Opportunity Information: Apply for PAR 13 296

  • The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Biomarkers Bridging Pediatric and Adult Therapeutics (R01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865 Child Health and Human Development Extramural Research.
  • This funding opportunity was created on Aug 1, 2013 and posted on Aug 1, 2013.
  • Applicants must submit their applications by Sep 7, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Special district governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
  • 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 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 PAR-13-296, titled "Biomarkers Bridging Pediatric and Adult Therapeutics (R01)," supports research projects that take biomarkers already developed and well-studied in adults and intentionally adapt them for use in children. The central goal is to speed up and strengthen pediatric diagnosis and treatment decisions by leveraging existing adult biomarker knowledge, rather than starting from scratch. Applications are expected to focus on biomarkers that have a clear relationship to a clinical observation and a strong body of adult evidence, with credible rationale that the same biomarker can be meaningfully applied in pediatric settings.

Projects under this FOA are geared toward the application and validation of adult-derived biomarkers for pediatric use. That includes work where the biomarker could help with pediatric diagnosis, predicting prognosis, estimating disease progression, evaluating toxicity, or assessing response to therapy. In practice, this kind of study often involves determining whether an adult biomarker behaves similarly in children, whether pediatric reference ranges or age-specific thresholds are needed, and whether developmental factors (such as growth, maturation of organ systems, or differences in metabolism) change how the biomarker should be interpreted. The emphasis is on translation and validation, meaning investigators should be prepared to demonstrate clinical relevance in children and show that the biomarker can reliably inform pediatric clinical observations or outcomes.

At the same time, the announcement draws sharp boundaries around what it will not fund. It is not intended for discovering entirely new biomarkers, whether for early-stage drug development, exploratory discovery work, or preclinical-only research. It also excludes biomarker efforts focused on diseases that are unique to childhood and do not have adult correlates, since the premise of this program is to bridge from adult evidence to pediatric application. In other words, the work needs to start with an adult biomarker that already has substantial supporting data and then extend that biomarker into pediatric contexts where the underlying condition, or a closely related counterpart, exists across the lifespan.

This opportunity uses the NIH R01 grant mechanism, reflecting a scope consistent with full research project support rather than small pilot awards. The FOA falls under the broader NIH mission area of health and is associated with CFDA 93.865 (Child Health and Human Development Extramural Research), signaling a strong alignment with pediatric and developmental research priorities. No cost sharing or matching is required, which lowers barriers for a wide range of institutions to apply.

Eligibility is broad and includes most common applicant categories across academia, government, nonprofit, and industry. Eligible applicants include public and private institutions of higher education, state and local governments (including county, city/township, special districts, and public housing authorities), nonprofit organizations both with and without 501(c)(3) status, for-profit entities (other than small businesses) and small businesses, independent school districts, and Native American tribal governments and organizations. The eligibility language also explicitly includes a wide range of mission-driven and historically underrepresented institution types, such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and AANAPISIS institutions, along with faith-based and community-based organizations where appropriate. Importantly, non-U.S. entities are eligible, including foreign organizations and foreign institutions, and foreign components of U.S. organizations are allowed under NIH policy, which supports international collaboration when it is scientifically justified.

Administratively, the FOA was posted on August 1, 2013, with an original and current closing date listed as September 7, 2016, and an archive date of October 8, 2016, indicating it is no longer accepting applications as a live opportunity. The sponsoring agency is the National Institutes of Health. For applicants or readers needing the original announcement text, the opportunity points to an NIH Grants Guide link (PAR-13-296). The provided contact route for access or technical problems is the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@OD.NIH.GOV), which is specifically intended for issues accessing or linking to the announcement rather than scientific program questions.

Overall, this FOA is best understood as a translational bridge program: it tries to close a common gap in medicine where adult biomarker science is mature but pediatric evidence is limited. It encourages research teams to take biomarkers with strong adult clinical grounding and do the careful pediatric validation work needed so that clinicians and researchers can use those tools responsibly for children, including for tracking disease course, anticipating outcomes, monitoring toxicity, and evaluating therapeutic response.

FAQs: NIH PAR-13-296 - Biomarkers Bridging Pediatric and Adult Therapeutics (R01)

What is NIH PAR-13-296?

PAR-13-296 is an NIH funding opportunity announcement titled "Biomarkers Bridging Pediatric and Adult Therapeutics (R01)." It supports research projects that adapt biomarkers that are already developed and well-studied in adults for meaningful use in children.

What is the main goal of this funding opportunity?

The main goal is to speed up and strengthen pediatric diagnosis and treatment decision-making by leveraging existing adult biomarker evidence, rather than starting pediatric biomarker work from scratch.

What kind of research does this FOA support?

This FOA supports translational and validation research that applies adult-derived biomarkers in pediatric settings. Projects are expected to test whether an adult biomarker can reliably inform pediatric clinical observations or outcomes.

What types of pediatric uses for biomarkers are in scope?

In-scope pediatric applications include using an adult-derived biomarker to support pediatric diagnosis, predict prognosis, estimate disease progression, evaluate toxicity, or assess response to therapy.

Does the biomarker need to be connected to clinical outcomes?

Yes. Applications are expected to focus on biomarkers with a clear relationship to a clinical observation, supported by a strong body of adult evidence, plus a credible rationale for meaningful pediatric application.

What does "bridging" from adults to pediatrics mean in practice?

It generally means determining whether an adult biomarker behaves similarly in children, whether pediatric reference ranges or age-specific thresholds are needed, and whether developmental factors (such as growth, organ maturation, or metabolic differences) change how the biomarker should be interpreted.

Is this FOA intended for biomarker discovery?

No. The announcement draws clear boundaries that it is not intended for discovering entirely new biomarkers, including exploratory discovery work, early-stage drug development biomarker discovery, or preclinical-only research.

Are preclinical-only studies supported?

No. The emphasis is on translation and validation in pediatric contexts, not preclinical-only biomarker efforts.

Can projects focus on diseases unique to childhood?

No. Biomarker efforts focused on diseases that are unique to childhood and do not have adult correlates are excluded, because the program premise is to bridge from adult evidence to pediatric application.

Do projects need an adult disease counterpart?

Yes. The work must start with an adult biomarker that already has substantial supporting data and then extend it to pediatric contexts where the underlying condition (or a closely related counterpart) exists across the lifespan.

What grant mechanism does this opportunity use?

This opportunity uses the NIH R01 grant mechanism, indicating full research project support consistent with a substantial research scope (rather than a small pilot award format).

Is cost sharing or matching required?

No. The opportunity states that no cost sharing or matching is required.

Which agency sponsors this funding opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

What is the CFDA number associated with this FOA?

The FOA is associated with CFDA 93.865, "Child Health and Human Development Extramural Research," reflecting alignment with pediatric and developmental research priorities.

Who is eligible to apply?

Eligibility is broad and includes public and private institutions of higher education; state and local governments (including county, city/township, special districts, and public housing authorities); nonprofit organizations with or without 501(c)(3) status; for-profit entities (other than small businesses) and small businesses; independent school districts; and Native American tribal governments and organizations.

Are specific institution types explicitly included?

Yes. The eligibility language explicitly includes institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and AANAPISIS institutions, along with faith-based and community-based organizations where appropriate.

Are non-U.S. organizations eligible?

Yes. Non-U.S. entities are eligible, including foreign organizations and foreign institutions. Foreign components of U.S. organizations are also allowed under NIH policy when scientifically justified.

Is this funding opportunity still open?

No. It was posted on August 1, 2013, and lists an original and current closing date of September 7, 2016, with an archive date of October 8, 2016, indicating it is no longer accepting applications as a live opportunity.

Where can applicants find the original announcement text?

The opportunity points readers to the NIH Grants Guide listing for PAR-13-296 for the original announcement text.

Who should be contacted for access or technical problems with the announcement link?

For issues accessing or linking to the announcement (not scientific program questions), the contact route provided is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.

What is the overall purpose of this FOA in the pediatric research landscape?

Overall, it is a translational bridge program intended to close a gap where adult biomarker science is mature but pediatric evidence is limited, by supporting the pediatric validation work needed for responsible clinical and research use in children.

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