JEFO.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

Acquisition Title: ANSYS Multi-Physics Simulation Software Suite - Logical Follow-On

Agency: FDA

Acquisition Year (FY): 2026

Author:

2. Description of Action:

Nature: New Requirement Follow-on Order

Modification to Existing Delivery/Task Order/Contract Number:

Order Against: Multiple Award ID/IQ Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost Type

Funds: OMA Other Funds:

3. Description of Applicable Contract Provisions:

This action is issued under the terms and conditions of the parent multiple-award IDIQ contract and associated delivery order. The contract includes FAR 52.217-9, Option to Extend the Term of the Contract, which provides for the exercise of option periods evaluated at the time of award. The original delivery order, 75F40124F80112, was issued following a fair opportunity process consistent with FAR Part 16 ordering procedures. This action is a logical follow-on to that delivery order for the continued provision of the ANSYS Multi- Physics Simulation Software Suite, including licenses, maintenance, and technical support. Due to a delay in receipt of a funded requisition, the Government was unable to exercise Option Year One prior to the expiration of its period of performance, resulting in a lapse in contractual coverage. This action reestablishes contractual coverage and is being executed via bilateral modification to exercise Option Year Two in order to ensure continuity of services. This determination is made in accordance with Revolutionary FAR Overhaul (RFO) FAR 16.507-6(b)(3) (HHS FAR CLASS DEVIATION 2026-01 Amendment 2), which authorizes a logical follow-on exception to fair opportunity in the interest of economy and efficiency. While certain references within the form reflect legacy FAR 16.505 citation structure, this justification has been prepared in accordance with the current FAR ordering procedures as updated by the RFO rule, and all citations and determinations herein reflect the updated FAR framework. All actions taken are consistent with the terms of the contract and applicable FAR requirements.

4. Description of Supplies or Services:

The estimated value of the proposed action, including all options, is: $ 238,171.73

The requirement is for continued access to the ANSYS Multi-Physics Simulation Software Suite, including software licenses, maintenance, and technical support. The software provides advanced computational modeling and simulation capabilities used by the Food and Drug Administration (FDA) to conduct regulatory science and in silico research and to support the review of medical products.

These services are utilized across multiple FDA centers, including the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER), and are essential to maintaining ongoing research, analysis, and regulatory review activities.

5. Authority and Rationale:

The Contracting Officer shall give every awardee a fair opportunity to be considered for a delivery/task order exceeding the micro purchase threshold unless one of the following statutory exceptions applies. FAR 16.505(b)(2). Mark the applicable exception:

The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays [FAR 16.505(b)(2)(i)(A)];

Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized [FAR 16.505(b)(2)(i)(B)];

The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order [FAR 16.505(b)(2)(i)(C)];

The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

This action is authorized in accordance with FAR 16.507-6(3), which permits issuance of an order on a sole-source basis in the interest of economy and efficiency when the action is a logical follow-on to an order previously issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order. The original delivery order was competitively awarded under the parent multiple-award IDIQ contract, and all eligible contract holders were provided a fair opportunity to be considered. Due to a delay in receipt of a funded requisition, the Government was unable to exercise Option Year One prior to the expiration of its period of performance, resulting in a lapse in contractual coverage. The requirement, however, has remained continuous and unchanged. The Government has now received funding approval and intends to restore services by issuing a bilateral modification to exercise Option Year Two. Awarding this requirement to a source other than the incumbent would result in substantial duplication of cost and unacceptable delay. Transitioning to an alternative contractor would require reestablishing software access, rebuilding existing models and configurations, retraining personnel, and reimplementing enterprise licensing infrastructure, all of which would significantly disrupt ongoing regulatory science and research activities. Consistent with RFO guidance and Executive Order 14275, “Restoring Common Sense to Federal Procurement,” the Contracting Officer applied sound business judgment in determining that a logical follow-on action is the most efficient and practical approach to restore services following a funding-related lapse. This approach ensures continuity of mission-critical operations while avoiding unnecessary duplication of cost and operational disruption and remains consistent with applicable FAR requirements.

It is necessary to place the order to satisfy a minimum guarantee [FAR 16.505(b)(2)(i)(D)]; or

A statute expressly authorizes or requires that the purchase be made from a specified source. [FAR 16.505(b)(2)(i)(E)].

6. Agency Actions to Take or Remove Barriers That Led to Fair Opportunity Exception (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

The lapse in contractual coverage resulted from a delay in receipt of a funded requisition rather than a change in requirement. To prevent recurrence, the Government has improved coordination with the requiring activity to ensure timely submission of funded requisitions and enhanced tracking of option exercise timelines. The Government also intends to pursue a future competitive acquisition for this requirement. This logical follow-on action is a temporary measure to restore services and is not intended to replace competition.

7. Fair and Reasonable Price/Cost Determination: I hereby determine that the anticipated price/cost for this contract action will be fair and reasonable.

The Contracting Officer has determined that the anticipated price for this contract action, in the amount of $238,171.73, is fair and reasonable. This determination is based on pricing established through prior competition at the time of award under the NASA Solutions for Enterprise-Wide Procurement (SEWP) Governmentwide Acquisition Contract, as well as price analysis conducted during option evaluation. The pricing remains consistent with the terms of the contract and current market conditions.

8. Any other facts supporting the justification:

The lapse in contractual coverage resulted from a delay in receipt of a funded requisition and not from a change in requirement or acquisition strategy. The need for the ANSYS Multi-Physics Simulation Software Suite has remained continuous and essential to FDA mission operations. The incumbent contractor is already integrated into the existing technical and operational environment and can resume performance immediately without additional transition time or cost.The ANSYS software suite is deeply integrated into FDA regulatory science workflows, including validated models, custom configurations, and enterprise licensing infrastructure developed over time. Transitioning to an alternative solution would require significant effort to recreate models, reestablish infrastructure, and retrain personnel, resulting in substantial duplication of cost and operational disruption.This action represents a one-time, funding-related circumstance and is not indicative of a recurring acquisition approach, and continued performance by the incumbent contractor ensures continuity of services and supports ongoing mission-critical activities.