Opportunity Information: Apply for PAR 24 096
The NIH funding opportunity PAR-24-096, titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)," supports projects that move a strong biomarker candidate from promising evidence to real clinical credibility in the patient population where it is intended to be used. The central aim is clinical validation: generating rigorous data that show how well a biomarker measurement performs in practice, specifically by establishing positive predictive value and negative predictive value in a defined clinical context of use, in a way that aligns with FDA expectations for biomarker evaluation. In other words, the program is designed to answer the practical questions clinicians, researchers, and regulators will ask: when the biomarker result is positive, how often is that truly associated with the condition or outcome of interest, and when it is negative, how often does it reliably rule it out?
This announcement is not meant for early discovery work. It assumes key groundwork is already done before applying. First, the biomarker itself must already be identified as a candidate with strong supporting evidence. Second, the measurement method or detection technology must already exist and be analytically validated, meaning the assay or measurement approach has already been shown to work technically (for example, accuracy, precision, reliability, and other analytical performance features have been characterized). Third, there must already be a clear research and/or clinical need, along with a plausible and well-defined context of use, such as supporting diagnosis, prognosis, patient stratification, monitoring disease progression, or assessing treatment response in a specified neurological or neuromuscular disorder setting. The grant is therefore aimed at bridging the gap between analytical readiness and clinical readiness, focusing on validation in the real-world clinical population where the biomarker would ultimately matter.
The funding mechanism is a Cooperative Agreement (U44), which typically means the NIH expects an active partnership role compared with a standard research project grant. This often involves closer coordination with NIH program staff and milestones-oriented project management, particularly appropriate for translational efforts like biomarker validation where study design rigor, recruitment feasibility, and performance targets are critical. The opportunity is labeled "Clinical Trial Optional," indicating that applicants may propose studies that include clinical trial elements if appropriate, but a clinical trial is not automatically required for every project; the key requirement is that the work directly supports clinical validation of the biomarker in the relevant population.
Eligible applicants span a broad range of organization types, reflecting the program's translational and implementation-oriented nature. Eligible entities include state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations (other than federally recognized tribal governments); nonprofits with or without 501(c)(3) status (excluding institutions of higher education where noted); for-profit organizations (including those other than small businesses); and small businesses. The announcement also explicitly notes additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions. At the same time, it draws a clear boundary around non-U.S. involvement: non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined under the NIH Grants Policy Statement, are allowed, which can enable certain internationally located activities or collaborations when they are justified and structured within NIH policy.
Administratively, the opportunity is offered by the National Institutes of Health and is categorized under discretionary funding for health (CFDA 93.853). The original closing date is listed as June 22, 2026. The award ceiling and expected number of awards are not specified in the provided listing, which often means applicants should review the full announcement for budget guidance, project period limits, milestone expectations, and any institute- or program-specific caps or preferences.
Overall, this program is best understood as a translational push to produce clinically meaningful evidence for a biomarker that is already technically mature and biologically plausible. The emphasis is on careful validation design in the intended patient population, producing predictive value data that can support next-step adoption, qualification discussions, or regulatory-aligned decision-making, rather than on discovering new biomarkers or inventing new assay platforms from scratch.Apply for PAR 24 096
- 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 (U44 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 2024-01-22.
- Applicants must submit their applications by 2026-06-22. (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-24-096 - Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
What is the goal of NIH funding opportunity PAR-24-096?
The goal is to clinically validate a strong candidate biomarker for a neurological or neuromuscular disorder by generating rigorous evidence of how well the biomarker performs in the real intended patient population and clinical setting.
What does "clinical validation" mean in this opportunity?
Clinical validation here means producing data that show the biomarker measurement works in practice in a defined context of use, including establishing positive predictive value (PPV) and negative predictive value (NPV) so the results are meaningful for clinicians, researchers, and regulators.
What specific performance questions is the program trying to answer?
The program is focused on practical performance questions: when the biomarker result is positive, how often is it truly associated with the condition or outcome of interest (PPV), and when the result is negative, how often does it reliably rule it out (NPV), within a defined clinical context of use.
Is this funding opportunity intended for early-stage biomarker discovery?
No. It is not meant for early discovery work. It assumes the biomarker candidate has already been identified and supported by strong evidence before applying.
What must already be in place before applying?
Three major pieces of groundwork are expected to already be done: (1) a biomarker has already been identified as a candidate with strong supporting evidence, (2) the measurement method or detection technology already exists and has been analytically validated, and (3) there is a clear research and/or clinical need with a plausible, well-defined context of use.
What does "analytically validated" mean in this context?
It means the assay or measurement approach has already been shown to work technically, with analytical performance features characterized, such as accuracy, precision, reliability, and related technical measures.
What kinds of contexts of use are appropriate for the biomarker?
The opportunity describes contexts of use such as supporting diagnosis, prognosis, patient stratification, monitoring disease progression, or assessing treatment response, in a specified neurological or neuromuscular disorder setting.
What is the main gap this program is trying to bridge?
It is designed to bridge the gap between analytical readiness (the assay works technically) and clinical readiness (the biomarker is shown to perform reliably in the intended clinical population and use case).
What funding mechanism is used for PAR-24-096?
The mechanism is a Cooperative Agreement (U44), which generally involves an active partnership role by NIH compared with a standard research project grant.
What does it mean that this is a U44 Cooperative Agreement?
A U44 cooperative agreement typically implies closer coordination with NIH program staff and a milestones-oriented approach to project management, which fits translational efforts like biomarker clinical validation where study rigor, recruitment feasibility, and performance targets are critical.
Does the project have to include a clinical trial?
No. The opportunity is labeled "Clinical Trial Optional," meaning studies may include clinical trial elements if appropriate, but a clinical trial is not automatically required. The key requirement is that the proposed work directly supports clinical validation of the biomarker in the relevant population.
What disease areas are targeted by this opportunity?
The focus is on neurological or neuromuscular disorders, with validation performed in the patient population where the biomarker is intended to be used.
Who can apply for PAR-24-096?
Eligible applicants include many organization types, such as state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations (other than federally recognized tribal governments); nonprofits with or without 501(c)(3) status (excluding institutions of higher education where noted); for-profit organizations (including those other than small businesses); and small businesses.
Are specific institution types explicitly mentioned as eligible?
Yes. The announcement explicitly notes additional eligible categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions.
Are non-U.S. (non-domestic) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply.
Can a U.S. organization include a non-domestic component?
No. Non-domestic components of U.S. organizations are not eligible to apply under this opportunity.
Are foreign components allowed at all?
Yes. Foreign components, as defined under the NIH Grants Policy Statement, are allowed, which can support certain internationally located activities or collaborations when they are justified and structured within NIH policy.
Which agency is offering this grant opportunity?
The opportunity is offered by the National Institutes of Health (NIH).
How is this opportunity categorized in federal assistance terms?
It is categorized under discretionary funding for health and is associated with CFDA 93.853.
What is the closing date listed for this opportunity?
The original closing date listed is June 22, 2026.
Is the award ceiling or the expected number of awards provided in the listing?
No. The provided listing does not specify an award ceiling or an expected number of awards, which typically means applicants should consult the full announcement for budget guidance, project period limits, milestones, and any program-specific caps or preferences.
What kind of evidence is the program emphasizing for FDA-aligned biomarker evaluation?
The emphasis is on rigorous clinical validation data, particularly PPV and NPV in a defined context of use, generated in a way that aligns with FDA expectations for biomarker evaluation.
What types of projects are not the focus of this program?
Projects focused on discovering new biomarkers or inventing new assay platforms from scratch are not the focus. The program expects the biomarker candidate and an analytically validated measurement method to already exist.
What is the overall "best fit" description for this program?
It is a translational program aimed at producing clinically meaningful, regulator-relevant evidence for a technically mature and biologically plausible biomarker, supporting next-step adoption, qualification discussions, or regulatory-aligned decision-making.
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| Funding Opportunity |
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| Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional) Apply for PAR 24 095 Funding Number: PAR 24 095 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional) Apply for PAR 24 097 Funding Number: PAR 24 097 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional) Apply for PAR 24 098 Funding Number: PAR 24 098 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Limited Competition: Specific Pathogen Free Macaque Colonies to Support HIV/AIDS Research (U42 Clinical Trial Not Allowed) Apply for PAR 24 129 Funding Number: PAR 24 129 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Understanding Mechanisms and Outcomes of Trained Immunity (R01 Clinical Trial Not Allowed) Apply for PAR 24 112 Funding Number: PAR 24 112 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Understanding Mechanisms and Outcomes of Trained Immunity (R21 Clinical Trial Not Allowed) Apply for PAR 24 111 Funding Number: PAR 24 111 Agency: National Institutes of Health Category: Health Funding Amount: $275,000 |
| Evaluation and Coordinating Center for the AHRQ/PCORI Learning Health System Embedded Scientist Training and Research Centers (U18) Apply for RFA HS 24 002 Funding Number: RFA HS 24 002 Agency: Agency for Health Care Research and Quality Category: Health Funding Amount: $1,000,000 |
| Novel Approaches for Radiation Biodosimetry Assays and Devices Development (U01 Clinical Trial Not Allowed) Apply for RFA AI 24 003 Funding Number: RFA AI 24 003 Agency: National Institutes of Health Category: Health Funding Amount: $350,000 |
| USAID/Kenya and East Africa Global Health Security (GHS) Activity Apply for 72061524RFI00002 Funding Number: 72061524RFI00002 Agency: Kenya USAID-Nairobi Category: Health Funding Amount: Case Dependent |
| NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required) Apply for PAR 24 099 Funding Number: PAR 24 099 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) Apply for PAR 24 100 Funding Number: PAR 24 100 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Localization in Health Apply for 620 24 0002 Funding Number: 620 24 0002 Agency: Nigeria USAID-Abuja Category: Health Funding Amount: Case Dependent |
| NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required) Apply for PAR 24 124 Funding Number: PAR 24 124 Agency: National Institutes of Health Category: Health Funding Amount: $350,000 |
| NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required) Apply for PAR 24 116 Funding Number: PAR 24 116 Agency: National Institutes of Health Category: Health Funding Amount: $1,050,000 |
| NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required) Apply for PAR 24 115 Funding Number: PAR 24 115 Agency: National Institutes of Health Category: Health Funding Amount: $350,000 |
| Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required) Apply for PAR 24 123 Funding Number: PAR 24 123 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| USAID Strengthening Local Health Security Apply for 72044024RFA00001 Funding Number: 72044024RFA00001 Agency: USAID-VIETNAM Category: Health Funding Amount: $21,500,000 |
| Mechanistic Investigations into ADRD Multiple Etiology Dementias (R01 - Clinical Trial Not Allowed) Apply for PAR 24 147 Funding Number: PAR 24 147 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| Investigating Distinct and Overlapping Mechanisms in TDP-43 Proteinopathies, including in LATE, FTD and other ADRDs (R01 - Clinical Trial Not Allowed) Apply for PAR 24 148 Funding Number: PAR 24 148 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| Multi-Scale Models Bridging Levels of Analysis in Aging and Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (R01 Clinical Trial Not Allowed) Apply for RFA AG 25 016 Funding Number: RFA AG 25 016 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
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