Opportunity Information: Apply for PAR 21 058
The NIH funding opportunity PAR-21-058, titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)," supports projects that move beyond biomarker discovery and focus instead on clinical validation. The main purpose is to rigorously validate a strong, already-identified candidate biomarker in the real clinical population where it is intended to be used, with the specific aim of establishing performance metrics such as positive predictive value (PPV) and negative predictive value (NPV) in a way that aligns with FDA expectations and guidance. In practical terms, the program is geared toward determining how well the biomarker distinguishes between clinically relevant states (for example, disease vs. no disease, subtype A vs. subtype B, progression vs. stability, or likely responder vs. non-responder) when applied to the target patient group under conditions that resemble intended clinical use.
This announcement is intentionally positioned late in the biomarker pipeline. Applicants are expected to come in with several key prerequisites already in place: first, a candidate biomarker that has already been identified and is supported by strong preliminary evidence; second, a detection or measurement method that has already been developed and analytically validated (meaning the assay or measurement approach has been tested for technical performance characteristics such as accuracy, precision, sensitivity, specificity, reproducibility, and robustness as appropriate); and third, a clear clinical or research need and a plausible "context of use" describing how the biomarker would be used in decision-making. The funding is therefore not aimed at inventing a new assay from scratch or conducting early discovery work, but at executing the clinical studies needed to establish whether the biomarker truly performs reliably and predictively in the intended population.
The activity uses a U01 cooperative agreement mechanism, which generally means the NIH anticipates substantial scientific and/or programmatic involvement during the project period compared to a typical research project grant. While clinical trials are described as optional under this announcement, the scope is still centered on clinical validation within patient populations, so applicants should expect to justify study design choices carefully and show that the clinical evaluation plan is rigorous and appropriate for generating clinically meaningful predictive values. A strong application would typically emphasize well-characterized cohorts, careful definition of clinical endpoints, appropriate reference standards or comparator measures, pre-specified statistical analysis plans, and steps to reduce bias and improve generalizability (for example, multi-site enrollment, standardized operating procedures, and attention to confounders that might affect biomarker readings).
Eligibility is broad and includes many types of U.S.-based organizations and governments, such as state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (both with and without 501(c)(3) status); for-profit organizations (other than small businesses) as well as small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments). The announcement explicitly highlights additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
Foreign eligibility is limited. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S. applicant may include certain foreign collaborations or elements if they are justified and meet NIH policy requirements.
Administratively, the opportunity is listed as a discretionary funding program under the health category, administered by the National Institutes of Health, with CFDA number 93.853. The funding instrument is a cooperative agreement (U01). The original closing date provided in the source information is 2023-09-07, and the opportunity record creation date is 2020-11-19. The award ceiling and expected number of awards are not specified in the provided listing, so applicants would typically look to the full funding announcement and related NIH institute/center guidance for budget expectations, project period norms, and any institute-specific priorities.
Overall, the core idea of PAR-21-058 is to bridge the gap between promising biomarker candidates and real-world clinical usefulness in neurology and neuromuscular disease by funding the kind of careful, population-based validation work needed to support eventual regulatory qualification, clinical adoption, or use in therapeutic development and clinical research.Apply for PAR 21 058
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
- This funding opportunity was created on 2020-11-19.
- Applicants must submit their applications by 2023-09-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: 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.
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FAQs: NIH PAR-21-058 - Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
What is PAR-21-058?
PAR-21-058 is an NIH funding opportunity titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)." It supports projects that focus on clinical validation of an already-identified biomarker candidate in the real patient population where it is intended to be used.
What is the main goal of this funding opportunity?
The goal is to rigorously validate a strong candidate biomarker in the intended clinical population and establish performance metrics, including positive predictive value (PPV) and negative predictive value (NPV), in a way that aligns with FDA expectations and guidance.
What stage of biomarker development is this program designed for?
This announcement is positioned late in the biomarker pipeline. It is meant for projects that have moved beyond discovery and assay development and are ready for clinical validation in the target population under conditions resembling intended clinical use.
Is biomarker discovery supported under PAR-21-058?
No. The program is not aimed at biomarker discovery or early exploratory studies. Applicants are expected to propose clinical validation studies for a biomarker that has already been identified and supported by strong preliminary evidence.
Does the funding support developing a new assay from scratch?
No. Applicants are expected to already have a detection or measurement method that has been developed and analytically validated. The focus is on clinical validation, not building a brand-new assay or measurement approach.
What does "clinical validation" mean in this opportunity?
Clinical validation here means determining how well the biomarker performs in the real clinical population where it is intended to be used, including how well it distinguishes between clinically relevant states such as disease vs. no disease, subtype A vs. subtype B, progression vs. stability, or likely responder vs. non-responder.
What types of performance metrics are emphasized?
The opportunity specifically emphasizes establishing predictive performance metrics like PPV and NPV. More broadly, the intent is to generate clinically meaningful measures of performance consistent with FDA expectations and guidance.
What prerequisites should applicants already have in place?
Applicants are expected to come in with: (1) a strong candidate biomarker supported by preliminary evidence, (2) a measurement method/assay that has already been analytically validated for technical performance characteristics, and (3) a clear clinical or research need and a plausible context of use describing how the biomarker will be used in decision-making.
What is meant by "analytically validated" for the measurement method?
Analytical validation means the assay or measurement approach has been evaluated for relevant technical performance characteristics such as accuracy, precision, sensitivity, specificity, reproducibility, and robustness, as appropriate.
What is a "context of use" in this program?
A context of use is a description of how the biomarker would be used in practice to support decisions. The opportunity expects applicants to define a plausible context of use tied to a clear clinical or research need.
Are clinical trials required?
Clinical trials are described as optional under this announcement. However, the scope is still centered on clinical validation within patient populations, and applicants should be prepared to justify the chosen study design and show it is rigorous enough to yield clinically meaningful predictive values.
What award mechanism is used for PAR-21-058?
The opportunity uses a U01 cooperative agreement mechanism.
What does a U01 cooperative agreement imply?
A U01 cooperative agreement generally indicates the NIH anticipates substantial scientific and/or programmatic involvement during the project period compared to a typical research project grant.
What kinds of study design elements does NIH expect for a strong application?
Based on the announcement description, strong applications typically emphasize well-characterized cohorts, careful definition of clinical endpoints, appropriate reference standards or comparator measures, pre-specified statistical analysis plans, and steps to reduce bias and improve generalizability (such as multi-site enrollment, standardized operating procedures, and addressing confounders that could affect biomarker readings).
Why is multi-site enrollment and standardization mentioned?
These approaches are highlighted as examples of steps that can reduce bias and improve generalizability, helping ensure the biomarker performance observed in the study reflects how it may perform under intended clinical use.
What disease areas does the opportunity target?
The focus is neurological and neuromuscular disorders, with an emphasis on validating biomarkers for use in real clinical populations relevant to those conditions.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organizations and governments, including state/county/city/township governments, special district governments, independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), public housing authorities/Indian housing authorities, and Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments).
Are specific institution types explicitly highlighted as eligible?
Yes. The opportunity explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
Can a foreign (non-U.S.) organization apply as the applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization under this opportunity.
Are non-domestic components of U.S. organizations allowed to apply?
No. Non-domestic components of U.S. organizations are not eligible to apply as the applicant.
Are foreign components allowed in any form?
Yes. Foreign components are allowed as defined in the NIH Grants Policy Statement. A U.S. applicant may include certain foreign collaborations or elements if they are justified and meet NIH policy requirements.
Which federal agency administers this opportunity?
The opportunity is administered by the National Institutes of Health (NIH).
What is the CFDA number listed for this opportunity?
The CFDA number provided is 93.853.
What category is this program listed under?
It is listed as a discretionary funding program under the health category.
What is the closing date provided in the listing?
The original closing date provided in the source information is 2023-09-07.
What is the opportunity record creation date?
The opportunity record creation date provided is 2020-11-19.
Is the award ceiling specified in the provided information?
No. The award ceiling is not specified in the provided listing.
Is the expected number of awards specified?
No. The expected number of awards is not specified in the provided listing.
Where should applicants look for budget expectations or project period norms?
Because the provided listing does not specify an award ceiling or expected number of awards, applicants would typically consult the full funding announcement and related NIH institute/center guidance for budget expectations, typical project periods, and any institute-specific priorities.
What is the overall intent of PAR-21-058 in practical terms?
The intent is to bridge the gap between a promising biomarker candidate and real-world clinical usefulness by funding careful, population-based validation work needed to support potential regulatory qualification, clinical adoption, or use in therapeutic development and clinical research.
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| Funding Opportunity |
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| Graduate Research Training Initiative for Student Enhancement (G-RISE) (T32 - Clinical Trial Not Allowed) Apply for PAR 21 026 Funding Number: PAR 21 026 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIDCR Small Grant Program for New Investigators (R03 Clinical Trial Not Allowed) Apply for PAR 21 084 Funding Number: PAR 21 084 Agency: National Institutes of Health Category: Health Funding Amount: $100,000 |
| Limited Competition: Small Grant Program for ORIP Special Emphasis Research Career Award (SERCA) K01 Recipients (R03 Clinical Trials Not Allowed) Apply for PAR 21 090 Funding Number: PAR 21 090 Agency: National Institutes of Health Category: Health Funding Amount: $75,000 |
| NEI Institutional Mentored Physician Scientist Award (K12 Clinical Trial Optional) Apply for PAR 21 073 Funding Number: PAR 21 073 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NHLBI Program Project Applications (P01 Clinical Trials Optional) Apply for PAR 21 088 Funding Number: PAR 21 088 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIH Faculty Institutional Recruitment for Sustainable Transformation (FIRST) Program: FIRST Coordination and Evaluation Center (U24 Clinical Trial Not Allowed) Apply for RFA RM 20 023 Funding Number: RFA RM 20 023 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIH Faculty Institutional Recruitment for Sustainable Transformation (FIRST) Program: FIRST Cohort (U54 Clinical Trial Optional) Apply for RFA RM 20 022 Funding Number: RFA RM 20 022 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIDCD Mentored Career Development Award for Postdoctorate Au.D./Ph.D. Audiologists (K01 Independent Basic Experimental Studies with Humans Required) Apply for PAR 21 087 Funding Number: PAR 21 087 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIDCD Mentored Career Development Award for Postdoctorate Au.D./Ph.D. Audiologists (K01 No Independent Clinical Trials) Apply for PAR 21 086 Funding Number: PAR 21 086 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIDCD Mentored Career Development Award for Postdoctorate Au.D./Ph.D. Audiologists (K01 Clinical Trial Required) Apply for PAR 21 085 Funding Number: PAR 21 085 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Mood Disorders in People Living with HIV: Mechanisms and Pathways (R21 Clinical Trial Optional) Apply for RFA MH 21 117 Funding Number: RFA MH 21 117 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Mood Disorders in People Living with HIV: Mechanisms and Pathways (R01 Clinical Trial Optional) Apply for RFA MH 21 116 Funding Number: RFA MH 21 116 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Research Experiences in Genomic Research for Data Scientists (R25) Apply for PAR 21 075 Funding Number: PAR 21 075 Agency: National Institutes of Health Category: Health Funding Amount: $250,000 |
| Mentored Research Experiences for Genetic Counselors (R25) Apply for PAR 21 074 Funding Number: PAR 21 074 Agency: National Institutes of Health Category: Health Funding Amount: $250,000 |
| NIAMS Centers of Research Translation (CORT) (P50 - Clinical Trial Not Allowed) Apply for RFA AR 22 001 Funding Number: RFA AR 22 001 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Aging Effects on Osteoimmunology (R01 Clinical Trials Not Allowed) Apply for RFA AG 22 002 Funding Number: RFA AG 22 002 Agency: National Institutes of Health Category: Health Funding Amount: $300,000 |
| New Chemistries for Un-drugged Targets through A Specialized Platform for Innovative Research Exploration (ASPIRE) Collaborative Research Program (UG3/UH3 Clinical Trials Not Allowed) Apply for RFA TR 21 001 Funding Number: RFA TR 21 001 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Virtual Approaches Towards New Chemistries for Un-drugged Targets through A Specialized Platform for Innovative Research Exploration (ASPIRE) Collaborative Research Program (U18 Clinical Trials Not Allowed) Apply for RFA TR 21 002 Funding Number: RFA TR 21 002 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R34 Clinical Trial Optional) Apply for PAR 21 097 Funding Number: PAR 21 097 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R61/R33 Clinical Trial Optional) Apply for PAR 21 098 Funding Number: PAR 21 098 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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