Combined synopsis.docx

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, and a separate written solicitation will not be issued. This solicitation number is 75N94025Q00143 and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2025-03. The North American Industry Classification (NAICS) Code is 325411 and the business size standard is 1,000. This solicitation is set aside for small business.

It is the intent of The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute on Child Health and Human Development (NICHD) to award a purchase order, without providing for full and open competition, to US Specialty Formulations, LLC. of Allentown, PA for the clinical materials batch production Ethanol. The Sterile Ethanol product will be provided with the following required specifications:

· Primary Package Type: Vial w/butyl septum, size 100 mL with fill Volume 65 mL

· Potency: 92 – 98 %

· AQL Inspection: Clear solution free of particulates Critical 0.65 Major 1.0 Minor 2.5

· Bacterial Endotoxins: < 0.25 EU/mL

· Sterility: No growth

· Particulate Matter: ≤ 6000 particles / mL of ≥10µm ≤ 600 particles / mL of ≤ 25 µm

· Manufactured using cGMP techniques and procedures in clean room facilities and by personnel suitably trained to appropriate standards.

This is a Notice of Intent to receive the services US Specialty Formulations, LLC. because USSF utilizing a different vendor to create the sterilized Ethanol would add variables in the current ongoing research.

The offeror must include a completed copy of the following provision’s along with their quote: FAR Clause 52.212-3, Offeror Representations and Certifications – Commercial Items; FAR Clause 52.204-24, Representation Regarding Certain Telecommunication and Video Surveillance Services or Equipment; FAR Clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

The provisions of FAR Clause 52.212-1 Instructions to Offerors – Commercial Items; FAR Clause 52.212-2, Evaluation – Commercial Items: Evaluation Factors (1) technical capability to provide all services/consumables, etc; (2) price; and (3) past performance. Technical capability and past performance, when combined, are significantly more important than cost/price; FAR Clause 52.212-4, Contract Terms and Conditions – Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items – Deviation for Simplified Acquisitions applies to this acquisition, apply to this acquisition.

The offeror must include their Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. The clauses are available in full text at http://www.arnet.gov/far. Interested vendors capable of providing the Government with the services specified in this synopsis should submit their quotation to the below address. Quotations will be due ten (10) calendar days from the publication date of this synopsis or July 31 , 2025 at 12:00 PM. The quotation must reference “Solicitation number” 75N94025Q00143. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Quotations must be submitted by email to Kelly Robinson at Kelly.Robinson@nih.gov. Faxed copies will not be accepted