SOURCES SOUGHT
66 -- Cigarette Smoking Machine
- Notice Date
- 3/15/2016
- 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 - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1163703
- Archive Date
- 4/14/2016
- 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 cigarette smoking machine to evaluate the toxicity and inflammation produced by cigarette smoke using human in vitro airway models. 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), has a collaborative research project with the Center for Tobacco Products (CTP) to conduct toxicity evaluation of whole smoke generated from a variety of tobacco products using several machine smoking regimens (e.g., ISO regimen and Canadian Intense regimen) in airway in vitro tissue models (project No. E07549.01). Such collaborative work will generate scientific evidence that support the regulatory mission of CTP using the toxicology expertise and facilities at NCTR. Generating whole smoke aerosols from conventional burning cigarettes for exposing cells in vitro or animals in vivo requires using a specialized smoking robot. The smoking machine will be the core equipment in this joint study and the performance of the smoking machine is crucial for the success of this project. The NCTR has not determined yet whether it will purchase the smoke machine, lease or lease to own. Study design for in vitro smoke exposure at the air-liquid-interface To better mimic the human puffing pattern, NCTR propose to expose airway air-liquid-interface cultures to diluted whole smoke in an intermittent manner. Up to five cigarettes for each dose will be smoked one at a time. Concentrated smoke from one cigarette will be delivered to a dilution system interfaced with Vitrocell® Exposure Modules and diluted with clean air, and then will be drawn to the air-liquid interface of the cultures by a vacuum pump. In this way, cells will be exposed to various dilutions of whole cigarette smoke produced once every 60 s (for the ISO smoking protocol) or 30 s (for CI machine smoking regimen), with up to 5 cigarette-equivalents of smoke being used to expose cultures for each run. Preliminary dose-range finding studies will expose the cultures to 9%, 20%, and 34% of whole cigarette smoke using the smoking protocols mentioned above every day for 5 days. Changes in cytotoxicity, tissue integrity, cilia beating frequency, mucin secretion, and cytokine secretion will be measured after 1, 3, and 5 exposures. The test doses and treatment durations will be further adjusted based on the responses measured with these endpoints. Should changes in the frequency of smoke delivered to the cells be deemed necessary, the smoking machine will be programmed to smoke more than 1 cigarette at the same dose at a time, resulting in higher rates of smoke delivery. 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 (115 V or 208 V, 60 Hz). - The engineering of the smoking machine shall be in compliance with ISO3308:2012 Routine analytical cigarette-smoking machine; ISO3308-specified parts shall be provided by the manufacturer; - The Contractor shall include information demonstrating the compatibility of the smoking machine with the commercially available Vitrocell® in vitro cell exposure modules; - The smoking machine shall be operated in a rotary fashion; - The smoking machine shall automatically load, light, and extract cigarettes; - The smoking machine shall have at least 2 syringe drives with pinch valves; - The valves of the syringe drive shall not be in direct contact with mainstream smoke for easy cleaning and switching between tobacco products; - The leakage rate of the smoking robot shall be in compliance with the ISO3008 and no more than 5 millimeters/minute; - The smoking machine shall be capable of adjusting the air flow rate in accordance with the ISO3308; - The smoking machine shall operate without consuming a large quantity of oil-free compressed air. Machine shall use compressed air commercially available in cylinder/tanks; - Regarding the source of compressed air for the tobacco smoke generating machines, the requirements for the compressed air source shall be specified by the contractor in order to properly determine the compressed air requirements in each room; - If the tobacco smoke generating machine requires fume extraction for operation, the requirements for the exhaust shall be specified by the Contractor in order to properly determine the requirements in the smoking lab; - The smoking machine shall NOT include any piston dilution for the whole smoke; - The smoking machine shall be equipped with a cigarette feeder having the capacity of holding more than 200 cigarettes for the smoking machine to load into the carousal for extended exposure runs; - The smoking machine shall have no less than 10 cigarette positions on the cigarette carousal; - The smoking machine shall have the capability of smoking 1 cigarette at a time or up to 10 cigarettes in series; - The smoking machine shall be equipped with a butt length sensor and be able to be operated under both puff count mode or butt length mode; - The smoking machine shall be able to smoke cigarettes using either bell-shaped or square-shaped puffs; - The smoking machine shall be able to smoke cigarettes using partial puffs at the accuracy of 0.1 puff (10% of a whole puff); - Each smoking machine shall be designed with the capability of delivering intact whole mainstream cigarettes smoke (i.e., gas phase and particulate phase) as it is generated; - The smoking machine shall have at least 10 individual exhaust lines for delivering whole smoke to the exposure system; - The dead space within the smoking machine shall be as small as possible, e.g., less than 10 mL; - The smoking machine shall be able to deliver whole smoke to the piston pump with minimum total particulate matter (TPM) loss; - The smoking machine shall be capable of operating under the ISO, Canadian Intense (CI), and Massachusetts regimens or under a user-defined machine smoking regimen without additional upgrades; - The smoking machine shall be capable of delivering whole smoke at higher frequencies than ISO and CI by smoking different cigarettes consecutively; - The smoking machine shall be able to be connected to an external human puff profiler and capable of smoking the recorded human puff profiles; - The Contractor shall provide cigarette holders for all commercially available cigarette sizes (i.e., length and diameter). The smoking machine also shall have the capability of smoking other smoked tobacco products, such as e-cigarettes, small cigars, etc.; - The smoking machine shall have a position for holding in-line Cambridge filter holders for TPM collection; - The smoking machine shall be operated using software that is capable of recording the operational data (number of cigarettes smoked, puff counts, start/end time of an experiment); - The smoking machine shall be capable of storing an unlimited number of standard or user-defined smoking recipes; - Operational information stored on the computer shall be able to be exported in the Excel format; - Any computer components, whether it be hardware or software or an actual computer that is required to perform the functions of the smoking machine, shall be included with the machine and listed as line items on the quote; - The Contractor shall supply, with the quote, information regarding installation requirements, including unit footprint, electrical, air supply, and smoke extraction requirements; - The Contractor shall provide Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) data on the smoking machine delivered, including measurements of TPM and CO as the testing parameters; - The Contractor shall supply information on chemical and solvent compatibility for the parts of the smoking machine that may come in contact with the test articles. Specifically, the Contractor will provide documentation on preferred cleaning procedures for the equipment following the use of the test articles and provide information regarding the compatibility of the components to detergents and solvents that may be used in the cleaning process; - This purchase will be dependent on the availability of funds. Installation, Training and Additional System Requirements. The contractor shall provide inside delivery, installation and operator familiarization training for each system. The contractor shall provide two (2) days of on-site training (in addition to installation of the system) for up to six personnel to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements. The contractor shall provide all installation materials. The US Government is responsible for room preparations for the installation of the equipment. Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and components/materials 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. The contractor shall provide warranty and maintenance service response time during warranty period. Post-Warranty Preventative Maintenance Agreement shall, at a minimum, include the following - Minimum of two (2) planned preventative maintenance visits 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); - One emergency service repair visit including all parts, labor and travel. - 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. FOB Point Destination. All items shall include shipping, handling, any import or custom fees and in-side delivery to the destination identified herein. Delivery/installation date is within 180 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 March 30, 2016 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 FDA1163703. 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/FDA1163703/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN04050547-W 20160317/160315234832-84303247bc9ab51bbd57e90dea934431 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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