Notice of Sole Source: GastroPlus PBPK and PBBM modeling platform subscription

-August 31, 2029 Option Period 3: September 1, 2029 -August 31, 2030 Responses Due: Friday, August 14, 2026, 5:00 PM EDT Government Point of Contact: Name: Dorothy Fessler Title: Contract Specialist Email: Dorothy.Fessler@psc.hhs.gov 1. Background This is a Notice of Intent to Sole Source for the acquisition of commercial products and commercial services prepared in accordance with the Revolutionary FAR Overhaul (RFO) Part 12, Acquisition of Commercial Products and Commercial Services. Notice number 7571TE26Q00153 is issued to announce the Government's intent to negotiate and award a sole-source purchase order to Simulations Plus Inc. for twenty (20) GastroPlus licenses and five (5) DDDPlus licenses. The Office of Mission Government Acquisition Solutions (OMAS), Office of Acquisition (OA), on behalf of the Office of Research and Standards (ORS) located within the Office of Generic Drugs (OGD) under the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Simulations Plus Inc. 800 Park Offices DR STE 401, Research Triangle Park, North Carolina 27709 for software licenses to accommodate the need for commercial physiologically based pharmacokinetic (PBPK) modeling software. This notice incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov. 2. Description of Requirement The Office of Research and Standards (ORS) located within the Office of Generic Drugs (OGD) under the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) conducts internal research projects using a variety of computational tools to support modeling and simulation pertaining to generic drug products. 2.1 Requirement Summary ORS has a requirement for a contract for twenty (20) GastroPlus and five (5) DDDPlus Software licenses for a base year and three one-year option periods. 2.2 Software Specifications: GastroPlus licenses � Quantity 20 Minimum Specifications: Standard, individual licenses DDDPlus � Quantity 5 Minimum Specifications: Standard, individual licenses 2.3 Period of Performance: This contract consists of a base year and three option years, beginning on September 1, 2026. The base period and option years are defined below: BASE: September 1, 2026-August 31, 2027 Option Period 1: September 1, 2027 -August 31, 2028 Option Period 2: September 1, 2028 -August 31, 2029 Option Period 3: September 1, 2029 -August 31, 2030 2.4 Place of Performance: U.S. Food and Drug Administration White Oak campus, Silver Spring, MD, USA Food and Drug Administration 10903 New Hampshire Avenue Building 75, Room 4686 Silver Spring, MD 20993 2.5 Order Type This is a Firm Fixed-Price order. This notice is not a request for competitive quotations or offers. The Government intends to negotiate and award a sole-source purchase order to Simulations Plus Inc. Any responsible source that believes it is capable of meeting the Government's requirement may submit a capability statement and supporting information by the response date identified in this notice. The Government will consider all responses received solely for the purpose of determining whether to conduct a competitive procurement. Responses received after the closing date may not be considered. Capability statements shall clearly demonstrate the respondent's ability to provide the required GastroPlus and DDDPlus software licenses, including any supporting documentation establishing that the respondent is the manufacturer or an authorized reseller, if applicable. This notice incorporates Provision 52.212-1 Instructions to Offerors�Commercial Products and Commercial Services, and FAR 52.212-2, Evaluation�Commercial Products and Commercial Services, by reference. Interested sources shall comply with the instructions and requirements set forth in this notice. Interested sources submitting a capability statement in response to this notice must be registered in the System for Award Management (SAM) at https://sam.gov at the time of response submission. Responses received by the due date will be reviewed to determine whether they demonstrate the capability to satisfy the Government's requirement. The Government will consider all timely responses solely for the purpose of determining whether another responsible source can satisfy the Government's requirement and whether a competitive procurement should be conducted. 52.212-2(a) Evaluation of Responses. Responses received by the closing date identified in this notice will be reviewed to determine whether they demonstrate that another responsible source is capable of satisfying the Government's requirement. The Government will consider all timely responses solely for the purpose of determining whether a competitive procurement should be conducted. This notice is not a request for competitive quotations or offers and does not constitute a commitment by the Government to award a contract. 52.212-2(b) Capability Determination. Capability statements shall clearly demonstrate the respondent's ability to provide the required GastroPlus and DDDPlus software licenses, including documentation establishing that the respondent is the Original Equipment Manufacturer (OEM) or an authorized reseller, if applicable. The Government will evaluate the information submitted to determine whether another source is capable of meeting the Government's requirements. 3. Inspection/Acceptance and Order of Precedence: This notice incorporates Clause 52.212-4 Terms and Conditions � Commercial Products and Commercial Services by reference. Deliveries will be evaluated for acceptance in accordance with the criteria specified in FAR 52.212-4 and the notice addenda below: 52.212-4(b) Inspection and acceptance will be at destination by the COR or assigned Technical Point of Contact (TPOC) in accordance with FAR clause 52.212-4(b). In accordance with FAR 52.212-4(b), the Government has the right either to reject or to require correction of nonconforming supplies and services. Supplies are nonconforming when they are defective in material or workmanship or are otherwise not in conformity with agreement requirements. Services are nonconforming when they are not in conformity with the agreement requirements. The Government may reject nonconforming supplies and services with or without disposition instructions. The COR will load the software and licensing to verify that the platform can execute high performance and scalable visual modeling tools. The COR shall have 30 working days to inspect and verify that the software is operational, functional and compatible with FDA server and software. 52.212-4(r) Order of precedence. Should the contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor�s document, the Order of Precedence shall be as specified in Clause 52.212-4(r). The Contractor shall not auto-renew any subscriptions, licenses, maintenances and services not authorized under this contract. Any auto-renewals are at the risk of the Contractor, and the Government will not reimburse the Contractor. In the event of any inconsistencies between any licensing agreement incorporated into this order as an attachment