Opportunity Information: Apply for PAR 11 303
Apply for PAR 11 303
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173 Research Related to Deafness and Communication Disorders 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Sep 4, 2013 and posted on Aug 11, 2011.
- Applicants must submit their applications by Sep 4, 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 $150,000.00 in funding.
- Eligible applicants include: County governments Public housing authorities/Indian housing authorities Independent school districts Special district governments Small businesses Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) City or township governments State governments Nonprofits that do not have 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 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.
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Opportunity Summary:
The NIH grant opportunity titled "Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R21)" (Funding Opportunity Number PAR-11-303) is a discretionary research grant designed to speed early, exploratory work that improves how medicines are formulated and delivered for children. The main focus is on the practical realities of pediatric use: children are not simply smaller adults, and different pediatric age groups have distinct needs related to dosing flexibility, safety of excipients, swallowability, taste and texture acceptability, administration routes, caregiver usability, and adherence. This FOA aims to support research that directly addresses those age-specific formulation challenges while also advancing the science behind pediatric drug delivery systems.
A central theme of the announcement is encouraging innovative, nontraditional approaches. Applicants are pushed to explore concepts that are new to pediatric formulation development and testing, and to apply newly developed techniques that outperform or improve upon standard methods used in the field. In practice, that can include novel formulation strategies (for example, dosage forms that allow accurate dose adjustment across infancy through adolescence), palatability-masking technologies that do not compromise drug release, and child-friendly solid or semi-solid options that reduce reliance on liquids when liquids are unstable or hard to dose. It can also include new delivery platforms and devices tailored to pediatric anatomy, physiology, and behavior, along with methods to evaluate acceptability and real-world administration in a developmentally appropriate way.
The FOA explicitly includes the development and testing of novel pediatric drug delivery systems as part of its scope. That means projects can go beyond reformulating an active ingredient and instead focus on the delivery mechanism itself, such as age-appropriate oral delivery formats, improved enteral delivery compatibility, pediatric-friendly inhalation or nasal systems, transdermal approaches suitable for sensitive skin, or other technologies that make administration safer, more reliable, and more acceptable to children and caregivers. The emphasis is on addressing complementary research needs across different pediatric age ranges rather than assuming a single formulation will work for all children.
This opportunity uses the NIH R21 mechanism, which is typically intended for early-stage, high-impact exploratory or developmental studies that generate feasibility data or proof-of-concept results. The listed award ceiling is $150,000, and the announcement indicates there is no cost sharing or matching requirement. The awarding agency is the National Institutes of Health, and the activity category is Health, Income Security, and Social Services. The CFDA numbers connected to the posting include 93.865 (Child Health and Human Development Extramural Research) and 93.173 (Research Related to Deafness and Communication Disorders), reflecting the broader NIH programmatic areas that may intersect with pediatric therapeutic needs and delivery challenges.
Eligibility is broad and includes many types of organizations that commonly apply for NIH grants. Eligible applicants listed include state, city/township, county, and special district governments; federally recognized tribal governments and other tribal organizations; public and private institutions of higher education; independent school districts; small businesses and other for-profit organizations (other than small businesses); public housing authorities/Indian housing authorities; and nonprofits both with and without 501(c)(3) status (with the caveat about institutions of higher education). The eligibility information also highlights additional eligible entities such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and non-U.S. (foreign) entities. This breadth signals NIH interest in drawing on diverse expertise, including academic, clinical, engineering, public health, and industry perspectives.
Key administrative details in the provided record include a posted date of August 11, 2011, an archive date of October 4, 2013, and a current closing date shown as September 4, 2013 (with an original closing date of September 7, 2014 listed in the record as well). The full announcement was linked through the NIH grants guide at http://grants.nih.gov/grants/guide/pa-files/PAR-11-303.html (as written in the source). For access or technical issues, the contact point provided is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Overall, the grant is best understood as NIH support for creative, early-stage research that makes pediatric medicines easier to administer correctly and more acceptable to children, while improving the underlying formulation and delivery science using newer, better techniques than those that have traditionally been used.
FAQs: NIH "Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R21)" (PAR-11-303)
What is this NIH grant opportunity?
This is an NIH discretionary research grant opportunity titled "Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R21)" with Funding Opportunity Number (FON) PAR-11-303. It is designed to speed early, exploratory research aimed at improving how medicines are formulated and delivered for children.
What is the main goal of the FOA?
The main goal is to support early-stage, practical, pediatric-focused formulation and drug delivery research that makes medicines easier to administer correctly and more acceptable to children and caregivers, while advancing the underlying science of pediatric formulation and delivery systems.
Why does this FOA emphasize that children are not "small adults"?
The FOA is centered on the reality that pediatric patients have age-specific needs. Different pediatric age groups can require different dosing flexibility, safety considerations (including excipients), swallowability, taste and texture acceptability, administration routes, caregiver usability, and adherence support.
What kinds of pediatric formulation challenges are specifically highlighted?
The FOA highlights challenges such as dosing flexibility across pediatric age ranges, excipient safety for children, swallowability, palatability (taste/texture), developmentally appropriate administration routes, caregiver usability, and adherence in real-world settings.
What does "R21" mean in this announcement?
The opportunity uses the NIH R21 mechanism, which is typically used for early-stage, high-impact exploratory or developmental studies that produce feasibility data or proof-of-concept results.
What is the award ceiling for this R21 opportunity?
The listed award ceiling is $150,000.
Is cost sharing or matching required?
No. The announcement indicates there is no cost sharing or matching requirement.
Who is the awarding agency?
The awarding agency is the National Institutes of Health (NIH).
What activity category is associated with this opportunity?
The activity category listed in the record is Health, Income Security, and Social Services.
What CFDA numbers are connected to this grant posting?
The record lists CFDA 93.865 (Child Health and Human Development Extramural Research) and 93.173 (Research Related to Deafness and Communication Disorders).
What types of projects does the FOA encourage?
The FOA encourages innovative, nontraditional approaches to pediatric formulation development and testing, including concepts new to pediatric formulation work and newly developed techniques that improve on standard methods used in the field.
Does this FOA support work on drug delivery systems, not just formulations?
Yes. The FOA explicitly includes development and testing of novel pediatric drug delivery systems as part of its scope, including projects that focus on the delivery mechanism or platform itself.
What are examples of formulation or dosage-form innovations mentioned as in-scope?
Examples described include dosage forms that allow accurate dose adjustment from infancy through adolescence, palatability-masking technologies that do not compromise drug release, and child-friendly solid or semi-solid options that reduce reliance on liquids when liquids are unstable or hard to dose.
What are examples of delivery platforms or routes mentioned as in-scope?
The FOA indicates scope can include age-appropriate oral delivery formats, improved enteral delivery compatibility, pediatric-friendly inhalation or nasal systems, transdermal approaches suitable for sensitive skin, and other technologies that make administration safer, more reliable, and more acceptable for children and caregivers.
Does the FOA assume a single formulation will work for all pediatric patients?
No. The FOA emphasizes addressing complementary research needs across different pediatric age ranges rather than assuming one formulation works for all children.
What does the FOA say about evaluating acceptability and real-world use?
It encourages methods to evaluate acceptability and real-world administration in developmentally appropriate ways, recognizing that caregiver use and child behavior can affect administration success and adherence.
Who is eligible to apply?
Eligibility is broad and includes state, city/township, county, and special district governments; federally recognized tribal governments and other tribal organizations; public and private institutions of higher education; independent school districts; small businesses; other for-profit organizations (other than small businesses); public housing authorities/Indian housing authorities; and nonprofits with or without 501(c)(3) status (with the noted caveat about institutions of higher education).
Are minority-serving institutions and similar organizations eligible?
Yes. The eligibility information 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 or community-based organizations are listed among eligible entities.
Are U.S. territories or regional organizations eligible?
Yes. The eligibility information includes U.S. territories or possessions and regional organizations.
Are non-U.S. (foreign) entities eligible to apply?
Yes. The eligibility section includes non-U.S. (foreign) entities.
What are the key dates listed in the provided record?
The record shows a posted date of August 11, 2011, an archive date of October 4, 2013, and a current closing date shown as September 4, 2013. The record also lists an original closing date of September 7, 2014.
Where is the full announcement posted?
The full announcement is linked through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PAR-11-303.html
Who should be contacted for access or technical issues related to the posting?
The contact point provided for access or technical issues is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
How should this grant be understood overall based on the description provided?
Overall, it is NIH support for creative, early-stage research that improves pediatric medicine administration and acceptability while advancing pediatric formulation and drug delivery science using newer, improved techniques compared with traditional approaches.
Browse more opportunities from the same category: Health Income Security and Social Services
Next opportunity: Development of Appropriate Pediatric Formulations and Drug Delivery Systems SBIR (R43)
Previous opportunity: Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R03)
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