• 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 Title 32, Code of Federal Regulations (CFR) Section 219.101(b)(4) or be eligible for expedited review under 32 CFR 219.110 or 21 CFR 56.110.
• Research projects must be innovative, feasible, and supported by a strong rationale.
• Innovation is an important review criterion.
• Preliminary data are not required.
• Clinical trials are not allowed.

• Maximum funding of $150,000 for direct costs, if the program receives $8M appropriation. Maximum funding of $200,000 for direct costs, if the program receives $10M appropriation. Plus indirect cost.


• Maximum period of performance is 2 years.

or 

New-to-the-Field Investigators:
Independent investigator at or below the level of Assistant Professor (or equivalent) or established independent investigators in an area other than TSC at or above the level of Assistant Professor seeking to transition to a career in TSC, thereby bringing their 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.) 

• Supports new ideas that have the potential to yield high-impact findings and new avenues of investigation.
• Impact and Innovation are important review criteria.
• Preliminary data are expected.
• Clinical trials are not allowed.
• The New-to-the-Field Investigators 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 $500,000 for direct costs, if the program receives $8M appropriation. Maximum funding of $575,000 for direct costs, if the program receives $10M appropriation. Plus indirect cost.


• Maximum period of performance is 3 years.

• Supports studies that will move promising, well-founded preclinical and/or clinical research findings closer to clinical application, including the diagnosis, prognosis, or treatment of TSC.
• Studies advancing clinical trial readiness through the development of biomarkers, clinical endpoints, and validation of pharmacokinetic/pharmacodynamics, as well as studies piloting clinical trials that include behavioral interventions, are of particular interest.
• Supports studies that encompass the analysis of existing real-world data practices to develop/improve guidelines for better outcomes in defined areas relevant to the Focus Areas of the program.
• 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.
• Applications may include a small, pilot clinical trial intended to inform the next step in the continuum of translational research.
• Clinical Translational Potential and Impact are important review criteria.
• Partnering PI Option available.
• Collaborations between laboratory scientists and clinicians are strongly encouraged.
• Preliminary data are required.

• Maximum of $1 million for direct costs (plus indirect costs).


• Maximum of $1.15 million for direct costs (plus indirect costs) for applications including a Partnering PI Option.


• Maximum period of performance is 3 years.