Signal Detection Software Support

NOTE TO ALL INTERESTED VENDORS: THIS REQUIREMENT WILL BE ISSUED AS A COMBINED SYNOPSIS / SOLICITATION IN ACCORDANCE WITH FAR PART 12.6 PROCEDURES. THE COMBINED SYNOPSIS NUMBER WILL BE: FDA-SOL-10-1071337. The U. S. Food and Drug and Administration intends to award a contract using full and open competition to provide Operation and Maintenance (O&M) for FDA Empirica Signal Software. The NAICS code is 541511. The small business size standard is $25M. This is a commercial acquisition prepared in accordance with FAR Subparts 12 and 15. The anticipated contract type is Indefinite Delivery Indefinite Quantity (IDIQ). The minimum order value will be met by issuance of concurrent task orders. Therefore, no funds are awarded with the issuance of an IDIQ contract. The maximum cumulative ordering ceiling value for a five year IDIQ period is anticipated to be approximately $14 million. Each individual task order issued under this contract may be a firm fixed price, time and material, labor hours or a combination thereof. The Period of Performance is five years. The data used by Empirica Signal Software is the result of data extract from FDA's adverse event data repositories into a data warehouse. In this data warehouse, data management services are performed such as standardizing product names against a product dictionary and a duplicate report algorithm is used to eliminate duplicate reports. This data set is then extracted from the data warehouse for use by Empirica Signal. Empirica Signal software provides a reproducible and systematic approach to see important and useful safety signals. It is an effective tool for the early detection of previously unknown adverse reactions to both newly approved and established regulated products. Empirica Signal provides multiple graphical illustrations of data that can serve as valuable input to the overall process of product safety monitoring and review. Safety signals identified by Empirica Signal are individual product-event combinations that occur in a higher than expected proportion. These signals are carefully investigated to understand if regulatory action needs to be taken. These regulatory actions might include additional information to the product label, programs to mitigate risk for the product, or in extreme cases removal of the product from the market. Please note that FDA is not seeking licenses for software, rather, it is seeking technical support for data management, software configuration, software implementation and training. Currently, FDA has multiple Centers that are utilizing the Empirica Signal Detection for their signal detection management needs. The intent is to provide support for each center. The Government intends to issue a Request for Proposal (RFP) on or around July 1, 2010. The solicitation no. is FDA-SOL-10-1071337. Offerors will be given an opportunity to submit questions via e-mail ONLY after the solicitation is issued. All questions and answers will be posted to www.fedbizopps.gov. No phone calls please.