6505--illuccix psma vasd

Closed Special Notice Posted

This opportunity was awarded. See the award notice from .

Solicitation number
36C26225Q0343
Agency
Veterans Integrated Service Network 22 Veterans Health Administration, Department of Veterans Affairs
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
325412 Pharmaceutical Preparation Manufacturing
PSC
6505 Drugs And Biologicals
Points of contact

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Veterans Affairs (VA) Network Contracting Office 22, located in Long Beach, California, has issued a Special Notice announcing its intent to award a sole-source, firm-fixed price contract to Cardinal Health 414, LLC. The contract pertains to Illuccix PSMA radioactive therapy injection, which is used in Positron Emission Tomography (PET) imaging for prostate cancer patients. The procurement falls under the North American Industry Classification System (NAICS) code 325412 for Pharmaceutical Preparation Manufacturing, with a small business size standard of 1,300 employees. The VA San Diego Healthcare System Nuclear Medicine Service requires this specialized radiopharmaceutical for patients with prostate cancer that may have spread or recurred, as indicated by elevated prostate-specific antigen (PSA) levels.

The primary purpose of this Special Notice is to provide an opportunity for potential alternative contractors to demonstrate their capability to provide the required radiopharmaceutical service. Interested parties must submit a detailed capability statement by 10:00 am PT on January 21, 2025, to Hestia.Sim@va.gov. Contractors must be FDA-certified manufacturers or fully licensed, authorized distributors of the radiopharmaceutical, capable of delivering the product in compliance with Nuclear Regulatory Commission (NRC) and FDA regulations. Eligibility requires respondents to provide a tailored capability statement, their System for Award Management (SAM) Unique Entity Identifier (UEI) number, organization details, and business classification. While the notice invites potential offerors to express interest, the VA retains sole discretion to determine whether to compete the procurement. If no responsive submissions are received by the deadline, the contract will be awarded to Cardinal Health 414, LLC without further notice, based on the justification that they are the only source capable of providing the required supplies at the necessary quality level.

Notice text

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 Cardinal Health 414, LLC 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 San Diego Healthcare System Nuclear Medicine Service has a requirement for Illuccix PSMA radioactive therapy injection used with a medical imaging procedure called Positron Emission Tomography (PET) of lesions identified as prostate-specific membrane antigen (PSMA) positive. ILLUCCIX is FDA approved for used in patients with prostate cancer whose cancer may have spread to other parts of the body and may need initial therapy or whose cancer may have come back, based on elevated serum prostate-specific antigen (PSA) levels.

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 and deliver the radiopharmaceutical IAW Nuclear Regulatory Commission (NRC) and FDA regulations.

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, Tuesday, January 21, 2025, to: Hestia.Sim@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 delivery order purchase award will be made to Cardinal Health 414, LLC 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.

Attachments

Files attached to this notice, newest first
File Type Posted
36C26225Q0343.docx DOCX document

Notice history

Notices posted for this opportunity, newest first
Notice Type Posted
6505--Illuccix PSMA VASD Award Award Notice
6505--illuccix psma vasd This notice · Latest special notice Special Notice

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