Opportunity Information: Apply for PAR 13 346
Apply for PAR 13 346
- 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 Drug Delivery Systems STTR (R41)" 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 93.350 National Center for Advancing Translational Sciences 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Sep 6, 2013 and posted on Sep 6, 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: Small businesses.
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The NIH grant opportunity titled "Development of Appropriate Pediatric Formulations and Drug Delivery Systems" is a Small Business Technology Transfer (STTR) Phase I (R41) funding announcement designed to push forward practical, child-friendly ways to formulate and deliver medicines for pediatric patients. Led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) with participation from other NIH institutes, the program targets research gaps that slow down the creation of safe, effective, and usable drug products for infants, children, and adolescents. The central idea is to support early-stage, proof-of-concept work that can translate into real pediatric-ready products, especially where existing adult formulations are not suitable and where new delivery approaches could improve dosing accuracy, adherence, safety, or therapeutic performance.
A major emphasis of the opportunity is that pediatric patients are not simply "small adults" and often need formulations tailored to specific developmental stages. Different age groups can have very different needs related to swallowing ability, taste sensitivity, metabolic capacity, dosing flexibility, and tolerance for certain excipients. As a result, the announcement encourages projects that create age-appropriate formulations across multiple pediatric cohorts, such as neonates, infants, toddlers, school-aged children, and adolescents. Work supported under this announcement can include strategies that improve stability, palatability, dose flexibility, and accurate measurement, while also reducing risks tied to inappropriate excipients or dosing errors. In parallel, the FOA explicitly encourages the development and testing of novel drug delivery systems intended for pediatric use, recognizing that the method of delivery can be just as important as the drug itself when it comes to achieving reliable real-world outcomes in children.
This funding announcement also clarifies its role in the broader innovation ecosystem: it is meant to complement and accelerate pediatric formulation and delivery development rather than duplicate or compete with private-sector activity. In practice, that means NIH is signaling interest in enabling work that may be scientifically important but commercially challenging at an early stage, such as high-risk technical feasibility studies, platform technologies that could be adapted across multiple drugs, or pediatric-specific delivery solutions that require specialized validation. As an STTR mechanism, the program is structured to promote formal collaboration between a small business and a nonprofit research institution, combining product-driven development capacity with academic or clinical research strengths.
Administratively, this opportunity is a discretionary grant under the NIH umbrella, categorized under health-related activities. The funding opportunity number is PAR-13-346, and it was posted on September 6, 2013, with an original and final closing date of September 7, 2016; it was archived on October 8, 2016. There is no cost-sharing or matching requirement listed, which is typical of many NIH small business awards. Eligibility is limited to small businesses, and the announcement specifies that non-U.S. (foreign) institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible; however, foreign components (as defined by NIH policy) may be allowed in certain circumstances. The listing references multiple CFDA numbers associated with participating NIH programs, including 93.865 (Child Health and Human Development Extramural Research) and other related translational and communications disorder research areas, reflecting the cross-institute interest in pediatric drug development challenges.
For full details, the archived announcement is linked through the NIH Grants Guide at http://grants.nih.gov/grants/guide/pa-files/PAR-13-346.html, and the NIH Office of Extramural Research (OER) webmaster contact is provided for technical access issues.
Frequently Asked Questions (FAQ)
1) What is the name of this NIH funding opportunity?
The opportunity is titled "Development of Appropriate Pediatric Formulations and Drug Delivery Systems."
2) What type of grant mechanism is this?
This is a Small Business Technology Transfer (STTR) Phase I (R41) funding announcement. It is designed for early-stage, proof-of-concept research and development.
3) What is the main purpose of the program?
The program supports practical, child-friendly ways to formulate and deliver medicines for pediatric patients. The intent is to address research gaps that slow the creation of safe, effective, and usable drug products for infants, children, and adolescents, especially when adult formulations are not appropriate for children.
4) Which NIH Institute is leading the announcement?
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is leading the opportunity, with participation from other NIH institutes.
5) Why does the announcement emphasize that pediatric patients are not "small adults"?
The announcement highlights that children often need formulations tailored to specific developmental stages. Needs can differ by age group in areas like swallowing ability, taste sensitivity, metabolic capacity, dose flexibility, and tolerance for certain excipients. These differences can affect safety, effectiveness, and real-world use.
6) What pediatric age groups does the FOA encourage applicants to consider?
The FOA encourages development of age-appropriate formulations across multiple pediatric cohorts, including neonates, infants, toddlers, school-aged children, and adolescents.
7) What kinds of formulation improvements are in scope?
Projects may include strategies to improve stability, palatability, dose flexibility, and accurate measurement. The FOA also points to reducing risks tied to inappropriate excipients or dosing errors.
8) Does the opportunity support drug delivery system development, or only formulations?
It supports both. The FOA explicitly encourages the development and testing of novel drug delivery systems intended for pediatric use, noting that the delivery method can be as important as the drug in achieving reliable outcomes in children.
9) What stage of work is NIH trying to fund through this STTR Phase I announcement?
The focus is on early-stage, proof-of-concept efforts that can translate into real pediatric-ready products. This includes feasibility-oriented work meant to establish that an approach can work and could be advanced further.
10) How does NIH describe the role of this FOA in the broader innovation ecosystem?
The announcement is meant to complement and accelerate pediatric formulation and delivery development rather than duplicate or compete with private-sector activity. NIH signals interest in enabling early work that may be scientifically important but commercially challenging.
11) What kinds of projects does NIH highlight as potentially relevant when commercial activity may be limited?
Examples described include high-risk technical feasibility studies, platform technologies that could be adapted across multiple drugs, and pediatric-specific delivery solutions that require specialized validation.
12) What is the collaboration requirement under STTR for this opportunity?
As an STTR mechanism, the program is structured to promote formal collaboration between a small business and a nonprofit research institution, combining product-driven development capacity with academic or clinical research strengths.
13) What is the funding opportunity number?
The funding opportunity number is PAR-13-346.
14) When was this opportunity posted, and what were the closing dates?
It was posted on September 6, 2013. The original and final closing date listed is September 7, 2016. The announcement was archived on October 8, 2016.
15) Is this opportunity still active?
No. Based on the provided information, it has a final closing date of September 7, 2016 and was archived on October 8, 2016.
16) Is cost sharing or matching required?
No cost-sharing or matching requirement is listed. The description notes this is typical of many NIH small business awards.
17) Who is eligible to apply?
Eligibility is limited to small businesses.
18) Are non-U.S. (foreign) institutions eligible to apply?
No. The announcement specifies that non-U.S. (foreign) institutions are not eligible to apply.
19) Are non-U.S. components of U.S. organizations eligible?
No. The announcement specifies that non-U.S. components of U.S. organizations are also not eligible.
20) Are any foreign activities allowed under this FOA?
Foreign components (as defined by NIH policy) may be allowed in certain circumstances, according to the information provided.
21) What is the administrative category of this program?
It is described as a discretionary grant under the NIH umbrella and categorized under health-related activities.
22) What CFDA numbers are associated with this opportunity?
The listing references multiple CFDA numbers linked to participating NIH programs, including 93.865 (Child Health and Human Development Extramural Research) and other related areas, reflecting cross-institute interest in pediatric drug development challenges.
23) Where can applicants or readers find the archived announcement?
The archived announcement is available through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-346.html
24) Who is listed for technical access issues related to the announcement?
The NIH Office of Extramural Research (OER) webmaster contact is provided for technical access issues.
Browse more opportunities from the same category: Health Income Security and Social Services
Next opportunity: USO GRANT
Previous opportunity: Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R43)
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PAR 13 346
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 13 346) also looked into and applied for these:
| Funding Opportunity |
|---|
| Sustained Release of Antivirals for Treatment and Prevention of HIV (SRATP) (R01) Apply for PAR 13 349 Funding Number: PAR 13 349 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Enhancing the Capacity for Biomedical Research on Tuberculosis for HIV infected Mothers and Children in India (R01) Apply for RFA HD 14 025 Funding Number: RFA HD 14 025 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $350,000 |
| Developmental Origins of Health and Disease (DOHaD) Epigenetic Modification in Gametogenesis and Transgenerational Inheritance (R01) Apply for PAR 13 385 Funding Number: PAR 13 385 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $250,000 |
| Female Contraceptive Development Program (U01) Apply for RFA HD 14 024 Funding Number: RFA HD 14 024 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $250,000 |
| Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (SBIR) (R43/R44) Apply for RFA HD 14 031 Funding Number: RFA HD 14 031 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (R01) Apply for PAR 13 389 Funding Number: PAR 13 389 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| 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 |
| Centers for Collaborative Research in Fragile X (U54) Apply for RFA HD 14 033 Funding Number: RFA HD 14 033 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $1,300,000 |
| Juvenile Protective Factors and Their Effects on Aging (R03) Apply for PAR 14 022 Funding Number: PAR 14 022 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| U.S South Africa Program for Collaborative Biomedical Research (U01) Apply for RFA AI 14 018 Funding Number: RFA AI 14 018 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $225,000 |
| Data Sharing for Demographic Research Infrastructure Program (U24) Apply for RFA HD 14 015 Funding Number: RFA HD 14 015 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Intellectual and Developmental Disabilities Research Centers 2014 (U54) Apply for RFA HD 14 012 Funding Number: RFA HD 14 012 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $1,300,000 |
| Population Dynamics Centers Research Infrastructure (P2C) Apply for RFA HD 14 016 Funding Number: RFA HD 14 016 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Data Coordinating Center for the Collaborative Pediatric Critical Care Research Network (U01) Apply for RFA HD 14 020 Funding Number: RFA HD 14 020 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Collaborative Pediatric Critical Care Research Network (UG1) Apply for RFA HD 14 022 Funding Number: RFA HD 14 022 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| 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 |
| Isolation, Purification, and Synthesis of Human Milk Oligosaccharides with Antimicrobial Activity (R43) Apply for RFA HD 15 008 Funding Number: RFA HD 15 008 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $150,000 |
| Isolation, Purification, and Synthesis of Human Milk Oligosaccharides with Antimicrobial Activity (R41) Apply for RFA HD 15 007 Funding Number: RFA HD 15 007 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $150,000 |
| Male Contraceptive Development Program (U01) Apply for RFA HD 14 034 Funding Number: RFA HD 14 034 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| Global Omics Approaches Targeting Adverse Pregnancy and Neonatal Outcomes Utilizing Existing Cohorts (R01) Apply for PAR 14 264 Funding Number: PAR 14 264 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PAR 13 346", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.