6505--PLUVICTOâ„¢ (lutetium Lu 177 vipivotide tetraxetan) Prostate Cancer Therapy (NDC Code: 69488-0010-61) VA Palo Alto Health care System 36C26126Q0002
Summary
AI-generated · Aug 27, 2025Pluvicto (Lutetium-177 vipivotide tetraxetan) is required as a radiopharmaceutical therapy for PSMA-positive metastatic castration-resistant prostate cancer, to be provided under a sole-source, firm-fixed-price contract to Novartis Pharmaceuticals Corporation under FAR 8.405-6(a)(1)(B) because only one source can meet the required quality. Vendors must be manufacturers or fully licensed, authorized distributors for radiopharmaceuticals and be FDA certified; if you supply this therapy through a GSA or other Federal Supply Schedule, identify the applicable contract number and how it applies to this item.
Interested parties should submit a tailored capability statement showing ability to provide the product and related services, including your SAM UEI, organization name, address, point of contact, and business type (e.g., SDVOSB/VOSB). Indicate whether you offer this radiopharmaceutical on an FSS contract and provide the relevant contract details. Submissions must be electronic in Word or PDF and received by 3:00 pm PT on Tuesday, June 10, 2025, at the provided email address. Responses are not a guarantee of award; if no timely response is received, a single-source delivery order may be issued to Novartis without further notice. The government may use information provided as needed, and there is no obligation to acknowledge receipt or provide feedback.
Special Notice Special Notice Page 3 of 3 *= Required Field Page 1 of 3 This notice is published IAW Federal Acquisition Regulation (FAR) Subpart 5.101 requiring posting of information for proposed contract actions. The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 21 intends to award a sole source firm-fixed price contract to Novartis Pharmaceuticals Corporation under the authority of FAR 8.405-6(a)(1)(B), Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized. The North American Industry Classification System (NAICS) for this requirement is 325412, Pharmaceutical Preparation Manufacturing. The Federal Supply Class (FSC) is 6505, Drugs and Biologicals. The Small Business Administration (SBA) size standard for this sector is 1,300 Employees. VA Palo Alto Healthcare System Nuclear Medicine Department has a requirement for Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan), a radioactive therapy treatment for Prostate-specific Membrane Antigen-Positive Metastatic Castration-Resistant Prostate Cancer (PSMA-Positive mCRPC). If your firm provides the radiopharmaceutical therapy on GSA Federal Supply Schedule or any Federal Supply Schedule, please provide applicable contract number and identify which supply/service are applicable to that FSS contract, and the following additional information (1) A tailored capability statement indicating the firm s ability to provide a product and related services; (2) The respondents SAM UEI number, organization name, address, point of contact, and size and type of business (e.g., SDVOSB/VOSB, etc.,) pursuant to the applicable NAICS code; (3) Information should be provided electronically in a Microsoft Word or Adobe PDF format. Potential offerors must be a manufacturer or fully licensed, authorized distributor for the radiopharmaceutical items. Potential offerors must be FDA certified. This notice of intent is not a request for competitive quotes. However, interested parties may identify their interest and capability to respond to the requirement and submit capability statement no later than 03:00 pm., PT, Tuesday June 10, 2025, to Mohammed.Hussain2@va.gov . Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses received to this notice is solely within the discretion of the Government. If no written response is received within the closing date of this notice, a single source delivery order award will be made to Novartis Pharmaceuticals Corporation without any further notice. This notice does not obligate the Government to award an agreement or otherwise pay for the information provided in response to this notice. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. However, responses to this notice will not be considered adequate responses to a notice.
From Special Notice posted on Jun 03, 2025Notice history
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