OpportunityTitle: Development and Validation of Disease Biomarkers (R01)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:  Alaska Native and Native Hawaiian Serving Institutions; 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.
Description: Purpose. This Funding Opportunity Announcement (FOA) issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Nursing Research (NINR), and the Office of Dietary Supplements (ODS) of the National Institutes of Health, will provide resources to validate candidate biomarkers for well-defined human diseases of the liver, kidney, urological tract, and digestive and hematologic systems, as well as endocrine and metabolic disorders, diabetes and its complications, and obesity, for which there are no or very few biomarkers, or for which standard biomarkers are currently prohibitively invasive or expensive. A biomarker is an indicator of a disease process, and could replace hard clinical end points as a measure of the effect of new therapies. Appropriate studies will validate candidate biomarkers in well-defined patient populations, provide new technologies to monitor biomarkers or establish reliable assays for validated markers. Progress in this area has the potential to advance translational research related to efficacy of treatments and bio-behavioral interventions. This FOA is not appropriate for biomarker discovery projects. Mechanism of Support. This FOA will utilize the NIH Research Project Grant (R01) award mechanism. Developmental/Exploratory Research (R21) applications within the scientific scope of the FOA can be submitted in response to the NIH Parent R21 PA http://grants.nih.gov/grants/guide/pa-files/PA-06-181.html. Funds Available and Anticipated Number of Awards. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
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