FDA approved TheraSphere product

Closed Pre-Solicitation Posted

Solicitation number
W81K0022Q0171
Agency
Medical Command Department of the Army, Department of Defense
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
325412 Pharmaceutical Preparation Manufacturing
PSC
6515 Medical And Surgical Instruments, Equipment, And Supplies
Place of performance
Jbsa Ft Sam Houston, Texas 78234, United States

Notice details come from SAM.gov. Updated .

About this opportunity

This notice announces the Department of the Army Medical Command's intent to award a sole source contract to Boston Scientific for FDA-approved TheraSphere doses for the treatment of primary liver cancer. TheraSphere is a liver cancer therapy utilizing radioactive microspheres and is the only FDA-approved treatment for this indication. Responses to this pre-solicitation notice shall include capability statements and be submitted by August 1, 2022 to be considered for the award, which is targeted for September 1, 2022.

There is no set-aside designated for this requirement. The applicable NAICS code is 325412 for Pharmaceutical Preparation Manufacturing with a size standard of 1,250 employees. Boston Scientific is identified as the current sole source provider given their FDA approval for this therapy. Interested parties must appropriately mark any proprietary information submitted in response.

Notice text

Notice of Intent to Award Sole Source

The Regional Health Contracting Office-Central, JBSA - Fort Sam Houston, Texas intends to award a Firm Fixed Price sole source contract to Boston Scientific under the authority of Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), sole source, for the FDA approved TheraSphere doses product, which is a liver cancer therapy that consists of millions of small glass microspheres containing radioactive Y90 and who has the only FDA approved treatment for Primary liver cancer.  TheraSphere is indicated for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters.  These supplies are needed to treat liver cancer patients in the Regional Health Command Central (RHC-C).  

The applicable NAICS code for this requirement is 325412.  Pharmaceutical Preparation Manufacturing.  The samll business Size Standard is 1,250 employees.  Award will be made on or around 1 September 2022. 

The solicitation number is W81K0022Q0171 and was generated for the purposes of this notice.  THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE PROPOSALS.  All responses shall include capability statements and shall be submitted by 1 August 2022 at 3:00PM CST to be considered by the Government.  A determination by the Government not to compete the purchase order based upon responses to this notice is solely within the discretion of the Government.  Interested sources who submit data are responsible for appropriately marking information if it is proprietary in nature.

Wayne Shavers

wayne.shavers.civ@mail.mil     

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