DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS
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NEWS RELEASE

Released: April 15, 2013

DEPARTMENT OF DEFENSE TUBEROUS SCLEROSIS COMPLEX RESEARCH PROGRAM
FISCAL YEAR 2013



The Fiscal Year 2013 (FY13) Defense Appropriations Act provides $6 million to the Department of Defense Tuberous Sclerosis Research Program (TSCRP). This program is administered by the US Army Medical Research and Materiel Command through the Office of the Congressionally Directed Medical Research Programs (CDMRP).

The TSCRP is providing the information in this pre-announcement to allow time to plan and develop applications. FY13 TSCRP program announcements and general application instructions for the following award mechanisms are anticipated to be posted on Grants.gov in May 2013. This pre-announcement should not be construed as an obligation by the government.

Areas of Focus: The FY13 TSCRP encourages research projects applications that specifically address the critical needs of the TSC community in the following areas of focus:

  • Genetic, epigenetic, and non-genetic modifiers of TSC.
  • Identification and development of preclinical models and therapeutic strategies (e.g., cytotoxic agents, combination therapies).
  • Identifying biomarkers for early detection, prognosis, and prediction of treatment outcomes (such as serum markers, imaging, electrophysiology, prenatal testing, and pharmacogenetics).
  • Impact of TSC manifestations in adults (e.g., care management, age-specific pathogenesis, epidemiology, renal, reproductive issues, and lymphangioleiomyomatosis [LAM])).
  • Long-term benefits and effects of mTOR inhibitors or other agents.
  • Novel strategies for diagnosis, treatment, and prevention of TSC manifestations including those geared toward early identification and intervention.
  • Understanding the cellular and molecular mechanisms of TSC and LAM pathogenesis.
  • Understanding the mechanism and improving the treatment of epilepsy in TSC.
  • Understanding the mechanism and improving treatment of TSC-associated neurocognitive disorders (TAND) including cognitive impairment, and psychiatric, behavioral, and sleep disorders.

Award Mechanism Eligibility Key Mechanism Elements Funding
Pilot Clinical Trial Award Must be an independent investigator at or above the level of Assistant Professor (or equivalent)
  • Fund pilot clinical trials, especially observational or feasibility studies.
  • Supports collection of preliminary data to support the rationale and design of subsequent clinical trials
  • Preliminary or preclinical data is required
  • Maximum funding of $200,000 in direct costs (plus indirect costs)
  • Period of performance should not exceed 2 years
Exploration -Hypothesis Development Award Investigators at all academic levels (or equivalent)
  • Fund the initial exploration of innovative, untested research, and pursue serendipitous observations
  • 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 $100,000 in direct costs (plus indirect costs)
  • Period of performance should not exceed 2 years
Idea Development Award Independent investigators with a documented faculty appointment (or equivalent)
  • Encourage high-impact, innovative research that will drive the field forward
  • Optional Feature: Applications that include either a Qualified Collaborator or Nested Postdoctoral Fellow who meet criteria identified in the announcement may apply for a higher level of funding
  • Preliminary data required
  • Clinical trials not allowed
  • Maximum funding of $425,000 in direct costs (plus indirect costs)
  • Maximum funding of $575,000 in direct costs (plus indirect costs) for applications including an Optional Qualified Collaborator or Nested Postdoctoral Fellow.
  • Period of performance should not exceed 3 years

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 upon official announcement of funding opportunity release. Submission deadlines will not be available until the program announcements are released. Requests for email notification of the program announcements release may be sent to help@cdmrp.org. For more information about the TSCRP or other CDMRP-administered programs, please visit the CDMRP website (https://CDMRP.HEALTH.MIL).

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