R--Intent to Sole Source - Fecal Microbiota Transplant (FMT)

The Department of Veterans Affairs, Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) intends to enter a sole source procurement with its academic affiliate, the University of Minnesota, in accordance with FAR 6.302-5 for services supporting a clinical trial. The contract is necessary to support the Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) is planning a clinical trial (CSP #2004) to determine the efficacy of orally administered fecally derived material for prevention of further recurrences in patients with recurrent Clostridium difficile infection (CDI). The University of Minnesota is an affiliate and collaborative research partner of the Minneapolis Medical Center. Additionally, The University of Minnesota has FDA approval for an Investigational New Drug (IND) related to their product. 38 U.S.C. 8153 allows for sole source awards related to research with our academic affiliates. This notice of intent is not a request for competitive proposals; however, any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than November 7, 12:00, EST. Interest/capability statements may be sent to Lynn Portman at contact@example.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.