This HEAL Initiative grant aims to discover robust biomarkers or biomarker signatures to accelerate Phase II clinical trials for non-opioid pain therapeutics. The funding supports clinical research focused on identifying pain biomarkers that predict and/or monitor therapeutic response. Projects may target a single pain condition or several related conditions with common pathophysiology. Applications require Multiple Principal Investigator (MPI)-led teams representing relevant expertise or pain conditions. These teams are expected to standardize measures, biomarker modalities (e.g., omics, QST, EEG), and data collection. Centralized resource groups are also required to coordinate clinical trials, ensure standardized sample collection, technology development, and statistical analysis. This grant is for advancing effective non-opioid pain treatments by identifying reliable indicators of therapeutic success.
Opportunity ID: 346176
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-24-018 |
| Funding Opportunity Title: | HEAL Initiative: Discovery of Biomarkers and Biomarker Signatures to Facilitate Clinical Trials for Pain Therapeutics (UG3/UH3 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Education Health Income Security and Social Services |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.121 — Oral Diseases and Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Feb 16, 2023 |
| Last Updated Date: | Feb 16, 2023 |
| Original Closing Date for Applications: | Oct 23, 2023 |
| Current Closing Date for Applications: | Oct 23, 2023 |
| Archive Date: | Nov 28, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts State governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Special district governments |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery of strong candidate biomarkers or biomarker signatures for pain that can be used to facilitate the testing of non-opioid pain therapeutics in Phase II clinical trials.The biomarkers or biomarker signature will be developed through clinical research specifically focused on the identification of pain biomarkers or biosignatures that predict and/or monitor response to pain therapeutics. The resulting biomarkers or biomarker signatures may be focused on a single pain condition or on several pain conditions with common underlying pathophysiology. Applications to identify biomarkers or biomarker signatures that predict or monitor a therapeutic response across several related pain conditions should feature Multiple Principal Investigator (MPI)-led teams that represent each of the related pain conditions and associated clinical networks. The MPI-led teams are expected to decide upon a single set of measures or biomarker modalities (i.e., combination of omics, QST, actigraphy, EEG, digital measures, etc.) as components of the biosignature for all pain conditions represented in the application. Applications should feature centralized resource groups that will coordinate clinical trials and standardize all sample or data collection methods, technology development, statistical analysis and algorithm development across the pain conditions under investigation. Applications seeking to develop biomarkers or biomarker signatures that will be used to predict and/or monitor a therapeutic response for a single pain condition must also feature MPI-led teams that represent the cross functional expertise necessary for biomarker and/or signature development, along with the same types of centralized resource groups that coordinate clinical trials and standardize sample or data collection methods, technology development and statistical analysis. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-018.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 346176 Full Announcement-RFA-NS-24-018 -> RFA-NS-24-018-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00279947 | May 10, 2023 | Oct 23, 2023 | View |
Package 1
Mandatory forms
346176 RR_SF424_5_0-5.0.pdf
346176 PHS398_CoverPageSupplement_5_0-5.0.pdf
346176 RR_OtherProjectInfo_1_4-1.4.pdf
346176 PerformanceSite_4_0-4.0.pdf
346176 RR_KeyPersonExpanded_4_0-4.0.pdf
346176 RR_Budget_3_0-3.0.pdf
346176 PHS398_ResearchPlan_5_0-5.0.pdf
346176 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
346176 RR_SubawardBudget30_3_0-3.0.pdf
346176 PHS_AssignmentRequestForm_3_0-3.0.pdf
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