SOURCES SOUGHT
66 -- Turnable Resistive Pulse-Sensing Bsed Particle Analyzer
- Notice Date
- 6/27/2013
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1120652
- Archive Date
- 7/5/2013
- Point of Contact
- Crystal G. McCoskey, Phone: 8705437267
- E-Mail Address
-
crystal.mccoskey@fda.hhs.gov
(crystal.mccoskey@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration, is conducting market research to support the U.S. Food and Drug Administration (FDA), Laboratory of DNA Viruses requirement for one (1) Tunable Resistive Pulse-Sensing Based Particle Analyzer to include inside delivery, installation, set-up, and on-site training. This is a sources sought to determine the availability and capability of small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer. The associated North American Industry Classification System (NAICS) Code is‐ 334516 ‐ Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. REQUIREMENTS: Background The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) and Arkansas Regional Laboratory of the Office of Regulatory Affairs (ORA), divisions within the Food and Drug Administration (FDA), require one (1) tunable resistive pulse sensing (TPRS)-based particle analyzer for use in research. In particular, the system will be used to support nanotechnology needs to perform complete physicochemical characterization of nanomaterials in consumer products, including the determination of the nanomaterial average size, size distribution, zeta potential and concentration. Traditional particle sizing techniques such as electron microscopy and chromatography are labor intensive, and require expensive instrumentation and complex sample preparation, which are not suitable for field laboratories. Other popular techniques such as dynamic light scattering can give rise to erroneous results due to strong biases caused by larger particles. High-throughput, field-amendable and accurate characterization of nanomaterials can be accomplished with a system that is portable, and performs rapid and real-time size and charge analysis of nano- and micro-particles (e.g. viruses, bacteria and cells, liposomes, silicon dioxide, titanium dioxide, gold, etc.) on a particle-by-particle basis. General specifications • The components shall be newly manufactured units, not used, refurbished or previously used for demonstration. • The system shall include all shipping and handling charges to the place of performance (Jefferson, AR). • The system shall be delivered with all necessary supplies and accessories required for installation and start-up. • Installation and 2 days of on-site training covering the operation, calibration, and routine maintenance of the system components, sample preparation for analysis, and use of the software to operate the system and perform data analysis shall be provided by the contractor. • The vendor shall demonstrate, upon installation, that the system meets all performance specifications. The instrument will not be accepted until those performance specifications have been met. System specifications • Shall operate on US standard 120V electric service. • The system shall be portable. • The system shall be composed of a non-optical nanopore-based instrument that uses tunable resistive pulse sensing (TRPS) to perform precise physical characterization (e.g. size, zeta potential and concentration) of micro- and nano-particles. • The system shall possess a variable pressure module (VPM) that provides pressure and vacuum control of sample flow to complement the electrophoretic operation of the base instrument. • The system shall include a fluid cell that allows for the easy positioning of the nanopore and could be easily fitted to the base instrument. The fluid cell shall be fitted with silver chloride electrodes and allow for a minimum sample volume requirement of 40 µL. • The system shall be capable of accurately and reliably measuring particle size and size distribution (in the 50 nm-10 µm size range) of polydisperse samples in aqueous solutions. • The system shall be capable of rapidly and precisely measuring particle concentration of biological, organic and inorganic particles (in the 105 to 1012 particles/mL concentration range). • The system shall be capable of real-time monitoring and detection of aggregation, functionalization and particle-particle interaction events. • The system shall be capable of simultaneously determining particle size and zeta potential of particles on a particle-by-particle basis. • Software • The system shall be capable of instrument control and data analysis. Data analysis software shall allow for installation on at least two computers. • The system shall perform all functions without the requirement of internet access. • Contractor shall include coverage for software and firmware updates that can be installed without internet access. Accessories The system shall include the following accessories: • User's manual. • Appropriate tubing/power cords/miscellaneous fittings and parts required for turnkey operation. • A starter package that includes calibration standards, reagents and appropriate nanopores. • A laptop for instrument control, data acquisition, and data analysis. Warranty • The system must be covered by warranty (parts and labor) for 12 months from the date of acceptance. Place of Performance/Deliver to: U.S. Food and Drug Administration Attn: Vicki Harris 3900 NCTR Road, Bldg 26 Jefferson, AR 72079 Delivery, installation, set-up and training shall be closely coordinated with the COR, Vicki Harris. Period of Performance: Delivery, to include inside delivery, installation, set-up, and training, shall occur within 30 days of award. Responses to this sources sought shall unequivocally demonstrate that respondent is regularly engaged in the manufacture and/or sale of same or substantially similar items. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; [Provide this same information again for the manufacturer/producer if responding to provide a product manufactured by another firm.] • Three (3) years of past performance information for the manufacture and/or sale of same or substantially similar items, which are or have been used with same or similar equipment for same or similar purposes, to include date of sale, description (should also include technical literature and specifications), dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent; • Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the items the responding firm is regularly engaged in manufacturing and/or selling; • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; • If a large business, identify the subcontracting opportunities that would exist for small business concerns • Although this is not a request for quote, informational pricing is encouraged. • The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. The Government is not responsible for locating or securing any information, not identified in the response. Interested Parties must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before July 3, 2013 by 1:00 PM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Crystal G. McCoskey, 3900 NCTR Road, Bldg 50/Room 426, HFT‐320, Jefferson, AR 72079‐9502 or email crystal.mccoskey@fda.hhs.gov. Reference #1120652 in all correspondence with the point of contact listed above. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open acquisition procedures. Disclaimer and Important Notes 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 information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a combined synopsis/solicitation (No. 1120652) may be published via FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. 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).
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