Opportunity Information: Apply for RFA RM 12 013
Apply for RFA RM 12 013
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Utility of Extracellular RNA for Biomarker Development (UH2/UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310 Trans NIH Research Support.
- This funding opportunity was created on Aug 3, 2012 and posted on Aug 3, 2012.
- Applicants must submit their applications by Nov 13, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Small businesses Special district governments Public and State controlled institutions of higher education Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education.
- 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIH funding opportunity titled "Clinical Utility of Extracellular RNA for Biomarker Development (UH2/UH3)" (Funding Opportunity Number RFA-RM-12-013) is a cooperative agreement designed to push extracellular RNA (exRNA) biomarkers closer to real clinical use. The program focuses on exRNA found in human body fluids, including blood, saliva, urine, breast milk, amniotic fluid, cerebrospinal fluid, and clinical effusions such as ascites and pleural fluid. The central idea is to support projects that can reliably identify and qualify exRNA-based signals that help clinicians diagnose disease, track how a disease changes over time, and measure whether a treatment is working.
A key emphasis is clinical utility rather than exploratory discovery alone. In practical terms, NIH is looking for biomarkers that are not just statistically interesting, but that can be shown to matter for patients and clinical decision-making. The opportunity frames success in terms of meaningful patient outcomes commonly used in clinical trials: how patients feel, how they function, and how long they survive. Applications are expected to move beyond early-stage associations by working in well-defined patient populations and producing evidence that a biomarker is robust, reproducible, and relevant in a clinical context.
Projects supported under this announcement can take multiple forms as long as they advance credible biomarker development. Appropriate studies include identifying and validating candidate exRNA biomarkers in carefully characterized patient cohorts, establishing or improving technologies for monitoring these biomarkers, and developing reliable assays for biomarkers that have already shown promise. This includes the kind of work needed to make an assay dependable enough for broader research use or eventual clinical deployment, such as standardizing measurement approaches, improving analytical performance, and demonstrating that the marker can be consistently measured in real-world samples.
The mechanism is UH2/UH3, which generally indicates a phased approach: an initial stage to establish feasibility and generate convincing early results (UH2), followed by a later stage focused on expanded development, validation, or translation (UH3), with NIH involvement typical of cooperative agreements. Because it is a cooperative agreement rather than a standard grant, awardees should expect substantive programmatic participation from NIH, which often means coordinated milestones, close communication, and an expectation of progress toward clearly defined deliverables.
From an eligibility standpoint, the announcement is broad and inclusive. Eligible applicants include a wide range of U.S.-based organizations such as public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations, small businesses, state and local governments, tribal governments and tribal organizations, public housing authorities, school districts, and regional organizations. It also explicitly allows applications from non-U.S. entities (foreign institutions) and foreign components of U.S. organizations, consistent with NIH policy. There is no cost-sharing or matching requirement stated for this opportunity, which reduces barriers for applicants who may not be able to contribute significant non-federal funds.
Administratively, the opportunity falls under the NIH (Agency Name: National Institutes of Health) and is categorized as discretionary funding supporting health research (CFDA 93.310, Trans-NIH Research Support). The opportunity was posted on August 3, 2012, with an original and final closing date of November 13, 2012, and it was archived on December 14, 2012. The estimated total funding amount listed is $4,000,000, suggesting a relatively targeted program with a limited number of awards or a focused set of projects.
Overall, this FOA is aimed at bridging the gap between promising exRNA signals in body fluids and clinically reliable biomarkers. The NIH is essentially inviting teams to bring rigor, validation, and practical assay development to exRNA biomarker science so that the outputs can be used credibly in clinical trials and, ultimately, support decisions that improve patient care.
FAQs: Clinical Utility of Extracellular RNA for Biomarker Development (UH2/UH3) (RFA-RM-12-013)
What is the goal of this NIH funding opportunity?
The goal is to move extracellular RNA (exRNA) biomarkers closer to real clinical use by supporting projects that can reliably identify and qualify exRNA-based signals that help clinicians diagnose disease, track disease changes over time, and measure whether a treatment is working.
What is the official title and funding opportunity number?
The title is "Clinical Utility of Extracellular RNA for Biomarker Development (UH2/UH3)" and the Funding Opportunity Number is RFA-RM-12-013.
Which agency is offering this opportunity?
The agency is the National Institutes of Health (NIH).
What type of funding mechanism is used (grant vs. cooperative agreement)?
This opportunity uses a cooperative agreement mechanism, meaning NIH expects substantive programmatic participation during the project rather than a hands-off relationship typical of some standard research grants.
What does the UH2/UH3 mechanism mean in practice?
UH2/UH3 generally indicates a phased approach: an initial stage (UH2) to establish feasibility and generate convincing early results, followed by a later stage (UH3) that focuses on expanded development, validation, or translation, with NIH involvement and coordinated milestones.
What does NIH mean by "clinical utility" in this FOA?
The FOA emphasizes biomarkers that matter for patients and clinical decision-making, not just statistically interesting findings. Success is framed around meaningful patient outcomes commonly used in clinical trials, including how patients feel, how they function, and how long they survive.
Is this opportunity focused on discovery research or later-stage biomarker development?
The emphasis is on clinical utility rather than exploratory discovery alone. Applications are expected to move beyond early-stage associations by working in well-defined patient populations and producing evidence that a biomarker is robust, reproducible, and clinically relevant.
What kinds of biological materials or samples are relevant for exRNA in this program?
The program focuses on exRNA found in human body fluids, including blood, saliva, urine, breast milk, amniotic fluid, cerebrospinal fluid, and clinical effusions such as ascites and pleural fluid.
What types of studies or projects are considered appropriate under this FOA?
Appropriate studies include identifying and validating candidate exRNA biomarkers in carefully characterized patient cohorts, establishing or improving technologies for monitoring these biomarkers, and developing reliable assays for biomarkers that have already shown promise.
Does the FOA support assay development and standardization work?
Yes. The FOA includes work needed to make assays dependable for broader research use or eventual clinical deployment, such as standardizing measurement approaches, improving analytical performance, and demonstrating consistent measurement in real-world samples.
What level of evidence is NIH looking for regarding biomarkers?
NIH is looking for evidence that biomarkers are robust, reproducible, and relevant in a clinical context, supported by work in well-defined patient populations and aligned with clinically meaningful outcomes.
Will NIH be actively involved during the award?
Yes. Because this is a cooperative agreement, awardees should expect substantive NIH programmatic participation, which can include coordinated milestones, close communication, and an expectation of progress toward clearly defined deliverables.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, small businesses, state and local governments, tribal governments and tribal organizations, public housing authorities, school districts, and regional organizations.
Are non-U.S. (foreign) organizations allowed to apply?
Yes. The announcement explicitly allows applications from non-U.S. entities (foreign institutions) and foreign components of U.S. organizations, consistent with NIH policy.
Is cost-sharing or matching required?
No cost-sharing or matching requirement is stated for this opportunity.
What is the estimated total funding amount?
The estimated total funding amount listed is $4,000,000.
When was the opportunity posted and when did it close?
The opportunity was posted on August 3, 2012. The original and final closing date was November 13, 2012.
Is this funding opportunity still open?
No. It was archived on December 14, 2012.
How is this opportunity categorized within federal funding listings?
It is categorized as discretionary funding supporting health research, under CFDA 93.310 (Trans-NIH Research Support).
What is the core scientific focus area?
The core focus is extracellular RNA (exRNA) biomarkers in human body fluids and the rigorous development, validation, and assay work needed to support credible clinical trial use and, ultimately, improved patient care decisions.
What is the overall "bridge" this FOA is trying to build?
The FOA is designed to bridge the gap between promising exRNA signals in body fluids and clinically reliable biomarkers by emphasizing rigor, validation, reproducibility, and practical assay development.
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