Electronic Common Technical Document (eCTD) Validation and Review Software

The Food and Drug Administration (FDA) hereby issues a notice of intent in accordance with FAR 6.302-1. The FDA is contemplating a sole source award with GlobalSubmit, Inc., located at 123 South Broad Street, Philadelphia, PA 19109. The activities required are for maintaining and supporting the GlobalSubmit Review and GlobalSubmit Validate software. In this context, maintenance and support includes enhancing or upgrading the GlobalSubmit software products to meet FDA requirements. These services are critical to the review functions of the FDA. In accordance with FAR 6.302-1, the Government is contemplating this sole source award for the following reason: a) To the FDA's knowledge GlobalSubmit, Inc. is the only Contractor able to meet the requirement of this procurement. The FDA intends to award a contract to GlobalSubmit, Inc. for up to twelve (12) months to support the GlobalSubmit Review and GlobalSubmit Validate software. The NAICS code is 511210, Software Publishers. This notice is not a request for competitive quotes or proposal. No solicitation document is available and telephone requests will not be accepted. Respondents may submit information pertaining to their capabilities to perform the services required above within a timely manner to Michele Andrews at Michele.Andrews@ fda.hhs.gov, which may be considered by the agency. A determination to compete this procurement from the responses received shall be based upon the discretion of the Government. It is anticipated that an award will be issued to GlobalSubmit, Inc. approximately fifteen (15) days after the date of this notice unless, the Government determines another vendor has the capabilities of meeting this requirement and is more advantageous to the Government. All responses to this notice of intent shall be received no later than 3:00 PM Eastern Time (ET) on May 30, 2017 via email to Michele Andrews at Michele.Andrews@ fda.hhs.gov.