The FY19 Defense Appropriation provides $125 million (M) to the Department of Defense Psychology Health/Traumatic Brain Injury Research Program (PH/TBIRP) to support critical psychological health (PH) - and traumatic brain injury (TBI)-related research and development efforts to benefit Service members, Veterans, and other beneficiaries of the military health system. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The U.S. Army Medical Research and Materiel Command (USAMRMC) Congressionally Directed Medical Research Programs (CDMRP) provides execution management support for DHA research program areas, including the Joint Program Committee-8/Clinical and Rehabilitative Medicine Research Program (JPC-8/CRMRP). The managing agent for this Program Announcement is the CDMRP with strategic oversight from the JPC-8/CRMRP.

The JPC-8/CRMRP seeks to implement long-term strategies to develop knowledge and materiel products to reconstruct, rehabilitate, and provide definitive care for injured Service members.  The ultimate goal is to return Service members to duty and improve their quality of life. The PH/TBIRP is providing the information in this pre-announcement to allow investigators time to plan and develop applications. FY19 PH/TBIRP Complex TBI Rehabilitation Research (CTRR) Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in July 2019. Pre-application and application deadlines will be available when the Program Announcements are released. This pre-announcement should not be construed as an obligation by the government.

FY19 PH/TBIRP will solicit research applications for the following CTRR Areas of Emphasis (all three bulleted areas are for CRA; only 2^nd and 3^rd areas are for CTA):

• ·       Return to Duty (RTD) Risk Assessment; Computational Model Development or Validation

• Integrate objective mild TBI (mTBI) patient data from multiple domains through computational modeling to inform RTD capability 
• Clinical support tool leveraging computational modeling to measure and communicate risk associated with returning injured warfighters to duty following mTBI

• ·       Determination of the Objective Outcome Measures of Brain Impairment after mTBI with Existing FDA cleared Devices

• Develop objective measure(s) of brain function that determine severity of functional impairment
• Correlate brain function to RTD performance

• ·       Optimization of Treatment Strategy based on Patient Classification to improve management of patients with mTBI as described above

Projects focused on other research areas relevant to the intent of the CTRR-CRA may be submitted for consideration, provided that sufficient justification is included in the application.

https://cdmrp.army.mil/pubs/press/2019/19phtbipreann_ctrr

CTRR – Clinical Research Award (CTRR-CRA)

Independent investigators at all academic levels (or equivalent)

• Supports applied and translational research to advance the development of knowledge and materiel products for rehabilitation and restoration of function following TBI.
• Supported research can include preclinical studies using human subjects or samples and observational or mechanistic clinical research studies.
• Clinical trials are not allowed.
• Preclinical research using animals is not allowed.
• Must address one or more FY19 PH/TBIRP CTRR Areas of Emphasis.
• Preproposal is required; application submission is by invitation only.

• Maximum funding of $2.0M for total costs (direct plus indirect costs).
• Maximum period of performance is 3 years.

CTRR – Clinical Trial Award (CTRR-CTA)

Independent investigators at all academic levels (or equivalent)

• Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, Phase 0), to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.
• Interventions should be limited, existing, and manualized. Studies may include seeking to optimize dosing in existing interventions.
• Preclinical studies are not allowed.
• Must address one or more FY19 PH/TBIRP CTRR Areas of Emphasis.
• Preproposal is required; application submission is by invitation only.
• Maximum funding of $4.0M for total costs (direct plus indirect costs),
• Maximum period of performance is 3 years.

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline.  All applications must conform to the final Program Announcement and General Application Instructions that will be available for electronic downloading from the Grants.gov website.  The application package containing the required forms will also be found on Grants.gov.  A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

Submission deadlines are not available until the Program Announcement is released.  For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.  For more information about the PH/TBIRP, or other CDMRP-administered programs, please visit the CDMRP (https://cdmrp.army.mil).

Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil