Notice of Intent to Sole Source – Intera 3000 Hepatic Artery Infusion Pumps (NIH/NCI)

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 a sole source Firm-Fixed-Price contract action to: Inter Oncology Inc. 180 Wells Avenue, Suite 300A Newton, MA 02459 UEI: TNMCLD8W1RR9 for the procurement of Intera 3000 Hepatic Artery Infusion Pumps. The anticipated base period of performance is April 6, 2026 through April 5, 2027. The award will include option line items for additional Intera 3000 Hepatic Artery Infusion Pumps, priced on a per-unit basis. Option quantities may be exercised individually as needed to support requirements under an IRB-approved clinical protocol. The period of performance associated with exercised options may be less than one year, depending on clinical enrollment and treatment needs. Authority: 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.