Sirturo (Bedaquiline) tablets for the NIH (Notice of Intent to sole source)

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, a Notice of Intent was posted on Beta.Sam.Gov May 15, 2020 and closing May 31, 2020. Cardinal Health/Metro Medical responded with a Sole Source notice. 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 this posting that they are the sole source vendor.

Previous acquisitions and research revealed this requirement should be a sole source requirement. More recently, a Request for Quotes was posted under RFQ-CC-24-008485 and it was reconfirmed that Cardinal Health/Metro Medical is the sole source vendor as they are the official authorized reseller of this equipment via their relationship with the manufacturer. Thus, Cardinal Health/Metro Medical is the only responsible and authorized source for Sirturo.

Requirements: 1x SIRTURO (BEDAQUILINE) 100 mg tablet in 188-count bottles (NDC# 59676070101) 1x SIRTURO (BEDAQUILINE) 20 mg tablet in 60-count bottles (NDC#59676070260) Period of performance/Date of Delivery: Within 30 days of award, or mutually agreed upon.

Place of Performance or Delivery:

Place of Performance: NIH Clinical Center in Bethesda, MD The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-CC-26-000039) by 11:00 AM eastern standard time on 01/27/2026 to:

lu-chang.lu@nih.gov All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.