High Pressure Liquid Chromatograph and Accurate Mass Mass Spectrometer

Sources Sought Synopsis Notice to Small Businesses The purpose of this notice is to obtain information regarding the availability and capability of qualified small business concerns; 8(a), Woman-Owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone), Small Businesses, and Service-Disabled Veteran-owned Small Businesses (SDVOSB). The Food and Drug Administration intends to provide maximum practicable opportunities in its acquisitions to small businesses. The Food and Drug Administration (FDA) is conducting a market survey to assess the availability of small business firms as defined by NAICS code 334516 to provide three (3) High Pressure Liquid Chromatographs (HPLCs) and three (3) Accurate-Mass Mass Spectrometers. This notification is for market research purposes and does not constitute a commitment, implied or otherwise, that a procurement will be accomplished. FDA welcomes responses from all interested parties. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this sources sought with any interested parties. However, FDA reserves the right to contact vendors if additional information is required. Background The Food and Drug Administration's Office of Regulatory Affairs has a requirement for the purchase of three (3) High Pressure Liquid Chromatographs (HPLCs) and three (3) Accurate-Mass Mass Spectrometers. These instruments will be used for analyzing drugs and adulterated dietary supplements. The accurate mass feature has the resolution to provide confident compound identification. Advanced signal processing allows for rapid scan speed for demanding samples in complex matrices. True high mass resolution data avoids false positives and reduces the need to reanalyze samples. This is necessary for detecting unknown chemical adulterants in dietary supplements. Requirement The potential requirement is to procure three (3) High Pressure Liquid Chromatographs (HPLCs) and three (3) Accurate-Mass Mass Spectrometers that adhere to the following minimum salient characteristics: HPLC - LC pump shall allow column pressure up to 1000 bar - LC pump shall operate in traditional HPLC or UHPLC modes - LC autosampler shall allow nL to mL sample volumes with minimal carryover and flexible sample (vial) formats - Shall include thermostated column compartment - Shall include thermostated autosampler Accurate Mass Mass Spectrometer - Mass Range: Shall have a mass/charge range of greater than m/z 3000 - Resolving power (resolution): Shall have a minimum resolving power (resolution) of 17,500 at 10 scans per second; shall be capable of producing resolving powers of greater than 125,000 at slower scan rates (defined at m/z 200) with an optional resolution up to 280,000. - Mass Accuracy: Shall have a mass accuracy to within 5 ppm when using an external calibration; shall have a mass accuracy to within 1 ppm when using an internal calibrant - Dynamic range: Shall have a dynamic range of greater than 5000 at the mass accuracies specified above - Shall have a sensitivity of less than 500 femtograms (100:1 signal to noise ratio for the selected ion chromatogram, of the parent ion) for the on-column injection of a test compound - Shall have a sensitivity of less than 50 femtograms (100:1 signal to noise ratio for the selected ion chromatogram, of the parent ion) for the on-column injection of a test compound - Shall have polarity switching capability for alternate positive and negative ion scans; resolving power on alternate scans shall be at least 17,000 and the alternate scans shall have a duty cycle of less than one second - Source probes: Shall be capable of performing electrospray ionization, atmospheric pressure chemical ionization (APCI) and nanospray ionization and appropriate sources to do so shall be available. - Electrospray (ESI) at flow rates of 1 ?l/min to 1 ml/min - Atmospheric pressure chemical ionization (APCI) at 50 ?l/min to 2 ml/min without - Nanospray at flow rates of 50 nl/min to 2 ul/min - Shall be able to perform the following full scan functions - Full MS with high resolution accurate mass detection - All ion fragmentation with high resolution accurate mass detection - In-source fragmentation with full scan high resolution accurate mass detection - Shall have true mass selection capability with a first stage mass analyzer and be able to perform the following functions: - Mass selection window ranging from 0.4 Da to full mass range - Selected ion monitoring with mass selection and high resolution mass detection - Mass selection followed by fragmentation in a collision cell at energies > than 5 ev, followed by mass analysis of fragment ions at >125,000 resolution - Shall be supplied with power conditioning equipment necessary for proper instrument performance - Shall be supplied with a computer-based data system and operating software capable of running the instrument and associated, user-selected liquid chromatograph systems; shall be supplied with appropriate data analysis software. Delivery Locations Food and Drug Administration Pacific Regional Lab Northwest 22201 23rd Dr SE Bothell, WA 98021 Food and Drug Administration Pacific Regional Lab Southwest 19701 Fairchild Irvine, CA 92612 Food and Drug Administration Southeast Regional Laboratory 60 Eighth St NE Atlanta, GA 30309 General Instructions Contractors that believe they possess the ability to provide the required equipment must submit documentation of their ability to meet each of the characteristics listed in the Requirement section to the Contracting Officer (i.e. brochure, information on equipment that meets specifications, etc.). The capability statement should also include the organization name, type of business, DUNS number, point of contact name/telephone number/email address, and applicable NAICS code. Capability statements that do not provide sufficient information for assessment will be considered non-responsive. When submitting the information, please reference the solicitation number FDA-14-1130883-SS. Responses should be submitted via email to Tania Gates at Tania.Gates@fda.hhs.gov by 12:00 noon on April 14, 2014.