Significance of Clonal Hematopoiesis (CH) in Aging Humans (R01 Clinical Trial Not Allowed)?

Background
The purpose of this Notice of Funding Opportunity (NOFO) is to stimulate the use of existing biospecimens and datasets (i.e., secondary analysis) which will increase our understanding of the clinical significance of clonal hematopoiesis (CH) mutations, their causality, directionality, relationships with different human aging phenotypes, and the underlying biological mechanisms. CH is a condition related to aging wherein clonal expansion of hematopoietic cells driven by somatic mutations increases markedly with age in humans.

Grant Details
The NOFO will use the R01 grant mechanism to support studies using sequencing-based analyses of biospecimens from epidemiological cohorts with extensive physiologic, genetic, and omics data to assess the clinical significance of somatic mutations for a variety of age-related outcomes. New data and specimen collection to supplement existing datasets is allowed when essential for addressing the specific aims of the proposed study. Studies should consider both potential deleterious and protective effects of CH mutations and the molecular mechanisms underpinning pleiotropic effects of CH in aging. Analysis of biospecimens from clinical trials focused on age-related outcomes is also strongly encouraged to assess and clarify the relationship of CH to treatment effects and to evaluate the clinical utility of CH screening in clinical practice for risk prediction and prognosis for age-related disease.

Eligibility Requirements
Eligible applicants include Higher Education Institutions, Public/State Controlled Institutions of Higher Education, Private Institutions of Higher Education, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education), Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education), For-Profit Organizations (including Small Businesses), Local Governments, State Governments, County Governments, City or Township Governments, Special District Governments, Indian/Native American Tribal Governments (Federally Recognized), Indian/Native American Tribal Governments (Other than Federally Recognized), Federal Governments, U.S. Territory or Possession, Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations.

Period of Performance
The period of performance will be determined by the scope of the proposed project but should not exceed 5 years.

Grant Value
NIA intends to commit $5 million in fiscal year 2024 to fund up to 4 applications. Application budgets are limited to up to $1 million in direct costs.