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FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 24, 2015 FBO #4809
SOURCES SOUGHT

66 -- Exposure Modules for Aerosol Nanoparticle Cell Cultures

Notice Date

1/22/2015
 

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

FDA1142612
 

Archive Date

2/20/2015
 

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 System that is specially designed for dose-controlled and spatially uniform deposition of liquid aerosols on cells cultured at the air-liquid interface (ALI Cultures) in 12-well culture sized inserts. 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) anticipate requirements for multiple exposure modules or systems that are specially designed for dose-controlled and spatially uniform deposition of liquid aerosol nanoparticles on cells cultured at the air-liquid interface (ALI Cultures) in 12-well culture sized inserts. The Division of Genetic and Molecular Toxicology (DGMT) has several collaborative on-going research projects involving nanoparticles. The exposure modules will be used for exposing the 3D tissue culture cell models (ALI cultures) to nanoparticle aerosols that are nebulized. The research aim is to develop 3D tissue culture models to mimic human like exposures to nanoparticles. The exposures of the 3D tissue cultures to nebulized aerosol nanoparticles require the use of a highly specialized exposure module. The ALI culture models will be cultured in 12-well inserts and then get consistent exposure using the exposure modules specified herein. The project involves exposing human cell ALI cultures used in the cytotoxicity assay to nebulized 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. 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). Stainless steel exposure modules for the ALI cell culture inserts 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 (i.e. cultivation base for ALI exposures) 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; • Nebulizing Aerosol exposure capability; • Module (i.e. cultivation base for ALI exposures) shall be made of medical grade stainless steel; • Aerosol generator head with a range of 4.0-6.0 micron • Aerosol generator control unit • Housing for the exposure system • Exposure of cultures shall take place at the air/liquid interface for realistic assessment of nanoparticle exposures; • The nebulized nanoparticle aerosols shall be delivered to each compartment for ALI cultures in a dose-controlled and spatially uniform aerosol deposition • System shall have an integrated base plate with electronic heating to maintain the ideal temperature consistent with the culture of the cells or bacteria; • Aerosol nanoparticle exposure shall be applied in a short time, less than 4 minutes; • 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 the culture medium supply to be static, intermittent or continuous; • Exposure system shall be expandable to connect an inline photometer for dose control online in real time for each single compartment. Stainless Steel Dilution System: • aerosol nanoparticle distribution system for 12-well SS exposure modules delivering the aerosol to the 12 inserts in the module at specific programmable concentrations • Shall have 12 dose outlets for 9 places for exposures & 3 places for controls • Shall measure dose online in real time using a quartz crystal microbalance which can be set instead of a culture insert. Minimum resolution 10/ng/cm2 per second • Microbalance shall have separate controller computer workstation with monitor with all required connectors and software.Module shall hold 12-well plate culture inserts and have optional adapters for 24-well sized inserts. 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. 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 February 5, 2015 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 FDA1142612. 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/FDA1142612/listing.html)
 

Place of Performance

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

Zip Code: 72079
 

Record

SN03622453-W 20150124/150122235012-0caaa09a042bf3334f17441ec032b0fb (fbodaily.com)
 

Source

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

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