@fda.hhs.gov