This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the procedures of FAR Part 12-Acquisition of Commercial Items. This requirement is being solicited under unrestricted full and open competition, using the Simplified Acquisition Procedures of FAR Subpart 13.5 and is issued as a request for quotation (RFQ). The government is not obligated to make an award. The Government is not obligated to pay costs incurred by the Contractor during quote preparation and quote submission.
Background:
The Center for Tobacco Product (CTP) Tobacco Products Laboratory (TPL) located in Atlanta, Georgia has a requirement for a preventative maintenance agreement/operational qualification for two Agilent 1200 HPLC/UHPLC instruments (1260 Infinity II, 1290 Infinity II, and 1260 System Enhanced). The instruments are integral components that support the Food and Drug Administration (FDA) Office of Chief Scientist (OCS) 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 FDA regulatory jurisdiction and to establish expertise in the analyses of tobacco products.
Preventive Maintenance and Repair Services Minimum Performance Requirements:
1. The Contractor shall provide at least one (1) preventative maintenance inspection (PMI) service visit during each 12-month period of performance, which accounts for all instruments.
2. The Maintenance and Repair activities shall be performed by qualified service engineers. The service provider should follow the OEM specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc. The Contractor shall provide documentation that the system is functioning according to the OEM’s specifications.
3. The Contractor shall only employ tools, parts, instruments, test apparatus, methodologies, techniques, and practices approved for use by the OEM with the OEM instruments specified in this contract.
4. The Contractor shall include software and firmware updates required during on-site instrument repair and instrument’s performance check during preventive maintenance during the coverage period(s).
5. The Contractor shall provide factory-certified replacement parts.
6. The Contractor shall provide unlimited telephone and email access to instrument technical support, Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Eastern Time.
7. All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. for the system.
Deliverables: Service 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 and Contract Specialist, not later than 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.
Place of Performance:
Food and Drug Administration
Tobacco Products Laboratory
60 Eighth Street NE
Atlanta, GA 30309
Period of Performance:
12 consecutive months commencing upon date of Award.
Please see the attached Statement of Work and corresponding justification for reference/utilization. Quotes are due by email on or before September 4, 2025, by 4:00 P.M. (Eastern Standard Time) and should be sent to brandon.rafus@fda.hhs.gov.
