Army Congressional Special Interest Medical R&D RFI

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W81XWH-16-RFI-JWMR

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Sources Sought

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Added: Nov 09, 2015 8:34 am

1.0 SUBJECT: The Joint Warfighter Medical Research Program (JWMRP) provides an opportunity for the Department of Defense (DoD), through the Defense Health Program (DHP), to advance the outcomes of previously funded Congressional Special Interest medical research and development (R&D) projects addressing the military medical requirements of the Services. The JWMRP compliments and enhances the DHP by facilitating the further development of promising industry and academic solutions through the developmental process. Each year, a broad spectrum of research is considered under the JWMRP. The research is aligned to one of the five Joint Program Committee (JPC) scientific domains. These are: Medical Simulation and Health Information Sciences (JPC-1), Military Infectious Disease (JPC-2), Military Operational Medicine (JPC-5), Combat Casualty Care (JPC-6), 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 for the benefit of our Service members other military health system beneficiaries.

2.0 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. 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 2016 JWMRP has requirements in the following areas

Joint Program Committee-1/Medical Simulation and Information Sciences Research Program
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 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 information management and technologies
o Military Healthcare Services: Enhance the efficiency of health care operations, ensure the delivery of high-quality healthcare services by improving information accessibility and by providing better decision support for clinicians
o IT Infrastructure and Data Management: Improve management of IT and communications infrastructure, healthcare data management, and architecture
o Medical Resourcing: Improve the management of healthcare human and financial resources

Joint Program Committee-2/Military Infectious Disease Research Program
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

Joint Program Committee-6/Combat Casualty Care Research Program
o Forward Surgical Critical Intensive Care
o En-route care
o Hemorrhage Control & Resuscitation
o Neurotrauma/TBI
o Military Medical Photonics

Joint Program Committee-5/Military Operational Medicine Research Program
Injury Prevention and Reduction
o Musculoskeletal Injury
 Develop validated comprehensive standards and strategies enabling accurate, safe, and rapid decisions regarding the return of Service members to specific military occupations after musculoskeletal injury in the training and operational environment.
 Identify biochemical, physiological, and genetic biomarkers that predict risk of musculoskeletal injury and re-injury that will inform the ability to perform military duty.
 Develop validated interventions and non-invasive assessment tools to identify and mitigate injury risk.
 Identify training and other strategies to minimize acute and overuse musculoskeletal injuries in Service members and identify best practices for optimizing physical performance of Service members.
o Sensory Performance, Injury and Protection
 Develop validated medical criteria that will shape guidance, procedures, and requirements for personal protection equipment and validate DoD medical standards for exposure to hazardous noise, blast, ballistic and blunt trauma threats in the training and operational environment.
 Develop validated functional and FDA-approved clinical assessments that will improve neurosensory fitness for duty and return to duty (go/no go) decisions for mounted and dismounted Service members in the training and operational environment.
 Develop diagnostic and monitoring tools and equipment.
 Develop therapeutic countermeasures that prevent injury, or for acute management as rescue agents to mitigate damage.
o Aircrew Health and Performance
 Develop validated clinical guidelines that will inform requirements for the acquisition of current and future technologies that are stressors to aircrew physiology and performance.
 Establish aeromedical standards for assessing and optimizing aircrew proficiency and fitness to operate in degraded visual environments.
Psychological Health and Resilience
o Behavioral Health, Wellness, and Resilience
 Develop and revise resilience training that incorporates key behavioral health outcomes, markers of resilience, and evidence-based techniques.
 Develop evidence-based recommendations for identifying and addressing difficulties with post-combat adjustment.
 Benchmark emerging behavior health trends for Service members and their families and use this information to create a revised Unit Behavioral Health Needs Assessment survey tool.
 Develop and validate resilience training and leader-based interventions that reduce psychological health problems, anger and violence below benchmark rates.
 Develop and deliver evidence-based individual and group interventions, tools and technologies to better prevent, diagnose, and treat mental health issues such as suicide and substance abuse.
o Psychiatry and Clinical Psychology Disorders
 Elucidate the interrelationships of neurological systems as they relate to developing and maintaining the symptomology of posttraumatic stress disorder (PTSD).
 Identify candidate neurological intervention targets.
 Identify effective early screening and diagnostic tools appropriate for use in a variety of settings through use of a Systems Biology research model.
 Conduct medication, psychotherapeutic and alternative medicine clinical intervention trials.
 Identify the most efficient and effective methods of health services implementation of evidence-based approaches, then develop training and processes with accompanying confirmation trials for effective dissemination of research products to the provider communities.
o Millennium Cohort Study
 Understand and detect emerging threats related to military service across the health spectrum (physical, psychological, acute, and chronic) for the purpose of protecting Service Members and their Families.
Physiological Health and Performance
o Cognitive Health and Performance
 Develop strategies and technologies (e.g., software) to optimize and maintain cognitive performance during continuous and sustained operations.
 Develop methods to improve alertness and decrease sleep and/or fatigue-related error and accidents.
 Develop research tools, mobile technologies, and end-user applications to assess militarily-relevant performance and readiness.
o Nutrition and Weight Balance
 Identify and optimize Warfighter nutrition-based, personalized strategies to maintain physical and mental performance.
 Develop validated protocols to promote efficient and timely recovery from injury and maintain overall performance in garrison and during operations through nutrition-based interventions.
 Develop nutritional strategies to promote a resilient force able to maintain physical functioning in austere training and operational environments.
Environmental Health and Protection
o Warfighter Physical Performance
 Develop physical standards, predictive models, and countermeasures to prevent or mitigate effects of extreme environments.
 Develop interventions that sustain operational performance in extreme heat, cold and at high terrestrial altitudes to prevent and manage altitude sickness, heat, cold and dehydration injuries.
 Determine the combined impact of heat, humidity, and terrestrial altitude on human performance and develop novel mitigation strategies to enhance tolerance, sustain performance, and protect the Warfighter against environmental injury.
 Develop novel mitigation strategies to enhance tolerance, sustain performance, and protect the Warfighter against optic barotrauma, decompression sickness, oxygen toxicity, CO2 toxicity and hypothermia.
o Environmental Toxicant Exposure
 Develop an integrated experimental and computational platform to characterize host responses to environmental hazards.
 Identify biomarkers suitable for evaluation of Warfighters’ exposure to military relevant chemicals, airborne nanomaterials, diesel exhaust and other combustion products, and fuels.
 Use applicable biomarkers for Servicemembers exposures diagnostic assays, risk assessment, return to duty evaluations, and assessment of behavioral, medical, and causative factors.

Joint Program Committee-8/Clinical Rehabilitative Medicine Research Program
Neuromusculoskeletal Injury Rehabilitation
o Functional outcome assessments focusing on RDT and/or community reintegration
o Rehabilitative strategies that restore function after sustaining neuromusculoskeletal injuries
o Therapies to restore tissue and function
o Amputee-specific technologies and strategies that address/assess fitness sustainment and residual limb health
o Prevention and treatment of heterotopic ossification
o Mechanistic approaches to optimizing function in rehabilitative techniques and technologies
Vision Restoration and Rehabilitation
o Treatment of traumatic and war-related injuries (including blast and burn injuries) to ocular structures and the visual system
o Diagnosis, treatment, and mitigation of TBI-associated visual dysfunction
o Diagnostic capabilities and assessment strategies
o Restoration/regeneration of the visual system/tissue repair after injury
o Vision rehabilitation strategies
Hearing Loss/Dysfunction, Balance Disorders, and Tinnitus
o Strategies and technologies to restore and/or rehabilitate hearing loss/dysfunction, balance disorders, and/or tinnitus due to trauma (including TBI)
o Etiology of injury/dysfunction, including studies to support an understanding of the molecular, cellular, and physiological mechanisms
o Objective diagnostics for hearing loss/dysfunction, balance disorders, and tinnitus
o Biopsychosocial aspects of auditory and vestibular dysfunction
Pain Management
o Opioid alternatives
o Acute pain management (deployed and non-deployed settings)
o Chronic pain management(deployed and non-deployed settings)
o Identification of pain generators
o Substance abuse/misuse
o Biopsychosocial aspects of pain
Regenerative Medicine and Composite Tissue Engineering
o Innovative technologies to restore Service members who have suffered extremity injuries, craniomaxillofacial injuries, burn injuries, or genitourinary/lower abdomen injuries
o Regenerative medicine-based technologies to repair functional nerve deficits (other than central nervous system or spinal cord)
o Repair/replace neuromuscular tissue units of the extremities or face, including composite facial features
o Regeneration/repair of bone defects, skin, cartilage/musculoskeletal connective tissues, muscle, and composite tissue units composed of two or more of the above
o Vascular repair/re-vascularization; vascularized tissue allotransplantation, immunomodulation, and tolerization related to vascularized tissue allotransplantation
o Wound management and tissue preservation (e.g., scarless wound healing, not to include infection control)
o Pelvic reconstruction addressing injury to the anus
o Urogenital reconstruction addressing injury to genitalia (penile, scrotal, urethral tissues), perineal tissue, and bladder

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. 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.

5.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Barry Sayer at barry.g.sayer.civ@mail.mil no later than 12:00 PM ET, 14 DEC 15. Telephonic communication will not be considered as submission or receive response.

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Attn: MCMR-AAA

820 Chandler Street
Frederick, MD 21702-5014,

Maryland

21702-5014

United States

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