Brand Name or Equal Laser Diffraction System for characterizing Over-the-Counter (OTC) spray drug products
Closed Solicitation Posted
- Solicitation number
- 75F40125Q00182
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- PSC
- 6640 Laboratory Equipment And Supplies
- Place of performance
- Saint Louis, Missouri 63110, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The U.S. Food and Drug Administration's Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, is seeking to procure a brand name or equal laser diffraction system specifically designed for characterizing over-the-counter spray drug products. The requirement is based on the Spraytec system manufactured by Malvern Panalytical Inc and includes a complete package with a 950mm optical bench, 300mm lens, extraction system, software, air purge system, and related accessories capable of analyzing aerosol particles from 0.1 to 900 micrometers. The procurement follows FAR Part 12 and Part 13 procedures for commercial products and services, with vendors required to submit three-volume quotes demonstrating their ability to provide system delivery, installation, qualification, and user familiarization. The government will use a lowest price, technically acceptable (LPTA) evaluation approach to select the winning contractor. The solicitation was posted on June 30, 2025, with an amendment issued on July 7, 2025, and quotes are due by 2:00 PM ET on July 14, 2025.
This procurement does not utilize any set-aside designations and is open to all qualified contractors under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) with a small business size standard of 1,000 employees. The government anticipates awarding a single Firm-Fixed Price purchase order with a 12-month base period of performance expected to commence on September 2, 2025. While specific award values are not disclosed, the procurement represents an entirely new effort rather than a recompete of existing work, as confirmed in the government's responses to vendor questions. The system will be delivered and installed at the FDA facility in St. Louis, Missouri, to support the agency's testing and research activities on nonprescription spray drug products. The government reserves the right to make an award decision without further negotiations following the quote submission deadline.
Notice text
2 versions
Update #2 · Latest ·
***This RFQ 75F40125Q00182 has been amended via Amendment 1 to add a new attachment titled, "Attachment B – Questions and Answers." Please note that the deadline for submitting quotes has NOT been extended. ***
This requirement is for the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ).
In accordance with the attached Request for Quotation (RFQ) no. 75F40125Q00182, the Government anticipates awarding one (1) Firm-Fixed Price (FFP) type Purchase Order. The anticipated Period of Performance (PoP) is the 12-month period following the date of award, anticipated to commence on September 2, 2025. The actual PoP will be determined at time of award. The objective of this Purchase Order is to acquire a laser diffraction system to support testing and research on nonprescription spray drug products. The salient characteristics are based upon the Spraytec system manufactured by MALVERN PANALYTICAL INC (UEI: YYDEKQG2AR67).
This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6- Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This is Request for Quotation (RFQ) no. 75F40125Q00182 for commercial products and commercial services in accordance with the procedures of FAR Part 12- Acquisition of Commercial Products and Commercial Services, and FAR Part 13- Simplified Acquisition Procedures.
The associated North American Industry Classification System (NAICS) code is 334516 - Analytical Laboratory Instrument Manufacturing. The associated small business size standard is 1,000 employees.
Update #1 ·
This requirement is for the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ).
In accordance with the attached Request for Quotation (RFQ) no. 75F40125Q00182, the Government anticipates awarding one (1) Firm-Fixed Price (FFP) type Purchase Order. The anticipated Period of Performance (PoP) is the 12-month period following the date of award, anticipated to commence on September 2, 2025. The actual PoP will be determined at time of award. The objective of this Purchase Order is to acquire a laser diffraction system to support testing and research on nonprescription spray drug products. The salient characteristics are based upon the Spraytec system manufactured by MALVERN PANALYTICAL INC (UEI: YYDEKQG2AR67).
This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6- Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This is Request for Quotation (RFQ) no. 75F40125Q00182 for commercial products and commercial services in accordance with the procedures of FAR Part 12- Acquisition of Commercial Products and Commercial Services, and FAR Part 13- Simplified Acquisition Procedures.
The associated North American Industry Classification System (NAICS) code is 334516 - Analytical Laboratory Instrument Manufacturing. The associated small business size standard is 1,000 employees.
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