Notice of Intent to Sole Source Pluvicto and Lutathera

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) 22, located at 4811 Airport Plaza Drive, Long Beach, CA 90815 intends to award a sole source firm-fixed price contract to Advanced Accelerator Applications USA 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 Greater Los Angeles has a requirement for Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan) and Lutathera (Lutetium LU 177 Dotatate) radioactive therapy treatments for Prostate-specific Membrane Antigen-Positive Metastatic Castration-Resistant Prostate Cancer (PSMA-Positive mCRPC) and gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

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 10:00 am., PT, Wednesday September 25, 2024 to:

peter.kim33@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 blanket purchase agreement award will be made to Advanced Accelerator Applications USA 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.