04-JUN-2019, UPDATE TO NOTICE: The purpose of this notice amendment is to issue Solicitation Amendment W81XWH-19-R-0036-0001 for the ECLS Reduced Dialysate requirement and upload the amendment (SF30), amended RFP/Solicitation (SF33), and Attachment 10 (new). The proposal due date is not extended. The US Army Medical Materiel Development Activity's (USAMMDA's) mission is to develop and deliver quality medical capabilities to protect, treat, and sustain the health of our Service Members. The Joint Program Committee - 6's (JPC-6's) mission seeks to drive medical innovation through the development of knowledge and materiel solutions for the acute and early management of combat-related trauma. ECLS is administered to critically ill patients suffering from life-threatening renal injuries. Although this is a life-saving intervention, current technology is limited by the immense logistical footprint required to support these devices. Current standard of care ECLS devices that provide support to the kidneys require ~70L of replacement fluid per patient per day. This is an immense logistical burden in the far forward environment where supply lines are limited or non-existent making the support of these devices infeasible. Therefore, the aim of this effort is to reduce the amount of replacement fluid required to support these patients in a logistically constrained environment. The United States Army Medical Research Acquisition Activity (USAMRAA), in support of the USAMMDA Combat Trauma and Acute Rehabilitation (CTAR) Project Management Office (PMO) and JPC-6, is soliciting for research and development (R&D) services to: (1) develop a small, lightweight, rugged ECLS device that provides continuous renal replacement therapy (CRRT) to critically injured patients using less than or equal to 0.5 Liters (L) of replacement fluid per patient per day; (2) conduct necessary clinical trials to support U.S. Food and Drug Administration (FDA) submission; and (3) obtain FDA clearance for the device. The Government anticipates that the solicitation will result in the award of a cost-plus-fixed-fee R&D contract, with up to thirty-six (36) months of performance. The Government's objectives are outlined in the solicitation. The North American Industry Classification System (NAICS) Code selected for this acquisition is 541715-Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology); and the size standard is 1,000 employees. This procurement is a 100% small business set-aside. Award shall be made on a competitive basis, using the best value tradeoff process among cost and non-cost factors described at FAR 15.101-1. The Government intends to evaluate offers and award a contract without discussions with Offerors. Therefore, the Offeror's initial offer should contain the Offeror's best terms from a cost and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received. Those interested in obtaining the solicitation can access it at the Federal Business Opportunities (FedBizOpps) website at www.fbo.gov and search for solicitation W81XWH-19-R-0036. Vendors wishing to submit an offer are responsible for downloading their own copy of the RFP (and accompanying exhibits/attachments) and for frequently monitoring the site for any amendments. Requests made by phone will not be accepted. No solicitations will be provided by hard copy, fax, or e-mail. Failure to respond to the electronically posted RFP and associated amendments prior to the date and time set for receipt of proposals specified on the solicitation may render vendor offer non-responsive and result in rejection of the same. The Government is not responsible for any loss of internet connectivity or for an Offeror's inability to access the documents posted at the referenced website. Solicitation Release Date: 24 May 2019 Question Submission Date: 03 June 2019, 8AM ET Proposal Submission Date: 24 June 2019, 3PM ET Anticipated Award Date: 23 September 2019 To be eligible for an award or payment from any Department of Defense activity, Offerors must provide registration information to the System for Award Management (SAM)*. All Offerors must be registered in SAM for "All Awards" prior to receiving an award. The Offeror's SAM record must be active and should include the NAICS that has been selected for this procurement. An entity can be registered in SAM under multiple NAICS if they are applicable to the entity's business. EARLY REGISTRATION IS ADVISED. Registration instructions may be obtained, and online registration may be accomplished, at www.sam.gov. This includes the online representations and certifications located within SAM. *Entities registering in SAM must submit a notarized letter appointing their authorized Entity Administrator. Please note that the instructions for domestic and international entities differ. It is recommended that Offerors allow sufficient time to complete the SAM registration process. Please visit the following URL to learn more: https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/sam-update-updated-july-11-2018
