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FBO DAILY ISSUE OF JULY 28, 2012 FBO #3899
SOURCES SOUGHT

66 -- Stainless Stell Exposure Module to Hold Four Inserts for 6-Well Plates

Notice Date

7/26/2012
 

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, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
 

ZIP Code

72079
 

Solicitation Number

FDA1108213
 

Archive Date

8/18/2012
 

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 exposure module to hold four inserts for 6-well plates. The FDA is seeking business sources, including total small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, 8(a) certified companies and other than small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort. The government is seeking capability statements from manufacturing businesses capable of meeting the performance requirements. The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), has a requirement for one Stainless steel exposure module to hold four inserts for 6-well plates for exposing Micronucleus (MN) assay cell cultures to tobacco smoke. The exposure modules will also involve AMES Test cultures, Mouse Lymphoma assay (MLA) and a 3D human airway model to tobacco smoke. The exposure modules must be compatible with a Jaeger-Baumgartner 30-Port Cigarette Smoking Machine. The exposures of the various assays require the use of a highly specialized exposure module. Performance requirements: • Module must have at least 4 places for 6-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 6-well plate culture inserts and have options for 24-well and 12-well sized inserts; • Module shall hold 60-85ml of media for each of the 4 6-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; • 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; • 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; • Calibration valves required for the system; • Phone and email technical support shall be included for a minimum of 1-year. • Optional Items: vacuum pump, clean air distribution system, water bath with pumping function, calibration valves, mass flow meter for vacuum flow, and mass flow meter for dilution air system. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offeror is capable of providing the required products identified above. Firms believing they can meet the requirements to the above specifications are encouraged to respond electronically with no less than the following information: • 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; • Sufficient descriptive literature that unequivocally demonstrates that offered products meet the specifications. • At a minimum provide the following: All descriptive material necessary for the government to determine whether the 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. Indicate whether the organization is the manufacturer of the items or authorized reseller. If reseller, include the manufacturer's name, address and DUNS number. Provide delivery lead time for the units. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. • Provide comments on draft performance requirements if any of these specifications are too restrictive or vague. No response will be considered that the listed specifications are adequate in a competitive acquisition. • • If a large business, provide if subcontracting opportunities exist for small business concerns. • Suggestions on applicable NAICS code for this requirement. • Though this is not a request for quote, informational pricing must be submitted. If options to purchase additional units are included in a solicitation, provide what is the farthest amount of time that you can provide firm fixed prices of the units. That is how many days does the government have to exercise an option. It is estimated that additional purchases would not be made until the first quarter of 2013. The government is not responsible for locating or securing any information, not identified in the response. The associated North American Industry Classification System (NAICS) Code is- 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. Interested Contractors 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 August 3, 2012 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email nick.sartain@fda.hhs.gov. Reference FDA1108213. 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. The FDA is also conducting this market research to determine if these products are available domestically at a fair and reasonable cost to the Government. 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/FDA1108213/listing.html)
 

Place of Performance

Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States

Zip Code: 72079
 

Record

SN02816657-W 20120728/120727000240-63acd9a31b729c5ba1e744f2c78606e7 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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