75F40121Q00104 - Laser Diffraction System (Brand-Name or Equal)

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- 75F40121Q00104 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 a brand-name or equal 100% Small Business Set-Aside RFQ. Simplified acquisition procedures will be utilized.

The U. S Food & Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) requires one (1) SYMPATEC HELOS Laser Diffraction system or equal.

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 August 3, 2021 5:00 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

The FDA Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Office of Testing & Research (OTR) operates as an integrated testing and research FDA laboratory to develop scientific methods and tools to assess pharmaceutical quality issues and support the following core functions: standard, guidance, and policy development, pharmaceutical quality surveillance, quality assessment of regulatory submissions, and rapid response to public health emergencies.

To fulfill its mission, OTR’s Division of Complex Drug Analysis (DCDA) utilizes a Sympatec HELOS laser diffraction instrument. The instrument is approaching the end of its useful life and needs to be replaced. To facilitate Generic Drug User Fee Amendments (GDUFA) research, DCDA requires a laser diffraction system that provides faster processing, range combination capability, and new algorithm functionality.

Note: Reference attachment titled, "FDA RFQ 75F40121Q00104," for complete combined synopsis solicitation.