Justification for Exception to Fair Opportunity (JEFO) – ANSYS Multi-Physics Simulation Software Suite

The U.S. Food and Drug Administration, under the Department of Health and Human Services, is exercising a sole-source continuation of the ANSYS Multi-Physics Simulation Software Suite through a Justification for Exception to Fair Opportunity under FAR 16.507-6(b)(3), citing economy and efficiency as the basis for bypassing competitive reprocurement. This action follows a previously competed delivery order under the SEWP GSA contract and represents the exercise of Option Year Two via bilateral modification to restore services interrupted by a funding lapse during Option Year One. The estimated value of this action is $238,171.73, funded through the Other Management Appropriation with agency code 7570. The contract is administered as a multiple-award IDIQ vehicle with firm-fixed-price terms, and the scope includes ongoing software licensing, maintenance, technical support, and integration critical to FDA’s regulatory science activities across centers such as CDRH and CDER. Continuity is essential due to deep institutional integration of the incumbent’s software configurations, validated computational models, and proprietary licensing infrastructure, which would incur significant retraining costs, operational delays, and risk to scientific integrity if transitioned to a new provider. No competitive evaluation factors, pricing breakdowns, inspection criteria, or packaging requirements are applicable because this is a non-competitive follow-on action. The justification emphasizes avoidance of duplication, prevention of disruption, and elimination of transition delays as core rationales, with no requirement for new proposals or offeror certifications. The period of performance lacks explicit start and end dates, and the place of performance is not formally defined beyond general reference to FDA facilities. Key contractual authority stems from FAR 52.217-9 for option exercise and FAR 16.505(b)(2)(i)(C) for logical follow-on status, supported by a HHS class deviation. The primary point of contact is Jesse Weidow, with submission of the justification due by May 22, 2026. No COTR, COR, or payment office details are provided, and while security clearances and OCI mitigation plans are not formally documented, the incumbent’s embedded role implies functional barriers to competition. This action preserves mission-critical simulation capabilities without recompeting a proven, tightly integrated solution.