Opportunity Information: Apply for PAR 13 325
Apply for PAR 13 325
- 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 (R01)" 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.)
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education City or township governments Small businesses County governments State governments Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education.
- 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) grant opportunity titled "Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R01)" (Funding Opportunity Number PAR 13 325) is a discretionary, health-focused research grant that supports projects aimed at improving how medicines are formulated and delivered for children. The core purpose is to encourage research that addresses practical, age-specific needs in pediatric drug formulation, including making medicines more acceptable to children and caregivers across different pediatric age groups. In addition to formulation work, the announcement explicitly includes the development and testing of novel pediatric drug delivery systems, reflecting a broader interest in not just what the drug is made into (for example, liquids, mini-tablets, orally disintegrating dosage forms, films, etc.), but also how it is administered (devices, delivery approaches, and systems designed for pediatric use).
This opportunity uses the NIH R01 mechanism, meaning it is intended for substantial, hypothesis-driven or well-justified research programs rather than small pilot efforts. The research scope is framed around complementary needs in pediatrics, which typically implies attention to real-world constraints that make pediatric medicines uniquely challenging: dosing flexibility across rapidly changing body weights and developmental stages, safe and appropriate excipients for infants and young children, palatability and swallowability, caregiver usability, stability and storage concerns, and the feasibility of administration in clinical and home settings. The FOA also emphasizes acceptability, which often encompasses taste masking, texture, volume, dosing frequency, ease of measuring, and how well a formulation fits into daily routines for families, schools, and care facilities.
From an administrative standpoint, the announcement falls under the NIH and is categorized as a grant within the Health, Income Security and Social Services activity area. It is associated with CFDA numbers 93.173 (Research Related to Deafness and Communication Disorders) and 93.865 (Child Health and Human Development Extramural Research), signaling that the participating NIH components may include institutes and centers aligned with child health and developmental considerations as well as communication-related conditions where pediatric drug delivery challenges can be especially relevant.
Eligibility is broad and includes a wide range of applicant organizations across the public, private, nonprofit, and academic sectors. Eligible applicants include nonprofits with and without 501(c)(3) status (other than institutions of higher education), private and public institutions of higher education (including public and state-controlled institutions), for-profit organizations (other than small businesses) as well as small businesses, and multiple levels of government entities such as state, county, city or township governments, special district governments, independent school districts, and public or Indian housing authorities. The FOA also permits applications from Native American tribal governments (federally recognized) and tribal organizations (including those other than federally recognized tribal governments), and it highlights eligibility for institutions serving specific populations, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). Faith-based or community-based organizations and eligible federal agencies are also listed as eligible.
A notable feature of this announcement is that non-U.S. participation is allowed. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, may apply, and non-domestic components of U.S. organizations are eligible as well. The FOA also allows foreign components as defined by the NIH Grants Policy Statement. This makes the program accessible to international research efforts and collaborations, which can be important for pediatric formulation work where global standards, region-specific product needs, and diverse patient populations may influence design and testing.
The opportunity does not require cost sharing or matching, which can reduce barriers for applicants proposing complex formulation development and delivery system research that may require specialized equipment, clinical input, or iterative prototyping. Key dates show that the FOA 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, indicating the announcement is no longer active but remains an important reference point for NIH priorities in pediatric formulations and delivery technologies during that period.
For applicants or institutions seeking the full official details, NIH provided an additional information link to the archived FOA page (http://grants.nih.gov/grants/guide/pa-files/PAR-13-325.html). For technical issues accessing the announcement or problems with links, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is the name of this NIH grant opportunity?
The opportunity is titled "Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R01)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR 13 325.
What type of funding mechanism does this opportunity use?
This opportunity uses the NIH R01 grant mechanism.
What kind of projects is this FOA intended to support?
It supports health-focused research projects aimed at improving how medicines are formulated and delivered for children, with attention to practical, age-specific needs across different pediatric age groups.
Is this more appropriate for small pilot studies or substantial research programs?
Based on the R01 mechanism, it is intended for substantial, well-justified (often hypothesis-driven) research programs rather than small pilot efforts.
What is the main purpose of the FOA?
The core purpose is to encourage research that addresses real-world pediatric needs in drug formulation and drug delivery, including making medicines more acceptable to children and caregivers.
Does the scope include pediatric drug delivery systems as well as formulations?
Yes. The announcement explicitly includes the development and testing of novel pediatric drug delivery systems, not only the formulation itself.
What are examples of pediatric formulations mentioned or implied in the description?
Examples referenced include liquids, mini-tablets, orally disintegrating dosage forms, and films (among other appropriate pediatric dosage forms).
What does "drug delivery systems" mean in the context of this FOA?
It refers to how a drug is administered to children, including devices, delivery approaches, and systems designed specifically for pediatric use.
What pediatric-specific challenges does the FOA highlight or imply applicants should address?
The scope is framed around practical pediatric constraints such as dosing flexibility across changing body weights and developmental stages, safe and appropriate excipients for infants and young children, palatability and swallowability, caregiver usability, stability and storage concerns, and feasibility in clinical and home settings.
What does "acceptability" mean for pediatric medicines in this FOA?
Acceptability commonly includes considerations like taste masking, texture, dose volume, dosing frequency, ease of measuring, swallowability, and how well the medicine fits into daily routines for families, schools, and care facilities.
Which federal agency is associated with this grant opportunity?
The opportunity is associated with the National Institutes of Health (NIH).
How is the opportunity categorized administratively?
It is categorized as a grant within the Health, Income Security and Social Services activity area.
Which CFDA numbers are associated with this FOA?
The associated CFDA numbers are 93.173 (Research Related to Deafness and Communication Disorders) and 93.865 (Child Health and Human Development Extramural Research).
What do the CFDA associations suggest about NIH participation?
They signal that participating NIH components may include institutes and centers aligned with child health and developmental considerations and communication-related conditions where pediatric drug delivery challenges can be relevant.
Who is eligible to apply?
Eligibility is broad and includes organizations across public, private, nonprofit, and academic sectors, as well as certain government entities and other eligible institutions listed in the FOA summary.
Are nonprofit organizations eligible?
Yes. Nonprofits with and without 501(c)(3) status (other than institutions of higher education) are listed as eligible.
Are universities and colleges eligible?
Yes. Private and public institutions of higher education are eligible, including public and state-controlled institutions.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) and small businesses are listed as eligible.
Which government entities are eligible applicants?
Eligible government entities listed include state governments, county governments, city or township governments, special district governments, independent school districts, and public or Indian housing authorities.
Are Native American tribal governments and tribal organizations eligible?
Yes. Native American tribal governments (federally recognized) and tribal organizations (including those other than federally recognized tribal governments) are listed as eligible.
Are institutions serving specific populations explicitly included in the eligibility list?
Yes. The eligibility list highlights HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are included in the eligibility list.
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are listed as eligible applicants.
Is non-U.S. participation allowed?
Yes. Non-U.S. (non-domestic) entities, including foreign organizations and foreign institutions, may apply.
Can non-domestic components of U.S. organizations be included?
Yes. Non-domestic components of U.S. organizations are eligible, and the FOA allows foreign components as defined by the NIH Grants Policy Statement.
Does this opportunity require cost sharing or matching funds?
No. The opportunity does not require cost sharing or matching.
When was this FOA posted and created?
It was posted and created on September 4, 2013.
What were the closing dates for this funding opportunity?
The original and current closing date listed is September 7, 2016.
Is this FOA still active?
No. The archive date is October 8, 2016, indicating the announcement is no longer active.
Where can applicants find the official archived FOA details?
NIH provided an archived FOA page at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-325.html
Who should be contacted for technical issues accessing the announcement or problems with links?
The technical contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
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| Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R21) Apply for PAR 13 326 Funding Number: PAR 13 326 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
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| Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R43) Apply for PAR 13 345 Funding Number: PAR 13 345 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $150,000 |
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| Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (STTR) (R41/R42) Apply for RFA HD 14 032 Funding Number: RFA HD 14 032 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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| Sustained Release for Antiretroviral Treatment or Prevention (SRATP) of HIV Infection (UM1) Apply for RFA AI 14 008 Funding Number: RFA AI 14 008 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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