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“Single Blood Donor Collection and Storage Bags Manufactured in Continental United States (CONUS)” The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Re... “Single Blood Donor Collection and Storage Bags Manufactured in Continental United States (CONUS)” The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) in support of the Defense Health Agency (DHA) in alignment with the Department of Defense (DoD) 2022 National Defense Strategy. This effort aims to invest in manufacturing capabilities within the Continental United States (CONUS) as part of a greater effort to bolster the Defense Industrial Base and secure domestic supply chains. In recent years, there has been a shortage of much needed blood storage bags, which is acute within the DoD system where there is a requirement for individually wrapped blood bags for use in far forward situations. The U.S. Government (USG) is looking for solutions to stand up CONUS manufacturing capabilities to ensure rapid scalable blood bag production in the event of need. ___________________________________________________________________________ Background: DoD’s diverse capabilities involve Warfighters operating in a vast array of challenging, remote, and austere environments. In forward positions, there is a high probability of traumatic injury and wounds leading to blood loss. Hemorrhage is the leading cause of death in combat zone trauma. The gold standard for immediate treatment of hemorrhage is transfusion of whole blood. Delays in transfusion result in increased deaths. However, the availability of whole blood and conventional blood products on forward missions is very limited owing to challenging logistical requirements for transport and storage of blood components. Often, the best approach is to collect blood locally, as opposed to transporting over long distances. In recent years, there have been supply chain disruptions across the continuum of military and civilian products, including components used in the manufacture of blood bags, from the polymers to the anticoagulant/preservative solutions within the bag. This has resulted in shortages of single blood storage kits most often used in austere environments especially for collections from on-site donors in “walking blood bank” scenarios. According to the U.S. Food and Drug Administration Center for Biologics Evaluation and Research’s product shortages website, the shortage of blood collection bag kits and products is ongoing. Shortages of ingredients, components, and manufacturing supplies, as well as delays in manufacturing and transport, are intermittent and unpredictable. A request for surge production may be required dependent on DoD needs. This vital product is required in steady supply to meet the needs of wounded warfighters to enable timely transfusion near the point of injury with donated blood. Technical Objective: This RPP focuses on the CONUS manufacture of single blood bags for use by the Armed Services Blood Program and far forward medical services as well as commercial/civilian blood services. The technical objectives of this program are to: Blood Bag Specifications: Produce detailed documentation and manufacture blood bags within the CONUS that meet the following existing specifications: Individually wrapped single aseptic collection kit inclusive of 16-gauge donor phlebotomy needle with protection needle guard, tubing, labels, and a sample diversion pouch Compliant with FDA (21 CFR 864.9100), ISO 10993 and 3826, USP and MIL 810H standards and guidance[1],[2] Supports whole blood donor phlebotomy of 500 mL (+/-10%, 450-550 mL) or 450 mL (+/-10%, 405-495 mL) Contains a solution of anticoagulant and preservatives meeting the USP standards that allows for storage of blood for a minimum of 21 days up to 35 days. Novel formulation will be considered based on budgetary and regulatory provisions Foil wrapping that is easy to open requiring no tools and if practical, textured for better grip with brightly marked notches not only at the corners but also in the center of the packaging The manufactured bags should have a shelf life of 18 - 24 months at room temperature (15 – 30 ºC) Appropriate fatigue and distortion testing Achieve FDA clearance or exemption for the kit Manufacturing Expected Deliverables: Capability to manufacture no less than 10,000 standard blood donor/storage bags per year Have a validated surge capability plan to increase manufacture to 240,000 bags every 60 days during times of increased demand (i.e., near peer conflict or domestic disaster) for full single blood bag kits with compliant materials and processes Demonstrate redundancy in sourcing of raw materials (e.g., anticoagulant solution, tubing, PVC, seals) from multiple vendors. Develop contingency plans for raw material disruptions. Experience: Leverage the experience of a team that has relevant expertise: Designing medical devices, specifically blood products, and adhering to verification and validation guidance. Established current Good Manufacturing Practice (cGMP) ready methods with fully designed hardware and functional disposables Additional points of consideration: Proposals are encouraged to include relevant industry partners, especially considering that the eventual goal is to transition products to industry for U.S. Food and Drug Administration (FDA) approval and/or commercialization. Manufacturers implementing cGMP that require financial assistance to meet all requirements of the FDA with clear standard operating procedures and compliance documentation (21 CFR 864.9100). Potential Funding Availability and Period of Performance: The USG currently has up to $4M available for the upcoming program. MTEC expects to make one or more awards for approximately $1-3 M to a qualified Offeror(s) for an initial base period of performance (Phase I) not to exceed 12 months, but preferably 6 months. The Government anticipates a performance period after Phase I and continuation in subsequent stages of development not to exceed 42 months, including all proposed phases of work (Phases I, II, and III) (see below for more details) based up performance, military relevancy and funds availability. The Government intends to utilize a downselect approach during the performance of prototype projects awarded as a result of this effort. Using this approach, the Government intends to award projects, structured into two or more Periods of Performance, with an initial base period reflecting the first of three phases. After an In-Process Review, an evaluation of project deliverables, and other considerations to include progress towards completion of the base tasks, the Government intends to award additional Phase II and III tasks for selected performer(s). During Phase I (approximately 6 months, no longer than 12 months), the Offeror shall submit documentation and evidence in support of detailed technical, test and control plans with regard to standing up blood bag manufacturing. During Phase II (approximately 24 months), the Offeror shall stand up CONUS manufacturing inclusive of capital equipment procurement, sourcing materials and manufacturing pilot runs for the kits. This is inclusive of activation of manufacturing lines, implementation of the processes for Quality Control for production of articles, and optimization of production. This will be when the single blood bags are assessed for regulatory fitness including any required studies from the FDA. Upon clearance by regulatory authority, sample lots to perform testing within DoD test groups during field exercises will be provided to DHA as well as contemporaneously obtaining FDA 510(k) clearance. During Phase III (approximately 12 months), the Offeror shall execute manufacturing to ensure rapid scalable production capacity in the event of need and acquisitions by DHA and potential partners. A reasonable plan for sustainment should be provided. Acquisition Approach: Full proposals will be required in response to this RPP thus reflecting a single stage acquisition approach. MTEC membership is required for the submission of a full proposal. The Government will evaluate proposals submitted and will select those that best meet their current technology priorities using the criteria noted in the upcoming RPP. The upcoming RPP will be posted to the MTEC website (mtec-sc.org). The RPP is expected to be released as soon as possible and will have a proposal preparation period of approximately 30 days. MTEC membership is required for the submission of a proposal in response to the upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/. MTEC: The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters’ health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the Defense Health Agency Contracting Activity (DHACA), formerly known as the U.S. Army Medical Research Acquisition Activity. MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, “nontraditional” defense contractors, academic research institutions and not-for-profit organizations. Point of Contact: For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Chuck Hutti, MTEC Biomedical Technology Liaison, chuck.hutti@mtec-sc.org. Sincerely, MTEC Project Team [1] https://www.fda.gov/media/142959/download [2] https://quicksearch.dla.mil/Transient/4E6C137B24C842BFA150851C51FCC505.pdf