SOURCES SOUGHT
66 -- High Temp Spiking System
- Notice Date
- 2/18/2016
- 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 - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA-1162607
- Archive Date
- 3/19/2016
- 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 National Center for Toxicological Research (NCTR) requirement for a high temp spiking system to expose 3D tissue culture model to liquids with low vapor pressures. 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-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Genetic and Molecular Toxicology (DGMT) has a collaborative research project involving liquids with low vapor pressures. DGMT requires equipment that is able to aerosolize compounds such as aldehydes and benzene. The compounds need to be heated to a vapor so the cell cultures can be exposed to the vapor thus the need for a high temp spiking system. The equipment/system must also be capable to be used with gases. The project involves exposing human cells in ALI cultures used in the cytotoxicity assays to aerosol nanoparticles. This equipment will be used to conduct the studies outlined above to provide needed data to determine the risks associated with exposure to specific levels of nanoparticles, thus filling in data-gaps that exist in risk assessment models. In addition, the equipment will allow the FDA to be able to quantify the toxicity of nanoparticles, and will provide the FDA with data regarding the relative toxic and biomarkers of harm for FDA regulated nanoparticles. Annual quantities are estimates only, more or less quantities may be ordered as needed. A Firm Fixed-Price Indefinite Delivery, Requirements contract is anticipated. Performance requirements General specifications: The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration. All electrical components shall be US standard plugs and voltages (115V, 60 Hz). • Spiking System shall heat to a minimal of 400o C and supply gas/vapor mixtures in a ppm/ppb range. • Spiking System shall come as a turnkey item including all necessary parts to function including a controller, syringe drive, heated injector, heated injection line, mass flow control system, stainless steel dilution system, heated lines/tubing, stainless steel tubing, stainless steel injection spiral, and any other required accessory. • Spiking system shall have a humidification station that provides a pressure regulator with safety valve, liquid separator, water bath with cover, a heated probe, instrument panel for monitoring relative humidity and temperature, a rotameter for bypass function, and all connectors must be provided. • module must have at least 48 places for 24-well (6.5mm) sized cell culture inserts that are currently commercially. • Module shall have electronic heating system; • Module shall have an aerosol exposure top with 48 individual inlets to allow 7 doses with 6 replicates; • Modules shall come with the required vacuum calibration valves, all required tubing and distribution line/tubing/materials; • module shall be made of medical grade stainless steel; • module which is in contact with media, cells, bacteria, etc. shall be autoclavable at 121°C for 20 min; • module shall allow dose regulation via dilution, exposure time and/or flow rate; • module shall have condensation-free operation, 2 shell housing, 2 heating systems, 2 sensors for heating monitoring, and software for read-out of sensor data to computer • module shall allow the culture medium supply to be static • exposure of cultures shall take place at the air/liquid interface for realistic assessment of exposure particles • dilution system must be made of medical grade stainless steel and have a rack system with locking device • shall provide a mass flow controller with a dynamic range of 2 x 5 and 2 x10L/min; • shall provide a mass flow controller with a dynamic range of 1 x 1 and 3 x 2 L/min • shall include a high performance water bath with pumping function and a cover • system shall include a second heating unit with base plate for heating the 24/48 module; • all electrical components will be US plugs 115V 60hz; • module shall have a vacuum pump, clean air distribution system, humidification station, water bath with pumping function, calibration valves, mass flow meter for vacuum flow, and mass flow meter for dilution air system • system shall have an integrated heating system to maintain the ideal temperature consistent with the culture of the cells or bacteria (must not require an incubator to maintain the temperature. • System shall include a vacuum pump with minimal performance of 2 m3/h; • Rack / Cart System: • Stainless Steel cart on casters that shall hold all items in solicitation and shall be capable of supporting the weight of all of the items. Cart shall be capable of being rolled from room to room. Installation, Training and Additional System Requirements. The contractor shall provide in-side delivery, installation and operator familiarization training for each system. The contractor shall provide two (2) 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. Contractor shall provide all installation materials. 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. Post-Warranty Preventative Maintenance Agreement shall, at a minimum, include the following - Minimum of one (1) planned preventative maintenance visit per contract period. - Unlimited phone and email support during the contractor's normal operating hours. - Preventative maintenance shall include all labor, travel, and parts (except consumables); - Performance by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. - Access by the FDA Contracting Officer's Representative (COR) and system operator personnel to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. - System software and firmware updates required for reliability improvements and correction of any defects; - Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer 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. FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery/installation date is within 180 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 3900 NCTR Road, Jefferson, AR 72079. 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. • 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 March 4, 2016 by 13:00 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 FDA1162607. 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/FDA-1162607/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN04023668-W 20160220/160218234630-38a25543c170de7c3f6cb89d8acd7633 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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