Description
Background The Food and Drug Administration (FDA) Center for Tobacco Products (CTP) is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009. This law commonly called the Tobacco Control Act gives CTP broad authority to regulate the manufacturing, distribution, and marketing of tobacco products. Purpose The Forensic Chemistry Center (FCC) requires an Electronic Cigarette (E-Cigarette) smoking machine that can automatically smoke at least (8) electronic cigarettes simultaneously and collect the vapors on filter pads and impinger systems for offline chemical analysis. Additionally, this system will be used for joint studies with Southeast Tobacco Laboratory (STL). Scope The Contractor shall provide an instrument that can perform as specified in the Statement of Work: Salient Characteristics The following are the minimum salient characteristics that the instrument shall have: The smoking machine shall run on 110-120 VAC electrical supply. The smoking machine shall be able to hold at least 8 electronic cigarettes simultaneously during operation. The smoking machine shall allow for the devices to be held and smoked at an adjustable downward angle of at least negative forty-five degrees (-45°). This is to allow for the devices to be positioned downward, so the internal heating mechanisms of the E-Cigarettes remain in contact with the liquids in the devices. The smoking machine shall have a mechanism to depress or actuate a button on an electronic cigarette so that the electronic cigarette will operate unattended. The smoking machine shall have a mechanism to balance or hold large electronic cigarettes with a diameter up to 33 millimeters (mm) and length up to 200 mm. The smoking machine shall be supplied with one (1) set of eight (8) Cambridge Filter Pad (CFP) holders each equipped with a standard round device holder and labyrinth seals for 7.50 – 9.00 mm devices. The smoking machine shall be supplied with an additional one (1) set of eight (8) filter pad holders each equipped with an oval device holder and the following labyrinth seals to accommodate a range of device sizes: 8-10 x 3-4 mm 10-12 x 3-4 mm 8-10 x 4-5 mm 10-12 x 4-5 mm 8-10 x 5-6 mm 10-12 x 5-6 mm The smoking machine shall accommodate dual glass or Teflon impingers at each electronic cigarette position so that vapors can be collected in the impingers for offline chemical analysis. The smoking machine shall be supplied with dual glass or Teflon impingers for each electronic cigarette position (total of 16 impingers). All required connectors, support racks, tubing, etc., shall be supplied with the impingers so they can be connected to the smoking machine. The smoking machine shall be controlled through an interface that allows the user to select different puff profiles, puff durations, puff volumes and puff numbers. Trade and Service Specifications The instrument shall be a newly manufactured unit and, not used and refurbished or previously used for demonstration. Equipment shall have at least a minimum one (1) year OEM-warranty for parts and labor. Equipment shall be delivered with all necessary supplies and accessories required for installation and start-up. Contractor shall install and perform installation and operation qualification (IQ/OQ) and include all supplies needed to perform the IQ/OQ. Contractor shall provide at least 1 full day of onsite training for up to 4 analysts. Training will be provided at time of installation or shortly thereafter (within 30 days), such that operators may independently operate the instrument and with increased familiarity and proficiency. FOB Point destination to include inside delivery and clean-up of area after installation. The shipping and handling price must include the removal of the crates from the delivery truck to the receiving area at FCC and removal of any wooden pallets and or crates once installation is completed. Preventative Maintenance - Repair Service – Operation Qualification The contractor shall provide full coverage of parts, labor and travel for all repairs within any restrictions stated in the warranty. The Contractor shall make arrangement for the fastest delivery and will resume work upon receipt of parts within 72 business hours (3 days) or a mutually agreed upon timeframe. All parts replaced shall be new replacement parts which meet the original manufacturer’s specifications. Service Calls The Contractor shall respond within 2 business days after receipt of a service call. The Contractor shall provide unlimited telephone and email access to instrument technical support Monday – Friday between the hours of 9-5 p.m. EST. All repairs must result in the instrument(s) serviced meeting the manufacturer specifications and must use factory new replacement parts. Any parts or components removed for replacement shall become the property of the Contractor unless otherwise agreed to by the parties. The Contractor shall remove the parts from the site at the time of the service call or provide shipping instructions and return shipping information that the FDA may return the parts to the Contractor at the Contractor’s cost within 3 days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments. The Contractor shall perform a diagnostic test results or narrative summary demonstrating that the instrument is meeting the manufacturer’s specifications Service Conditions To the maximum extent practicable, service must be rendered on-site at the FDA. In the event a part needs to be repaired off-site, the Contractor shall be responsible for all packaging, shipping, and transportation costs as well as liability for the shipment to and from the FDA, 6751 Steger Dr, Cincinnati, OH 45237. The Contractor shall be responsible for providing a “Return Authorization Number” or other information authorizing return of the shipment to their facility prior to the shipment. The Contractor shall also provide a shipping account number to pay for the shipment. The Contractor shall only employ tools, parts, instruments, test apparatus, methodologies, techniques, and practices approved for use by the manufacturer. Deliverables Deliverable Quantity Delivery Date E-Cigarette Smoking Machine and all required accessories to install the system 1 1 August 2021 Installation and Operational Qualification of E-Cigarette Smoking Machine 1 1 September 2021 Familiarization Training 1 Concurrent with IQ/OQ (1 September 2021) Service Reports Varies NLT 5th work day following the end of each month during any months which work is performed on the instrument. Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment 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. Packing, Marking and Shipping All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. All packing material shall be removed from the FDA premise by the Contractor. Shipping Destination/Place of Performance Satisfactory performance of this contract shall be deemed to occur upon delivery, installation, training, and performance of services described above or upon acceptance by the Contracting Officer, or the COR, of these products/services. Deliveries required by the contractor shall be made F.O.B. destination within 60 days from receipt of the award of order to the address listed below: Food and Drug Administration (FDA) Forensic Chemistry Center (FCC) 6751 Steger Dr Cincinnati, OH 45237 POC: TBD Period of Performance The period of performance shall be for a base period of one year starting from the date the instrument is accepted by the government.