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The National Institutes of Health (NIH) is offering a grant through the HEAL Initiative to support the discovery of biomarkers or biomarker signatures for pain. The grant aims to assist in testing non-opioid pain therapeutics in Phase II clinical trials by identifying predictive or monitoring biomarkers for response to pain treatments. Projects should focus on developing biomarkers for a single pain condition or multiple related pain conditions. Applicants should involve Multiple Principal Investigator (MPI)-led teams to cover diverse pain expertise and centralized resource groups to ensure standardization in clinical trials and data collection methods.
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Opportunity ID: 337892
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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:: | |
| Category of Funding Activity:: | Education |
| Category Explanation:: | |
| Expected Number of Awards:: | |
| Assistance Listings Number(s):: | 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:: | 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:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 1 | Feb 08, 2022 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | |
| Competition ID: | FORMS-G |
| Competition Title: | Use for due dates on or before January 24, 2023 |
| Opportunity Package ID: | PKG00271975 |
| Opening Date: | Feb 11, 2022 |
| Closing Date: | Jan 24, 2023 |
| Agency Contact Information:: | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V5.0] PHS 398 Cover Page Supplement [V5.0] Research And Related Other Project Information [V1.4] Project/Performance Site Location(s) [V4.0] Research and Related Senior/Key Person Profile (Expanded) [V4.0] Research & Related Budget [V3.0] PHS 398 Research Plan [V4.0] PHS Human Subjects and Clinical Trials Information [V3.0] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V3.0] PHS Assignment Request Form [V3.0] |
Package No: 2
| Assistance Listings: | |
| Competition ID: | FORMS-H |
| Competition Title: | Use for due dates on or after January 25, 2023 |
| Opportunity Package ID: | PKG00278477 |
| Opening Date: | Nov 15, 2022 |
| Closing Date: | Feb 23, 2023 |
| Agency Contact Information:: | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V5.0] PHS 398 Cover Page Supplement [V5.0] Research And Related Other Project Information [V1.4] Project/Performance Site Location(s) [V4.0] Research and Related Senior/Key Person Profile (Expanded) [V4.0] Research & Related Budget [V3.0] PHS 398 Research Plan [V5.0] PHS Human Subjects and Clinical Trials Information [V3.0] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V3.0] PHS Assignment Request Form [V3.0] |
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Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00271975 | Feb 11, 2022 | Jan 24, 2023 | View | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ | Organization Applicants |
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| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278477 | Nov 15, 2022 | Feb 23, 2023 | View | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ | Organization Applicants |
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