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Subject: Peer Reviewed Traumatic Brain Injury and Psychological Health Research Program Fiscal Year 2021 Stakeholder Request for Information THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR ... Subject: Peer Reviewed Traumatic Brain Injury and Psychological Health Research Program Fiscal Year 2021 Stakeholder Request for Information THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ); IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT. 1.0 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. Survey Monkey is a website hosted on a public domain and is a privately owned company in which the government does not have any legal authority or control of. By responding to this survey you fully acknowledge that the government cannot be held responsible for any amount of data leakage from information marked or deemed proprietary. 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. 2.0 SUBJECT: The Congressionally Directed Medical Research Program (CDMRP) will hold a Stakeholders meeting where experts from different subject areas are brought together to identify knowledge gaps, outcomes, and product needs for the state of the science and patient care. To expedite the process, the CDMRP is currently soliciting information on the identification of knowledge gaps, outcomes, and product needs in traumatic brain injury (TBI) and psychological health research. 3.0 BACKGROUND: A Peer Reviewed Traumatic Brain Injury and Psychological Health Research Program (TBIPHRP) for Fiscal Year 2021 (FY21) is included in the United States FY21 Department of Defense appropriation at $175 Million (M). The FY21 TBIPHRP will be managed by the CDMRP according to Congressional intent to support research in the treatment, prevention, and detection of TBI and improved psychological health. The CDMRP will utilize its two-tiered review process (http://cdmrp.army.mil/about/2tierRevProcess) to efficiently manage the TBIPHRP. The CDMRP will also hold a TBIPHRP Stakeholders meeting where experts from different subject areas are brought together to identify knowledge gaps, outcomes, and product needs for the state of the science and patient care. After the stakeholders meeting, a vision setting meeting will be held to recommend an investment strategy to answer some of the unmet medical needs, knowledge gaps, and consumer concerns. 4.0 RESPONSE INSTRUCTIONS: Please provide responses to this RFI by clicking on the following link: https://www.surveymonkey.com/r/FY21TBIPHRP-RFI. A copy of the RFI is provided below. 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. Survey Monkey is a website hosted on a public domain and is a privately owned company in which the government does not have any legal authority or control of. By responding to this survey you fully acknowledge that the government cannot be held responsible for any amount of data leakage from information marked or deemed proprietary. 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. SUBJECT: A Peer Reviewed Traumatic Brain Injury and Psychological Health Research Program (TBIPHRP) for Fiscal Year 2021(FY21) is included in the United States FY21 Department of Defense appropriation at $175 Million (M). The FY21 TBIPHRP will be managed by the Congressionally Directed Medical Research Program (CDMRP) according to Congressional intent to support research in the treatment, prevention, and detection of traumatic brain injury (TBI) and improved psychological health. The CDMRP will hold a Stakeholders meeting where experts from different subject areas are brought together to identify knowledge gaps, outcomes, and product needs for the state of the science and patient care. In order to expedite the process, the CDMRP is currently soliciting information on the identification of knowledge gaps, outcomes, and product needs in traumatic brain injury and psychological health. BACKGROUND: The National Research and Action Plan (NRAP) of 2013 developed by the Departments of Defense, Veterans Affairs, Health and Human Services, and Education provides a framework in which TBI and psychological health research needs can be categorized. The categories are: Foundational Science: Basic discovery science; starting point for exploration of scientific ideas Epidemiology: Population-level descriptive studies of patterns, trajectories, causes, and effects of health and disease conditions that aim to identify risk factors and targets for preventative medicine Etiology: Biological processes/mechanisms; psycho-social and environmental causes Prevention and Screening: Population, selective, and indicated prevention interventions; stigma and barriers; resilience; screening measures; assessment tools and measures Treatment: Aimed at symptom amelioration at different stages of illness; includes psychotherapies, non-pharmacological interventions, and medications; addresses comorbidities Follow-up Care: Encompasses length and durability of treatment, long-term consequences of treatment, rehabilitation, relapse, and relapse prevention Health Services/Implementation Research: Focused on the system of care improvements, access to care, delivery of health care services, and treatment adherence Using this framework as a guide, please provide responses to the following request for information: Traumatic Brain Injury-Specific Questions In your opinion, which of the following research categories will have the most impact on TBI research (chose a maximum of three): Foundational Science Epidemiology Etiology Prevention and Screening Treatment Follow-Up Care Health Services/Implementation Research Based on your response above and the format below, what are the top three specific research area, knowledge, or clinical capabilities that are currently missing or not well-funded and, if funded, could make a significant impact on the state of the science and clinical outcomes? Please provide a bulleted list that starts with an NRAP category (e.g., Treatment: Comparative effectiveness studies to evaluate current management standards of TBI). What elements from the patient or care provider perspective (e.g., quality of life) require additional research or emphasis? Psychological Health-Specific Questions In your opinion, which of the following research categories will have the most impact on psychological health research (chose a maximum of three): Foundational Science Epidemiology Etiology Prevention and Screening Treatment Follow-Up Care Health Services/Implementation Research Based on your response above and the format below, what are the top three specific research area, knowledge, or clinical capabilities that are currently missing or not well-funded and, if funded, could make a significant impact on the state of the science and clinical outcomes? Please provide a bulleted list that starts with an NRAP category (e.g., Health Services/Implementation Research: Development of implementation interventions to increase uptake and consistent practice of evidence-based clinical practice guidelines within treatment facilities). What elements from the patient or care provider perspective require additional research or emphasis? Traumatic Brain Injury and Psychological Health Research Program What are the barriers (e.g., scientific, administrative, financial, collaborative, or other) to translating findings to clinical practice and how can they be addressed by the TBIPHRP? What types of funding opportunities could the TBIPHRP release that uniquely respond to the current research gaps and obstacles to clinical impact? Early Ideas-Preclinical Research Clinical/Translational Research Implementation Studies Team Science Clinical Trials Other (please specify) Demographics and Contact Info Which of the following best describes your role in the TBI and psychological health community? (Select all that apply.) Traumatic brain injury interest Psychological health interest Academia Industry Clinician Patient/Caregiver/Advocate Foundation/Governmental Program Administrator Other (please specify) If you would like to be contacted regarding attendance at the upcoming FY21 TBIPHRP Stakeholders meeting (tentatively planned for April 2021), please provide your name, organization, email, and phone number. 5.0 CONTACT INFORMATION: Any and all questions related to this RFI shall be directed to Luke Burke at luke.e.burke.civ@mail.mil All information regarding responses to section to this RFI shall be submitted via email to luke.e.burke.civ@mail.mil no later than 4:00 PM (EST) on 05 March 2021.