SOURCES SOUGHT
66 -- replacement parts on a Nikon Fluorescence Microscope imaging system
- Notice Date
- 8/22/2016
- Notice Type
- Sources Sought
- NAICS
- 333314
— Optical Instrument and Lens Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1165663
- Archive Date
- 9/13/2016
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@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 (CBER) requirement for replacement parts on a Nikon Fluorescence Microscope imaging system such as a wavelength switcher, light source and components. The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort. The associated North American Industry Classification System (NAICS) Code is-333314- Optical Instrument and Lens Manufacturing ; Small Business Size Standard is 500 employees. A. Introduction The mission of the Tumor Vaccines and Biotechnology Branch (TVBB) at the Division of Cellular and Gene Therapy (DCGT), Office of Cellular, Tissue and Gene Therapy within CBER is to develop and promote technology for safer Cancer Vaccines to improve public health. TVBB needs to assess the identity and characterization of gene therapy products to perform critical path research for its mission to develop and promote technology to regulate cancer vaccines. TVBB have developed many molecular and cellular biological technologies to understand the tumor biology and regulation of receptors for the Th2 cytokines IL-4 and IL-13. TVBB demonstrated that these receptors are overexpressed in a variety of human cancers at protein and mRNA levels. To understand the biological significance of IL-13 and IL-4 receptor overexpression on tumors, TVBB have developed chimeric fusion immunotoxins consisting of IL-13 or IL-4 and truncated Pseudomonas exotoxin. TVBB have produced these immunotoxins in prokaryotic expression systems and purified to a single band of pure protein as evidenced by SDS-PAGE utilizing an AKTA FPLC system. In addition, TVBB examined their tumor biology in vitro and in pre-clinical mice models of human cancers. TVBB have also developed cellular and molecular biological assays to examine molecular regulation and the identity, potency safety and efficacy of these immunotoxins and other related biological biomarkers using highly sensitive non-isotopic fluorescence detection. These studies are the core of the TVBB's mission, which focuses on studying the efficacy, stability and potency of these two cancer vaccines and many other biological products. B. Background The NIKON fluorescence imaging system is a state of art imaging system, which can image, quantitate and pixelate the tumor associated antigen and biomarkers in tumor cells and tumor biopsy specimens at sub organelle levels by using UV, visible, fluorescence or near infrared fluorescent conjugated reagents. The wave length switcher, light source and its components need to be replaced which are approximately ten year old NIKON fluorescence imaging system components are not working optimally. In addition, the new system has technologically advanced optics, components and quantitation program to evaluate the cell organelle expression of tumor antigen or biomarker in pre-clinical and clinical tissue specimens. In fact, many investigators within DCGT will use the updated system once the old system is replaced for their research projects. C. Scope The wavelength switcher, light source and visible camera components of the existing NIKON imaging system will be replaced as they are either not functioning optimally or gone bad. The newly updated system will be housed in the same place where the current system is housed in the laboratory. It will be continuously used by many users in the TVBB and DCGT for their mission related research. Performance requirements General specifications: The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration. Minimum specifications- Brand name or equal NIS-Elements: Wavelength Switcher with the following integrated components: 1. Cy7 Brightline Filter Set Mounted in an NTE Cube; Excitation Filter: FF01-710/40-12.5 Emission Filter: FF01-775/46-25 Dichroic Beamsplitter: FF741-Di01-25x36 1 2. Penta Pass Filter for SpectraX 77060007, DAPI-FITC-TRITC-CY5-CY7; FF01-440/521/607/694/809-25 (Em) with Dichroic FF408/504/581/667/762-Di01-25x36, mounted in Ti/Ni cube. 3. Lumencor - Spectra X LED illuminator - Custom configuration for NIR - Replaces 510nm unit with 740nm far red unit. Includes LLG adapter only, 7 EX Filters and Paddles. Includes Semrock Excitation Filters: 390/18; 438/24; 485/20; 740/13 (NIR); 560/25; 585/29; 650/13. LLG (77060021) and Ti Adapter (MBF72315) 4. Spectra X; ET435/26m, ET515/30m, ET595/40m, ET705/72m, Single Band-pass Emission Filter Set for 25mm emission filter wheel. 5. DS-Fi2 Color NIKON camera 6. DS-L2 Camera Control Unit 7. Interface Cable 20-26 for Digital Sight DS-U3 Camera Controller 8. AC Adapter 9. DS-L3 Deluxe Support Kit 10. 0.7x C-Mount Relay Lens 11. ECLIPSE NI-E MAIN BODY upgrade, which will need the following components: NI-CTLA CONTROL BOX A, Ni-LH Precentered Lamphouse for Ni Microscope 12 Volt 100 Watt NI-CH CONDENSER HOLDER, NI-CUD Universal Condenser Dry, NI-SS SUBSTAGE, NI-ND6-I INTELLI DIC SEXTUPLE NOSEPIECE, USB 2.0 Cable A-B 15 foot, Required for DS-U2 Controller, NIE-CAM CONTACT ARM, CFI60 Plan Apochromat Lambda 100x Oil Immersion Objective Lens, N.A. 1.45, W.D. 0.13mm, F.O.V. 25mm, DIC" and CFI60 Plan Apochromat Lambda 60x Oil Immersion Objective Lens, N.A. 1.4, W.D. 0.13mm, F.O.V. 25mm, DIC" Installation, Training and Additional System Requirements. The contractor shall provide in-side delivery, installation and operator familiarization training for the system. The contractor shall provide a minimum of one (1) day of on-site training (in addition to installation of the system) to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements. Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA's stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include trouble-shooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of 1-year. FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery/installation date is within 120 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 10903 New Hampshire Ave, building 52, Room 3134, Silver Spring, MD 20993. Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum brand name or equal technical requirements. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. 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, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm); • Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. • Information on available service/maintenance plans. • Three (3) years of past performance information for the manufacture and/or sale and maintenance support in which the offeror has provided same or substantially similar system solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, 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. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement. • Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. • If a large business, identify the subcontracting opportunities that would exist for small business concerns; • Standard commercial warranty and payment terms; and • Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. 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. Interested Parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before August 29, 2016 by 09:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1165663. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source 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 pre-solicitation synopsis and solicitation may be published in 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1165663/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04233841-W 20160824/160822234425-f8fad37f96f7a9899d81b16e61d0d139 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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