Description

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA) is conducting market research to support the Office of the Chief Scientist (OCS), requirement for Preventive Maintenance and Repair Service Agreement for multiple types of Waters instrument systems identified herein. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required supplies. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort. The associated North American Industry Classification System (NAICS) Code is- 811210 - Electronic and Precision Equipment Repair and Maintenance; the applicable Small Business Size Standard is $34 million. Statement of Work Purpose: The purpose of this requirement is to obtain preventive maintenance, repair services, and related service agreement coverage for three (3) Waters Acquity H-Class systems, three (3) Waters Acquity Classic systems, seven (7) Waters Arc systems, one (1) Waters Alliance system used for the certification of color additives, and twenty (20) Waters Empower software licenses. Background: The U.S. Food and Drug Administration (FDA) enforces the Federal Food, Drug, and Cosmetic Act and other applicable laws and regulations intended to protect consumers' health and safety. FDA's Color Certification Program assures the safe use of certified color additives (synthetic dyes and pigments) in foods, drugs, cosmetics, and certain medical devices. Certified color additives are listed in 21 CFR Parts 74 and 82 together with specifications for their impurities. High-performance liquid chromatography (HPLC) is the primary technique used by certification chemists to determine levels of subsidiary colors, intermediates, and related impurities, which range from a few percentage points to nanograms per gram. Reliable and timely maintenance and repair of the HPLC instrument systems is critical to the successful performance of FDA's Color Certification Program. It is therefore important that these instruments be placed under a service contract. See attachment 1 for list of instruments to be covered. A service contract (Order No. 75F40121F80010) was previously in place for the preventive maintenance and repair of Waters instruments used for the certification of color additives. That contract ended on December 7, 2024 and the instruments have been without active service contract since that time. This service contract was discontinued due to lack of funds. This requirement is to reestablish service for the Division of Color Certification and Technology's HPLC instruments. For purposes of this requirement, line item references herein are notional. If a future solicitation is issued, it is anticipated that Line Item 1 would be the base service agreem…

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• Attachment 1