Request for Information: Extracorporeal Life Support (ECLS) - Lung/Renal (L/R) Reduced Dialysate

REQUEST FOR INFORMATION 1.0 RFI TITLE: Extracorporeal Life Support (ECLS) - Lung/Renal (L/R) Reduced Dialysate 2.0 AGENCY: US Army Medical Materiel Development Activity (USAMMDA)/Joint Program Committee - 6 (JPC-6) 3.0 OFFICE: Combat Trauma and Acute Rehabilitation (CTAR) Program Management Office (PMO)/Prolonged Field Care Portfolio 4.0 LOCATION: 1430 Veterans Drive, Fort Detrick, MD 21702/504 Scott Street, Fort Detrick, MD 21702 5.0 SUBJECT: The CTAR PMO of the USAMMDA and Prolonged Field Care Portfolio of the JPC-6 are conducting market research to determine whether a solution exists that can meet requirements for the ECLS - L/R program. This market research may also assist with the further development and/or refinement of the requirements. 6.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained. 7.0 DESCRIPTION: The CTAR PMO and Prolonged Field Care Portfolio has a requirement for a device that provides continuous renal replacement therapy (CRRT), weighing less than 15lbs., and requiring less than 500mL of replacement fluid per day to operate. The CTAR PMO and Prolonged Field Care Portfolio anticipate the need for the prototype device to be taken through the FDA approval process as well. 8.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish a white paper. The subject header of the email for submission of questions and/or the RFI response shall be: ECLS - L/R Reduced Dialysate RFI. All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately. The RFI response shall not exceed five typed pages additional sheets for cover page, table of contents, tables and charts will not be counted toward page limitation. Submission should include the following information: 8.1 A white paper detailing the device's capability to provide kidney support through CRRT while using less than 500mL of replacement fluid per patient per day and device specifications on dimensions and weight. The white paper shall include sufficient data from preliminary studies to support claims related to the device's capability, provide sufficient information to support a technology readiness level (TRL) of 6 or higher, provide status of timeline and regulatory strategy to achieve FDA market authorization for CRRT in an acute kidney injury population, and funding gaps required to include performance, physical, chemical, biocompatibility, animal, feasibility, pilot trial, pivotal trial, etc., with associated unfunded costs necessary to complete the trials. For TRLs, see Appendix E: Biomedical TRLs http://www.acqnotes.com/Attachments/Technology%20Readiness%20Assessment%20Deskbook.pdf 8.2 Appropriate contact information 9.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Mr. Doug Medcalf at douglas.a.medcalf.civ@mail.mil no later than the close of business on 28 December 2018. Telephonic communication will not be considered as submission nor receive response.