Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional) | PAR 22 089

Opportunity Information: Apply for PAR 22 089

The NIH funding opportunity PAR 22 089, titled "Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)," supports projects aimed at moving promising biomarkers from early discovery into a state where they are genuinely ready for rigorous, definitive validation. The core idea is practical: the program is looking for biomarkers or combinations of biomarkers (biomarker signatures) that can serve as reliable tools to speed and strengthen the development of neurotherapeutics and, eventually, improve how therapies are used in real clinical settings. Rather than focusing on very early, speculative discovery alone, the FOA emphasizes building a strong evidence base for candidates that already look compelling and then generating the biological, analytical, and initial clinical data needed to justify larger validation efforts.

The scientific scope centers on neurological and neuromuscular disorders, with an emphasis on identifying and performing early evaluation of biomarkers and biomarker signatures. This includes establishing that a biomarker is biologically meaningful for the disease process, can be measured in an analytically sound and reproducible way, and shows initial evidence of clinical relevance in humans. While animal work can be part of the package, the FOA makes clear that it cannot be the whole story. Every supported project must include preliminary evaluation in humans using carefully standardized human specimens or well-curated human datasets. In practice, that means applicants should be prepared to describe how human samples will be collected, handled, and processed under standardized conditions, or how existing datasets will be harmonized and analyzed to support credible, reproducible conclusions.

The mechanism is an R61/R33, which is designed for a staged, milestone-driven development path. The R61 phase generally supports early, high-impact activities that de-risk the biomarker candidate and generate the key proof-of-concept data needed to justify moving forward. The R33 phase then supports the next step of development once predefined milestones are met, pushing the biomarker toward readiness for later definitive analytical and clinical validation studies. The FOA is labeled "Clinical Trial Optional," meaning a clinical trial is not required for every application, but clinical trial activity can be proposed when it is appropriate for the biomarker work being done. Regardless of whether a clinical trial is included, the program is clearly oriented toward translational outcomes, with an end point of delivering candidates positioned for formal validation rather than stopping at exploratory signals.

Eligible applicants are broad and include many types of U.S.-based organizations: state, county, city, and 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 other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible groups such as Historically Black Colleges and Universities, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions, along with faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it places boundaries on foreign participation: non-U.S. entities and non-U.S. components of U.S. organizations are not eligible to apply, but foreign components may be included when allowed under NIH policy (as defined in the NIH Grants Policy Statement). This structure is meant to keep the application and primary award anchored in an eligible U.S. organization while still permitting justified international collaboration in a compliant way.

Administratively, the opportunity is offered by the National Institutes of Health under a grant funding instrument in the health category, with CFDA numbers 93.853 and 93.866. The original closing date listed is 2025-05-07, and the FOA was created on 2022-02-23. Taken together, the program is best understood as a translational biomarker pipeline opportunity: it is trying to produce well-characterized, human-relevant biomarker candidates or multi-marker signatures that have enough biological rationale, measurement rigor, and early clinical evidence to be strong contenders for subsequent, definitive validation and eventual adoption in therapeutic development and clinical practice.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 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, 93.866.
• This funding opportunity was created on 2022-02-23.
• Applicants must submit their applications by 2025-05-07. (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.

Apply for PAR 22 089

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