The FY16 Defense Appropriations Act provides $6
million (M) to the Department of Defense Tuberous Sclerosis
Complex Research Program (TSCRP) to support innovative, high-impact TSC
research. 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 TSCRP is providing the information in this pre-announcement to
allow investigators time to plan and develop applications. FY16 TSCRP
Program Announcements and General Application Instructions for the following
award mechanisms are anticipated to be posted on the Grants.gov website in March
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.
Focus
Areas: The goal of the FY16 TSCRP is to encourage innovative research
aimed at understanding the pathogenesis, and preventing and treating the
manifestations of TSC. Within this context, the FY16 TSCRP encourages
applications that address the critical needs of the TSC community in one or
more of the following FY16 Focus Areas:
· Understanding phenotypic heterogeneity in TSC
· Gaining a deeper knowledge of TSC signaling pathways and the
cellular consequences of TSC deficiency
· Improving TSC disease models
· Developing clinical biomarkers for TSC
· Facilitating therapeutics and clinical trials research
Exploration – Hypothesis Development Award
Investigators at all academic levels (or equivalent), including
postdoctoral fellows.
Supports the initial exploration of innovative, high-risk,
high-gain, and potentially groundbreaking concepts in the TSC research field.
Projects involving human subjects or human biological substances
must be exempt under 32 CFR 219.101(b)(4) or eligible for
expedited review under 32 CFR 219.110 or 21 CFR 56.110.
Preliminary data is not required.
Research projects must be innovative, feasible, and supported by a
strong rationale.
Clinical trials not allowed.
Maximum funding of $200,000 for direct costs
(plus indirect costs).
Maximum
period of performance is 2 years.
Idea Development Award
Established Investigators:
Independent investigators with a documented faculty appointment
(or equivalent); Or
New Investigators:
Investigators who are early in their faculty appointments or in
the process of developing independent research careers.
Supports ideas that have the potential to yield high-impact
findings and new avenues of investigation.
Preliminary data is expected.
Clinical trials not allowed.
New Investigator Option supports applicants
who early in their faculty appointments or in the process of developing
independent research careers.
Applications from New Investigators and Established Investigators
will be peer- and programmatically reviewed separately.
Maximum funding of $450,000 for direct costs
(plus indirect costs).
Maximum
period of performance is 3 years.
Pilot
Clinical Trial Award
Must be an independent investigator at or above the level of
Assistant Professor (or equivalent).
Supports exploratory studies with limited human exposure that
produce diagnostic or therapeutic information, toxicity studies of an
intervention, and studies to determine the mechanism of action and side effects
of an intervention.
Aims at collecting preliminary data to support the rationale and
design of subsequent clinical trial(s).
Preliminary or preclinical data is required
Maximum funding of $300,000 for direct costs
(plus indirect costs).
Maximum
period of performance is 2 years.
Postdoctoral Training Award
Must have successfully defended a doctoral thesis or possess an
M.D. degree.
Supports TSC research training opportunities for postdoctoral
trainees who are recent doctoral graduates.
PIs must have a designated mentor who is an experienced TSC
researcher.
Maximum funding of $150,000 for direct costs
(plus indirect costs).
Maximum
period of performance is 3 years.
Synergistic Idea Development Award
Each PI must be an independent investigator at or above the level
of Assistant Professor (or equivalent).
Supports new or existing partnerships between two or three independent investigators, who should
utilize their complementary and synergistic perspectives to address a central
innovative question or problem in TSC.
PIs
are expected to demonstrate within the application the synergistic components
(i.e., leveraging disciplines, expertise, or critical resources) that will
significantly advance the project such that the research outcomes as a whole
will be realized rapidly and efficiently and could not otherwise be
accomplished through independent efforts of a single PI.
Each partner will be recognized as a PI, and a separate
award will be made to each PI, even if the PIs are at the same
organization.
Preliminary data is expected.
Clinical trials are not allowed.
Maximum funding of $750,000 for direct costs
(plus indirect costs).
Maximum period of performance is 3 years.
A pre-application (letter of intent) 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 TSCRP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).
Point of
Contact:
CDMRP Public
Affairs
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