The Office of Cyber Infrastructure and Computational Biology (OCICB) Software Engineering Branch (SEB) uses the Liquent Insight Software to prepare, manage and submit eCTD versions of IND applications and New Drug Applications to regulatory agencies worldwide, including the FDA. This software is the industry/FDA standard and must be used for applications. The renewal of the software subscription will provide the maintenance and support required to successfully execute this NIAID initiative/requirement. The maintenance service agreement will provide unlimited access to the Parexel's support center, software upgrades, products, software enhancements, modifications and fixes, and online access to the support site.
The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-RML-D-1837101) to Bevin Feutrier at [email protected], by 5:00 pm eastern standard time Tuesday, March 28th, 2017 All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.