Opportunity Information: Apply for PAR 13 326
Apply for PAR 13 326
- 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 Sep 4, 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.)
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: State governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses County governments Special district governments Independent school districts Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Small businesses Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments).
- 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 National Institutes of Health (NIH) funding opportunity PAR 13-326, titled "Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R21)," is a discretionary research grant announcement designed to stimulate early-stage, exploratory work that improves how medicines are formulated and delivered for children. The central goal is to support research that addresses the practical and scientific challenges that make many existing drug products poorly suited for pediatric use, especially across different pediatric age groups where swallowing ability, taste preferences, dosing flexibility, and developmental physiology can vary dramatically. The FOA places emphasis not only on creating better pediatric formulations (how the drug is prepared and presented, such as liquids, mini-tablets, orally disintegrating forms, or other child-friendly formats) but also on developing and testing innovative pediatric drug delivery systems that can make administration safer, easier, and more acceptable for children and caregivers.
The opportunity targets gaps in pediatric therapeutics where adult formulations are commonly adapted in ways that are inconvenient, inaccurate, or unsafe, such as pill splitting, crushing tablets, mixing with food, or using compounded preparations with inconsistent quality. Projects responsive to this FOA would generally focus on improving acceptability (for example, taste masking, texture, volume of dose, ease of swallowing, and dosing frequency), ensuring age-appropriate dosing precision, and reducing administration burden in real-world settings like homes, schools, and clinics. Another major theme is that a "one size fits all" approach rarely works in pediatrics, so applications are encouraged to consider different developmental stages (for example, neonates, infants, toddlers, children, and adolescents) and the distinct constraints each group presents, including excipient tolerability, dose volume limits, and device usability.
This announcement uses the NIH R21 mechanism, which is intended for exploratory and developmental research. The listed award ceiling is $200,000, and there is no cost sharing or matching requirement. The funding instrument is a grant, and the activity category is aligned with health, income security, and social services. The FOA is connected to CFDA numbers 93.173 (Research Related to Deafness and Communication Disorders) and 93.865 (Child Health and Human Development Extramural Research), reflecting NIH interest areas that include pediatric health and development and, in some cases, conditions affecting communication and sensory function where pediatric drug delivery can be particularly challenging.
Eligibility is broad and includes many types of domestic and international organizations. Eligible applicants include public and private institutions of higher education, state and local governments (including county, city/township, special district governments, and independent school districts), nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), and small businesses. The FOA also explicitly allows applications from federally recognized tribal governments, tribal organizations, tribally controlled colleges and universities, and U.S. territories or possessions. In addition, it welcomes a wide range of mission-driven and capacity-building institutions and organizations such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, faith-based or community-based organizations, and eligible federal agencies. Non-U.S. entities are permitted to apply, including foreign organizations and foreign institutions, and foreign components of U.S. organizations are allowed consistent with NIH policy.
In terms of timing, the opportunity was posted and created on September 4, 2013, with an original and current closing date of September 7, 2016, and an archive date of October 8, 2016. While it is archived as listed, the announcement remains useful as a reference point for the types of pediatric formulation and delivery research NIH has historically prioritized under this initiative. Applicants or interested parties are directed to the full announcement at the NIH Grants Guide page (http://grants.nih.gov/grants/guide/pa-files/PAR-13-326.html). For access or technical issues related to the electronic posting, the contact provided is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is PAR 13-326?
PAR 13-326 is a National Institutes of Health (NIH) funding opportunity announcement titled "Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R21)." It is a discretionary research grant announcement focused on early-stage, exploratory projects aimed at improving how medicines are formulated and delivered for pediatric patients.
What is the main purpose of this funding opportunity?
The central purpose is to stimulate exploratory research that addresses practical and scientific barriers that make many existing drug products poorly suited for children. The FOA prioritizes work that improves pediatric formulation design and/or develops innovative pediatric drug delivery systems to make medication administration safer, easier, and more acceptable for children and caregivers.
What types of problems in pediatric medication use does the FOA aim to address?
The FOA targets gaps where adult drug products are commonly adapted for children in ways that can be inconvenient, inaccurate, or unsafe. Examples mentioned include pill splitting, crushing tablets, mixing medicines with food, or relying on compounded preparations that may have inconsistent quality.
What kinds of research topics are considered responsive to this FOA?
Projects are generally responsive when they focus on improving pediatric acceptability and usability of medicines (such as taste masking, texture, dose volume, ease of swallowing, and dosing frequency), improving age-appropriate dosing precision, and reducing the real-world burden of administration in settings like homes, schools, and clinics. The FOA also emphasizes innovation in pediatric drug delivery systems in addition to formulation improvements.
Does the FOA focus only on pediatric formulations, or also on delivery devices/systems?
It emphasizes both. The FOA highlights the need for better pediatric formulations (how the drug is prepared and presented, such as liquids, mini-tablets, or orally disintegrating forms) and also supports development and testing of innovative pediatric drug delivery systems that improve administration for children and caregivers.
What examples of pediatric-friendly dosage forms are mentioned?
The FOA references child-friendly formats such as liquids, mini-tablets, and orally disintegrating forms, and it also allows for other appropriate pediatric formulations that improve acceptability and administration.
Why does the FOA stress differences across pediatric age groups?
Because pediatric patients are not a single uniform population. The FOA notes that swallowing ability, taste preferences, dosing flexibility needs, and developmental physiology can vary dramatically across age groups, so a "one size fits all" formulation or delivery approach often does not work.
Which pediatric developmental stages are specifically encouraged for consideration?
The FOA encourages applicants to consider differences across developmental stages such as neonates, infants, toddlers, children, and adolescents, and to account for distinct constraints each group may present.
What constraints or considerations by age group are highlighted?
The FOA points to considerations including excipient tolerability, dose volume limits, and device usability, which can differ significantly depending on the child's developmental stage.
What is the NIH grant mechanism used for this opportunity?
This opportunity uses the NIH R21 mechanism, which is intended to support exploratory and developmental research, particularly early-stage work that may be high-impact but not yet ready for larger-scale funding.
What is the award ceiling listed for this FOA?
The listed award ceiling is $200,000.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
What is the funding instrument?
The funding instrument is a grant.
What is the activity category associated with this opportunity?
The activity category is aligned with health, income security, and social services.
Which CFDA numbers are associated with this FOA?
The FOA is connected to CFDA 93.173 (Research Related to Deafness and Communication Disorders) and CFDA 93.865 (Child Health and Human Development Extramural Research).
What do the CFDA linkages suggest about NIH interests for this FOA?
They reflect NIH interest areas that include pediatric health and development, and in some cases conditions affecting communication and sensory function where pediatric drug delivery can be particularly challenging.
Who is eligible to apply?
Eligibility is broad and includes many domestic and international organizations. Eligible applicants include public and private institutions of higher education, state and local governments (including county, city/township, special district governments, and independent school districts), nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), and small businesses.
Are tribal governments and tribal organizations eligible?
Yes. The FOA explicitly allows applications from federally recognized tribal governments, tribal organizations, tribally controlled colleges and universities, and U.S. territories or possessions.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are explicitly included as eligible applicants.
Are historically underrepresented or mission-driven institutions encouraged?
The FOA welcomes applications from a wide range of institutions and organizations, including historically Black colleges and universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, and faith-based or community-based organizations.
Can federal agencies apply?
Yes. The FOA lists eligible federal agencies among the eligible applicants.
Are non-U.S. (foreign) organizations eligible?
Yes. Non-U.S. entities are permitted to apply, including foreign organizations and foreign institutions.
Are foreign components of U.S. organizations allowed?
Yes. Foreign components of U.S. organizations are allowed, consistent with NIH policy.
When was the opportunity posted?
The opportunity was posted and created on September 4, 2013.
What were the closing and archive dates?
The original and current closing date listed is September 7, 2016, and the archive date is October 8, 2016.
Is this FOA still open for applications?
Based on the dates provided, it is archived (archive date October 8, 2016) and the closing date listed is September 7, 2016, so it is not presented as an open opportunity in the provided information.
If the FOA is archived, why might it still be useful?
The FOA is described as a useful reference point for the types of pediatric formulation and pediatric drug delivery research that NIH has historically prioritized under this initiative.
Where can the full funding opportunity announcement be found?
The full announcement is available on the NIH Grants Guide page at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-326.html.
Who should be contacted for access or technical issues with the electronic posting?
For access or technical issues related to the electronic posting, the contact provided is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
What real-world settings does the FOA consider for pediatric medication administration?
The FOA explicitly mentions real-world administration settings such as homes, schools, and clinics, emphasizing that research should consider practical administration burdens outside of controlled research environments.
What is meant by improving "acceptability" in this FOA?
In the FOA context, acceptability refers to child- and caregiver-centered features that influence whether a medication can realistically be taken as intended, including taste masking, texture, dose volume, ease of swallowing, and dosing frequency.
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