Sirturo (Bedaquiline) tablets for the NIH (Notice of Intent to sole source)
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Description
Acquisition Description: This is a Notice of Intent, not a request for proposal. The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with Cardinal Health. This requirement will be sole sourced to Cardinal Health under FAR 13.501(a) or 8.405-6 (b) - sole source requirements. The National Institutes of Health (NIH) Clinical Center (CC) (NIH-CC or �Program�) is a clinical research hospital providing all medical services for patients participating in human research protocols of the NIH. The CC Pharmacy department provides a range of pharmaceutical care services to inpatients and outpatients enrolled in clinical trials. The CC Pharmacy department is responsible for acquiring the supply of medications required for patient care. The NIH-CC has a pharmacy center that requires Sirturo (Bedaquiline) drug tablets for patient care. Sirturo is supplied in the following forms: 100 mg tablets in 188 count bottles and 20 mg tablets in 60 count bottles. Various different quantities are needed every year. Based on Program�s purchase history in the past, and factoring in the anticipated patient enrollment, Program expects to need approximately 12 - 36 bottles of each type of Sirturo� bottles per year. Justification: Only this Sirturo medication can be accepted as there are no substitutes for this medication. The manufacturer (Janssen Therapeutics) has designated Cardinal Health (DBA Metro Medical Supply) as the sole distributor of Sirturo in the U.S. Previous acquisitions and research indicated that this requirement should be a sole source requirement. For the previous acquisitions, Notice of Intent notices were posted on SAM.gov. Cardinal Health/Metro Medical was the only sole source provider. In order to confirm this is still applicable, this requirement was previously posted on SAM.gov as an RFQ under full and open competition under RFQ-CC-24-008485. No other companies responded, and it was confirmed by th…