SOURCES SOUGHT
66 -- 12-Well Stainless Steel Exposure Modules for Tobacco Smoke
- Notice Date
- 10/31/2014
- 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
- FDA1142428
- Archive Date
- 11/29/2014
- 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 Stainless Steel (SS) Exposure Modules to hold twelve (12) inserts for 12-well plates. 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 up to two (2) Stainless Steel (SS) Exposure Modules to hold twelve (12) inserts for 12-well plates to serve the tobacco research needs of the NCTR and collaborative research with the FDA's Center for Tobacco Products (CTP). The modules will be used for exposing the 3D human bronchial airway culture model to tobacco smoke. The project involves exposing Ames test bacteria cultures, and cell cultures used in the Micronucleus (MN) assay, Mouse Lymphoma assay (MLA) and a 3D human airway model to tobacco smoke generated by a Jaeger-Baumgartner 30-port Cigarette Smoking Machine. The exposure modules shall be compatible with the Jaeger-Baumgartner 30-Port Cigarette Smoking Machine. 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, and will provide the FDA/CTP with data regarding the relative toxic and genotoxic potency of tobacco products. The exposure modules shall be used to validate the whole smoke experiment and optimize the in vitro studies of whole smoke or gas mixtures. The cells will be cultured in 12-well inserts and then get consistent exposure using the exposure modules specified herein. The project involves exposing human cell cultures used in the cytotoxicity assay to tobacco smoke generated by a Jaeger-Baumgartner 30-port Cigarette Smoking Machine. The exposure modules shall be compatible with the Jaeger-Baumgartner 30-Port Cigarette Smoking Machine. 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, and will provide the FDA/CTP with data regarding the relative toxic and biomarkers of harm for tobacco products. Performance requirements General specifications: The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration. Modules shall be compatible with a Jaeger-Baumgartner 30-Port Cigarette Smoking Machine. The modules shall be compatible with existing Vitrocell vacuum pump, clean air distribution system, humidification station, water bath with pumping function, mass flow meter for vacuum flow and mass flow meter for dilution air. Stainless steel exposure modules shall have at least 12 places to hold 12-well plate culture inserts that are commercially available. Module shall be compatible with the existing inserts that the Government is currently using (Corning PET Membrane Transwell Clear inserts catalog 3470, 3460 and 3450 and Greiner Bio-One ThinCert Cell Culture Inserts catalog 657-641, 665-641 and 662-641; • Stainless steel exposure modules shall have at least 12 places to hold 12-well plate culture inserts that are commercially available. Module shall be compatible with the existing inserts that the Government is currently using (Corning PET Membrane Transwell Clear inserts catalog 3470, 3460 and 3450 and Greiner Bio-One ThinCert Cell Culture Inserts catalog 657-641, 665-641 and 662-641; • Module shall hold 12-well plate culture inserts and have optional adapters for 24-well sized inserts; • Module shall hold 30-40ml of media for each of the 12 12-well plate culture inserts. • Module shall be compatible with a Jaeger-Baumgartner 30-Port Cigarette Smoking Machine; • Exposure of cultures shall take place at the air/liquid interface for realistic assessment of smoke constituents; • The tobacco generated smoke shall be diluted with clean air dynamically for dose-response measurements in a freely defined dilution range of 0.1 - 15 liter air/min; • The tobacco generated smoke shall be delivered to each compartment for cells or bacteria with a controlled flow rate ranging from 2- 150 mL/min; • Stainless steel non-stick surface module inlets for controlled flow and good distribution/deposition with exposures to volatile liquids and gases: • System shall have an integrated heating to maintain the ideal temperature consistent with the culture of the cells or bacteria; • Exposure system shall be airtight with a Borgwaldt leak tester drop rate maximum of 15 mm/min; • Smoke exposure shall be compatible with any standard smoking regimen (ISO 3308 specification, Federal Trade Commission cigarette test method and Canadian Intense Regime) as well as user-defined protocols, and real human pattern smoking conditions and have a clean air phase where all smoke from one puff is evacuated by clean air before the next fresh puff arrives in order to simulate the human smoking behavior; • Module which is in contact with media, cells, bacteria, etc., shall be capable of withstanding standard autoclavable procedures (i.e. at 121 °C for 20 min); • Module shall allow dose regulation via dilution, exposure time and/or flow Rate; • Module shall allow the culture medium supply to be static, intermittent or continuous; • Calibration valves required for the system shall be included with module; • Exposure system shall be capable/compatible to measure dose online in real time using an existing quartz crystal microbalance. • Exposure system shall be expandable to connect an inline photometer for dose control online in real time. • Tobacco smoke distribution system for 12-well SS exposure modules delivering smoke to the 12 inserts in the module at specific programmable concentrations. 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 one (1) day of on-site training 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. Post-Warranty Service Agreement (preventive 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 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. Delivery/installation date is within 160 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 November 14, 2014 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 FDA1142428. 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/FDA1142428/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN03563623-W 20141102/141031234346-d76d03222e137c4170269c304e29d2bd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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