Opportunity Information: Apply for PAR 11 248
Apply for PAR 11 248
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Translational Research in Pediatric and Obstetric Pharmacology (R21)" 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 Jul 12, 2011 and posted on Jul 12, 2011.
- Applicants must submit their applications by May 15, 2013. (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 $275,000.00 in funding.
- Eligible applicants include: City or township governments Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Private institutions of higher education Special district governments State governments Small businesses Public and State controlled institutions of higher education County governments Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts.
- 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.
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Opportunity Summary:
The Translational Research in Pediatric and Obstetric Pharmacology (R21) opportunity (Funding Opportunity Number PAR-11-248) is an NIH discretionary grant program designed to push forward early-stage, high-impact work that connects basic pharmacology findings to real-world clinical use in two populations that often face major evidence gaps: children across different developmental stages and pregnant women, including effects on the developing fetus. The central theme is translational and clinical research, including clinical trials, that clarifies how drugs work, why patients respond differently, and what drives drug-related safety risks in these settings. In practical terms, the FOA aims to generate actionable knowledge about mechanisms of drug action, variability in drug response, and toxicity or adverse outcomes when medicines are used in pediatrics or during pregnancy, where physiology can differ dramatically from the typical adult populations used to establish dosing and labeling.
A key purpose of the FOA is to improve the safety and effectiveness of drugs that are already in use for pediatric or obstetric patients. That includes work that can lead to better dosing strategies, improved monitoring, risk mitigation, or clearer guidance on when and how to use existing therapies. At the same time, the FOA also supports research that contributes to developing new drugs or enabling safer and more tailored use of existing drugs, with an emphasis on therapies that better match the needs of these special populations. The description highlights “tailored therapies,” which signals interest in approaches that account for developmental biology, pregnancy-related physiological changes, and other factors that influence pharmacokinetics (how the body processes a drug) and pharmacodynamics (how the drug affects the body), along with safety outcomes.
The grant mechanism is an R21, which typically supports exploratory and developmental projects intended to test novel concepts, generate proof-of-concept data, or establish feasibility for larger follow-on studies. Consistent with that role, the FOA’s stated goals focus on advancing knowledge of underlying mechanisms and translating that knowledge into clinically meaningful improvements. The program explicitly allows clinical trials, making it suitable for projects that move beyond laboratory studies into patient-centered research when appropriate and justified. The administering agency is the National Institutes of Health, and the CFDA listing provided is 93.865 (Child Health and Human Development Extramural Research), indicating alignment with NICHD-related mission space even though the broader NIH structure is referenced.
From a funding and administrative standpoint, the opportunity was posted July 12, 2011, with an original and current closing date of May 15, 2013, and an archive date of June 15, 2013, meaning it was time-limited and is now archived as written. The award ceiling listed is $275,000, and there is no cost sharing or matching requirement, which reduces barriers for applicants that may not be able to contribute non-federal funds. The funding instrument type is a grant, and the activity category falls under Health, Income Security, and Social Services.
Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants span state, county, city or township governments, special district governments, and independent school districts, as well as public and private institutions of higher education. Nonprofits are eligible whether they have 501(c)(3) status or not (with the noted carve-out “other than institutions of higher education” for certain categories), and for-profit entities are eligible, including small businesses and for-profit organizations other than small businesses. The FOA also lists public housing authorities/Indian housing authorities and multiple tribal and tribal-serving categories, such as federally recognized Native American tribal governments, tribal organizations that are not federally recognized, and tribally controlled colleges and universities (TCCUs). It explicitly includes Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), faith-based and community-based organizations, regional organizations, U.S. territories or possessions, and eligible agencies of the federal government. Foreign institutions may apply, and non-U.S. components of U.S. organizations are also eligible, which is important for studies that require international cohorts, global pharmacology expertise, or cross-country clinical collaborations.
The official announcement link is hosted on the NIH grants site (http://grants.nih.gov/grants/guide/pa-files/PAR-11-248.html). For access or technical issues related to the announcement, the contact provided is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV, including support for difficulties accessing the full announcement electronically or linking problems.
Frequently Asked Questions (FAQs)
What is the Translational Research in Pediatric and Obstetric Pharmacology (R21) opportunity?
This funding opportunity (PAR-11-248) is an NIH discretionary grant program focused on early-stage, high-impact translational research in pediatric and obstetric pharmacology. The emphasis is on moving promising pharmacology insights toward real-world clinical use in children (across developmental stages) and in pregnant women, including consideration of effects on the developing fetus.
What is the main purpose of this FOA?
The FOA is designed to generate actionable knowledge that improves how medicines are used in pediatrics and pregnancy. It prioritizes research that clarifies mechanisms of drug action, explains why patient responses differ, and identifies drivers of drug-related safety risks or adverse outcomes in these populations.
Why does the FOA focus on children and pregnant women?
The FOA highlights that these groups often face major evidence gaps. Pediatric patients and pregnant women can have physiology that differs substantially from typical adult populations used to establish dosing and labeling, which can affect drug exposure, response, and safety.
What types of research does the FOA support?
The FOA supports translational and clinical research, including studies that connect basic pharmacology findings to clinical application. It is aimed at understanding how drugs work, variability in drug response, and toxicity or adverse outcomes when medications are used in pediatric patients or during pregnancy.
Are clinical trials allowed under this opportunity?
Yes. The FOA explicitly allows clinical trials, making it suitable for projects that extend beyond laboratory work into patient-centered clinical research when appropriate and well-justified.
What is meant by "translational" in this FOA?
In this context, translational research means bridging the gap between basic pharmacology discoveries (for example, mechanistic insights) and practical clinical use (for example, dosing strategies, monitoring approaches, and safety guidance) in pediatric and obstetric settings.
Does this FOA focus on existing drugs, new drugs, or both?
Both. A key purpose is to improve the safety and effectiveness of drugs already used in pediatric or obstetric patients (including better dosing, monitoring, risk mitigation, or clearer guidance on use). The FOA also supports research that contributes to developing new drugs or enabling safer and more tailored use of existing therapies.
What does the FOA mean by "tailored therapies"?
"Tailored therapies" signals interest in approaches that better match the needs of children and pregnant women by accounting for developmental biology, pregnancy-related physiological changes, and other factors that influence pharmacokinetics (how the body processes a drug), pharmacodynamics (how the drug affects the body), and safety outcomes.
What does the R21 mechanism imply about the type of project NIH is looking for?
The R21 mechanism typically supports exploratory and developmental projects. It is commonly used to test novel concepts, generate proof-of-concept data, or establish feasibility that could support larger follow-on studies. This aligns with the FOA's emphasis on early-stage, high-impact translational work.
Who administers this opportunity?
The administering agency is the National Institutes of Health (NIH).
What CFDA number is associated with this opportunity?
The CFDA listing provided is 93.865 (Child Health and Human Development Extramural Research), which indicates alignment with NICHD-related mission space within the broader NIH structure.
What is the maximum award amount listed for this opportunity?
The award ceiling listed is $275,000.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
What is the funding instrument type?
The funding instrument type is a grant.
What activity category does this opportunity fall under?
The activity category is listed as Health, Income Security, and Social Services.
When was this opportunity posted, and what are the key dates?
The opportunity was posted on July 12, 2011. The original and current closing date is May 15, 2013. The archive date is June 15, 2013.
Is this funding opportunity still open?
Based on the provided dates and the note that it is archived, the FOA as written was time-limited and is now archived (closing date May 15, 2013; archive date June 15, 2013).
What kinds of applicants are eligible to apply?
Eligibility is broad and includes a wide range of domestic and non-domestic organizations. Eligible applicants include various levels of government, educational institutions, nonprofits, for-profits, tribal entities, housing authorities, regional organizations, U.S. territories or possessions, and eligible federal agencies. Foreign institutions and non-U.S. components of U.S. organizations are also eligible.
Are state and local governments eligible?
Yes. The FOA lists state governments, county governments, city or township governments, special district governments, and independent school districts as eligible applicants.
Are colleges and universities eligible?
Yes. Both public and private institutions of higher education are eligible. The FOA also includes tribally controlled colleges and universities (TCCUs) and identifies several types of minority-serving institutions as eligible.
Are nonprofit organizations eligible?
Yes. Nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status are eligible (with the noted category phrasing "other than institutions of higher education" for certain nonprofit categories).
Are for-profit organizations eligible?
Yes. For-profit entities are eligible, including small businesses and for-profit organizations other than small businesses.
Are tribal organizations eligible?
Yes. The FOA includes federally recognized Native American tribal governments, tribal organizations that are not federally recognized, and tribally controlled colleges and universities (TCCUs). It also references tribal and tribal-serving categories.
Are public housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.
Are minority-serving institutions specifically included?
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 and community-based organizations eligible?
Yes. The FOA explicitly includes faith-based and community-based organizations.
Can foreign organizations apply?
Yes. Foreign institutions may apply, and non-U.S. components of U.S. organizations are also eligible.
Why might foreign or non-U.S. components be relevant to this research area?
The FOA notes eligibility for foreign institutions and non-U.S. components, which can be important for studies requiring international cohorts, global pharmacology expertise, or cross-country clinical collaborations.
Where can applicants find the official announcement?
The official announcement is hosted on the NIH grants site at: http://grants.nih.gov/grants/guide/pa-files/PAR-11-248.html
Who should be contacted for access or technical issues with the announcement?
For difficulties accessing the full announcement electronically or for linking problems, the contact provided is the NIH Office of Extramural Research webmaster: FBOWebmaster@OD.NIH.GOV
What kinds of outcomes is the FOA trying to enable in practical clinical terms?
The FOA aims to support research that can lead to clinically meaningful improvements such as better dosing strategies, improved monitoring, risk mitigation approaches, and clearer guidance on when and how to use existing therapies in pediatric and obstetric populations.
What specific scientific questions does the FOA emphasize?
The FOA emphasizes questions about mechanisms of drug action, variability in drug response, and the basis for toxicity or adverse outcomes in children and in pregnancy, including potential effects on the developing fetus.
Does the FOA address pharmacokinetics and pharmacodynamics?
Yes. The description calls out interest in factors that influence pharmacokinetics (how the body processes a drug) and pharmacodynamics (how the drug affects the body), along with safety outcomes, especially as these differ by developmental stage or pregnancy-related physiological changes.
Browse more opportunities from the same category: Health Income Security and Social Services
Next opportunity: Translational Research in Pediatric and Obstetric Pharmacology (R01)
Previous opportunity: Translational Research in Pediatric and Obstetric Pharmacology (R03)
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