Combat Wound Care Research

Sources Sought Technical Description for: Combat Wound Care Research. INTRODUCTION The U.S Army Medical Research Acquisition Activity (USAMRAA) in support of U.S. Army Institute of Surgical Research, Combat Wound Care Research Team, is issuing this Sources Sought for informational and planning purposes only. Contact with Government personnel, other than those specified in the Sources Sought/RFI (request for information), by potential vendors or their employee's regarding this requirement is not permitted. This RFI is in support of the USAISR Combat Wound Care team to provide a cerium-ion-releasing solid wound dressing to include details of the formulations and release kinetics of the cerium ion from the dressing. If the information provided contains propriety information, such information must be identified with appropriate disclaimers. The result of this market research will contribute to determining the method of procument, if a requirement materializes. Based on the responses to this sources sought notice/market research, this requirement may be set-aside for small businesses (in full, or in part) or procured through full and open competition. Multiple awards may be made. All small business set-aside categories will be considered. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding submissions. DISCLAIMER THIS SOURCES SOUGHT IS FOR INFORMATIONAL PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSAL (RFP) TO BE SUBMITTED. IT DOES NOT CONSTITUTE A SOLICITATION AND SHALL NOT BE CONSTRUED AS A COMMITMENT BY THE GOVERNMENT. RESPONSES IN ANY FORM ARE NOT OFFERS AND THE GOVERNMENT IS UNDER NO OBLIGATION TO AWARD A CONTRACT AS A RESULT OF THIS ANNOUNCEMENT. NO FUNDS ARE AVAILABLE TO PAY FOR PREPARATION OF RESPONSES TO THIS ANNOUNCEMENT. ANY INFORMATION SUBMITTED BY RESPONDENTS TO THIS TECHNICAL DESCRIPTION IS STRICTLY VOLUNTARY. PROGRAM BACKGROUND The USAISR is part of the U.S. Army Medical Research and Development Command (USAMRDC). The USAISR is dedicated to both laboratory and clinical trauma research. Its mission is to provide requirements-driven combat casualty care medical solutions and products for injured soldiers from self-aid through definitive care across the full spectrum of military operations; provide state-of-the-art trauma, burn, and critical care to Department of Defense beneficiaries around the world and civilians in our trauma region; and provide Burn Special Medical Augmentation Response Teams. The USAISR's mission is to provide combat casualty care medical solutions and products for wounded warriors, from self-aid through definitive care across the full spectrum of military operations; provide state-of-the-art trauma, burn, and critical care to Department of Defense beneficiaries and civilians; and provides Burn Flight Teams. REQUIRED CAPABILITIES At a minimum, the following information is requested: (1) Capability Statement; (2) Company Cage Code, DUNS, SAM registered, name, address, point of contact and their telephone number and e-mail address; (3) Approximate annual gross revenue; (4) Any small business status (8(a), HUB Zone, veteran-owned, women-owned, etc.); and (5) Indicate which NAICS code(s) your company usually performs under for Government contracts. You are encouraged to submit the following highly desirable information in response to this RFI: The Capability Statement should include general information and technical background describing your company's experience within the last three to five years, specifically with federal government or commercial market contracts similar in scope, complexity and size to meet the program objectives in accordance with the DRAFT PWS. The Capability Statement should include describe your company's experience supporting/staffing multiple projects at various stages within the life cycle while concurrently responding to multiple stakeholders. The ability to produce solid wound dressings (with and without cerium-ions) that are lightweight and easily deployed by medical and nonmedical personnel to treat wounds at or near point of injury. Dressing should not require special storage requirements. When placed on the wound, the dressing must be easily removable to allow wound wash with sterile water or saline, and replaced with a fresh dressing. Dressing must have shelf life of at least 1 year. Dressing containing cerium-ions should provide sustained release of the cerium-ions for at least 3 and up to 7 days. Dressing should be easy to cut with scissors to fit different size of wounds. Must be able to provide details of formulations for the addition of the metal to the substrate and for the release of cerium-ions. Additionally, must report in vitro release kinetics of cerium-ions from the cerium-ion containing dressing as well as provide details of the fabrication process for the cerium-ion releasing dressing. Must demonstrate ability to comply with product stability testing (in accordance to ICH guidelines) and product safety testing (in accordance with ISO 10993-5:2009). Must be able to provide individually packaged cerium-ion releasing-dressings in the following sizes and quantities: 4'x4 (125 pieces) and 4'x12 (25 pieces). Must also provide control dressings without cerium in the following sizes and quantities: 4'x4 (125 pieces) and 4'x12 (25 pieces). Must be willing to schedule bi-weekly conference calls with USAISR to discuss progress as well as keep and provide minutes of the meetings. Must also provide monthly written reports focusing on progress, schedule, issues and mitigation plans to solve concerns. If your company is capable of providing the requirements described in the attached DRAFT PWS, please provide a Capability Statement to Tammy McRae at tammy.n.mcrae.civ@mail.mil. Please do not respond with generic material only such as brochures, advertisements or other similar material, which is highly discouraged. A response to this RFI must be provided no later than (NLT) 23 July 2021 at 10:00pm Eastern Time. No extensions will be granted. THIS IS NOT A SOLICITATION ANNOUNCEMENT OR REQUEST FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. If your company is capable of providing the requirements described in the attached DRAFT PWS, please provide a Capability Statement to Tammy McRae at tammy.n.mcrae.civ@mail.mil. Please do not respond with generic material only such as brochures, advertisements or other similar material, which is highly discouraged.