The FY23 HRRP FRA mechanism is intended to support promising research that accelerates drug discovery and therapeutic development for hearing restoration after military-relevant auditory system injury.
Applications involving multidisciplinary collaborations among academia, industry, the military Services, the VA, and other federal government agencies are highly encouraged.
Program priorities: To maximize impact and return, the HRRP will prioritize investments in research that overcome major scientific obstacles to hearing restoration. Currently, no drug has been approved by the FDA to treat hearing loss associated with sensory, neural, synaptic, or central auditory dysfunction. Although significant progress has been made in the molecular and cellular understanding of hearing loss and regeneration mechanisms in the inner ear, the majority of research is preclinical. The unique anatomical features of the inner ear render it difficult to access and not amenable for biopsy. This creates a major hurdle for the clinical validation of preclinical findings and severely hinders the translation of preclinical findings to clinical applications. Furthermore, it has severely hindered the advancement of diagnostic capabilities beyond behavioral functional tests. As potential therapeutics to treat sensory, neural, synaptic, or central auditory dysfunction are discovered in animal studies, it will be crucial for the success of clinical trials to correctly match patient populations to appropriate interventions and accurately measure outcomes. The HRRP challenges the science community to design innovative studies to advance precision diagnostics, validate preclinical results, and translate potential therapies to clinical applications. The HRRP FY23 Focus Areas are designed to support these priorities.
Funding Levels: The FY23 HRRP FRA may be used to support preclinical studies in animals and/or clinical research involving human subjects and human anatomical substances. To support research projects at different stages and the exploration/development of ideas of different maturity levels, three funding levels are available under this program announcement. When submitting the pre-application, it is the responsibility of the applicant to select the funding level that is most appropriate for the research proposed. The funding level should be selected based on the stage and maturity level of the research project, rather than the amount of the budget.
○ Funding Level 1 supports exploratory, high-risk/high-reward research that is in the earliest stages of idea development. Research must have the potential to yield new avenues of investigation, such as new approaches, new research tools, or new paradigms.
○ Funding Level 2 supports the advancement of more mature research toward clinical translation.
○ Funding Level 3 supports translational research that includes a Pilot Clinical Trial (PCT).
Deadlines:
• Required Pre-Application Deadline: August 15, 2023
• Application Submission Deadline: September 1, 2023
To meet the intent of the award mechanism, all applications to the FY23 HRRP Focused Research Award (FRA) must address research in one or more of the following Focus Areas:
• Improvement and acceleration of the translation of biological regeneration/repair mechanisms into clinical applications. Research addressing the damage, repair, and regeneration of the auditory system after military-relevant injuries is strongly encouraged.
• Development of diagnostic tests that differentiate sensory, neural, synaptic, and central processing disorders, that may inform applicability and outcomes for current or future hearing restoration therapeutics.
• Development of reliable in-vitro human models to facilitate the understanding, derivation, and characterization of human auditory cells, and/or to facilitate the evaluation of hearing restoration therapies.
Independent investigators at all academic levels (or equivalent) are eligible to be named by the recipient organization as Principal Investigator (PI) on the applications. An eligible PI, regardless of ethnicity, nationality, or citizenship status, must be employed by or affiliated with an eligible organization.
The anticipated direct costs budgeted for the entire period of performance for an FY23 HRRP FRA – Funding Level 1 will not exceed $250,000. The anticipated direct costs budgeted for the entire period of performance for an FY23 HRRP FRA – Funding Level 2 will not exceed $750,000. The anticipated direct costs budgeted for the entire period of performance for an FY23 HRRP FRA – Funding Level 3 will not exceed $1,000,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.
