AN42--Research Product - Synthesis and Mfg Hydroxy for Clinical Trial - University of Minnesota

Closed Special Notice Posted

Solicitation number
36C24E24Q0126
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Veterans Affairs (VA) Office of Research and Development, Regional Procurement Office East, has issued a Special Notice regarding a sole source requirement for the University of Minnesota to optimize a synthetic process and manufacture 2-gram quantities of the active ingredient hydroxychloroquine sulfate. This requirement is for use in a Phase I/II clinical trial and will take place at a VA facility in Philadelphia, PA.

The purpose of this Special Notice is to justify the sole source award to the University of Minnesota under FAR 6.302-1, as the agency has determined the University is the only responsible source. Interested parties who believe they can meet the requirement may submit capability statements by September 11, 2024, at 10:00 AM EST. The agency will make a determination on whether to compete the requirement based on the responses received. The opportunity falls under NAICS code 541715 - Research and Development in the Physical, Engineering, and Life Sciences, and PSC code AN42 - Health R&D Services; Health Care - Other; Applied Research.

Notice text

The Veteran s Administration (VA) Office of Research and Development, Regional Procurement Office East in Pittsburgh, PA intends to negotiate on a sole source basis with the University of Minnesota based in Minneapolis, MN on behalf of the VA Philadelphia Healthcare System. The requirement is to optimize a synthetic process and analytical methodology for the active ingredient hydroxychloroquine sulfate on a 2-gram scale for clinical use as an investigational drug as well as to manufacture this ingredient on a 2-gram scale for clinical using in a Phase I/II clinical trial.

The requirement will take place at a VA facility Philadelphia, PA. The sole source is pursuant to FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This notice of intent is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation to the contracting office no later than Wednesday, Sept 11, 2024, (10:00 AM, EST). Interest/capability statements may be sent to Michael Haydo at Michael.haydo@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.

Files

File Type Posted
36C24E24Q0126.docx DOCX document

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