A -- HPV Type 16/18 Vaccine Trial in Costa Rica
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The Hormonal and Reproductive Epidemiology Branch (HREB) of the Division of Cancer Epidemiology and Genetics (DCEG) at the National Cancer Institute (NCI) plans to modify Contract No. N01-CP-11005, which supports the HPV Type 16/18 Vaccine Trial in Costa Rica conducted in partnership with Fundacion INCIENSA. This modification involves extending the contract by three years and increasing its total cost due to an unexpected delay in the availability of adequate GMP-grade HPV vaccine supplies required for the continuation of the trial. Additionally, the contract adjustment addresses the need to implement ethically mandated cross-over vaccination and the exit of participants from the trial, which were not anticipated at the study’s outset. The contract modification will be negotiated under a sole-source authority based on FAR 6.302-1 due to the unique circumstances related to the vaccine trial and its requirements. Although this notice is not a formal request for competitive proposals, the government invites interested parties to express their interest and capability within 45 days of the notice publication. Responses will be considered solely to determine whether a competitive procurement process should be conducted, with the final decision resting with the government. The contracting officers responsible for this action are Sharon J Miller and Karen C. McFarlane, who can be contacted for further information.
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