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US National Institutes of Health – Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Optional) – PAR-18-941
Sponsor: US National Institutes of Health 		Closing Date: 16-Feb-2019
The purpose of this funding opportunity announcement (FOA) is to encourage applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders. Applications are sought that will either 1) develop novel brain stimulation devices or 2) significantly enhance, by means of hardware/software improvements, the effectiveness of brain stimulation devices that are currently U.S. Food and Drug Administration (FDA)-approved or cleared. Novel devices should move beyond existing electrical/magnetic stimulation and develop new stimulation techniques capable of increased spatiotemporal precision as well as multi-focal, closed-loop approaches. Applications seeking to develop new capabilities should focus on significant enhancement of the spatial resolution, depth of delivery, and/or precision of the device. Incremental changes to existing devices (e.g., software updates) are not within the scope of this announcement. Applications should be submitted by multi-disciplinary teams with diverse expertise including systems neuroscience, engineering, clinical, and regulatory affairs. Applications submitted in response to this FOA should promote the development or significant enhancement of novel tools (hardware/software) for brain stimulation in humans. Although the application should focus on the engineering development and bench top testing of the tool, animals and limited human testing necessary to demonstrate initial proof of concept is allowable. Applications to this FOA are not expected to be hypothesis-driven, but should propose design-directed, developmental, or discovery-driven technology research using integrative approaches. Applications that seek to study scientific or clinical hypotheses that simply utilize devices are outside the scope of this FOA. This FOA uses the R21 grant mechanism, encouraging shorter, higher-risk applications, whereas its companion funding opportunity seeks R01 grant applications.

Topics of low program priority include:
• Devices with low spatial resolution.
• Models that focus on standard brains and are not specific to individual patient anatomy.
• Incremental improvements to existing devices, such as operating software system updates.
• Devices with no clear potential for human application.

Eligibility
• Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
• Applications from Foreign Organizations: Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Funding
• The combined budget for direct costs for the two-year project period may not exceed USD $275,000. No more than USD $200,000 may be requested in any single year.
• The project period may not exceed 2 years.

Please see the Funding Opportunity Announcement for further information. Applications may be prepared and submitted via the NIH ASSIST system or Grants.gov. For complete instructions, you must refer to both the NIH Application Guide and the Funding Opportunity Announcement (FOA), noting that instructions in the FOA take precedence over the Application Guide.

Key Dates
Letter of Intent (non-mandatory) due to NIH: Not Applicable
Applications due to UQ R&I:4 February 2019
Applications close with NIH: 16 February 2019, 5:00pm local time of applicant organisation
Future application closing dates: Standard dates apply until expiry
Expiration date of FOA: 8 September 2021 (New Date ) per issuance of NOT-MH-18-060. (Original Expiration Date: 27 November 2018)

Ahead of internal review, ensure all online components on ASSIST or Grants.gov are complete. To initiate review, email your completed Funding Application Coversheet to internationalgrants@research.uq.edu.au. Interested applicants are strongly encouraged to make contact with the UQ R&I international team (via internationalgrants@research.uq.edu.au) well in advance of the UQ R&I internal deadline to discuss their application.
Website: http://grants.nih.gov/grants/guide/pa-files/PAR-18-941.html

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