Cooperative AgreementPostedDiscretionary

Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

National Institutes of Health
PAR-24-096
Application Deadline
Jun 22, 2026
77 days left
Days Remaining
77
Until deadline
Award Ceiling
Total Program Funding

Grant Opportunity Analysis

The National Institutes of Health (NIH) has announced a funding opportunity titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)" aimed at supporting the clinical validation of candidate biomarkers for neurological diseases. This initiative seeks proposals from small businesses to demonstrate the clinical effectiveness of identified biomarkers, ensuring they meet FDA guidelines for validation, including establishing their clinical sensitivity and specificity. The funding opportunity allows for both Phase I and Phase II applications, with budget limits of up to $700,000 and $1,500,000, respectively, over a period of two to three years. Interested applicants should note that the application submission begins on February 22, 2024, and for further inquiries, they can contact NIH Grants Information at grantsinfo@nih.gov. More details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-24-096.html.

Eligible Applicants

Others
Additional Eligibility Information

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.

Grant Documents

2 Files
PAR-24-096-Full-Announcement.html
HTML0 KBAug 24, 2024
AI Summary
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PAR-24-096.html
HTML207 KBAug 24, 2024
AI Summary
The Department of Health and Human Services, via the National Institutes of Health (NIH), has issued a funding opportunity aimed at validating candidate biomarkers for neurological and neuromuscular disorders. This initiative, designated as PAR-24-096, encourages small businesses to propose studies that demonstrate the clinical effectiveness of biomarkers within defined contexts of use. The primary goal is to establish the clinical sensitivity and specificity of these biomarkers in alignment with FDA guidelines, ensuring they meet rigorous validation standards. Applicants must provide a comprehensive plan for enhancing diverse perspectives within their research teams and demonstrate the feasibility of integrating the biomarkers into clinical practice or trials. The funding supports both Phase I and Phase II applications with budget limits of up to $700,000 and $1,500,000, respectively, across a period of two to three years. Key dates for application submission begin on February 22, 2024, with a series of review cycles extending into 2027. This funding opportunity underscores the NIH's commitment to fostering diversity in scientific research and advancing public health through biomarker innovation.

Related Grant Opportunities

Project Timeline

postedOriginal Opportunity PostedJan 22, 2024
deadlineApplication DeadlineJun 22, 2026
expiryArchive DateJul 28, 2026

Funding Details

No cost sharing required

Agency & Classification

Agency
National Institutes of Health(HHS-NIH11)
Funding Category
Health
Funding Instrument
Cooperative Agreement

Grantor Contact

CFDA Numbers

93.853

Official Sources