Electronic Common Technical Document (eCTD) Licenses, Maintenance and Support

The Food and Drug Administration (FDA) hereby issues a notice of intent in accordance with FAR 5.203(a). The FDA is contemplating a sole source award under the authority of FAR 6.302-1, with SYNCHROGENIX INFORMATION STRATEGIES, LLC.to maintain continuity of operations for the FDA Legacy Electronic Common Technical Document (eCTD) Licenses, Maintenance and Support for GlobalSubmit Review and GlobalSubmit Validate. In this context, "lights on" maintenance and support of the GlobalSubmit software product includes problem resolution, technical discussions, minor system enhancements necessitated by regulatory requirements or mandates 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 SYNCHROGENIX INFORMATION STRATEGIES, LLC is the only Contractor able to meet the requirement of this acquisition. The FDA intends to award a contract to SYNCHROGENIX INFORMATION STRATEGIES, LLC estimated not to exceed twelve (12) months, or an estimated not to exceed amount of $1 million, for licenses and 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 proposals. 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 SYNCHROGENIX INFORMATION STRATEGIES, LLC 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 August 14, 2019 via email to Michele Andrews at Michele.Andrews@fda.hhs.gov.