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US National Institutes of Health – Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R21 Clinical Trial Not Allowed) – RFA-NS-18-042
Sponsor: US National Institutes of Health 		Closing Date: 12-Nov-2019
This R21 NIH Exploratory/Developmental Grant supports exploratory and developmental research projects by providing support for the early and conceptual stages of pain target discovery and validation projects. These studies may involve considerable risk but may lead to a breakthrough in a pain treatment.

The focus of this Funding Opportunity Announcement (FOA) is on the basic science discovery of targets in the peripheral nervous system, central nervous system, immune system or other tissues in the body that can be used to develop treatments that have minimal side effects and little to no abuse/addiction liability. Research supported by this FOA must include rigorous validation studies to demonstrate the robustness of the target as a pain treatment target. This will lower the risk of adopting the target in translational projects to develop small molecules, biologics, natural substances, or devices that interact with this target for new pain treatments. Translational research to develop new medical devices are not the focus of this FOA. Basic science studies of pain and related systems in the body are responsive to this FOA and are encouraged in the context of novel pain therapeutic target discovery.

Key Dates
Letter of Intent (non-mandatory) due to NIH: 12 October 2019
Applications due to UQR&I: 29 October 2019
Applications close with NIH: 12 November 2019, 5:00pm local time of applicant organisation
Expiration date of FOA: 13 November 2019

Overview

Aims
Research Objectives:
• Applications to this FOA must propose a research plan designed to discover and validate a novel target or to validate an existing target for pain treatment with little to no abuse liability.
• Applications to identify targets for devices, such as peripheral nerve, spinal cord, or deep brain stimulators may focus on identifying electrophysiological signatures for acute or chronic pain. Validation of these targets in large animals or nonhuman primates should be considered.
• Experiments to demonstrate a lack of abuse liability of the target should be considered.
• Early pain therapeutic target discovery projects are responsive to this FOA, but they must include a plan for validating the target once it is identified.
• In addition to discovery projects to identify pain therapeutic targets for small molecules, pain therapeutic targets for biologics, such as antibody or cell-based therapies, are encouraged.
• Applications focused on target validation alone will be considered within scope. Applications focused on target discovery alone should submit to https://grants.nih.gov/grants/guide/pa-files/PA-18-159.html instead.
• Scientific rationale: Projects should be supported by a cogent biological rationale. Applicants should also discuss how the experimental approach will lead to a novel target.
• Validation: Projects must include a plan for rigorously validating the target using multiple animal models, reproducing the work in another laboratory, or in human tissue etc.
• Relevance for pain therapeutic development: Projects should address the relevance of the target for subsequent pain therapy development.

Examples of studies that are NOT appropriate for this FOA:
• Natural history studies aimed at understanding disease pathophysiology, genetic, or epigenetic mechanisms in the absence of target discovery identification, development and validation.
• Large, prospective design clinical validation studies.
• Prospective design clinical utility studies.
• Preclinical animal studies focused only on therapeutic development (see https://grants.nih.gov/grants/guide/pa-files/PAR-18-761.html)
• Development of candidate therapeutics (see https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Translational-Research).
• Clinical trials to optimize dosing or timing of therapeutic intervention, studies to inform stratification of human subjects, or studies designed to test efficacy in human subjects.
• Technical development of neurostimulation or other medical devices for the treatment of pain
• Long-term projects, or projects designed to increase knowledge in a well-established area.

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 total project period may not exceed 2 years.

Overheads
The maximum rate of overheads allowed by the National Institutes of Health to non-US institutions is 8% on Modified Total Direct Costs (excluding equipment).

How to Apply

Step 1. Completing the application
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.

Interested applicants are strongly encouraged to make contact with the UQR&I international team (via internationalgrants@research.uq.edu.au) well in advance of the UQR&I internal deadline to discuss their application. UQ researchers who do not wish to lead an application are encouraged to contact their US colleagues to discuss collaborating on an application.

Step 2. UQ R&I internal review and feedback
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.
Website: http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-18-042.html

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