Software licenses and maintenance support services

The U.S. Food and Drug Administration intends to negotiate and award on a sole source basis to PPD Development, LP, under the authority 41 U.S.C. 253(c) (1), as set forth in FAR 6.302-1. This acquisition is to provide Table Trans software licenses and maintenance support currently being used for the FDA's Adverse Event Data from AERS. The Food and Drug Administration (FDA) requires TableTrans software which is a data mapping tool that can help with converting data to a more usable format. Modifying data to a usable format has been a major initiative at the FDA. Much of the data submitted to FDA requires reformatting to be used in analytic tools. TableTrans is used to prepare the Adverse Event Data from AERS for use in Empirical Signal, a data mining tool. This tool can also be used to modify pre-clinical and clinical trial data. The period of performance for the annual maintenance is one year. This requirement is currently being provided by PPD Development, LP and there are no resellers or 3rd parties that can provide these licenses. There are no other sources that can provide maintenance for this software. The purpose of this requirement is to provide additional licenses and software support for the FDA. The software must support data transformations as a sequence of basic steps. Specifically, the software should posses the following salient characteristics: - Specify, execute and automatically document complex data transformations - Specify and extract transformed data interactively or in batch mode to files or databases - Provides a wide range of built-in transformation operators and database functions to minimize programming - Visual Programming o Simplify data management and retrieval tasks through visual programming. o Transform data visually, step-by-step o Include visual transformations diagrams in order to facilitate explanation and modification - Selection from many data transformation operators - Provide SQL functionality without programming - Automatic documentation - 21 CFR compliant Additionally, the software vendor shall provide support, including installation support, updates and technical support during regular business hours. Technical support should be available through telephone, or email during regular business hours. The NAICS code is 511210 and the size standard is $25M. 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 Veronica Dhaness at the email address below by 12:00 PM Eastern Time on June 15, 2012. 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 PPD Development, LP, 929 N Front St., Wilmington, NC 28401. The anticipated award date of this order is around June 25, 2012. No collect calls will be accepted. If you have any questions regarding this announcement, please contact veronica.dhaness@fda.hhs.gov.