OCS Core Data Fitness Service

Notice of Justification for Exemption from Fair Opportunity

THIS ANNOUCMENT IS NOT A REQUEST FOR PROPOSAL

The US Food and Drug Administration {FDA), Office of Finance Budget Acquisition and Planning, intends to issue a single sole-source award, to provide data management and analysis to support FDA and its Core DataFitness Assessment, for the review of clinical and non-clinical study data; at The US Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring MD 20993.

The propose simplified acquisition is for services; the Government intends to solicit and negotiate to identified source only. A determination by the Government not to compete this proposed simplified acquisition is solely within the discretion of the Government.

Information received will NOT be considered for the purpose of determining whether to conduct a competitive requirement. No further solicitation is available.