New Service Agreement for Milestone UltraWAVE 3 Microwave Digestion- OC-2026-134408

NOTICE OF INTENT TO SOLE SOURCE In support of Project No: OC-2026-134408 The U.S. Food and Drug Administration, Office of Acquisitions and Grants Services, Office of the Chief Scientist (OCS) intends to award a firm fixed price purchase order to Milestone, Inc, 25 Controls Drive, Shelton, CT, 06484 for the purchase of the Milestone Total-Care Service Contract, including yearly maintenance in which all valves, hoses, connections, and safety components that are in constant contact with high pressure and high temperature acid vapors are replaced proactively. All other components are thoroughly cleaned, inspected, calibrated, and tested. Batch certification of color additives is a regulatory premarket enforcement function. During the certification process, analyses are performed to determine whether each batch meets the specifications listed in the Code of Federal Regulations (CFR). Results are used to certify or reject batches of color additives intended for use in foods, drugs, and cosmetics in the U.S. The microwave digestion equipment is an UltraWAVE3 single reaction chamber (SRC) with serial number 23090033. This is the primary instrument used to prepare color additives for elemental analysis by inductively coupled plasma (ICP) mass spectrometry (MS) at the Division of Color Certification and Color Technology (DCCT). The digestion process breaks down color additives into a clear, particle-free, and acidic solution. Reliable and timely maintenance and repairs of the microwave digestion system is critical to the mission of the Color Certification Program. The UltraWAVE 3 SRC microwave digestion unit shall be maintained and repaired under the new service agreement and the service agreement shall meet or exceed the requirements/specification listed below. Service and Support: The Contractor shall provide at least one yearly preventive maintenance service. The Contractor shall provide unlimited phone support. The Contractor shall cover all travel, non-consumable parts, and labor for yearly preventive maintenance service at no additional cost to the Government. Written reports shall be provided for all on-site service work within 7 business days of completion. Repairs Repairs shall be performed on-site at CPK2 (see Section 9, Place of Performance) with parts, labor, and travel costs covered by the Contractor. Requests for repair visits are unlimited. The Contractor shall provide service and application support within 2 business days and on-site repairs within 7 business days. Repair services shall be provided by trained engineers/technicians/personnel authorized by Milestone Inc. Technical support shall be available by telephone as needed within the hours of 8 am 5 pm. If parts must be shipped, the Contractor shall provide protective packaging supplies and cover all shipping costs. If parts must be shipped, the Contractor shall cover appropriate protective packaging and shipping costs. Milestone Inc. has been identified as the sole provider for the servicing Original Equipment Manufacturer parts, technical support and contractual maintenance of the UltraWAVE 3 SRC microwave digestion unit. The sole source letter and the quote from Milestone Inc. have been attached. Consequently, this procurement is being conducted in accordance with FAR subpart 13.106-1(b)(1)(i) which allows for the Contracting Officer to solicit one source if only one source is reasonably available. The North American Industry Classification System Code (NAICS) is 423490-Other Professional Equipment and Supplies Merchant Wholesalers. The Product Service Code (PSC) is J066, Maintenance/Repair/Rebuild of Equipment- Instruments and Laboratory Equipment. This notice is being distributed through the System for Awards Management website (www.SAM.gov). As Peak Scientific is the only source that can meet the Government s need at this time, this notice is not a request for competitive quotes. However, if any interested parties, especially a small business, believes it can meet the Government s needs, it may identify their interests and/or capability in relation to this procurement to the Contracting Officer, Brandon Rafus, at brandon.rafus@fda.hhs.gov no later than 4:00 PM EST on September 8, 2026. The primary objective of this Notice of Intent is to inform potential contractors of the government's intent to proceed with a sole source procurement while providing an opportunity for other parties to demonstrate comparable capabilities. Although this is not a competitive solicitation and no formal solicitation document exists, interested parties may submit capability statements demonstrating their ability by the September 8, 2026 deadline. All capability statements must be submitted electronically via email to brandon.rafus@fda.hhs.gov in Microsoft Office Word, Excel, or Adobe PDF format. The government will consider all capability statements received by the closing date, though the final determination whether to compete the requirement remains at the government's sole discretion. This notice represents a standard pre-award transparency measure that allows the marketplace to respond before a sole source award is finalized. All responses must include the following business information: Unique Entity Identification (UEI) Number Company Name, address, primary point of contact and their email and phone number Type of company as validated in SAM.gov. All interested parties must be registered in SAM.gov to receive consideration of government contracts. Technical capability to meet the requirement need as detailed in the attached Statement of Work (SOW).