The FY18 Defense Appropriation provides $125 million (M) to the Department of Defense Psychological Health/Traumatic Brain Injury Research Program (PH/TBIRP) to support critical traumatic brain injury (TBI)- and psychological health (PH)-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 (DHA) J9, Research and Development Directorate, manages the Defense Health Program’s Research, Development, Test, and Evaluation 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 PH/TBIRP is providing the information in this pre-announcement to allow investigators time to plan and develop applications.  FY18/19 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 June 2018.  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.

The FY18/19 PH/TBIRP will solicit research applications for the following CTRR Focus Areas:

Mechanisms of Recovery following isolated or cumulative TBI(s) in Service member-relevant injuries:  Clinical research in human subjects that measures physiologic responses to cognitive rehabilitation with the intent to better understand how rehabilitation remediates cognitive or sensorimotor deficits, and ultimately to optimize rehabilitation prescription.

Ecological Assessment:  Investigation of outcome measures focused on military-specific tasks that inform return-to-duty/participation decisions following rehabilitation in patients with TBI.

Cognitive Rehabilitation:  Evaluation of rehabilitation intervention effectiveness in remediating cognitive impairments and functional limitations after TBI.

http://cdmrp.army.mil/pubs/press/2018/18phtbipreann

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 FY18/19 PH/TBIRP CTRR Focus Areas.
• 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)
• Supports small, single-site, Phase I clinical trials to advance the development of knowledge and materiel products for rehabilitation and restoration of function following TBI in Service members, Veterans, and other individuals.
• 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 FY18/19 PH/TBIRP CTRR Focus Areas.
• Preproposal is required; application submission is by invitation only.
• Maximum funding of $1.5M for total costs (direct plus indirect costs).
• Maximum period of performance is 2 years.

CTRR – Clinical Trial Development Award (CTRR-CTDA)

• Independent investigators at all academic levels (or equivalent)
• Supports design and development of the necessary research resources that will serve as a foundation for investigator-initiated clinical trials as described above under CTRR – Clinical Trial Award (CTRR-CTA)
• Final supporting studies required for approval of Investigational New Drug Applications/Investigational Device Exemptions (IND/IDE-enabling) are allowed.  Other preclinical studies are not allowed.
• Clinical trials are not allowed within the period of performance of the CTRR-CTDA.
• Must address one or more FY18/19 PH/TBIRP CTRR Focus Areas.
• Preproposal is required; application submission is by invitation only.
• Maximum funding of $200,000 for total costs (direct plus indirect costs).
• Maximum period of performance is 1 year.

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 Announcements and General Application Instructions that will be available for electronic downloading from the Grants.gov website.  The application package containing the required forms for each award mechanism will also be found on Grants.gov.  A listing of all CDMRP and other USAMRMC 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 Announcements are 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 website (http://cdmrp.army.mil).

Point of Contact:

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