Notice of intent to issue a Sole Source Award for tuberculosis clinical trial management services

The Centers for Disease Control and Prevention Division of TB Elimination intends to award a sole source firm fixed price purchase order to OpenClinica LLC for tuberculosis clinical trial management services. The contract is for a 1-year bridge contract to ensure the continuation of a 10-year cycle research portfolio. The clinical trial data intake, analysis, and monitoring are essential for tracking performance of the active clinical trials and required by FDA regulation. • The contract is for commercial services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 12.102(a). • The contract action is for a firm fixed price purchase order. • The contract is for a 1-year bridge contract. • The clinical trial data intake, analysis, and monitoring are essential for tracking performance of the active clinical trials and required by FDA regulation.