MTEC RPP Pre-Announcement - Warfighter Brain Health (WBH): Late and Long-Term Consequences of Head Impact Exposure and Concussion/Mild Traumatic Brain Injury (mTBI) on Brain Health

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an upcoming Request for Project Proposals (RPP) focused on determining the relationship between concussion/mild traumatic brain injury (mTBI) and brain health (BH) outcomes through a longitudinal human subject study assessment. Background: The Department of Defense (DoD) Comprehensive Strategy for Warfighter Brain Health (CSWBH) addresses brain health, brain exposures, to include repetitive head impact exposures, TBI and long-term or late effects, with the goal of optimizing brain health and combating TBI. The DoD's pursuit of superior lethality, per the National Defense Strategy (2018) hinges on the Warfighter's optimal neurocognitive abilities, thus detection and management of brain injury at the time it occurs is paramount. One of the objectives of this strategy is to understand the nature and causes of long-term or late effects of single or repetitive head impact exposures and mTBI/concussion. This remains a significant gap that has stymied translatable knowledge or technology to be conveyed for the benefit of the Warfighter. Several gaps in the existing evidence remain related to the extent by which single and repetitive concussions and/or head impact exposures result in static or progressive changes in brain structure or function and performance. Additionally the need for predictive models to assist in mitigation and prognosis efforts is critical. Overall Program Objective: The overall objective of the WBH program is to advance both knowledge and technology prototypes (i.e., training, tools, and practice guidelines for assessment, metrics, and interventions) that will reduce or eliminate acute to late and long-term effects from single and repetitive concussion/mTBI. The DoD will be seeking Solution Briefs for utilization of an already established and experienced Clinical Consortium (CC) that will follow human subjects who have sustained a single or repeated concussion/mTBI to determine the relationship between concussion/mTBI, head impact exposures and brain health outcomes. The CC will be expected to interact with a Government Steering Committee with involvement from the U.S. Army Medical Research and Development Command (USAMRDC) and other stakeholders. Some desirable capabilities of the existing CC infrastructure are that it has (at the time of submission of the Solution Brief): The capability to recruit, enroll, and follow a large population of control and TBI patients who have sustained a single or repeated concussion/mTBI (preferably upwards of 15,000 human subjects, if feasible); Access to data already collected from human subjects that support the goals of this program and the ability to maintain and interpret these data; Ongoing relationships with both non-Government and DoD organizations that comprise the CC network; Experience with sports-related concussion; Access to military patients with brain trauma including repetitive concussion and/or head impact exposure; Access to human patients with concussion that are part of the National Collegiate Athletic Association (NCAA) [to compare with military patients to build the capability of predictive models and strategies for clinical interventions]; and, The focus to be metric-driven with requirements for prototype development toward clinical interventions, endpoints, policy and processes for mitigation and management of concussion, including the correlation of single and repetitive head impact exposure to Warfighter performance. The end goal of the program is to deliver translatable processes, knowledge and technology (i.e., training, and practice guidelines for assessment and interventions) to better prevent the immediate, long-term and late effects of repetitive head impact exposure (i.e. jump zones, training activities, shipboard, etc.) and single and repetitive concussions/mTBI in order to maximize WBH. It is expected that outcomes will be transitioned to inform practice guidelines, training and clinical trial endpoints. Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Sharing: The DoD requires that awardees make TBI research data generated by this award mechanism available to the research community through the FITBIR Informatics System. The FITBIR Informatics System is a free resource designed to accelerate research progress by allowing the storage, re-analysis, integration, and rigorous comparison of multiple datasets. Currently FITBIR eligible research include all studies generating prospectively collected human TBI subject data (e.g., clinical, demographic, phenotypic, imaging, and genomic). Data reporting to FITBIR is an opportunity for investigators to facilitate their own research and to collaborate with others engaged in similar research. While there is no direct charge to users of the FITBIR Informatics System, a project estimation tool (https://fitbir.nih.gov/jsp/contribute/fitbir-costs.jsp) is available to help estimate costs and manpower needs that may be associated with data submission. FITBIR guidance and policies, as well as the considerable advantages of FITBIR participation to the researcher, are detailed at http://fitbir.nih.gov/. In order to share data with FITBIR, three elements must be included in the proposed research: Updated informed consent language that includes FITBIR data sharing. Sample consent language is included in Appendix III. Global Unique Identifier (GUID): FITBIR encourages collaboration between laboratories, as well as interconnectivity with other informatics platforms. Such community-wide sharing requires common data definitions and standards. FITBIR allows for de-identification and storage of data (medical imaging clinical assessment, environmental and behavioral history, etc.) of various types (text, numeric, image, time series, etc.). Use of FITBIR's GUID system facilitates repeated and multi-user access to data without the need to personally identify data sources. In order to generate a GUID for a subject, the following personally identifiable information (PII) must be collected in the proposed research: Complete legal given (first) name of subject at birth Complete legal additional name of subject at birth (if subject has a middle name) Complete legal family (last) name of subject at birth Day of birth Month of birth Year of birth Name of city/municipality in which subject was born Country of birth Note that this PII is never sent to the FITBIR system. PII cannot be extracted from the GUID. Information on GUID compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations can be found at https://fitbir.nih.gov/content/global-unique-identifier. 3. Common Data Elements (CDEs): Research data elements must be reported using the National Institute of Neurological Disorders and Stroke (NINDS) TBI CDEs or entered into the FITBIR data dictionary as new, unique data elements (UDEs). For the most current version of the NINDS TBI CDEs, go to http://www.commondataelements.ninds.nih.gov. Assistance will be available to help the researchers map their study variables to specific CDEs and ensure the formats of the CDEs collected are compatible with the FITBIR Informatics System. Use of the TBI CDEs is required wherever possible in an effort to create standardized definitions and guidelines about the kinds of data to collect and the data collection methods that should be used in clinical studies of TBI. Use of UDEs is strongly discouraged and subject to program approval. Potential Funding Availability and Period of Performance (PoP): The USG DoD currently has available $25 Million (M) for a period of performance (PoP) for 5 years. Cost sharing, including cash and in kind (e.g., personnel or product), contributions are strongly encouraged and have no limit. MTEC anticipates that one award will be made to a qualified Offeror to accomplish the statement of work. Acquisition Strategy: The MTEC may use a streamlined, accelerated approach for this acquisition. This approach will consist of the following steps: Step 1: MTEC members who wish to offer a solution to the RPP must submit a Solution Brief. The Solution Brief will contain the MTEC Offeror's technical concept and approach along with their viability toward the specific effort. To meet the statutory requirement of the Other Transaction authority, Offeror Solution Briefs will also have to address the significant participation of a Nontraditional Defense Contractor or Nonprofit Research Institution on the team or the willingness to provide 1/3 cost share to the project. The Offeror will also be expected to present a rough order of magnitude (ROM) cost and schedule. Step 2: As part of the Government review of the Solution Brief, MTEC members who have submitted a favorable Solution Brief based on the RPP criteria may be invited to present and discuss their solution with the Government sponsors for the research via a virtual or in-person - pitch of the proposed project along with a SOW/Milestone Payment Schedule and cost information. Step 3: MTEC Offeror(s) will be notified of the down-select recommendation(s), and if selected, will be invited to submit a detailed Cost Proposal in accordance with the MTEC Proposal Preparation Guide (PPG). Because of the nature of the requirements set forth in the forthcoming RPP, this streamlined, interactive approach is anticipated to be a better means to highlight company methodologies and skills and allow the government to gain a fuller appreciation of the work required to be completed. It provides more freedom and initiative to the Offeror to describe how they would approach and solve such an action. The full description of this contracting approach is included in the RPP. MTEC Member Teaming: While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to proposal submission) if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government. MTEC members are encouraged to use the MTEC Database Collaboration Tool to help identify potential teaming partners among other MTEC members. The Database Collaboration Tool provides a quick and easy way to search the membership for specific technology capabilities, collaboration interest, core business areas/focus, R&D highlights/projects, and technical expertise. Contact information for each organization is provided as part of the member profile in the collaboration database tool to foster follow-up conversations between members as needed. The Collaboration Database Tool can be accessed via the - MTEC Profiles Site tab on the MTEC members-only website. MTEC: The MTEC mission is to assist the USAMRDC by providing cutting-edge technologies and supporting effective materiel 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 U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, - nontraditional government contractors, academic research institutions, and not-for-profit organizations. Administrative Information: The RPP will be posted to the MTEC website (mtec-sc.org) and a notice will be posted on Contract Opportunities (Beta.SAM.gov) to notify interested parties. MTEC membership is required for the submission of a Solution Brief in response to this upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/. For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Lauren Palestrini, MTEC Director of Research, contact@example.gov