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NEWS RELEASE

Released: March 2, 2015

Defense Health Program
Department of Defense Tuberous Sclerosis Complex Research Program
Funding Opportunities for Fiscal Year 2015 (FY15)

The FY15 Defense Appropriations Act provides $6.0 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 and executes the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The executing 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. FY15 TSCRP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in April 2015. Pre-application (letter of intent) 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 FY15 TSCRP is to encourage innovative research aimed at understanding the pathogenesis and preventing and treating the manifestation of TSC. Within this context, the FY15 TSCRP encourages applications that address the critical needs of the TSC community in one or more of the following FY15 Focus Areas:

  • Mechanisms Underlying Clinical Manifestations
    • Epilepsy
    • Neurocognition and behavior
    • Tumor development and progression
    • Cell and animal models
    • Genetics and disease modifiers
  • Novel Therapeutic Strategies
    • Dose, timing, and duration of mTOR inhibitors and other therapeutics
    • New targets and combination therapies
    • Preclinical and clinical studies
    • Biomarkers
    • Preventative therapies

If the proposed research project does not address one of the FY15 Focus Areas, justification that the proposed research project addresses an important problem related to TSC research and/or patient care should be provided.

Award Mechanism Eligibility Key Mechanism Elements Funding
Exploration - Hypothesis Development Award Investigators at all academic levels (or equivalent)
  • 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 encouraged but not required
  • Clinical trials not allowed
  • Maximum funding of $150,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 2 years
Idea Development Award Independent investigators with a documented faculty appointment (or equivalent)
  • Supports new ideas that are in the early stages of development and have the potential to yield high-impact findings and new avenues of investigation
  • Preliminary data is required
  • Clinical trials not allowed
  • Optional Qualified Collaborator encouraged
  • Collaborations between basic scientists and clinical researchers, and between academic and biotech scientists
  • Collaborations that bring new perspectives from other disciplines or bring new investigators into the TSC field
  • Maximum funding of $450,000 for direct costs (plus indirect costs)
  • Maximum funding of $600,000 for direct costs (plus indirect costs) for applications including an Optional Qualified Collaborator.
  • 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

A pre-application (letter of intent) is required and must be submitted through the CDMRP electronic Biomedical Research Application Portal (eBRAP) (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. Requests for email notification of the Program Announcements release may be sent to help@eBRAP.org. Email notifications of funding opportunities are sent as a courtesy and should not be used as a sole source of notification; applicants should monitor Grants.gov for official postings of funding opportunities.

For more information about the TSCRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

Point of Contact:

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