This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation is being issued in conjunction with FAR PART 13. The solicitation number is FDA-22-1254104. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-04, January 30, 2022. The associated North American Industry Classification System (NAICS) Code is- 334516 – Analytical Laboratory Instrument Manufacturing. This requirement is being competed as a small business set aside, meaning any qualified vendor of that size status may submit a quote. Respondents are responsible for submitting proposal/quote and any supporting documents before 1:00 PM Eastern Time on May 9, 2022 by e-Mail to
[email protected]. For information regarding this solicitation, please contact Julia Savage by e-Mail at
[email protected]. Background: The Food and Drug Administration (FDA), Center for Tobacco Product (CTP) is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which provided FDA with regulatory authority over the manufacture, marketing, and distribution of tobacco products. The Southeast Tobacco Laboratory (STL) located in Atlanta GA has been designated as the Office of Regulatory Affairs (ORA) Tobacco Testing Laboratory to uphold the mandates of the Tobacco Act. The Center for Tobacco Products (CTP) will set the regulatory guidelines on Tobacco products and the Southeast Tobacco Laboratory (STL) is responsible for providing analytical support. Objective The Southeast Tobacco Laboratory (STL) Center for Tobacco Product (CTP) has a requirement for a closed vessel microwave digestion system that is fully compatible with an existing CEM MARS Xpress 40 position turntable and TFM (modified polytetrafluoroethylene) digestion vessels with composite sleeves. The device shall be used to digest tobacco product samples for use in spectroscopy equipment. Scope • The microwave digestion system and accessories must be fully compatible with an existing CEM MARS Xpress 40 position turntable and TFM (modified polytetrafluoroethylene) digestion vessels with composite sleeves. The microwave digestion system must provide at a minimum 1800 watts of digestion power. The Contractor shall be capable of providing an instrument that can perform as specified in the Statement of Work and provide Preventative Maintenance in accordance with the manufacturer’s specification during the contract period of performance. Salient Characteristics All the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government. • The microwave digestion system and accessories must be fully compatible with an existing CEM MARS Xpress 40 position turntable and TFM (modified polytetrafluoroethylene) digestion vessels with composite sleeves. • The microwave digestion system must provide at a minimum 1800 watts of digestion power. • The microwave digestion system must have a footprint no greater than 21” (53.3 cm) W x 25” (63.5 cm) D x 25” (63.5 cm) H. • The microwave digestion system must have an electrical requirement equivalent of 208 – 230 VAC (207 – 253 VAC), 60Hz, 15 Amp @ 208 VAC. • The microwave digestion system must have an automatic temperature sensing function for each vessel so ongoing temperature monitoring and control can occur. The microwave digestion system must have an automatic temperature sensing function The microwave digestion system must have an electronic way to create, edit and store at a minimum of five (5) preparation methods that can be recalled and used. • The microwave digestion system must include an electronic user interface for entering and retrieving methods, general system information, and system diagnostics. • The microwave digestion system must include accessories and supplies to connect the microwave exhaust to an existing fume trunk line in the lab. • The microwave digestion system must include a supply of consumables needed for the normal maintenance and cleaning that would be consumed over a year of normal expected usage. • The microwave digestion system must be operational immediately after installation. • for each vessel so ongoing temperature monitoring and control Trade and Service Specifications • The microwave digestion system must be a newly manufactured unit, not used and refurbished or previously used for demonstration. • The microwave digestion system must include a twelve (12) month standard manufacturer warranty. • The contractor must be capable of servicing the instrument through the covered warranty period and shall include at a minimum: (1) coverage on all non-consumable items and parts supplied including base instrument, factory- certified replacement parts, and engineer labor and travel costs. (2) any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access the most current OEM factory training for both hardware and software components and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments to perform maintenance and repairs. All parts used for Preventative Maintenance (PM) and repairs must be guaranteed, factory tested, OEM quality parts. • Preventative Maintenance (PM) visit shall be included for the base contract year. Each PM visit shall be inclusive of all parts, labors, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Service engineers who perform this service shall be trained by the OEM. • Contractor shall provide onsite familiarization training for 3-5 users at the time of installation or within 30 days such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training. • The Contractor shall provide Installation Qualification with an employee who can provide proof of Installation Qualification/Operation Qualification (IQ/OQ) certification. • FOB Point destination to include inside delivery and clean-up of area after installation. • Shipping and handling price must include the removal of crates from the delivery truck, including any needed forklift, to a location in storage at the installation site and removal of the wooden pallets once installation is completed. 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 at no additional charge 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, 60 8th ST.NE, Atlanta, GA. 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 Microwave Accelerated Reaction System and all required accessories to install the system 15 July 2022 Installation 22 July 2020 Familiarization Training 7 business days after installation of instrument. Service Reports Varies NLT 5th workday 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. • In addition, the Contractor shall provide monthly reports to the FDA Project Officer or TPOC, not later that the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed). Contract Type- Commercial Item - Firm fixed price with N30 payment terms Evaluation Criteria The Government will award a contract resulting from this solicitation to the responsible quoter as a fixed‐price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non‐cost factor (technical conformance to the requirements of the solicitation). The Quoter’s initial quotation shall contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award. 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, COR or TPOC of these products/services. Deliveries required by the contractor shall be made F.O.B. destination within 14-16 weeks from receipt of the award of order to the address listed below: Place of Performance Food and Drug Administration (FDA) Southeast Tobacco Lab (STL) 60 8th Street NE Atlanta, GA 30309 POC: TBD Period of Performance The period of performance shall be for a base period of one year.This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation is being issued in conjunction with FAR PART 13. The solicitation number is FDA-22-1254104. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-04, January 30, 2022. The associated North American Industry Classification System (NAICS) Code is- 334516 – Analytical Laboratory Instrument Manufacturing. This requirement is being competed as a small business set aside, meaning any qualified vendor of that size status may submit a quote. Respondents are responsible for submitting proposal/quote and any supporting documents before 1:00 PM Eastern Time on May 9, 2022 by e-Mail to
[email protected]. For information regarding this solicitation, please contact Julia Savage by e-Mail at
[email protected]. Background: The Food and Drug Administration (FDA), Center for Tobacco Product (CTP) is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which provided FDA with regulatory authority over the manufacture, marketing, and distribution of tobacco products. The Southeast Tobacco Laboratory (STL) located in Atlanta GA has been designated as the Office of Regulatory Affairs (ORA) Tobacco Testing Laboratory to uphold the mandates of the Tobacco Act. The Center for Tobacco Products (CTP) will set the regulatory guidelines on Tobacco products and the Southeast Tobacco Laboratory (STL) is responsible for providing analytical support. Objective The Southeast Tobacco Laboratory (STL) Center for Tobacco Product (CTP) has a requirement for a closed vessel microwave digestion system that is fully compatible with an existing CEM MARS Xpress 40 position turntable and TFM (modified polytetrafluoroethylene) digestion vessels with composite sleeves. The device shall be used to digest tobacco product samples for use in spectroscopy equipment. Scope • The microwave digestion system and accessories must be fully compatible with an existing CEM MARS Xpress 40 position turntable and TFM (modified polytetrafluoroethylene) digestion vessels with composite sleeves. The microwave digestion system must provide at a minimum 1800 watts of digestion power. The Contractor shall be capable of providing an instrument that can perform as specified in the Statement of Work and provide Preventative Maintenance in accordance with the manufacturer’s specification during the contract period of performance. Salient Characteristics All the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government. • The microwave digestion system and accessories must be fully compatible with an existing CEM MARS Xpress 40 position turntable and TFM (modified polytetrafluoroethylene) digestion vessels with composite sleeves. • The microwave digestion system must provide at a minimum 1800 watts of digestion power. • The microwave digestion system must have a footprint no greater than 21” (53.3 cm) W x 25” (63.5 cm) D x 25” (63.5 cm) H. • The microwave digestion system must have an electrical requirement equivalent of 208 – 230 VAC (207 – 253 VAC), 60Hz, 15 Amp @ 208 VAC. • The microwave digestion system must have an automatic temperature sensing function for each vessel so ongoing temperature monitoring and control can occur. The microwave digestion system must have an automatic temperature sensing function The microwave digestion system must have an electronic way to create, edit and store at a minimum of five (5) preparation methods that can be recalled and used. • The microwave digestion system must include an electronic user interface for entering and retrieving methods, general system information, and system diagnostics. • The microwave digestion system must include accessories and supplies to connect the microwave exhaust to an existing fume trunk line in the lab. • The microwave digestion system must include a supply of consumables needed for the normal maintenance and cleaning that would be consumed over a year of normal expected usage. • The microwave digestion system must be operational immediately after installation. • for each vessel so ongoing temperature monitoring and control Trade and Service Specifications • The microwave digestion system must be a newly manufactured unit, not used and refurbished or previously used for demonstration. • The microwave digestion system must include a twelve (12) month standard manufacturer warranty. • The contractor must be capable of servicing the instrument through the covered warranty period and shall include at a minimum: (1) coverage on all non-consumable items and parts supplied including base instrument, factory- certified replacement parts, and engineer labor and travel costs. (2) any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access the most current OEM factory training for both hardware and software components and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments to perform maintenance and repairs. All parts used for Preventative Maintenance (PM) and repairs must be guaranteed, factory tested, OEM quality parts. • Preventative Maintenance (PM) visit shall be included for the base contract year. Each PM visit shall be inclusive of all parts, labors, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Service engineers who perform this service shall be trained by the OEM. • Contractor shall provide onsite familiarization training for 3-5 users at the time of installation or within 30 days such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training. • The Contractor shall provide Installation Qualification with an employee who can provide proof of Installation Qualification/Operation Qualification (IQ/OQ) certification. • FOB Point destination to include inside delivery and clean-up of area after installation. • Shipping and handling price must include the removal of crates from the delivery truck, including any needed forklift, to a location in storage at the installation site and removal of the wooden pallets once installation is completed. 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 at no additional charge 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, 60 8th ST.NE, Atlanta, GA. 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 Microwave Accelerated Reaction System and all required accessories to install the system 15 July 2022 Installation 22 July 2020 Familiarization Training 7 business days after installation of instrument. Service Reports Varies NLT 5th workday 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. • In addition, the Contractor shall provide monthly reports to the FDA Project Officer or TPOC, not later that the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed). Contract Type- Commercial Item - Firm fixed price with N30 payment terms Evaluation Criteria The Government will award a contract resulting from this solicitation to the responsible quoter as a fixed‐price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non‐cost factor (technical conformance to the requirements of the solicitation). The Quoter’s initial quotation shall contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award. 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, COR or TPOC of these products/services. Deliveries required by the contractor shall be made F.O.B. destination within 14-16 weeks from receipt of the award of order to the address listed below: Place of Performance Food and Drug Administration (FDA) Southeast Tobacco Lab (STL) 60 8th Street NE Atlanta, GA 30309 POC: TBD Period of Performance The period of performance shall be for a base period of one year.