DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS
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Tuberous Sclerosis Complex

NEWS RELEASE

Released: December 17, 2019

Defense Health Program
Department of Defense Tuberous Sclerosis Complex Research Program
Anticipated Funding Opportunities for Fiscal Year 2020 (FY20)

The Fiscal Year 2020 (FY20) Defense Appropriations Bill has not been signed into law. Although FY20 funds have not been appropriated for the Department of Defense Tuberous Sclerosis Research Program (TSCRP), the TSCRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY20 funding opportunities. This pre-announcement should not be construed as an obligation by the Government.

The FY20 Defense Appropriations Act is anticipated to provide funding 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 J9, Research and Development 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) at the U.S. Army Medical Research and Development Command (USAMRDC).

Subject to the FY20 Congressional appropriation for TSCRP funding, FY20 TSCRP Program Announcements and General Application Instructions for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the Program Announcements are released. 

Applications submitted to the FY20 TSCRP are encouraged to address one or more of the following Focus Areas:

  • Eradicating tumors associated with TSC and TSC-associated lymphangioleiomyomatosis (LAM), including gaining a deeper mechanistic understanding of TSC signaling pathways
  • Preventing epilepsy, improving treatment, and mitigating comorbidities associated with TSC-related seizures
  • Understanding the features of TSC-Associated Neuropsychiatric Disorders (TAND) and reducing their impact, including pharmacological and behavioral interventions
  • Advancing clinical trial readiness and optimizing clinical care through development of biomarkers and clinical outcome measures, patient selection and sample size determination, pharmacokinetic/pharmacodynamics (PK/PD) studies, and enhanced trial design
Award Mechanism Eligibility Key Mechanism Elements Funding
Exploration - Hypothesis Development Award Investigators at or above postdoctoral fellow (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 are not required.
  • Research projects must be innovative, feasible, and supported by a strong rationale.
  • Innovation is the most important review criterion.
  • Clinical trials are not allowed.
  • Maximum funding of $150,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 2 years.
Idea Development Award Established Investigators:
Independent investigators at or above the level of Assistant Professor (or equivalent);

or

New Investigators:
Independent investigator at or below the level of Assistant Professor (or equivalent); or Established independent investigator in an area other than TSC at or above the level of Assistant Professor seeking to transition to a career in TSC, thereby bringing his/her expertise to the field.
  • Must not have received more than $300,000 in total direct costs for previous or concurrent TSC research as a Principal Investigator of one or more Federally funded, non-mentored peer-reviewed grants. (National Institutes of Health K Awardees are eligible to apply.)
  • Must not have received a New Investigator Award previously from any program within the CDMRP.
  • Supports new ideas that have the potential to yield high-impact findings and new avenues of investigation.
  • Preliminary data are expected.
  • Impact and Innovation are important review criteria.
  • Clinical trials are not allowed.
  • New Investigator Option supports the continued development of promising independent investigators that are early in their faculty appointments and/or the transition of established investigators from other research fields into a career in TSC research.
  • 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.
Clinical Translational Research Award Independent investigators at or above the level of Assistant Professor (or equivalent).
  • Supports studies that will move promising, well-founded preclinical and/or clinical research findings closer to clinical application, including, diagnosis, prognosis, or treatment of TSC.
  • Studies advancing clinical trial readiness through development of biomarkers, clinical endpoint, and validation of PK/PD are of particular interest.
  • Applications may include a small, pilot clinical trial intended to inform the next step in the continuum of translational research. Pilot clinical trials, including behavioral interventions, are encouraged.
  • Preference will be given to studies that involve human samples, patients, or leverage existing clinical data and/or ongoing clinical studies.
  • Preclinical studies may be appropriate but must include a clinical component.
  • Projects that are exploratory and/or strictly animal research will not be considered for funding.
  • Clinical Translational Potential is the most important review criterion.
  • Preliminary data are required.
  • Maximum funding of $600,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 3 years.

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 and other USAMRMC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

Submission deadlines are not available until the Program Announcements are released. For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the TSCRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.health.mil).

Point of Contact:

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


Last updated Thursday, December 5, 2024