Intent to Issue a Single Source Purchase Order to Executive Information Systems, LLC for Maintenance and Support of SAS SDD and SAS LSAF Software License

THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, OFFICE OF ACQUISITION AND GRANTS INTENDS TO NEGOTIATE AND AWARD A SINGLE SOURCE SIMPLIFIED ACQUISITION PURCHASE ORDER UNDER THE AUTHORITY OF FAR 13.106-1(b)(1)(i) TO EXECUTIVE INFORMATION SYSTEMS, LLC (EIS), 6901 ROCKLEDGE DRIVE STE 600, BETHESDA, MD, TO PURCHASE A SOFTWARE MAINTENANCE AND SUPPORT LICENSE FOR THE FDA'S SAS DRUG DEVELOPMENT (SDD) AND SAS LIFE SCIENCE ANALYTICS FRAMEWORK (LSAF) LICENSE FOR ONE YEAR. THE MAINTENANCE AND SUPPORT WILL PROVIDE FDA CUSTOMERS WITH SOFTWARE UPDATES, BUG FIXES AND TECHNICAL SUPPORT FROM 08/31/2017 THROUGH 08/30/2018 IN SUPPORT OF THE CURRENT SDD TO LSAF MIGRATION. THE CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) OFFICE OF BUSINESS INFORMATICS (OBI) HAS ESTABLISHED SAS SOFTWARE (SAS DRUG DEVELOPMENT) AS PART OF ITS REGULATORY DRUG MARKETING APPLICATION SYSTEM. THE FDA IS MODERNIZING THE PROCESS WHEREBY DATA SUBMITTED AS PART OF A DRUG MARKETING APPLICATION IS READILY AVAILABLE FOR STATISTICAL AND MEDICAL REVIEW. THE FDA IS CURRENTLY TRANSITIONING FROM SAS DRUG DEVELOPMENT (SDD) TO SAS LIFE SCIENCE ANALYTICS FRAMEWORK (LSAF) AND REQUIRES THIS SAS ENVIRONMENT TO PROVIDE VERSION CONTROL, PERMISSIONS, AND OTHER CONTROLS OF THESE FILES, AND ALSO PROVIDE ALERTS TO THE APPROPRIATE REVIEWERS WHEN NEW DATA IS LOADED INTO THE SAS SYSTEM. IN ADDITION, THE CURRENT FDA REVIEW TOOLS (SUCH AS JMP, SAS, AND JREVIEW) NEED TO BE ABLE TO CONNECT TO THIS ENVIRONMENT. BASED ON AN EXCLUSIVE LICENSING AGREEMENT BETWEEN SAS AND EIS, EIS IS THE ONLY COMPANY AUTHORIZED BY SAS TO PROVIDE MAINTENANCE AND SUPPORT FOR THE FDA'S SAS SDD AND SAS LSAF SOFTWARE. THE PROPOSED SIMPLIFIED ACQUISITION ACTION IS FOR PRODUCTS FOR WHICH THE GOVERNMENT INTENDS TO SOLICIT AND NEGOTIATE WITH ONLY ONE SOURCE. INTERESTED PERSONS MAY IDENTIFY THEIR INTEREST AND CAPABILITY TO RESPOND TO THE REQUIREMENT OR SUBMIT QUOTES WITHIN 10 DAYS AFTER THE DATE OF PUBLICATION OF THIS NOTICE. A DETERMINATION BY THE GOVERNMENT NOT TO COMPETE THIS PROPOSED SIMPLIFIED ACQUISITION BASED UPON RESPONSES TO THIS NOTICE IS SOLELY WITHIN THE DISCRETION OF THE GOVERNMENT. INFORMATION RECEIVED WILL NORMALLY BE CONSIDERED SOLELY FOR THE PURPOSE OF DETERMINING WHETHER TO CONDUCT A COMPETITIVE REQUIREMENT. NO SOLICITATION IS AVAILABLE. ALL RESPONSIBLE VENDORS ARE ENCOURAGED TO SUBMIT A RESPONSE TO THIS NOTICE. FDA WILL CONSIDER ALL RESPONSES RECEIVED PRIOR TO THE CLOSING DATE OF THIS NOTICE AND WILL USE RESPONSES IN DETERMINING WHETHER IT IS NECESSARY TO USE FULL AND OPEN COMPETITION FOR THIS REQUIREMENT. FOR FURTHER INFORMATION, PLEASE CONTACT CONTRACT SPECIALIST ERIC FLAGG BY EMAIL AT ERIC.FLAGG1@FDA.HHS.GOV.