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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