6505--Notice of Intent to Sole Source F18 Piflufolastat (PYLARIFY) Doses for PET/CT for Overton Brooks VA Medical Center, Shreveport, LA
ID: 36C25625Q0554Type: Special Notice
Overview

Buyer

VETERANS AFFAIRS, DEPARTMENT OFVETERANS AFFAIRS, DEPARTMENT OF256-NETWORK CONTRACT OFFICE 16 (36C256)RIDGELAND, MS, 39157, USA

NAICS

Pharmaceutical Preparation Manufacturing (325412)

PSC

DRUGS AND BIOLOGICALS (6505)

Original Source

https://sam.gov/opp/326182c1aa0e422d85b2480c26c9cdbf/view
Timeline
    Description

    The Department of Veterans Affairs intends to award a sole-source contract to Progenics Pharmaceuticals, Inc. for the provision of 200 doses of F-18 Pifluflostat (PYLARIFY) for the Overton Brooks VA Medical Center in Shreveport, LA. The contractor must be licensed and experienced in supplying radiopharmaceuticals, ensuring compliance with regulatory standards set by the Nuclear Regulatory Commission and the FDA, and providing daily or as-needed deliveries to the facility's Nuclear Medicine department. This specialized radiopharmaceutical is crucial for PET imaging in prostate cancer patients, reflecting the government's commitment to high healthcare standards and patient safety. Interested vendors must submit their capability statements by March 3, 2025, and all inquiries should be directed to the contracting officer, Ross Futch, at ross.futch@va.gov or by phone at 713-770-2830.

    Point(s) of Contact
    Ross FutchContracting Officer
    (713) 770-2830
    ross.futch@va.gov
    Files
    Title
    Posted
    36C25625Q0554.docx
    The document is a Special Notice issued by the Department of Veterans Affairs, announcing the government's intention to award a sole-source contract to Progenics Pharmaceuticals, Inc. for the supply of 200 doses of F-18 Piflufolastat (PYLARIFY), a radioactive diagnostic agent used in PET scans for prostate cancer. The notice specifies that Progenics is the only vendor capable of providing this highly specialized product, referencing FAR 8.405-6(a)(1)(B) for justification. The delivery order will serve the Overton Brooks VA Medical Center in Shreveport, LA, with a performance period from April 1, 2025, to March 31, 2026. Interested parties must submit their capability statements by March 3, 2025, outlining their ability to meet the requirements, although there is no guarantee of a competitive process. The notice emphasizes that telephonic inquiries will not be accepted, directing all communications to the contracting officer via email. Overall, this document reflects the procurement process and regulatory adherence in the context of federal acquisitions within the Veterans Affairs system.
    PWS Pylarify.docx
    The Overton Brooks VA Medical Center (OBVAMC) issued a Performance Work Statement (PWS) for the provision of F18 Pifluflostat (PYLARIFY), a radiopharmaceutical for PET imaging in prostate cancer patients. The contractor must be licensed and experienced in providing radiopharmaceuticals, complying with numerous regulatory bodies including the Nuclear Regulatory Commission and FDA. Daily or as-needed supply of PYLARIFY to OBVAMC's Nuclear Medicine department is required, with orders placed 24 hours in advance. Key deliverables include product labeling compliance, quality control procedures, and established contingency plans for supply disruptions. The contractor must ensure secure deliveries with lead shielding and adhere to federal transportation regulations. Additionally, they must accept returns for credit under specified conditions and provide education at no cost to OBVAMC staff on safe handling and regulatory compliance. The expected contract term spans a base year from April 1, 2025, to March 31, 2026, with an estimated need for 200 doses of PYLARIFY for diagnostic imaging purposes. This PWS reflects the government's commitment to maintaining high standards in healthcare delivery and patient safety through stringent supplier selection and oversight.
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