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

Procurement Summary

Country : USA

Summary : 6 months of Sirturo (Bedaquiline) tablets for the NIH (Notice of Intent to sole source)

Deadline : 21 Apr 2025

Other Information

Notice Type : Tender

TOT Ref.No.: 117761323

Document Ref. No. : NOI-CC-25-000022

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

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.

This current requirement is for approximately half a year-s worth of Sirturo drugs.

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 drugs 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, th...
Active Contract Opportunity
Notice ID : NOI-CC-25-000022
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : NATIONAL INSTITUTES OF HEALTH
Office: NATIONAL INSTITUTES OF HEALTH - CC
General Information
Contract Opportunity Type: Presolicitation (Original)
Original Published Date: Apr 15, 2025 11:35 am EDT
Original Response Date: Apr 21, 2025 11:00 am EDT
Inactive Policy: 15 days after response date
Original Inactive Date: May 06, 2025
Initiative: None

Classification
Original Set Aside:
Product Service Code: 6505 - DRUGS AND BIOLOGICALS
NAICS Code: 325414 - Biological Product (except Diagnostic) Manufacturing

Place of Performance: MD 20814 USA

Documents

 Tender Notice