6505--Intent to sole source Pylarify PSMA PET prostate cancer imaging agent- VISN 2 Down State

NOTICE OF INTENT TO SOLE SOURCE Department of Veterans Affairs (VA) Network Contracting Office 2 (NCO 2) hereby gives notice of the Government s intent to sole source a purchase order for a period of performance of 1 year with Progenics Pharmaceuticals, Inc. through their sole Northeast Distributor Sofie, for Pylarify prostate-specific membrane antigen (PSMA) positive emission tomography (PET) prostate cancer imaging agent deliveries at the VISN 2 Down State Facilities, New York Harbor, New Jersey, Northport and Bronx VAMC s. Pylarify, (Piflufolastat F-18), is a radioactive diagnostic agent indicated for positive emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. It can be used for men with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. It is the Government s belief that the proposed candidate is the only provider of PSMA PET prostate cancer imaging agent that can meet the agency s needs. The applicable North American Industry Classification System (NAICS) code is 325412 (Pharmaceutical Preparation Manufacturing) with a small business size standard of 1,250 employees and the Federal Supply Code (FSC) is 6505(Drugs and Biologicals). This notice of intent is not a request for competitive quotes and no solicitation will be made available. Any response received NLT October 28, 2021 at 3PM will be considered for the purposed of determining sources for future procurements Tina.Cavalieri@va.gov. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirement. A determination by the Government not to compete the proposed acquisition based upon responses of this notice is solely within the discretion of the Government. No telephone inquiries will be accepted. THIS SYNOPSIS DOES NOT COMMIT THE GOVERNMENT TO CONTRACT FOR ANY SUPPLY OR SERVICE. THE GOVERNMENT WILL NOT PAY FOR ANY INFORMATION OR ADMINISTRATIVE COSTS INCURRED IN RESPONSE TO THIS SYNOPSIS. This will be the only notice of the Government s intent to solicit, negotiate, and award to one source to satisfy this requirement.