JA-26-Edg-0436_-_Justification_FAR_Part_6_Redacted.pdf

This is a Justification Review Document for Other than Full and Open Competition under FAR Part 6, prepared by the Army Contracting Command – Aberdeen Proving Ground, Edgewood Division in June 2025.

The contracting activity seeks to award a non-competitive, firm-fixed-price contract to PPD Development, L.P. (a subsidiary of Thermo Fisher Scientific) located in Richmond, Virginia for the generation of final Quality Assurance-reviewed reports for bioanalytical sample analysis of a study related to Biological Defense Pharmaceuticals. The requirement involves the reactivation of dormant projects and the preparation of final analytical reports for various sample analyses. These reports are required to support a previously submitted Clinical Study Report for a Phase II clinical trial and an upcoming FDA submission for the product. The justification cites Title 10 U.S.C. §3204(a)(1) as implemented in FAR 6.302-1(a)(2)(iii)(A) regarding substantial duplication of cost that is not expected to be recovered through competition.

The justification establishes that PPD is the sole source capable of performing the work because PPD retains exclusive ownership of proprietary raw data, validated analytical methods, and clinical testing results from the original bioanalytical method validation work performed under a previous contract that was terminated when the prime contractor filed for bankruptcy. The document asserts that conducting 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 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.