Pragmatic Data HL7 Data Exchange and Elist software license and maintenance; and professional services

The U.S. Food and Drug Administration intends to negotiate and award on a sole source basis to Pragmatic Data, Inc, under the authority 41 U.S.C. 253(c) (1), as set forth in FAR 6.302-1. This acquisition is in support of the FDA's HL7 data exchange services and automated drug registration and listing system (eLIST). HL7 data exchange service is essential for the processing of HL7 data files. HL7 data exchange services require a perpetual license for the Pragmatic Data Integrator, Adverse Event Modules, Review and Edit, and PRPPLR modules in order to continue using the HL7 date exchange services to meet various requirements. FDA also requires an annual license for the Pragmatic Data Edit and Review module for processing many types of SPL files and various other HL7 standardized data. In addition, FDA is renewing the license for the Pragmatic Data HL7 exchange standard testing and evaluation environment software to allow continued testing HL7 data exchange standards. The eLIST system supports the FDA's regulation for industry to submit timely product content of labeling, facility, registration and listing information in an electronic format. FDA has procured Regulatory Business Data Management Database (RBDMD) and integrated services (including PRPLLR) software licenses. Annual maintenance for these licenses is required to continue eList regulatory operations. The purpose of this requirement is to obtain perpetual licenses for pragmatic data integrator, adverse event modules, review and edit, and PRPLLR modules; continued annual software license and maintenance for the pragmatic review and edit module with Xforms and adverse events; annual license for the pragmatic testing environment and professional services support for the implementation and use of the eLIST system. Pragmatic Data is the only source for the software and there are no authorized resellers or 3rd parties that can provide pragmatic licenses and maintenance; and professional services. The NAICS code is 541512 and the size standard is $27.5M. This notice is not a request for competitive quotations. However, any firm that believes it can meet these requirements may submit a written response via email to Danielle Pena at the email address below by 10:00 AM Eastern Time on August 1, 2016. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirement. Information received will be considered; however, a determination by the Government not to compete the proposed acquisition based on responses to this notice is solely within the discretion of the Government. If no responses are received, the FDA will proceed with the sole source award to Pragmatic Data, 8839 Rexford Rd, Indianapolis, IN 46260. No phones calls will be accepted. If you have any questions regarding this announcement, please contact Danielle Pe'a at danielle.pena@fda.hhs.gov.