Justification and Approval for Sole Source Report Requirement

Awarded Limited / Sole Source Justification Posted

Solicitation number
JA-26-Edg-0436
Agency
Set-aside
No set-aside

Opportunity facts

Contract number
W911SR-26-P-A006
Place of performance
Wilmington, North Carolina 28401, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Army Contracting Command Aberdeen Proving Ground has awarded a sole-source contract to PPD Development, L.P. for generation of final quality assurance-reviewed technical reports on bioanalytical sample analysis from a completed study, under contract W911SR-26-P-A006 awarded on August 27, 2026.

The justification cites Title 10 U.S.C. 3204(a)(1) as implemented in FAR 6.302-1(a)(2)(iii)(A), citing substantial duplication of cost not expected to be recovered through competition. PPD is the sole source capable of performing the work because it retains exclusive ownership of proprietary raw data, validated analytical methods, and clinical testing results from the original bioanalytical method validation work. The previous contractor that originally performed the work filed for bankruptcy and the project was terminated. A competitive acquisition would be futile due to insuperable proprietary data barriers, would result in unrecoverable cost duplication requiring re-validation of analytical methods, and would cause unacceptable schedule delays critical to FDA submission timelines. The reports support a previously submitted Clinical Study Report for a Phase II clinical trial and an upcoming FDA submission for a biological defense pharmaceutical product. PPD Development, L.P. is located in Richmond, Virginia. The Contracting Officer determined the anticipated price will be fair and reasonable based on cost analysis, price analysis, and independent Government estimate with certified cost or pricing data required.

Notice text

The purpose of this other than full and open competition contract to PPD Development, L.P. to have technical reports written for a completed study using data PPD attained during performance of the study.

Awarded contract W911SR-26-P-A006 to unknown vendor for unknown amount on 2026-08-27.

Files

File Type Posted
JA-26-Edg-0436_-_Justification_FAR_Part_6_Redacted.pdf PDF

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