The National Institutes of Health Office of Logistics and Acquisition Operations is seeking to procure specialized pharmaceutical products for an ongoing interventional clinical trial study. The solicitation requires the production of Atorvastatin capsules in two dosage strengths - 20mg capsules totaling 1,050 units for 5 patients and 40mg capsules totaling 4,200 units for 20 patients - along with matching placebo capsules totaling 4,200 units. The procurement specifications indicate that capsule production runs must provide sufficient quantities for patients to take one capsule daily over a 7-month treatment period, with appropriate additional overage to ensure complete study coverage. The solicitation was posted on June 10, 2025, with responses due by June 13, 2025, providing only a three-day response window. The evaluation criteria and specific qualification requirements are not detailed in the available documentation.

This opportunity is designated as a Total Small Business set-aside under solicitation NIH-SS-7194601-A, restricting competition to small business entities. The contract involves manufacturing a total of 9,450 capsules across the various dosage strengths and placebo requirements to support 25 clinical trial participants. The place of performance is specified as Bethesda, MD 20892, which aligns with the NIH campus location. No incumbent contractors or potential award values are identified in the available documentation. The procurement falls under NAICS code 339112 for Surgical and Medical Instrument Manufacturing and PSC code 6505 for Drugs and Biologicals, indicating the specialized pharmaceutical manufacturing nature of the requirement.

Ongoing Interventional Clinical Trial Study Drugs

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