This grant is for discovering strong pain biomarkers and biomarker signatures to facilitate Phase II clinical trials of non-opioid pain therapeutics. Its goal is to predict and monitor treatment response across single or multiple pain conditions with shared pathophysiology. Applications must feature Multiple Principal Investigator (MPI)-led teams with diverse expertise, standardizing measures and biomarker modalities. Centralized resource groups are also required to coordinate trials, standardize sample/data collection, technology development, and statistical analysis, ensuring robust biomarker identification and validation for effective pain management.
Opportunity ID: 337892
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-22-050 |
| 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 08, 2022 |
| Last Updated Date: | Feb 08, 2022 |
| Original Closing Date for Applications: | Feb 23, 2023 |
| Current Closing Date for Applications: | Feb 23, 2023 |
| Archive Date: | Mar 31, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Private institutions of higher education Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Special district governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Small businesses For profit organizations other than small businesses State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. |
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: | http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-22-050.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 337892 Full Announcement-RFA-NS-22-050 -> RFA-NS-22-050-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster OERWebmaster03@od.nih.gov Email: OERWebmaster03@od.nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00271975 | Feb 11, 2022 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278477 | Nov 15, 2022 | Feb 23, 2023 | View |
Package 1
Mandatory forms
337892 RR_SF424_5_0-5.0.pdf
337892 PHS398_CoverPageSupplement_5_0-5.0.pdf
337892 RR_OtherProjectInfo_1_4-1.4.pdf
337892 PerformanceSite_4_0-4.0.pdf
337892 RR_KeyPersonExpanded_4_0-4.0.pdf
337892 RR_Budget_3_0-3.0.pdf
337892 PHS398_ResearchPlan_4_0-4.0.pdf
337892 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
337892 RR_SubawardBudget30_3_0-3.0.pdf
337892 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
337892 RR_SF424_5_0-5.0.pdf
337892 PHS398_CoverPageSupplement_5_0-5.0.pdf
337892 RR_OtherProjectInfo_1_4-1.4.pdf
337892 PerformanceSite_4_0-4.0.pdf
337892 RR_KeyPersonExpanded_4_0-4.0.pdf
337892 RR_Budget_3_0-3.0.pdf
337892 PHS398_ResearchPlan_5_0-5.0.pdf
337892 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
337892 RR_SubawardBudget30_3_0-3.0.pdf
337892 PHS_AssignmentRequestForm_3_0-3.0.pdf
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