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Monday 30 May 2016

U.S. Department of Defense (DoD) Peer Reviewed Alzheimer's Research Program Preannouncement

The FY16 Defense Appropriations Act provides $15 million (M) to the Department of Defense Peer Reviewed Alzheimer’s Research Program (PRARP) to support research which addresses the long-term consequences of traumatic brain injury (TBI) as they pertain to Alzheimer’s disease (AD) and related dementias (ADRD). The research impact will benefit the military, Veteran, and civilian communities. The PRARP’s mission is therefore devoted to (1) understanding the association between TBI and AD/ADRD; and (2) reducing the burden on affected individuals and caregivers, especially in the military and Veteran communities. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency, Research, Development, and Acquisition (DHA RDA) Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP).
The PRARP is providing the information in this pre-announcement to allow investigators time to plan and develop applications.  FY16 PRARP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in July 2016.  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.
FY16 PRARP Overarching Challenges and Focus Areas: 


All applications for the FY16 PRARP funding opportunities must address at least one of the following FY16 Overarching Challenges. The FY16 Overarching Challenges will be mechanism-specific.
The PRARP FY16 Overarching Challenges are as follows:
Paucity of Research Resources:  The paucity of research resources to examine the interrelationship between TBI and subsequent AD/ADRD for the military, Veteran, and civilian communities.
Paucity of Clinical Studies:  The paucity of clinical or epidemiological studies to examine the interrelationship between TBI and subsequent AD/ADRD for the military, Veteran, and civilian communities.
Diagnostic Technologies, Tests, Biomarkers, or Devices:  The need for technologies, tests, or devices to detect the progression to AD/ADRD subsequent to TBI.
Quality of Life:  The need for technologies, assessments, interventions, or devices to benefit individuals living with the common symptoms of TBI and AD/ADRD.
Caregiver Burden:  The need for technologies, assessments, interventions, or devices with the goal of reducing burden for caregivers of individuals living with the common symptoms of TBI and AD/ADRD.
Epidemiology:  The paucity of epidemiology research to examine the interrelationship between TBI and subsequent AD/ADRD for the military, Veteran, and civilian communities
In addition to addressing one or more of the specified FY16 Overarching Challenges, applications should also address at least one of the following FY16 Focus Areas in support of the FY16 Overarching Challenges. An application that proposes research outside of the FY16 Focus Areas is acceptable, as long as the applicant provides a strong rationale. The Focus Areas will be mechanism-specific.
The PRARP FY16 Focus Areas are as follows:
Genomics/Proteomics:  Studies or technologies (e.g., genetic, proteomic, and epigenetic strategies) intended to characterize neurological change(s) associated with TBI and subsequent AD/ADRD. In addition, relevant technologies or tests may be considered under this focus area.
Mechanisms of Pathogenesis: Identification of contributing mechanisms (e.g., pathology of Tau, non-neuronal cells, inflammatory factors, and vascular contributions) associated with TBI and subsequent AD/ADRD pathogenesis.
Care Interventions and Quality of Life:  Research intended to stabilize or improve the quality of life of those affected by the common symptoms of TBI and AD/ADRD.  Examples of research in this Focus Area include: Identification and management of co-morbidities and modifiable risk factors (e.g., sleep apnea, obesity); cognitive training interventions; studies of health and wellness and behavioral interventions.
Caregiver Support:  Research intended to reduce the burden of care on the caregiver for individuals affected by the common symptoms of TBI and AD/ADRD.  Examples of research in this focus area include: Caregiver training, home-based support, behavioral interventions, and relationship interventions.
Diagnostics and Biomarkers:  Development of strategies to characterize neurological changes associated with TBI and subsequent AD/ADRD (e.g., fluid based, imaging, physiological, and clinical approaches).
Novel Target Identification:  Basic research (non-human) directly leading to the identification of new targets for the development of existing or new investigational medicines, drugs, or agents.
Epidemiological Research:  Research focusing on the incidence, distribution, and other factors relating to the health of individuals affected by TBI and subsequent AD/ADRD.
The following is a summary of the FY16 PRARP Program Announcements. Four award mechanisms will be offered for FY16. This pre-announcement should not be construed as an obligation by the government.


Convergence Science Research Award
Principal Investigators (PIs) at or above the level of Assistant Professor (or equivalent) from any field or discipline, who seek to bring their expertise to address the PRARP’s mission; the research team must demonstrate traumatic brain injury (TBI)/Alzheimer’s disease (AD) experience.
Intent: Support efforts to generate research resources, tools, or novel research efforts for researchers and/or practitioners in health sciences
Applications must address one or more of the following FY16 PRARP Overarching Challenges:
·     Paucity of Research Resources
·     Paucity of Clinical Studies
·     Diagnostic Technologies, Tests, or Devices
·     Epidemiology
Applications should address at least one of the following FY16 PRARP Focus Areas:
·     Genomics/Proteomics
·     Mechanisms of Pathogenesis
·     Diagnostics and Biomarkers
·     Novel Target Identification
·     Epidemiological Research
Research considering pharmacologic interventions is specifically discouraged under this mechanism.
Preliminary data, while not required, are encouraged.
Preproposal submission is required; application submission is by invitation only.
·         Maximum funding of $500,000 for direct costs (plus indirect costs)
·         Maximum period of performance is 3 years
Indirect costs may be proposed in accordance with the institution's rate agreement

Quality of Life Research Award
Principal Investigators (PIs) at or above the level of Assistant Professor (or equivalent) from any field or discipline, who seek to bring their expertise to address the PRARP’s mission; the research team must demonstrate traumatic brain injury (TBI)/Alzheimer’s disease (AD) experience.
Intent: Supports preclinical, basic, epidemiological, or quality-of-life research to alleviate or characterize the common symptoms of TBI and AD/ADRD
Level I:
Intended to support investigator-initiated research that may be high-risk and/or high-gain.
Level II:
Intended to support advanced studies that may be multidisciplinary in nature, and/or have multiple collaborators.
Applications must address one or more of the following FY16 PRARP Overarching Challenges:
·      Paucity of Clinical Studies
·      Quality of Life
·      Caregiver Burden
Applications should address at least one of the following FY16 PRARP Focus Areas:
·      Care Interventions and Quality of Life
·      Caregiver Support
·      Diagnostics and Biomarkers
·      Epidemiological Research
Research considering pharmacologic interventions is specifically discouraged under this mechanism.
Preliminary data, while not required, are encouraged.
Preproposal submission is required; application submission is by invitation only.
Level I:
·         Funding limit is $500,000 direct costs.
·         Maximum period of performance is 3 years.
·         Indirect costs may be proposed inaccordance with the institution's rate agreement.
Level II:
·         Funding limit is $1.9M total costs.
·         Maximum period of performance is 4 years.
Indirect costs may be proposed in accordance with the institution’s rate agreement.

Epidemiology of Military Risk Factors Award
Principal Investigators (PIs) at or above the level of Assistant Professor (or equivalent) from any field or discipline, who seek to bring their expertise to address the PRARP’s mission; the research team must demonstrate traumatic brain injury (TBI)/Alzheimer’s disease (AD) experience.
Intent: To investigate the etiology and epidemiology of military-related TBI and AD/ADRD
Applications must address one or more of the following FY16 PRARP Overarching Challenges:
·      Paucity of Research Resources
·      Paucity of Clinical Studies
·      Diagnostic Technologies, Tests, Biomarkers, or Devices
·      Epidemiology
Applications should address at least one of the following FY16 PRARP Focus Areas:
·      Genomics/Proteomics
·      Diagnostics and Biomarkers
·      Epidemiological Research
Research considering pharmacologic interventions is specifically discouraged under this mechanism.
Preliminary data, while not required, are encouraged.
Preproposal submission is required; application submission is by invitation only.
Important Note:  Applications must detail and demonstrate expedited access to a well-defined, already identified study cohort.
·         Funding limit is $2.5M total costs.
·         Maximum period of performance is 4 years.
Indirect costs may be proposed in accordance with the institution’s rate agreement.

Translational Research Partnership Award
Principal Investigators (PIs) at or above the level of Assistant Professor (or equivalent) from any field or discipline, who seek to bring their expertise to address the PRARP’s mission; the research team must demonstrate traumatic brain injury (TBI)/Alzheimer’s disease (AD) experience.
One partner must be a researcher and the other must be a clinician.
Intent: To create an avenue for partnerships between clinicians and research scientists to address a translational research problem or question in a manner that would be unachievable through separate efforts
Supports the development of translational research collaborations between two independent, faculty-level (or equivalent) investigators
Must include clearly stated plans for interactions between the Principal Investigators (PIs) and institutions involved. The plans must include communication, coordination of research progress and results, and data transfer
Clinical trials not allowed.
Applications must address one or more of the following FY16 PRARP Overarching Challenges:
·     Paucity of Research Resources
·     Diagnostic Technologies, Tests, Biomarkers, or Devices
·     Quality of Life
·     Caregiver Burden
Applications should address at least one of the following FY16 PRARP Focus Areas:
·     Genomics/Proteomics
·     Mechanisms of Pathogenesis
·     Care Interventions and Quality of Life
·     Caregiver Support
·     Diagnostics and Biomarkers
Research considering pharmacologic interventions is specifically discouraged under this mechanism.
Preliminary data are required.
Preproposal submission is required; application submission is by invitation only.
·         Funding limit is $1.3M total costs.
·         Maximum period of performance is 3 years.
Indirect costs may be proposed in accordance with the institution’s rate agreement.
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 funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

Applications must be submitted through the federal government’s single-entry portal, Grants.gov.  Submission deadlines are not available until the Program Announcements are released. For email notification when Program Announcements are released go to the CDMRP website (http://cdmrp.army.mil) and select Subscribe to Funding Opportunities & Program Communications.  For more information about the PRARP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

For questions about the research programs, please contact the MRO Research Grants & Contracts Team (adm-researchgrants.contracts@monash.edu).


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