Notice of Intent to Sole Source Phoenix Quanturm Licenses

Title: Notice of intent to Sole Source Description: The Food and Drug Administration (FDA) hereby issues a notice of intent in accordance with FAR 5.201. Pursuant to FAR 6.302-1, the FDA will sole source with Certara USA, INC. 9666 Olive Blvd. Ste. 425, Saint Louis, MO. 63132-3013 for Phoenix Quantum licenses used to analyze the clinical pharmacology and pharmacometric data output of drugs submitted by sponsors. Certara is the only Contractor able to meet the requirement of this procurement. The FDA intends to award a purchase order to Certara for one year. Certara is the sole proprietor of Phoenix Quantum. Certara is the only Contractor who is able to provide licenses, maintenance and support for the software. The NAICS code is 511210, Software Publishers. This notice is not a request for competitive quotes or proposal. No solicitation document is available and telephone requests will not be accepted. Respondents may submit information pertaining to their capabilities to perform the services required above within a timely manner to Karen Conroy at karen.conroy@fda.hhs.gov , which may be considered by the agency. A determination to compete this procurement from the responses received shall be based upon the discretion of the Government. It is anticipated that an award will be issued the Certara USA, INC. approximately fifteen (15) days after the date of this notice unless, the Government determines another vendor has the capabilities of meeting this requirement and is more advantageous to the Government. All responses to this notice of intent shall be received no later than 12:00 PM Eastern Time (ET) on April 15, 2019 to Karen L. Conroy at karen.conroy@fda.hhs.gov