Sirturo (Bedaquiline) tablets for the NIH (Notice of Intent to sole source)
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Institutes of Health, Clinical Center (NIH-CC) intends to negotiate on a sole source basis with Cardinal Health for the acquisition of Sirturo (Bedaquiline) tablets. This is a Notice of Intent, not a request for proposal, to acquire this specific medication for patient care at the NIH Clinical Center in Bethesda, MD. Capability statements from responsible sources are due by January 27, 2026.
Scope of Work
The NIH-CC requires Sirturo (Bedaquiline) drug tablets, specifically:
- 100 mg tablets in 188-count bottles (NDC# 59676070101)
- 20 mg tablets in 60-count bottles (NDC#59676070260) Annual quantities are estimated at approximately 12-36 bottles of each type. The medication is for patient care at the NIH Clinical Center.
Justification for Sole Source
Sirturo is the only acceptable medication, with no substitutes. The manufacturer, Janssen Therapeutics, has designated Cardinal Health (DBA Metro Medical Supply) as the sole distributor of Sirturo in the U.S. Previous market research, including an RFQ (RFQ-CC-24-008485) posted under full and open competition, reconfirmed Cardinal Health as the sole authorized reseller. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1.
Contract & Timeline
- Type: Notice of Intent to Sole Source (Presolicitation)
- Set-Aside: None
- Period of Performance/Delivery: Within 30 days of award, or mutually agreed upon.
- Place of Performance: NIH Clinical Center, Bethesda, MD
- Capability Statement Due: January 27, 2026, 11:00 AM EST
- Published: January 21, 2026
Response Instructions
This is not a request for proposal. All responsible sources capable of providing the required Sirturo tablets may submit a capability statement for consideration. Submissions must be sent via email to lu-chang.lu@nih.gov with the subject line referencing NOI-CC-26-000039. The government retains discretion on whether to compete this requirement based on responses.