DoD Funding Pre-announcement for Tuberous Sclerosis Complex Research Program

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.

http://cdmrp.army.mil/pubs/press/2016/16tscrppreann.shtml

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 

usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil