| Funding Opportunity ID: | 329936 |
| Opportunity Number: | PAR-21-058 |
| 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: | |
| CFDA Number(s): | 93.853 |
| Eligible Applicants: | State governments
County governments
City or township governments
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
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
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
For profit organizations other than small businesses
Small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| 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 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. |
| Agency Code: | HHS-NIH11 |
| Agency Name: | Department of Health and Human Services
National Institutes of Health |
| Posted Date: | Nov 19, 2020 |
| Close Date: | Sep 07, 2023 |
| Last Updated Date: | Nov 19, 2020 |
| Award Ceiling: | $0 |
| Award Floor: | $0 |
| Estimated Total Program Funding: | |
| Expected Number of Awards: | |
| Description: | 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. |
| Version: | 1 |
