Name | Type | Posted | Actions |
|---|---|---|---|
Notice of Intent to Sole Source.pdf | Mar 9, 2026 |
Notice of Intent to Sole Source – Intera 3000 Hepatic Artery Infusion Pumps (NIH/NCI)
Contact and place of performance
WANG, NIEN-TZU G
USA
Notice of Intent to Sole Source Notice ID : 75N98026Q00079 Agency: U.S. Department of Health and Human Services (HHS) National Institutes of Health (NIH) National Cancer Institute (NCI) Center for Cancer Research (CCR) Surgical Oncology Program (SOP) Description: The National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Surgical Oncology Program (SOP) intends to award...
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This acquisition is being conducted using simplified procedures for certain commercial products and commercial services under FAR Subpart 13.5, in accordance with FAR 13.106-1(b) and 41 U.S.C. 3304(a)(1), as only one responsible source is capable of meeting the Government’s requirement.
Sole Source Rationale:
Market research conducted by the Government determined that the Intera 3000 Hepatic Artery Infusion Pump, manufactured and distributed by Inter Oncology Inc., is the only FDA-approved device available for this specific clinical indication. The Surgical Oncology Program requires this device to support an IRB-approved clinical protocol involving hepatic artery infusion therapy for oncology patients.
Substitution with an alternate device is not feasible, as no other FDA-approved device is available for this indication. Use of a non-equivalent device would introduce clinical risk, disrupt the IRB-approved protocol, and potentially compromise patient safety. Accordingly, Inter Oncology Inc. is the only responsible source capable of meeting the Government’s requirement.
NAICS Code: 339112 – Surgical and Medical Instrument Manufacturing
Size Standard: 1,000 employees
Response Information:
This notice of intent is not a request for competitive quotations. However, any responsible source that believes it can provide the required FDA-approved Hepatic Artery Infusion Pumps may submit a capability statement demonstrating its ability to meet the Government’s requirement.
Responses must be received within fifteen (15) days of publication of this notice. Responses shall be submitted via email to the Contracting Officer at [email protected] no later than 10:00 A.M. Eastern Time on March 24, 2026.
A determination by the Government not to compete this proposed contract action based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.
The National Institutes of Health (NIH), National Cancer Institute (NCI), Surgical Oncology Program intends to award a sole-source, firm-fixed-price contract to Inter Oncology Inc. for the procurement of Intera 3000 Hepatic Artery Infusion Pumps. This acquisition, identified under solicitation number 75N98026Q00079, supports an IRB-approved clinical protocol involving hepatic artery infusion therapy for oncology patients. The anticipated base period of performance runs from April 6, 2026, through April 5, 2027, and includes option line items for additional units to be exercised based on clinical enrollment and treatment needs.
The government’s market research indicates that Inter Oncology Inc. is the only responsible source capable of meeting this requirement, as the Intera 3000 is the only FDA-approved device available for this specific clinical indication. This procurement is classified under NAICS 339112 for Surgical and Medical Instrument Manufacturing and PSC 6515 for Medical and Surgical Instruments, Equipment, and Supplies. There is no set-aside designated for this action, which is being conducted under simplified procedures for certain commercial products.
While this notice is not a request for competitive quotations, responsible sources may submit capability statements demonstrating their ability to provide FDA-approved pumps that meet the government's requirements. Responses must be submitted via email to Nien-tzu Wang by 10:00 A.M. Eastern Time on March 24, 2026. The government will utilize information received solely to determine whether a competitive procurement is warranted. One attachment, a Notice of Intent to Sole Source PDF, was published with the notice on March 9, 2026.
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