Bio-Plex 3D Suspension Array System

**Amendment 001: The purpose of this amendment is to extend the due date for quotations through September 3, 2021 5:00 p.m. Eastern Standard Time. All other terms and conditions remain unchanged. ** This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-06. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION. A SEPARATE SOLICITATION DOCUMENT (I.E. STANDARD FORM) WILL NOT BE ISSUED. The solicitation number for this acquisition is RFQ-FDA-75F40121Q00143 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation: 334516 Analytical Laboratory Instrument Manufacturing. The Small Business Size Standard is 1,000 employees. This is an unrestricted full-and-open-competition BRAND-NAME ONLY acquisition. Simplified acquisition procedures will be utilized. The U. S Food & Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) requires one (1) Bio-Plex 3D Suspension Array System in accordance with the requirements identified herein. Inquires Offerors must submit all questions concerning this solicitation in writing electronically to adam.powell@fda.hhs.gov. Questions must be received no later than September 2, 2021 12:00 p.m. Eastern Standard Time. Any responses to questions will be made in writing, without identification of the questioner, and will be included in an amendment to the solicitation. Even if provided in other form, only the question responses included in the amendment to the solicitation will govern performance of the contract. BACKGROUND INFORMATION & BRAND-NAME JUSTIFICATION The Center for Food Safety and Applied Nutrition, known as CFSAN, is one of six product-oriented centers, in addition to a nationwide field force, that carry out the mission of the Food and Drug Administration (FDA). FDA is a scientific regulatory agency responsible for the safety of the nation's domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products. The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics. Most Center staff members work in the Center's headquarters in College Park, Maryland. The Center also operates research facilities in Laurel, Maryland; Bedford, IL, and in Dauphin Island, Alabama. To fulfill its mission, CFSAN utilizes two Bio-Plex 200 systems. One of the pre-existing systems is more than fifteen (15) years old (i.e., a first-generation model), which experiences frequent down-time subsequently creating congestion for the analysis of samples. CFSAN requires one Bio-Plex 3D Suspension Array System to support laboratory activities with sample analysis using the xMAP Food Allergen Detection Assay for food allergen research projects. The required Bio-Plex 3D will be utilized by the laboratory as a bead flow analyzer. Throughout the pre-existing Bio-Plex equipment's use over the past 15+ years, a large amount of data has been accumulated. CFSAN requires access to this data for future research projects. This pre-existing data is only readable and interchangeable with Bio-Rad's proprietary Bio-Plex Manager's software. Acquiring the Bio-Plex 3D Suspension Array System will ensure the continuous access to the pre-existing data and ensure that all new data is compatible and comparable to pre-existing data. Additionally, the Bio-Plex 3D Suspension Array System is 2-times faster in sample analysis compare to the previous Bio-Plex 200 system that can further mitigate the congestion for the analysis of samples. Lastly, the Bio-Plex 3D allows further expansion of multiplexing capability of the current method with up to 500 target analytes for future research needs. Note: Reference attachment titled, "RFQ-FDA-75F40121Q00143," for complete solicitation.