Simulations Plus GastroPlus Software Licensesview on SAM.gov

The Department of Health and Human Services (HHS), Centers for Disease Control (CDC) plans to procure, on a sole source basis, Simulations Plus GastroPlus Software Licenses from: Simulations Plus, Inc. P.O. Box 12317 Research Triangle Park, NC 27709 The closing date of this notice is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1 (b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code (NAICS) is 513210 - Software Publishers, and the small business size standard is $47M. Background 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. ORS is in need of a contract to Simulations Plus to procure GastroPlus Software. Objectives The purpose of this requirement is twenty (20) GastroPlus licenses with five DDDPlus (includes licenses to the Digit™ and MedChem Designer) licenses and five MembranePlus licenses to accommodate the need for commercial physiologically based pharmacokinetic (PBPK) modeling software. Requirements 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) is in need of a contract to Simulations Plus to procure GastroPlus Software for a base year period and four one-year option periods. GastroPlus software is the only known software that uses the ACAT model to predict oral absorption and combines non-oral delivery routes (such as ocular and pulmonary) in the prediction model. The ACAT model is widely accepted in the scientific community and many absorption models already built by FDA scientists have been created using the ACAT model. DDDPlus is a companion software that allows for the prediction of in vitro dissolution and lot-to-lot variability. MembranePlus is a companion software that allows for the prediction of the in vitro permeability of drugs. Equipment/Software Specifications 1. GastroPlus licenses – Quantity 20 Minimum Specifications:- Standard, individual, perpetual licenses 2. DDDPlus (includes licenses to the Digit™ and MedChem Designer) – Quantity 5 Minimum Specifications: -Standard, individual, perpetual licenses 3.MembranePlus™ – Quantity 5 Minimum Specifications: -Standard, individual, perpetual licenses This notice is not a request for competitive quotations. However, if any interested party, especially a small business, believes it can meet the Government's needs, it may submit a capability statement, proposal, or quote for the Government to consider. The response and any other informa…