Office of Special Health Issues (OSHI) Tracking System

This is a notice of intent by the U.S Food and Drug Administration (FDA) to contract with IQ Solutions on a sole source basis for the technical, training, maintenance, and related support to the new Office of Special Health Issues (OSHI) Tracking System. The U.S. Food and Drug Administration (FDA) are increasingly engaging patients in regulatory activities and decision-making processes. Patient Representatives (PR) serve as Special Government Employees on Advisory Committees, in divisional assignments and other FDA workshops and meetings. FDASIA (Food and Drug Administration Safety and Innovation Act) Section 1137 requires FDA to work with the medical product Centers to find ways to include the patient perspective earlier in the medical product review process. Therefore, requests for Patient Representative involvement in FDA regulatory meetings are rapidly increasing to meet the requirements of Section 1137. Therefore, this tracking system is critical to ensure FDA is able to track recruitment, training, participation in FDA regulatory meetings, and other activities for Congressional reporting. The FDA intends to award a firm-fixed price contract to IQ Solutions, Inc. 11300 Rockville Pike, Suite 901 Rockville, MD 20852-3003 for the (1) operations and maintenance (2) enhancements (3) user training and support. FDA believes that IQ Solutions is the only offeror that can meet the requirement. The period of performance for the technical, training, maintenance, and related support is a one year base period with up to 2 one-year option periods. The authority used for this sole source contract is FAR 6.302-1 (Only One Responsible Source) and is based on the proprietary nature and application customization of the Patient Representative Program. The NAICS code is 519130. This notice is not a request for competitive quotes; no solicitation document is available and telephone requests will not be accepted. However, sources may submit descriptive literature, fully documenting their capability to perform these services, which will be considered by the Agency, via email to Jacqueline Warren at the email address below by 4:00PM on Friday, August 8, 2014. 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. An award will be issued to IQ Solutions, Inc. upon closing date of this notice unless the Government determines the sole source is invalid. If no responses are received, the FDA will proceed with the sole source award to IQ Solutions, Inc. 11300 Rockville Pike, Suite 901 Rockville, MD 20852-3003. The anticipated award date of this purchase order is on around August 15, 2014. No collect calls will be accepted. If you have any questions regarding this announcement, please contact Jacqueline Warren at 240.402.7557 or at via email jacqueline.warren@fda.hhs.gov.