SOURCES SOUGHT
66 -- Microscope System
- Notice Date
- 2/7/2014
- 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
- FDA1128379
- Archive Date
- 3/1/2014
- 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 (FDA), is conducting market research to support the Center for Biologics Evaluation and Research's (CBER) requirement for one (1) Confocal Coherent Anti-Raman Scattering (CARS) Microscope System to include inside delivery, installation, testing, training, and post-warranty maintenance for up to four (4) option years. 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: Part I: General Information A. Introduction The U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) has a requirement for one (1) Confocal Coherent Anti-Raman Scattering (CARS) Microscope System to facilitate the live molecular imaging of viruses (to include but not limited to Influenza A virus, West-Nile, Dengue, Vaccinia, and Mumps), bacteria, cells, tissue and/or small animals (rodents) for CBER's Microscopy and Imaging Core Facility's broad research projects and microscopy demands. B. Background The Microscopy and Imaging Core Facility provides support for all FDA scientists and laboratories in morphological studies, in particular fluorescent light microscopic imaging. The Microscopy and Imaging Core Facility analyzes the host - pathogen (e.g. virus, bacteria) interaction using cultured (stained or unstained) cells, tissue and/or small animals in immunological responses and vaccine related studies. The research conducted in CBER's Microscopy and Imaging Core Facility focuses on the development of improving light and fluorescence microscopic imaging methods to evaluate the potency of vaccines/drugs and immune responses to pathogens. Confocal microscopy plays an important role on obtaining spatio-temporal information from biological samples, thus the microscope system with advanced modules is needed to provide precise localization analysis and/or molecular imaging for evaluating efficient vaccines and/or drugs. An upright confocal microscope system with molecular vibration and multicolor deep tissue imaging capabilities is critical for intra-vital and various standard microscopy applications. The Imaging Core Facility requires a microscope that has the ability to analyze cells or tissue visualizing its unique molecular vibrations without labeling. The Microscopy and Imaging Core Facility further requires a microscope that enables them to monitor host-pathogen interactions in real time in vivo by combining Fluorescence and CARS. C. Scope The Contractor shall provide one (1) completely configured Confocal CARS Microscope System to optimally achieve the work described above to include, but not be limited to, all necessary accessories, software, hardware, drivers, libraries, equipment, supplies, adapters, cables, workstations, plates, scanners, condensers, detectors, modules, imagers, filters, prisms, lasers, stages, slides, control and display panels, lenses, nose pieces, clamps and holders, etc. as a seamless, turn-key solution. The Contractor shall be responsible for inside delivery, installation, testing, Initial Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ), training, and up to four (4) 1-year option periods for post-warranty maintenance. Part II: Work Requirements A. Salient Characteristics of requirements The system shall: - have high resolution, high sensitivity and high speed imaging with efficient multicolor image acquisition for labeled and unlabeled cell, tissue and animals. - have multicolor nonlinear optical microscopy capability, including Coherent Anti-Stokes Raman Scattering (CARS), Multi-photon (MP), Stimulated Raman Scattering (SRS) and Second Harmonic Generation (SHG) for analyze the various vibration of molecules in unlabeled or labeled tissue /specimen. - be able to visualize viruses, bacteria, cell receptors, and/or nano-particles for super resolution imaging (i.e., minimum of 50 nm resolution). The system shall have ability to perform at least simultaneous two channels (green and red emission) with 3D depletion beam control, capable for real time visualization of influenza A virus, West-Nile, Dengue, Vaccinia viruses without image post processing. - be newly manufactured, not used, refurbished, or previously used for demonstration. - have all necessary detectors, a minimum of five (5) internal and four (4) external, to maximize multicolor non-linear imaging. - have the ability to track /visualize both very fast and slow movement of particles or organella /cells, such as fluorescently labeled peptide or viral particles or labeled organella /cells and ability for flexible /variable scan speed. - be capable to visualize new dye, fluorochrome and /or fluorescence proteins. - have molecular mobility assay such as Fluorescence Recovery After Photo-bleaching (FRAP) and/or molecular interaction assay (spectral, acceptor bleaching and sensitized emission FRET) modules. - have at a minimum the following laser lines for various imaging applications used in the Imaging Core Facility: UV405, 458, 476, 488, 496, 514, 561, 594, 633nm, Pulsed IR (690-1040nm tunable), CARS (780-940nm tunable), 660, Pulsed 775nm. - have a laser system capable of delivering the pulse to the deep tissue for multi-photon, SHG and CARS imaging, e.g. mouse lymph nodes, spleen, lung, intestine, muscle, skin and brain, Drosophila and C. Elegance. - have an Infrared laser system that provides ultimate deep tissue MP, SHG animal imaging. - be equipped with a mechanism or attachment, such as a black environmental chamber covering the entire system, to keep the system stabilized from drift as well as prevent exposer of stray light to the detectors. The mechanism or attachment shall also provide for temperature (i.e. around 37°C) and CO2 regulation. - be capable 3D and 4D scanning for various applications of slides, culture dishes and animals. - be equipped with a minimum of 10x, 20x, 40x, 63x and 100x Objective lens, ready for imaging slides, dishes and live animals. For small animal imaging purposes, the system shall provide an objective lens, such as a large 20x, Numerical Aperture (NA) 1.0 water objective lens with separate nose piece, for imaging. - be equipped with mouse and rat specific gas anesthesia system for safe anesthesia during intra-vital microscopic imaging. - include an active anti-vibration table, that also avoids laser light reflection, i.e. in "matte black", for laser safety purposes and to minimize any vibration from environment. - have ultra-microtome with cool temperature control. - include a minimum of a one (1) year parts and labor warranty and any available updates. B. Installation, Testing and Training Requirements: The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include inside delivery. Equipment must be tested once installed to verify all aspects of the system are operating within parameters of the required specifications. The Contractor shall demonstrate upon completion of installation and testing that the item meets all specifications. Upon acceptance of the system, on-site familiarization training shall be provided to a minimum of three (3) attendees/users by the Contractor's trained and certified application specialist. C. Qualification Service Requirements: The Contractor shall perform IQ/OQ/PQ for the complete microscope system. All standard information on the equipment, including but not limited to User Manuals, Operation and Maintenance (O&M) Manuals, Material and Safety Data Sheets (MSDS), troubleshooting guides and any other applicable documentation, shall be provided upon installation of the system. D. Service Requirements: At a minimum, the Contractor shall provide the following services during the option periods for post-warranty periods: - One (1) preventative maintenance visit per contract year inclusive of all labor, travel, and parts, components, subassemblies, etc. necessary to provide the service. - Unlimited on-site corrective/remedial maintenance/repairs to be scheduled within three (3) calendar days from service call. On-site repair service shall be inclusive of all labor, travel, certified replacement parts, components, subassemblies, etc. needed to return the system to operational capacity. - Unlimited technical support and trouble-shooting assistance, Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Eastern Time, within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.) - Formally trained and certified technicians/engineers for all maintenance and repair activities performed, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc. - Unlimited software and firmware updates. - The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket by email identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Contracting Officer's Representative and Contract Specialist by email, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed. Part III: Supporting Information A. Place of Performance Physical location for inside delivery, installation, testing, training and maintenance of the system at: U.S. Food and Drug Administration Bldg 52, Room 1231 10903 New Hampshire Avenue, Silver Spring, MD 20993 B. Period of Performance Delivery of microscope system, to include inside delivery, installation, testing, IQ/OQ/PQ, and training expected within ninety (90) calendar days of award with up to four (4) 1-year post-warranty maintenance option periods. 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 respondent is not the manufacturer/producer; • 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 any existing subcontracting opportunities 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 February 14, 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 #1128379 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. 1128379) 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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