Inactive Total Small Business Set-Aside (FAR 19.5)

This is a combined synopsis/solicitation for commercial services prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional informatio... This is a combined synopsis/solicitation for commercial services 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; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-24-1272763. This solicitation is a BRAND NAME request for quote (RFQ). The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2023-06, Effective 12/04/2023. The associated North American Industry Classification System (NAICS) Code is 334516 Analytical Laboratory Instrument Manufacturing with a small business size standard of 1,000 employees. This is for a total small business set aside. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. Please submit all quotes with: a) Pricing for all line items Quotes that do not price all line items may be deemed non-responsive. 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 Center for Tobacco Product (CTP) Tobacco Products Laboratory (TPL) require a service and qualification agreement for multiple Agilent Gas Chromatograph/Mass Spectrometer Systems (GC/MS) and One (1) Agilent Gas Chromatograph-Dual Detector (FID/TCD) System. The instruments are integral components that support the Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) to meet the legislative requirements and the sample workload that are an integral part of the Agency response to the legislation. The proposed instruments are needed to develop methods for identifying and, in some cases, quantifying analytes in tobacco products under the Food and Drug Administration (FDA) regulatory jurisdiction and to establish expertise in the analyses of tobacco products. REQUIREMENTS The contractor shall provide the following for Preventative Maintenance (PM) & Repair Services: The contractor shall provide at least one (1) preventative maintenance inspection (PMI) for the instruments during the one (1) year period of performance for each instrument. A PMI shall be scheduled through communication with the FDA Project Officer or alternate. The PM shall include parts, labor and travel for remedial repair. This includes MS filaments and vacuum pump oil. The contractor under the service agreement shall repair or replace any part or parts which prove to be defective at no additional charge to the government. All parts replaced shall be new replacement parts which meet the original manufacturer’s specifications. The Contractor Officer Representative (COR) will contact the Contractor to schedule a mutually acceptable date and time for the preventive maintenance visit. All visits must be scheduled at least 7 days in advance with the COR. Documentation of preventative maintenance duties performed must be provided. (See Records and Reports section). The contractor shall provide the following for Qualification Service: The Qualification service for each system shall include OQ/IPV to be performed after the planned preventative maintenance (PM). In the event of a critical repair, the contractor shall include the following: The contractor shall provide documentation for temperature verification, calibrations, and an instrument performance run. The OQ/IPV service shall be performed by a trained and certified engineer and must provide documentation that the instrument is functioning according to the manufacturer’s specifications. The Contractor shall provide one (1) annual OQ/PV report that is equal to or exceeds the qualification requirements of the manufacturer. If at any point during the qualification and the instrument fails a test, the Contractor shall provide onsite service to remedy the failure and re-execute the qualification and must demonstrate to the COR that the instrument passed the test. If parts are needed to re-execute the OQ, the Contractor shall schedule delivery of the necessary parts and a return service visit shall occur within 48 hours. The contractor shall provide the following for 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. 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 if taking possession 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. The contractor shall provide the following for Service Conditions: To the maximum extent practicable, service shall 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 Agilent with the Agilent systems specified in this contract. Warranty All labor, replacement parts and components (excluding consumables) shall be warrantied for at least a 12-month period. Records and Reports The Contractor shall 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. INSPECTION AND ACCEPTANCE CRITERIA Inspection and acceptance shall be in accordance with the clause 52.212-4(a). The Contracting Officer’s Representative (COR) is responsible for the inspection and acceptance of the services under this requirement. CONTRACT TYPE This is a firm fixed price purchase order PERIOD OF PERFORMANCE The period of performance is for a base year with one (1) one-year option. The anticipated dates are: Base Year – April 1, 2024 to March 31, 2025. Option Year 1 - April 1, 2025, 2025 to March 31, 2026 Unless otherwise specified, the Contractor shall perform work Monday through Friday (excluding Federal Holidays) between the hours of 8:00 a.m. and 4:30 p.m. EST. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. PLACE OF PERFORMANCE Food and Drug Administration Tobacco Products Laboratory 60 Eighth Street NE Atlanta, GA 30309 PLEASE SEE ATTACHED COMBINED SYNOPSIS/SOLICITATION for ALL REQUIREMENTS.