SPECIAL NOTICE
A -- FY18 Joint Warfighter Medical Research Program (JWMRP) - RFI Form - Clinical Trial and Technology Readiness Level Definitions
- Notice Date
- 2/27/2018
- Notice Type
- Special Notice
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-RFI-JWMRP-FY18
- Archive Date
- 4/24/2018
- Point of Contact
- Douglas A. Medcalf, , Toloria S. DuVall,
- E-Mail Address
-
douglas.a.medcalf.civ@mail.mil, toloria.s.duvall.civ@mail.mil
(douglas.a.medcalf.civ@mail.mil, toloria.s.duvall.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- See attached. Please complete and submit with RFI response. Synopsis: 1.0 SUBJECT: The Joint Warfighter Medical Research Program (JWMRP) provides an opportunity to advance previously funded DoD or Service medical R&D projects that address the medical requirements of the Services. The JWMRP complements and enhances the Defense Health Program by facilitating the further development of promising industry and academic efforts. Each year a broad spectrum of R&D initiatives are considered under the JWMRP. The efforts are aligned to one of the six Joint Program Committee (JPC) scientific domains. These are: Medical Simulation and Information Sciences (JPC-1), Military Infectious Diseases (JPC-2), Military Operational Medicine (JPC-5), Combat Casualty Care (JPC-6), Radiation Health Effects (JPC-7), and Clinical and Rehabilitative Medicine (JPC-8). Through research efforts focused in advanced technology development and product demonstration and validation, the JWMRP offers a pathway to transition maturing medical solutions to the Military Health System (MHS) for the benefit of our Service members and other MHS beneficiaries. 2.0 DISCLAIMER: This Request for Information (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. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI 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 RFP will not be entertained. 3.0 DESCRIPTION: The Fiscal Year 2018 JWMRP has requirements in the following areas: JPC-1/Medical Simulation and Information Sciences Research Program (MSISRP): The MSISRP manages research programs to explore the implications of models and technology for medical education and for the provision, management, and support of health services in the military. The major research and development focus areas are the following: Medical Modeling, Simulation, and Training Technologies: o Combat Casualty Training Initiative: Examine the efficacy of modern simulation system technology vs. current models for advancing combat casualty trauma training o Medical Readiness Initiative: Medical provider training systems and assessment of competence for sustained military medical readiness o Tools for Medical Education: Promote medical simulation-related technologies by providing tools for providers to easily develop new products and content o Health-Focused Initiative: Develop and test self-care technologies that patients use, whenever and wherever they choose, to manage personal health and wellness Health Informatics and Health Information Technologies: o Theater/Operational Medicine: Promote, improve, conserve, or restore the mental or physical well-being of personnel through improved health information management and technologies o Military Healthcare Services: Enhance the efficiency of healthcare operations, ensure the delivery of high- quality healthcare services by improving information accessibility and by providing better decision support for clinicians o Information Technology (IT) Infrastructure and Data Management: Improve management of health IT and communications infrastructure, healthcare data management, and architecture o Medical Resourcing: Improve the management of healthcare human and financial resources JPC-2/Military Infectious Diseases Research Program (MIDRP): The MIDRP focuses on preventative and therapeutic measures for infectious diseases. These efforts specifically focus on vaccines, anti-parasitic drugs, field-deployable clinical diagnostics (human and vector), prophylactics, and novel therapeutics to treat multidrug-resistant organisms in combat wound infections, as well as vector control pertinent to naturally occurring endemic diseases with demonstrated or potential capability to decrease military operational effectiveness. The major research and development focus areas are the following: o Novel drug delivery systems o Novel medical countermeasures and innovative treatment approaches for multidrug-resistant organisms in combat wound infections and/or biofilm formation, maintenance, or propagation o Treatment options for infectious diseases likely to lead to FDA-licensable, broadly active therapeutics against multiple endemic disease threats JPC-5/Military Operational Medicine Research Program (MOMRP): The MOMRP conducts biomedical research to deliver products and solutions to Service members that address health and fitness throughout the deployment cycle. The major research and development focus areas are the following: o Injury Prevention and Reduction o Musculoskeletal Injury o Psychological Health and Resilience Focused on Decreasing Post-Traumatic Stress Disorder, Depression and Anxiety Disorders, Suicide and Risk Behaviors o Physiological Health and Performance o Environmental Health and Protection JPC-6/Combat Casualty Care Research Program (CCCRP): The CCCRP provides integrated capabilities for current and future operations to reduce the mortality and morbidity associated with major combat-related trauma across the spectrum of en-route care and facilities-based treatment. A primary emphasis of the CCCRP is to identify and develop medical techniques and materiel (medical devices, drugs, and biologics) for early intervention in life-threatening battle injuries and Prolonged Field Care. The major research and development focus areas are the following: o Forward Surgical Critical Intensive Care o En-Route Care o Hemorrhage Control & Resuscitation o Neurotrauma/Traumatic Brain Injury o Military Medical Photonics JPC-7/Radiation Health Effects Research Program (RHERP): The RHERP focuses on developing countermeasures for acute ionizing radiation injury. The major research and development focus areas are the following: o Post-exposure mitigation of radiation injury o Protection and prevention of injury from ionizing radiation exposure (prophylaxis) o Development of novel radiation biodosimetry tools JPC-8/Clinical and Rehabilitative Medicine Research Program (CRMRP): The CRMRP focuses on the innovations required to reset our wounded Service members, both in terms of duty performance and quality of life. Innovations developed from CRMRP-supported research efforts are expected to improve restorative treatments and rehabilitative care to maximize function for return to duty or civilian life. The major research and development focus areas are the following: o Neuromusculoskeletal Injury Rehabilitation o Vision Restoration and Rehabilitation o Hearing Restoration and Hearing Loss Rehabilitation o Balance Disorders and Tinnitus o Pain Management o Regenerative Medicine and Composite Tissue Engineering 4.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish in writing, a 2-3 page (not including cover page, index or list of references) synopsis of their ability to address the areas listed above. Entities should describe efforts involving materiel product development at the following a technology readiness levels (TRL): • IM/IT - TRL 6: System tested with interfaces and support systems in relevant or simulated operational environment. Configuration Management Approach Developed. • Biomedical technology/medical devices - TRL 5: Investigational Device Exemption review had determined that the investigation can begin. For 510(k), preliminary results suggest the device will be substantially equivalent to a predicate device. • Biomedical technology/pharmaceuticals (drugs, vaccines, and biologics) - TRL 5: Pre-clinical studies, including Good Laboratory Practice animal safety and toxicity, sufficient to support Investigational New Device applications. Please complete the attached Request for Information Form for your submission and the use the attached Clinical Trial and Technology Readiness Levels Definitions in determining the current and projected TRL for the product development effort. In accordance with the Congressional language, these funds shall be used to augment and accelerate high priority DoD and Service medical requirements and to continue prior year initiatives that are close to achieving their objectives and yielding a benefit to military medicine. These funds shall not be used for new projects or for basic research. Companies responding to this notice must provide complete contact information (telephone, address, email address). Responders must identify their company's business size (based on the NAICS size standard), business status (i.e., small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please also include information regarding any prior experience with U.S. Government contracts. 5.1 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Doug Medcalf at douglas.a.medcalf.civ@mail.mil no later than 12:00 PM ET, 09 April 2018. Telephonic communication will not be considered as submission or receive response.
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