SOURCES SOUGHT
66 -- Floor Centrifuge
- Notice Date
- 6/13/2013
- 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
- FDA1119664
- Archive Date
- 6/21/2013
- 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) high performance, high capacity refrigerated floor model centrifuge to include inside delivery, installation, set-up, and post-warranty maintenance for up to 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: Background: The Food and Drug Administration (FDA), Laboratory of DNA Viruses requires one (1) high performance, high capacity refrigerated floor model centrifuge to include inside delivery, installation, set-up, and post-warranty maintenance for up to 4 option years. This instrument is necessary for studying the oncogenicity of DNA and the tumorigenicity of cell substrates used for vaccines. As part of the studies on vaccine safety, the FDA is developing in vivo assays to detect oncogenic activity of DNA. The centrifuge will be used at several stages of these experiments. In the case of mammalian cell cultures, protein and DNA are prepared from cell lines established from tumors. To prepare plasmid DNA, bacterial cells are harvested by centrifugation, and DNA plasmids are prepared and purified for inoculation into animals. Scope: In the research, rodents are used to study the possible induction of tumors that result from their subcutaneous exposure to various cell substrates and oncogenic DNA. Tumor formation can take up to six months, and in some cases, no tumors are observed. When preparing the DNA for inoculation, the DNA goes through an extensive purification process. First, large scale bacterial cultures are spun down in 500 mL bottles to isolate the bacterial cells carrying the desired DNA plasmid. Next, the cells are transferred to 40 mL round bottom tubes and are lysed to allow for separation of the plasmid. During this step, the tubes are spun at 18,000 rpm. From this stage, the plasmids are transferred to 50 mL conical tubes and are then spun at lower speeds. Once the DNA is purified it is used, as mentioned above, in rodent models to study tumor formation. When a tumor is induced, it is excised from the animal and a cell line is created. The cell lines are then carried in cell culture. This centrifuge will be used to spin down uninfected cells and viral-infected cells from these cultures. It will also be used for the clarification of virus supernatants to prepare viral stocks for frozen storage. These cells must be spun down at low speed in a refrigerated centrifuge to maintain viability. Technical Requirements: The system: - Shall be a refrigerated floor model centrifuge with temperature ranging from -10 to +40 degrees C - Shall have a speed range of 500 rpm to 24,000 rpm - Shall not be required to be bolted to the floor - Shall have an automatic rotor locking system securing rotor to spindle and push button release of rotor after run - Shall have rotors made of carbon fiber that are lighter, have a handle to lift and carry, do not derate, and are repairable - Shall include the following 3 carbon fiber rotors: one 6x500 ml bottle fixed angle carbon fiber rotor, one 14x50 ml conical tube fixed angle carbon fiber rotor, and one 12x50 ml round bottom tube fixed angle carbon fiber rotor - Shall also include one 4x400 ml bottle stainless steel swinging bucket rotor with aluminum buckets and conical adapters - Shall have an automatic rotor recognition system and automatic data entry - Shall have a touchscreen with library of setup programs to select from, integrated calculator for protocol modifications and operator run logging with password - Shall provide all labor, travel, and tools for inside delivery, installation and set-up of centrifuge to address provided below. Once installed, equipment must be tested to verify that all aspects are operating within parameters of required specifications - Shall be covered by a two year warranty on centrifuge and rotors Post-Warranty Maintenance Agreement: The vendor shall provide post-warranty maintenance/service for up to 4 option years, each year consisting of one (1) preventive maintenance visit and on-site, unscheduled repair visits/year with all costs covered for travel, labor and non-consumable parts. All services shall be performed by a technical specialist, factory-trained and certified in Original Equipment Manufacturer (OEM) specifications. Records and Reports of Service 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 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 COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed. Security: Contractor shall pass through NIH Main Campus (Bethesda) security for access to NIH Campus and deliver to 29 Lincoln Drive, Building 29A loading dock, Bethesda, MD 20892 Place of Performance/Deliver to: U.S. Food and Drug Administration Attn: Marilyn Lundquist (301-827-0393) 29 Lincoln Drive Building 29A, Room 3D08 (via loading dock) Bethesda, MD 20892 Delivery and installation shall be closely coordinated with the COR, Marilyn Lundquist. Period of Performance: Delivery, to include inside delivery, installation, set-up, and training, shall occur within 60 days of award with up to 4 post-warranty annual 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 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 June 20, 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 #1119664 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. 1119664) 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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