Renewal of Certara Simcyp

The U.S. Food and Drug Administration, Rockville, MD intends to award a firm-fixed price contract to renew FDA's subscription to Certara's Simcyp software licenses and associated maintenance. FDA intends to issue and award, to Certara UK Limited, Simcyp Division, Level 2-Acero, 1 Concourse Way Sheffield, UK S1 2BJ. FDA's Office of Clinical Pharmacology currently uses Simcyp to conduct Physiologically based pharmacokinetic (PBPK) modeling to review Investigational New Drug (IND), New Drug Applications (NDA) Biologics Licensing Applications (BLA), Abbreviated New Drug Applications (ANDA), and other submissions from sponsors. Reviewers and Pharmacometricians use the data to review sponsor submissions (pharmaceutical companies, academic institutions, and individuals) and adhere to schedules with timelines that must be met per the various user fee acts governing such work (Prescription Drug User Fee Act, Generic Drug User Fee Act, Biosimilars User Fee Act) and other FDA Mission-critical functions. If submissions are submitted to the FDA using Certara software they must also be reviewed using the Certara software, therefore no other PBPK modeling tool will meet OCP's needs. There are no set-aside restrictions for this procurement, and the anticipated Period of Performance is 9/21/2018 - 09/20/2019. Certara UK Limited offers a product with capabilities that are not available from any other vendor, and controls all propriety rights for this product: 1) The FDA has an ongoing business need for the Certara Simcyp software and maintenance. The annual software licensing is required by FDA to ensure continuity of operations. 2) The Certara Simcyp software is not available via a Government Best in Class (BIC) contract vehicle such as General Service Administration's Supply Schedules or another Government-wide Acquisition contract. The Government intends to solicit and negotiate with only one source under authority of FAR 6.302-1. Interested entities may identify their interest and capability to respond to the requirement or submit proposals. This notice is not a request for proposal and a solicitation will not be issued in conjunction with the notice of intent. Any vendor that believes it can provide the state supplies / equipment can provide supporting documents demonstrating their products capability and specifications statement. The FDA will review all responses received; however, the Government retains the sole discretion not to further compete the proposed acquisition based on responses to this notice. Information can be sent to Jody O'Kash at Jody.Okash@fda.hhs.gov. All correspondence must contain the notice number: FDA-18-PRESOL-1198255 and Project Title: Certara's Simpcyp Software and Maintenance. No telephone or facsimile requests will be accepted.