Opportunity Information: Apply for PAR 11 322
Apply for PAR 11 322
- 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 (R01)" 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 93.859 Biomedical Research and Research Training 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Aug 1, 2013 and posted on Sep 1, 2011.
- Applicants must submit their applications by Aug 1, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) State governments Small businesses Private institutions of higher education For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments Public and State controlled institutions of higher education City or township 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:
The Biomarkers Bridging Pediatric and Adult Therapeutics (R01) opportunity (Funding Opportunity Number PAR-11-322) is a National Institutes of Health (NIH) research project grant aimed at closing a common gap in medical research: many biomarkers are discovered and validated in adults, but are not automatically reliable or clinically meaningful in children. This FOA invites institutions and organizations to propose projects that adapt, apply, and validate adult-developed biomarkers for pediatric use. The central idea is to leverage what is already known in adult populations and carefully determine whether those same measurable indicators (such as molecular markers, imaging measures, physiologic signals, or laboratory tests) can be used in children for key clinical and research purposes.
The scope emphasizes practical translation of adult biomarker knowledge into pediatric settings. Proposed work can include evaluating biomarkers for pediatric diagnosis (helping identify or confirm disease), prognosis (predicting outcomes), estimating disease progression (tracking how a condition changes over time), and assessing toxicity or response to therapy (understanding safety signals and whether a treatment is working). In other words, the FOA supports studies that test whether an adult biomarker can be trusted in a pediatric population and under what conditions it performs well. This may involve accounting for differences in developmental biology, growth, maturation of organs and metabolic pathways, age-dependent baseline ranges, and pediatric-specific disease presentations that can change how a biomarker behaves compared with adults.
The funding mechanism is an R01, meaning it is intended for substantial, hypothesis-driven or well-justified research projects that can generate rigorous evidence. While the opportunity description is concise, the expectation behind an R01 typically includes strong study design, appropriate cohorts, well-defined endpoints, and robust validation plans. Projects supported by this FOA would generally focus on demonstrating analytic validity (the biomarker can be measured accurately and reproducibly in pediatric samples), clinical validity (the biomarker meaningfully correlates with pediatric clinical states or outcomes), and potentially clinical utility (the biomarker improves decision-making or trial efficiency in pediatrics), depending on the project goals.
Administratively, this is a discretionary grant opportunity under NIH, with activity areas touching education, health, income security, and social services, and it lists CFDA numbers 93.361 (Nursing Research), 93.859 (Biomedical Research and Research Training), and 93.865 (Child Health and Human Development Extramural Research). There is no cost sharing or matching requirement, which means applicants are not required to contribute a defined portion of project costs from non-federal sources as a condition of the award.
Eligibility is broad and includes many types of domestic and non-domestic applicants. Eligible applicants include public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3) organizations), for-profit organizations (including small businesses and other for-profits), and a wide range of governmental entities such as state, county, city/township governments, special district governments, and independent school districts. Tribal governments and tribal organizations are included, along with public housing authorities/Indian housing authorities. The FOA also explicitly includes Alaska Native and Native Hawaiian Serving Institutions, Hispanic-Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. Foreign institutions are eligible to apply, and foreign components of U.S. organizations are allowed as permitted under NIH policy, which can be important when pediatric cohorts or specialized biomarker capabilities are located outside the United States.
Key dates in the provided record indicate the opportunity was posted on September 1, 2011, with an original closing date of September 7, 2014, and later administrative dates showing a creation date of August 1, 2013, a current closing date of August 1, 2013, and an archive date of September 1, 2013. These dates suggest the listing reflects an archived or time-limited posting snapshot; applicants would normally confirm the currently active status and submission timelines via the NIH FOA page. The full announcement is linked at http://grants.nih.gov/grants/guide/pa-files/PAR-11-322.html, and NIH Office of Extramural Research (OER) webmaster contacts are provided for access or linking issues (FBOWebmaster@OD.NIH.GOV).
Overall, this FOA is geared toward improving pediatric therapeutics and pediatric clinical research by accelerating the responsible reuse of adult biomarker advances, while recognizing that children are not simply small adults and that biomarkers often require careful pediatric-specific confirmation before they can guide diagnosis, predict outcomes, monitor toxicity, or measure treatment response in younger populations.
Frequently Asked Questions (FAQs)
What is the Biomarkers Bridging Pediatric and Adult Therapeutics (R01) opportunity?
This opportunity (Funding Opportunity Number PAR-11-322) is a National Institutes of Health (NIH) research project grant (R01) focused on adapting, applying, and validating biomarkers that were developed and validated in adults for appropriate use in children.
What problem is this funding opportunity trying to address?
Many biomarkers are discovered and validated in adult populations, but they are not automatically reliable or clinically meaningful in pediatric populations. This FOA supports research to determine whether adult-developed biomarkers can be trusted in children, and under what pediatric-specific conditions they perform well.
What is the central goal of PAR-11-322?
The central goal is to leverage what is already known about biomarkers in adults and then carefully test those same measurable indicators in pediatric settings to establish evidence for pediatric use.
What kinds of biomarkers are included in the scope of this FOA?
The FOA describes biomarkers broadly and includes examples such as molecular markers, imaging measures, physiologic signals, and laboratory tests, as long as the work focuses on adapting and validating adult-developed biomarkers for pediatric application.
What types of research questions or uses of biomarkers does this FOA support?
Projects may evaluate adult-developed biomarkers for pediatric diagnosis, prognosis, estimating disease progression, and assessing toxicity or response to therapy. The emphasis is on practical translation into pediatric clinical and research use.
Does the FOA support studies that assess whether a biomarker can monitor treatment safety or effectiveness in children?
Yes. The scope explicitly includes assessing toxicity (safety signals) and response to therapy (whether a treatment is working) in pediatric populations using biomarkers originally developed in adults.
Why might an adult biomarker behave differently in children?
Children are not simply smaller adults. The FOA notes factors that can change biomarker behavior in pediatrics, including developmental biology, growth, organ maturation, age-dependent baseline ranges, maturation of metabolic pathways, and pediatric-specific disease presentations.
What does it mean that this is an R01 mechanism?
An R01 is an NIH research project grant intended for substantial research projects. In general, this implies a well-justified or hypothesis-driven study with rigorous design elements such as appropriate cohorts, clearly defined endpoints, and robust validation plans.
What kinds of validation are relevant to projects under this FOA?
The FOA describes expectations consistent with demonstrating analytic validity (measuring the biomarker accurately and reproducibly in pediatric samples), clinical validity (the biomarker correlates meaningfully with pediatric clinical states or outcomes), and potentially clinical utility (usefulness for pediatric decision-making or trial efficiency), depending on the project goals.
What is analytic validity in the context of this FOA?
Analytic validity refers to whether the biomarker can be measured accurately and reproducibly in pediatric samples or pediatric data streams.
What is clinical validity in the context of this FOA?
Clinical validity refers to whether the biomarker meaningfully correlates with pediatric clinical states, diagnoses, or outcomes.
What is clinical utility in the context of this FOA?
Clinical utility (as described in the FOA context) refers to whether using the biomarker improves pediatric decision-making or increases the efficiency of pediatric trials or research workflows, where that is part of the project goal.
Who is the funding agency for this opportunity?
The funding agency is the National Institutes of Health (NIH), and the opportunity is administered as an NIH discretionary grant.
What CFDA numbers are associated with this opportunity?
The record lists CFDA numbers 93.361 (Nursing Research), 93.859 (Biomedical Research and Research Training), and 93.865 (Child Health and Human Development Extramural Research).
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement, meaning applicants are not required to contribute a defined non-federal portion of project costs as a condition of the award.
What types of organizations are eligible to apply?
Eligibility is broad. Eligible applicants include public and private institutions of higher education; nonprofits (501(c)(3) and non-501(c)(3)); for-profit organizations (including small businesses and other for-profits); and many governmental entities such as state, county, and city/township governments, special district governments, and independent school districts.
Are tribal governments and tribal organizations eligible?
Yes. The opportunity includes tribal governments and tribal organizations among eligible applicants.
Are public housing authorities eligible to apply?
Yes. Public housing authorities and Indian housing authorities are listed as eligible applicants.
Are minority-serving institutions specifically included in the eligibility list?
Yes. The FOA explicitly includes Alaska Native and Native Hawaiian Serving Institutions, Hispanic-Serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. Faith-based and community-based organizations are explicitly listed among eligible applicants.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included in the eligibility list.
Can foreign (non-U.S.) institutions apply?
Yes. Foreign institutions are eligible to apply. In addition, foreign components of U.S. organizations are allowed as permitted under NIH policy.
Why would foreign eligibility matter for a pediatric biomarker project?
The FOA notes that foreign eligibility can be important when pediatric cohorts or specialized biomarker capabilities are located outside the United States.
What are the key dates shown in the provided record?
The record indicates the opportunity was posted on September 1, 2011, with an original closing date of September 7, 2014. It also shows administrative dates including a creation date of August 1, 2013, a current closing date of August 1, 2013, and an archive date of September 1, 2013.
Does the date information suggest this opportunity may be archived?
Yes. The presence of an archive date (September 1, 2013) and conflicting closing date entries suggests the listing reflects an archived or time-limited snapshot. Applicants would typically confirm current status and timelines on the official NIH FOA page.
Where can applicants find the full FOA announcement?
The full announcement is linked at: http://grants.nih.gov/grants/guide/pa-files/PAR-11-322.html
Who should be contacted for access or linking issues with the FOA page?
The NIH Office of Extramural Research (OER) webmaster contact provided is: FBOWebmaster@OD.NIH.GOV
How does this FOA aim to improve pediatric therapeutics and pediatric clinical research?
By accelerating the responsible reuse of biomarker advances from adult studies while requiring pediatric-specific confirmation, the FOA aims to strengthen pediatric diagnosis, prognosis, disease monitoring, toxicity monitoring, and evaluation of treatment response in children.
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| Ethical Issues in Research on HIV/AIDS and its Co morbidities (R01) Apply for PAR 12 244 Funding Number: PAR 12 244 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| Ethical Issues in Research on HIV/AIDS and its Co morbidities (R21) Apply for PAR 12 243 Funding Number: PAR 12 243 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $200,000 |
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