This Neurological Research Department is offering a grant program to enable the rigorous clinical validation of strong candidate biomarkers for neurological diseases and conditions. The primary purpose of this grant is to establish the positive and negative predictive values of these candidate biomarkers within relevant clinical populations, aligning with FDA guidelines. This funding opportunity supports projects where a candidate biomarker has already been identified, its detection method technology developed and analytically validated, and the research or clinical need, along with its potential context of use, has been clearly established. This grant is for researchers seeking to advance promising neurological and neuromuscular biomarkers through the crucial stage of clinical validation.
Opportunity ID: 351915
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-097 |
| Funding Opportunity Title: | Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jan 22, 2024 |
| Last Updated Date: | Oct 02, 2024 |
| Original Closing Date for Applications: | Jun 22, 2026 |
| Current Closing Date for Applications: | Oct 01, 2024 |
| Archive Date: | Oct 31, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses State governments Native American tribal organizations (other than Federally recognized tribal governments) County governments City or township governments Public and State controlled institutions of higher education Small businesses Native American tribal governments (Federally recognized) Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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 Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
(Reissue PAR-21-058). The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-097.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 |
|---|---|---|
| Update close date per reissued NOFO PAR-25-055. | Oct 02, 2024 | |
| Jan 22, 2024 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-097 |
| Funding Opportunity Title: | Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jan 22, 2024 |
| Last Updated Date: | Oct 02, 2024 |
| Original Closing Date for Applications: | Jun 22, 2026 |
| Current Closing Date for Applications: | Oct 01, 2024 |
| Archive Date: | Oct 31, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses State governments Native American tribal organizations (other than Federally recognized tribal governments) County governments City or township governments Public and State controlled institutions of higher education Small businesses Native American tribal governments (Federally recognized) Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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 Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
(Reissue PAR-21-058). The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-097.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 |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-097 |
| Funding Opportunity Title: | Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 22, 2024 |
| Last Updated Date: | Jan 22, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 22, 2026 |
| Archive Date: | Jul 28, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities County governments Native American tribal governments (Federally recognized) Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Special district governments State governments City or township 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 Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | (Reissue PAR-21-058). The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-097.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 |
Related Documents
There are no related documents on this grant.
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 | PKG00284507 | Feb 22, 2024 | Oct 03, 2024 | View |
Package 1
Mandatory forms
351915 RR_SF424_5_0-5.0.pdf
351915 PHS398_CoverPageSupplement_5_0-5.0.pdf
351915 RR_OtherProjectInfo_1_4-1.4.pdf
351915 PerformanceSite_4_0-4.0.pdf
351915 RR_KeyPersonExpanded_4_0-4.0.pdf
351915 PHS398_ResearchPlan_5_0-5.0.pdf
351915 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
351915 RR_Budget_3_0-3.0.pdf
351915 RR_SubawardBudget30_3_0-3.0.pdf
351915 PHS398_ModularBudget_1_2-1.2.pdf
351915 PHS_AssignmentRequestForm_3_0-3.0.pdf
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