Intent to Sole Source IQS, Inc.

THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, OFFICE OF ACQUISITION AND GRANTS INTENDS TO AWARD A SOLE SOURCE SIMPLIFIED ACQUISITION TO IQS, INC., 24950 COUNTRY CLUB BLVD. #120 NORTH OLMSTED, OH, TO PURCHASE SOFTWARE MAINTENANCE SERVICE FOR SEVERAL QIS LICENSE PACKAGES. THE MAINTENANCE SERVICE WOULD PROVIDE FDA CUSTOMER WITH PRODUCT UPDATES AND BUG FIXES, TECHNICAL SUPPORT, THE ABILITY TO ADD NEW MODULES TO THEIR CURRENT LICENSE PACKAGES, AND THE ABILITY TO MANAGE LICENSES ONLINE FROM 04/30/2017 THROUGH 04/29/2021. THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) AND THE CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) HAVE ESTABLISHED IQS BUSINESS SYSTEM SOFTWARE PACKAGE AS THEIR LABORATORY QUALITY SYSTEM. IQS, INC. IS THE ONLY COMPANY THAT PROVIDES MAINTENANCE AND SUPPORT FOR ITS SOFTWARE, WHICH IS WHY IT IS NECESSARY FOR IQS TO PROVIDE MAINTENANCE AND SUPPORT PRODUCTS FOR CBER AND CDER. THE IQS SOFTWARE PROVIDES EVALUATION AND TESTING OF REGULATED BIOLOGICAL AND DRUG PRODUCTS SOLD AND DISTRIBUTED IN THE UNITED STATES FOR HUMAN USE, INCLUDING TESTING PERFORMED IN SUPPORT OF PRODUCT APPROVAL, LICENSING, SUPPLEMENTS AND AMENDMENTS TO LICENSES, CONFIRMATORY LOT RELEASE TESTING, TESTING IN SUPPORT OF OFFICIAL INVESTIGATIVE ACTIONS, TESTING SUPPORTING THE DEVELOPMENT AND CHARACTERIZATION OF OFFICIAL REFERENCE MATERIALS AND STANDARDS, AND COLLABORATIVE STUDIES WHERE THE RESULTS ARE PERTINENT TO THE MISSIONS OF THE CENTERS. 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.