CO Monitor and Side Stream Smoke Exposure Chamber
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 one (1) Carbon Monoxide (CO) Monitor and one (1) Side Stream Smoke Exposure Chamber.
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) requires one (1) Carbon Monoxide (CO) Monitor and one (1) Side Stream Smoke Exposure Chamber that must be compatible with existing Jaeger-Baumgartner 30-port Cigarette Smoking Machine and Vitrocell Systems exposure modules which are set-up for exposing a variety of cell types in addition to a variety of exposure plates (35mm petri dishes, 6-well inserts, 12-well inserts and ALI 3D bronchial cultures. The CO monitor and smoke exposure chamber will serve the tobacco research needs of the NCTR. Options will include the purchase of additional quantities and a post-warranty preventative maintenance agreement.
Performance requirements
General specifications:
The CO monitor and side stream smoke exposure chamber will support projects involving exposing a variety of cell culture types used in genetic cytotoxicity assays to evaluate tobacco smoke generated by a Jaeger-Baumgartner 30-port Cigarette Smoking Machine. The CO monitor and side stream smoke exposure chamber shall be compatible with a Jaeger-Baumgartner 30-Port Cigarette Smoking Machine and Vitrocell Exposure modules currently in use on these projects. 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 whole tobacco smoke, 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 whole cigarette smoke, monitor in real time the CO level and will provide the FDA's Center for Tobacco Products (CTP) with data regarding the relative toxicity and biomarkers of harm for tobacco products.
The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration.
CO Monitor:
- Must connect "in-line" to Vitrocell Systems Distribution System. In-line is required because as the smoke comes out of the smoking machines directly into the Vitrocell exposure modules the CO level must be monitored at time of exposure.
- Compatible with existing Vitrocell Systems vacuum pumps, clean air distribution systems, water bath, calibration valves, mass flow meter for vacuum flow and mass flow meter for dilution air system.
- Shall sample air for CO content at the exit of the Vitrocell Dilution System.
- Minimum sampling gas flow of 0.3L/min.
- Shall have 4 CO cannel measurements with range 1:0-5,000ppm; range 2: 0-10,000 ppm; Range 3: 0-15,000 ppm and Range 4: 0-20,000 ppm.
- Shall be capable of manual and automatic range switching.
Smoke Exposure Chamber:
- Shall be compatible with Vitrocell Systems exposure modules, data
collection systems and allow set-up for exposing a variety of cell types in addition to a variety of exposure plates (35mm petri dishes, 6-well inserts, 12-well inserts, and ALI 3D bronchial cultures).
- side stream smoke inflow must have bypass
- Shall have an exhaust system
- Capability to mix and dilute the side stream smoke with clean air
- Ventilation/mixing system for homogenization
- Heating capability up to 40°C I 102°F
- At least 4 exposure probes (positions)
- Mount on a wheeled cart or other apparatus for easy transport
- Capability to install photometer dosimetry equipment to monitor smoke concentration level.
Installation, Training and Additional System Requirements.
The contractor will be required to provide in-side delivery, installation and one (1) day of on-site operator familiarization training for each item.
Offered items shall be turn-key solutions, i.e. the contractor shall be responsible for providing all hardware, components, cables, connectors, instruments, computers, software, and that otherwise required to meet these specifications and the FDA's stated need. The items shall be delivered (in-side delivery) with all necessary supplies and accessories required for installation and start-up.
Items shall be warranted for not less than one (1) year from FDA acceptance to include on-site training. Warranty service shall include trouble-shooting capabilities based on complete knowledge of the items, and immediate access to replacement parts.
Post-Warranty Service Agreement (preventive and corrective maintenance) 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 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.
- 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.
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 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 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 14, 2014 by 13:00 hours (Central Time in Jefferson, Arkansas) to [email protected], 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 FDA1135023.
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).
Nicholas E Sartain, Contract Specialist, Phone 870-543-7370, Email [email protected]
