INTENT TO SOLE SOURCE The VA Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center (CSPCRPCC), 2401 Centre Ave, SE, Albuquerque NM, (Research & Development) intends to negotiate on a sole-source basis with Microbiome Health Research Institute (DBA OpenBiome),Medford MA pursuant to FAR 6.302-1. The CSPCRPCC is planning a clinical trial to determine the efficacy of orally administered fecally derived material for prevention of further recurrences in patients with recurrent Clostridium Difficile Infection (CDI). This procurement is for the provision of ACTIVE Fecal Microbiota Transplant (FMT) and Matching Placebo. The anticipated contract will be a base +2 Option Years years with a 4th Option Year possible, should the trial go over the anticipated 36 months. Below are the quantities needed Line Item Description Qty UI 0001 Fecal Microbiota Transplant (FMT) Active 135 Dose 0002 Fecal Microbiota Transplant (FMT) Placebo 135 Dose 0003 Apply Active Labels to Bottles 135 EA 0004 Apply Placebo Labels to Bottles 135 EA This procurement is being conducted in accordance with FAR 6.302-1(b)(1)(i) (only 1 responsible source). Extensive market research was conducted and sources contacted. No other source was capable of meeting all requirements needed to conduct this important clinical trial. This notice of intent is not a request for competitive quotes; however any responsible source who believes it is capable of meeting this requirement may submit a capability statement to the contracting office no later than Wednesday, November 30 2016 at 2:00 PM ET. Interest/capability statements may be sent to Linda Buccigrossi at
[email protected]. 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. Additional information is being provided as follows: Fecal Microbiota Transplant (FMT) 405 doses for initial 36-month study duration and up to an additional 135 doses for up to a 12-month study extension. Capsule format must be targeted release capsules which allow for use of the product without the need for proton-pump inhibitor (PPI) pre-treatment. Each dose will be bottled and inductive sealed or sealed foil pouches in bottles. Bottles may be individually labeled at contractor if product must remain frozen. Vendor will perform stability testing and release testing and provide the data to CSPCRPCC. For stability testing background, CSPCRPCC s distribution plan is as follows: Required Shelf-Life is a minimum of 6 months to meet the following distribution plan CSPCRPCC requires being able to store for three (3) to five (5) months using vendor s recommended storage conditions. Â CSPCRPCC will ship to research site(s) using vendor recommended storage/shipment conditions. The research site will store for up to one (1) month at the vendor recommended storage conditions. Site personnel will hand-carry doses to participants with storage up to 3 days prior to ingestion. Â Vendor will initially store at vendor site using recommended storage conditions. Â Shipments to CSPCRPCC will be consistent with the recommended storage conditions. To ensure recommended conditions are known, vendor must have and share scientifically-based guidance about storage conditions, including shelf-life at various conditions and details on how to handle temperature excursions. Only limited intellectual property will be supplied to the contractor from the VA. Â Required safety information (e.g., reports of related or possibly related serious adverse events) will be shared but information which would allow participants to be identified will not. Some aspects of what information can be shared with the contractor are negotiable. Contractor will allow VA to reference FDA regulatory filings (Investigational New Drug (IND) submission, Biologics Master File (BMF), or Drug Master File (DMF)). These documents will cover donor program, cGMP processes (i.e. formulation, manufacturing, etc.) and Investigator s Brochure. Â Contractor must have at least preliminary data in regards to safety and efficacy for treatment of recurrent CDI.