Soliciation 75N98026Q01251 COMBINED SYNOPSIS .docx

COMBINED SYNOPSIS / SOLICITATION

Title: Assay Service request for assessing select required DMPK properties of potential therapeutic compounds generated in SMC.

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued.

The solicitation number is 75N98026Q01251. This solicitation is issued as a competitive combined synopsis/solicitation for commercial products or commercial services. The Government intends to award a contract or purchase order resulting from this solicitation using full and open competition.

This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Products or Commercial Services, and is not expected to exceed the simplified acquisition threshold of $350,000.00.

The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, seeks to award a Firm-Fixed-Price to the responsible offeror whose proposal represents the best value to the Government.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01 March 13, 2026.

The associated NAICS code is 541380, and the small business size standard is 1,000 employees.

This requirement is NOT SET-ASIDE for SMALL BUSINESSES.

Description of Requirement:

To develops new molecular entities with implications in improving health and treatment for various metabolic and alcohol associated diseases. To assess the translational potential of novel molecular entities, which would allow us to make decisions to proceed the compounds for further development we utilize multiple derisking assays. These assays comprise of both cell-based (in vitro) testing and then eventually in mice to assess pharmacokinetic parameters to see if the drug is orally available.

Request to procure services for orthogonal Assay Development & Laboratory Testing Services in SMC to produce grouped DMPK assays and perform a Pharmacokinetic study in C57BL6 mice. By including the Caco-2 Permeability Assay in our DMPK evaluation it will accurately predict the oral absorption potential of our compounds. This well-established in vitro model closely mimics the human intestinal epithelium, providing critical insights into a compound’s passive diffusion, active transport, and efflux processes, such as those mediated by P-glycoprotein (P-gp). In addition, the plasma protein binding and hepatic metabolic stability further allow to know the stability of the compounds in bodily fluids. These assays which are requested will also provide experimental validation of data generated insilico. The data generated from this assay are vital for informing structure-activity relationship (SAR) optimization, improving compound permeability, and reducing transporter-related liabilities that could hinder bioavailability.

The project requires certain in vitro assays for a specific project related to novel ligand regeneration. Having all assays under one vendor for a particular project, ease of result interpretation and cost effectiveness is required. We request that the period of services/performance be for one year from the date of award to allow us ample time to down select and ship the best samples for assay.

These assays are valuable to the work of section on medicinal chemistry at NIAAA for different projects. The results enable to progress compounds for further development as therapeutics in metabolic and alcohol use disorders.

The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition. Add any agency-specific instructions as required.

The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition.

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation represents the best value to the Government, price and other factors considered.

EVALUATION CRITERIA:

Award will be made to the contractor providing the most advantageous quote to the government, technical factors and cost/price considered.

Technical factors outweigh cost.

A written notice of award or acceptance of an offer, issued within the time specified in the offer, shall result in a binding contract without further action by either party. The Government reserves the right to accept any offer before the expiration date.

Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications—Commercial Items, with their offer.

FAR 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items, applies to this acquisition.

Submission Requirements:

Responses must include sufficient information to demonstrate the offeror’s capability to provide the required product or service. Quotes shall include, at a minimum:

· Unit and total price

· Shipping and handling costs

· Delivery timeframe after award

· Delivery terms

· F.O.B. point (destination)

· Product or catalog numbers (if applicable)

· Product/service description

Additional evaluation considerations may include past performance, warranty, lifecycle cost, maintenance availability, and environmental or energy efficiency.

Responses must include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

All responses must be received by September 28, 2026, at 9:00am EST and must reference solicitation number 75N98026Q01251. Responses may be submitted electronically to danielt@mail.nih.gov.