GlobalSubmit Review and GlobalSubmit Validate software.

This is a notice of intent by the U.S Food and Drug Administration (FDA) to contract with GlobalSubmit, Inc. on a sole source basis for the maintenance and support of GlobalSubmit Review and Global Submit Validate software. The Food and Drug Administration (FDA) is aggressively moving towards an electronic regulatory submission environment to streamline the regulatory review process. Electronic submissions provide FDA reviewers with quicker access to information, as well as provide potential time and cost savings during product development and submission preparation for Sponsors. One of the key strategies to accomplish this goal is using standards to leverage business functions and information technology systems for the processing and review of submissions for a variety of FDA regulated products. Since 2003, the FDA has been accepting submissions using the International Conference on Harmonization (ICH) Electronic Common Technical Document (eCTD) standard. After conducting a technical alternatives analysis, the FDA acquired and implemented a commercial software review tool known as "Global Submit Review" (GSReview). The GSReview tool facilitates the electronic submission process to reviewers by providing both the Sponsor and the FDA reviewer an identical vantage point; which increases the chances for submission approval. The need for this software is critical for the efficient review of eCTD submissions for the FDA centers. The period of performance for the annual maintenance and 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 of Global Submit Review and Global Submit Validate software. The NAICS code is 541519. 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 Syntoria L. Spencer at the email address below by 9:00AM on Tuesday, May 27, 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 GlobalSubmit 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 GlobalSubmit, Inc. 123 South Broad Street, Suite 1850 Philadelphia, PA 19109. The anticipated award date of this purchase order is on around June 16, 2014. No collect calls will be accepted. If you have any questions regarding this announcement, please contact Syntoria L. Spencer at 240.402.7555 or via email at syntoria.spencer@fda.hhs.gov.