Notice of Intent to Publish a Funding Opportunity Announcement for Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)

Notice Number: NOT-NS-18-080

Key Dates

Release Date: August 23, 2018
Estimated Publication Date of Funding Opportunity Announcement: October 27, 2018
First Estimated Application Due Date: November 27, 2018
Earliest Estimated Award Date: May 27, 2019
Earliest Estimated Start Date: May 27, 2019


Related Announcements
None

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The NINDS, with other NIH Institutes and Centers participating in the HEAL (Helping to End Addiction Long-term) Initiative, intends to publish a Funding Opportunity Announcement (FOA) to solicit applications to discover and validate novel nonaddictive pain targets.

The focus of this FOA will be 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 pain therapeutics that have minimal side effects and little to no abuse/addiction liability. Research that will be supported by this FOA must include rigorous validation studies to demonstrate the robustness of the target as a pain treatment target.  These studies should have the goal of definitively determining the utility of a potential target for future therapeutic and/or device development.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

This FOA is expected to be published in October 2018 with an expected application due date in November 2018.

Please note:

Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.

Matching Requirement: A grantee from a for-profit organization funded under this funding opportunity announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award.  NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement.  See 45 CFR 75.306 for additional details.

Research Initiative Details

This Notice encourages investigators with expertise and insights on targets for specific pain indications to begin to consider applying for this new FOA.

Investigators are encouraged to form collaborations with individuals knowledgeable in bioinformatics, statistical analysis, pain biology and physiology, clinical experience appropriate for the type of pain treatment discovery, as well as those familiar with the ultimate goal of a successful project for this FOA, which is to have a robust candidate target for nonaddictive therapeutics development.

Translational research to develop new therapeutics or medical devices is not the focus of this FOA. Basic science studies of the pain and related systems in the body are responsive to this FOA and are encouraged in the context of novel pain therapeutic target discovery and validation. Projects should be supported by a cogent biological rationale.

This FOA is not specific for any one or a group of pain conditions. Projects to identify novel targets for acute pain, chronic pain, migraine, other headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, sickle-cell pain, post stroke pain, etc. will be considered. Projects to identify novel targets for a combination of chronic overlapping pain conditions or for specific pathological conditions will be considered. Projects that seek to identify novel targets in specific patient populations such as women and children will also be responsive to this FOA.

Funding Information

Estimated Total Funding Issuing IC and partner components intend to issue 8-10 awards in 2019. Awards issued under this FOA are part of funds set aside to support the HEAL (Helping to End Addiction Long-term) initiative.
Expected Number of Awards TBD
Estimated Award Ceiling TBD
Primary CFDA Numbers TBD

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Michael L. Oshinsky, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
301-496-9964
michael.oshinsky@nih.gov