Takeda Group's Gammagard (Notice of Intent to Sole Source)
Open Pre-Solicitation Posted
- Solicitation number
- NOI-27-000636
- Agency
-
NIH Clinical Center
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 3254 Pharmaceutical and Medicine Manufacturing
- PSC
- 6505 Drugs And Biologicals
- Place of performance
- Maryland 20814, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services' National Institutes of Health Clinical Center intends to negotiate a sole-source award on an other-than-full-and-open competition basis with Takeda Pharmaceutical Company Limited for Gammagard S/D 10gm and Gammagard S/D 5gm kits, with responses due November 16, 2026. This is a Notice of Intent, not a request for proposal. No set-aside is used. The NIH Clinical Center Pharmacy department requests 10 bottles each of the 10gm and 5gm kits, plus additional quantities as needed to meet anticipated current patient care need. Place of performance is not stated beyond the NIH Clinical Center, a clinical research hospital. The stated justification is that Takeda is the only responsible source for Gammagard S/D, that multiple NIH patients are currently on therapy, and that additional patients may be transferred to NIH for evaluation and treatment. Gammagard S/D is on the Clinical Center's formulary, requiring a supply to be kept in the Pharmacy Department at all times, and NIH states it needs to continue using the same items to keep treatment consistent. The source does not state an award value or ceiling, and it names no industry day, sources sought notice, or RFI.
Notice text
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 Takeda Pharmaceutical Company Limited.
The National Institutes of Health (NIH) Clinical Center (CC) 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. This includes the purchase of Gammagard S/D 10gm and Gammagard S/D 5gm kits.
The NIH CC Pharmacy is requesting the purchase of 10 bottles each of Gammagard S/D 10gm and Gammagard S/D 5gm kits and as needed to provide anticipated current patient care need.
Justification:
TAKEDA Group is the only responsible source for Gammagard S/D. There are multiple patients in the NIH currently on therapy with Gammagard S/D and additional patients may be transferred to the NIH for evaluation and treatment. Gammagard S/D is on the Clinical Center’s formulary, requiring a supply to be available in the Pharmacy Department at all times to support ongoing patient care. The NIH needs to keep using the same items to keep treatment consistent.
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