Opportunity Information: Apply for PAR 11 324
Apply for PAR 11 324
- The National Institutes of Health in the education health income security and social services sector is offering a public funding opportunity titled "Biomarkers Bridging Pediatric and Adult Therapeutics (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.361 Nursing Research 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Sep 1, 2011 and posted on Sep 1, 2011.
- Applicants must submit their applications by Sep 7, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: City or township governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Special district governments Public housing authorities/Indian housing authorities Private institutions of higher education County governments Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Public and State controlled institutions of higher education Independent school districts 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 State governments.
- 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:
Biomarkers Bridging Pediatric and Adult Therapeutics (R21) is an NIH exploratory/developmental grant opportunity designed to speed up the translation of biomarker advances from adult medicine into pediatric care. The central idea is that many biomarkers are first discovered, optimized, and clinically studied in adults, but children often lack comparable, well-validated tools for diagnosis, prognosis, monitoring disease progression, predicting toxicity, or gauging response to therapy. This FOA encourages institutions and organizations to take biomarkers that already exist in adult populations and adapt, test, and validate them for use in infants, children, and adolescents, recognizing that developmental biology, growth, and age-specific physiology can change how a biomarker behaves and what it means clinically.
The scientific scope focuses on applying and validating adult-developed biomarkers in pediatric settings, with emphasis on demonstrating that a marker is fit for purpose in children. Projects may address how a biomarker performs for pediatric diagnosis, whether it can reliably predict outcomes or prognosis, how well it tracks disease course over time, whether it can estimate or predict treatment-related toxicity, and whether it can be used to measure or predict therapeutic response. Because this is an R21 mechanism, the expectation is generally early-stage, high-impact work that establishes feasibility and generates critical validation data needed to justify larger follow-on studies, rather than large definitive trials.
Administratively, this is a discretionary grant program run by the National Institutes of Health, tied to CFDA numbers 93.361 (Nursing Research) and 93.865 (Child Health and Human Development Extramural Research), reflecting the pediatric and clinical research orientation of the opportunity. The award ceiling listed is $200,000, and there is no cost sharing or matching requirement, which lowers the barrier for applicants who want to pursue exploratory validation work without committing institutional matching funds.
Eligibility is broad and includes a wide range of domestic U.S. organizations such as public and private institutions of higher education, nonprofits (including both 501(c)(3) and non-501(c)(3) organizations), small businesses and other for-profit entities (including those other than small businesses), and multiple levels of government (state, county, city/township, special district governments, and independent school districts), as well as public housing authorities/Indian housing authorities. The FOA also explicitly extends eligibility to a number of special categories and community-focused institutions and organizations, including Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), tribal governments and tribal organizations (including those other than federally recognized tribal governments), regional organizations, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. entities. Foreign institutions may apply, and foreign components of U.S. organizations are allowed, consistent with NIH policy for foreign components.
Key dates indicate the FOA was posted and created on September 1, 2011, with an original and final closing date of September 7, 2014, and it was archived on October 8, 2014. While it is no longer open, the announcement remains useful as a reference point for the kinds of pediatric biomarker-bridging studies NIH has historically encouraged, particularly work that confronts the practical challenges of pediatric validation such as age-stratified reference ranges, differences in disease presentation across developmental stages, limited sample volumes, and the need for child-appropriate endpoints.
The full announcement was hosted by NIH at http://grants.nih.gov/grants/guide/pa-files/PAR-11-324.html. For access or technical issues related to the posting, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs): Biomarkers Bridging Pediatric and Adult Therapeutics (R21)
What is the "Biomarkers Bridging Pediatric and Adult Therapeutics (R21)" opportunity?
It is an NIH exploratory/developmental (R21) grant opportunity focused on speeding up the translation of biomarker advances from adult medicine into pediatric care. The goal is to take biomarkers that already exist and have been studied in adults, then adapt, test, and validate them for use in infants, children, and adolescents.
What problem is this NIH opportunity trying to solve?
Many biomarkers are discovered, optimized, and clinically studied first in adults. Children often lack comparable, well-validated biomarkers for diagnosis, prognosis, monitoring disease progression, predicting toxicity, or measuring response to therapy. This opportunity is intended to close that gap by encouraging pediatric validation of adult-developed biomarkers.
What is the central scientific idea behind this FOA?
The central idea is that a biomarker that works in adults may not behave the same way in children because of developmental biology, growth, and age-specific physiology. This FOA encourages projects that directly evaluate whether an adult-developed biomarker is fit for purpose in pediatric populations.
What types of biomarker work does the FOA emphasize?
The FOA emphasizes applying and validating adult-developed biomarkers in pediatric settings and producing evidence that the biomarker is fit for purpose in children.
What pediatric uses of biomarkers are within the scientific scope?
Projects may address pediatric diagnosis, prediction of outcomes or prognosis, tracking disease course over time, estimating or predicting treatment-related toxicity, and measuring or predicting therapeutic response in pediatric patients.
Does this FOA support large definitive clinical trials?
Based on the R21 mechanism described, the expectation is generally early-stage, high-impact work that establishes feasibility and generates critical validation data needed to justify larger follow-on studies, rather than large definitive trials.
Why does pediatric validation require special attention compared to adult studies?
The FOA highlights that developmental biology and age-specific physiology can change how a biomarker behaves and what it means clinically. It also points to practical pediatric validation challenges such as age-stratified reference ranges, differences in disease presentation across developmental stages, limited sample volumes, and the need for child-appropriate endpoints.
What grant mechanism is used for this program?
This opportunity uses the NIH R21 exploratory/developmental research grant mechanism, which is typically aligned with early-stage feasibility and validation efforts.
What is the maximum award amount listed for this opportunity?
The award ceiling listed is $200,000.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
Which agency runs this program?
This is a discretionary grant program run by the National Institutes of Health (NIH).
What CFDA numbers are associated with this opportunity?
The opportunity is tied to CFDA 93.361 (Nursing Research) and CFDA 93.865 (Child Health and Human Development Extramural Research).
Who is eligible to apply?
Eligibility is broad and includes many domestic U.S. organization types: public and private institutions of higher education; nonprofits (including both 501(c)(3) and non-501(c)(3)); small businesses; other for-profit entities (including those other than small businesses); and various government entities (state, county, city/township, special district governments, and independent school districts), as well as public housing authorities/Indian housing authorities.
Are community-focused and special categories of organizations eligible?
Yes. The FOA explicitly includes Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), tribal governments and tribal organizations (including those other than federally recognized tribal governments), regional organizations, faith-based or community-based organizations, eligible federal agencies, and U.S. territories or possessions.
Can non-U.S. entities apply?
Yes. The FOA states that non-U.S. entities are eligible, foreign institutions may apply, and foreign components of U.S. organizations are allowed, consistent with NIH policy for foreign components.
Is this funding opportunity still open?
No. The FOA information indicates an original and final closing date of September 7, 2014, and it was archived on October 8, 2014.
When was the FOA originally posted and created?
The FOA was posted and created on September 1, 2011.
If it is archived, why might it still be useful?
Even though it is no longer open, it can serve as a reference point for the kinds of pediatric biomarker-bridging studies NIH has historically encouraged, especially projects addressing pediatric validation needs such as age-stratified reference ranges and child-appropriate endpoints.
Where can I find the full NIH announcement page?
The full announcement was hosted by NIH at: http://grants.nih.gov/grants/guide/pa-files/PAR-11-324.html.
Who should be contacted for access or technical issues with the posting?
The contact listed for access or technical issues is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
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