SOURCES SOUGHT
66 -- Stainless Steel (SS) Exposure Modules to hold twelve (12) inserts for 12-well plates
- Notice Date
- 2/8/2013
- 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
- FDA1114878
- Archive Date
- 2/24/2013
- 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 and Research (NCTR) requirement for Stainless Steel (SS) Exposure Modules to hold twelve (12) inserts for 12-well plates. The FDA is seeking business sources 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, including total small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, 8(a) certified companies. 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 FDA/NCTR requires (SS) Exposure Module to hold twelve (12) inserts for 12-well plates for exposing the 3D human bronchial airway culture model to tobacco smoke with options to purchase additional quantities. The FDA Center for Tobacco Products (CTP)-sponsored 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. 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. • Module must have at least 12 places for 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 options for 24-well sized inserts; • Module shall hold 30-40ml of media for each of the 12 12-well plate culture inserts. • Module must be compatible with a Jaeger-Baumgartner 30-Port Cigarette Smoking Machine; • Exposure of cultures must take place at the air/liquid interface for realistic assessment of smoke constituents; • The tobacco generated smoke must be diluted with clean air dynamically for dose-response measurements in a freely defined dilution range of 0.1 - 15 liter air/min; from tobacco generated smoke in a freely defined dilution range of 0.1-15 liter air/min. Allow dose regulation via dilution, exposure time and/or flow rate. • 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 must have an integrated heating to maintain the ideal temperature consistent with the culture of the cells or bacteria (must not require an incubator to maintain the temperature); • Exposure system shall be airtight with a Borgwaldt leak tester drop rate maximum of 15 mm/min; • Smoke exposure must be compatible with any standard smoking regimen (ISO 3308 specification, FTC (Federal Trade Commission cigarette test method) and CIR (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., must be capable of 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 either static, intermittent or continuous; • Calibration valves required for the system; • Dilution system. The tobacco generated smoke must be diluted with clean air dynamically for dose-response measurements in a freely defined dilution range of 0.1 - 15 liter air/min • Humidification station which includes a covered water bath, pressure regulator, safety release valve, permeation unit, liquid separator, heated probe, relative humidity and temperature monitoring instrument, rotameter for bypass function, and all connectors required to connect the humidification station to the stainless steel modules and accessories. • Microbalance and microbalance controller. Exposure system shall have the option to measure the dose online in real time using a quartz crystal microbalance which can be set instead of a culture insert/petri dish; this feature must be possible with each single compartment for cell culture insert/petri dish • 24-well adaptor inserts which gives the unit the ability for 24-well plates. • Exposure system shall have the option to connect an inline Photometer for dose control online in real time; this feature shall be possible with each single compartment for cell culture insert. Mass flow controller 0-10L/min; • Phone and email technical support shall be included for a minimum of 1-year. • Installation of exposure system, installation materials, and two (2) days on-site training. • Service Agreement to include complete exposure system with one scheduled preventative maintenance visit per contract year. Place of Performance 3900 NCTR Road Building 15, Room 104 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 meet or exceed above specifications. 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. • Three (3) years of past performance information for the manufacture and/or sale of same or substantially similar items to include 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. • Information on multiple types of service agreements plans available. • Applicability of the Service Contract Act (SCA) as it relates to the exposure system service agreement. Provide information that the service it will propose to fulfill this requirement is exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 (52.212-3(k) (1)) & FAR 22.1003-4(c) or is not exempt. • 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; 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 February 22, 2013 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email nick.sartain@fda.hhs.gov. Reference FDA1114878. 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/FDA1114878/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Building 15, Room 104, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN02982992-W 20130210/130208235012-2217aa87711adf6aaa9c10d863166d68 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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