Opportunity Information: Apply for PAR 13 345
Apply for PAR 13 345
- 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 (R43)" 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.)
- Each selected applicant is eligible to receive up to $150,000.00 in funding.
- 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.
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Opportunity Summary:
The grant opportunity titled "Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R43)" is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) solicitation focused on improving how medicines are formulated and delivered for children across different pediatric age groups. Led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) along with other participating NIH Institutes, the program is aimed at supporting early-stage, small business-driven research that addresses long-standing gaps in pediatric therapeutics. The core emphasis is on developing dosage forms that are actually suitable for children, recognizing that pediatric patients are not simply "small adults" and often need different excipients, strengths, routes of administration, and delivery approaches to ensure medicines are safe, acceptable, and effective.
A central theme of this opportunity is the advancement of age-appropriate pediatric formulations. That includes work that adapts or redesigns drug products so they can be dosed accurately, swallowed or administered more easily, and tolerated better by infants, toddlers, children, and adolescents. Pediatric formulation challenges commonly involve issues like taste masking, flexible dosing, stability in liquid preparations, minimizing harmful or unnecessary excipients, and designing products that fit the realities of caregivers and clinical settings. This funding call is meant to encourage research that addresses these practical problems in ways that can realistically move toward translation and broader use.
In addition to formulation work, the announcement explicitly encourages the development and testing of novel pediatric drug delivery systems. In practice, that can include new devices, delivery platforms, or administration methods that improve adherence, reduce dosing errors, or make treatment less invasive or less burdensome for children and families. The solicitation is positioned to support innovation where pediatric-specific constraints matter, such as small volumes for neonates, the need for non-swallow alternatives, and the challenges of controlled release or targeted delivery in developing bodies.
The stated intent is not for NIH to compete with private-sector product development, but to complement it by accelerating progress in areas where market forces alone may not prioritize pediatric needs. Many pediatric formulation and delivery problems persist because they can be expensive to solve, technically complex, and less commercially attractive than adult indications. Through this SBIR mechanism, NIH is essentially trying to de-risk early research and development so that promising solutions have a better chance of reaching later-stage development and eventual adoption.
From an administrative standpoint, the opportunity is a discretionary grant with a health-focused activity category, and it falls under an SBIR Phase I mechanism (R43). The award ceiling listed is $150,000, which is consistent with a Phase I-style scope intended to establish feasibility, generate proof-of-concept data, or build the prototype and initial performance evidence needed to justify further development. The solicitation does not require cost sharing or matching funds, which can be important for small businesses that may not have substantial non-dilutive capital available.
Eligibility is limited to small businesses, and the announcement makes clear that non-U.S. (foreign) entities are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. At the same time, it notes that foreign components, as defined under the NIH Grants Policy Statement, may be allowed, meaning a U.S.-based applicant might be able to include certain foreign elements in the work under NIH rules, but the applicant organization itself must be domestic and meet the SBIR small business requirements.
Key identifying details for the opportunity include the Funding Opportunity Number PAR-13-345 and a posted/created date of September 6, 2013. The original and current closing date shown is September 7, 2016, with an archive date of October 8, 2016, indicating that this specific announcement is no longer active but remains part of the public record. The opportunity is associated with CFDA numbers 93.865 (Child Health and Human Development Extramural Research) and also references 93.173 (Research Related to Deafness and Communication Disorders) and 93.350 (National Center for Advancing Translational Sciences), reflecting the broader NIH participation and translational intent behind the program.
For applicants or readers seeking the full, official announcement language, the archived NIH Grants Guide listing is provided at http://grants.nih.gov/grants/guide/pa-files/PAR-13-345.html. The contact information included is for technical issues accessing or linking to the announcement, directed to the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
FAQs: Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R43) (PAR-13-345)
What is the "Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R43)" opportunity?
It is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) solicitation focused on improving how medicines are formulated and delivered for children across pediatric age groups. The emphasis is on creating dosage forms and delivery approaches that are safe, acceptable, and effective for pediatric patients.
Which NIH Institute is leading this solicitation?
The opportunity is led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), with participation from other NIH Institutes.
What does "R43" mean in this announcement?
R43 indicates the SBIR Phase I mechanism. Phase I awards are generally intended to establish feasibility, generate proof-of-concept data, and/or build early prototypes and initial performance evidence that can justify further development.
What types of projects are encouraged under this solicitation?
The solicitation encourages early-stage, small business-driven research aimed at (1) developing age-appropriate pediatric formulations and (2) developing and testing novel pediatric drug delivery systems, devices, platforms, or administration methods that address pediatric-specific constraints.
What is meant by "age-appropriate pediatric formulations" in this program?
Age-appropriate formulations are dosage forms redesigned or adapted to meet the needs of infants, toddlers, children, and adolescents. This includes making products easier to dose accurately, easier to swallow or administer, and more tolerable for pediatric patients and caregivers.
What pediatric formulation challenges does the opportunity specifically highlight?
The description points to practical challenges such as taste masking, flexible dosing, stability in liquid preparations, minimizing harmful or unnecessary excipients, and designing products that align with real-world caregiver and clinical needs.
Does the announcement support work on pediatric drug delivery systems in addition to formulations?
Yes. In addition to formulation work, it explicitly encourages the development and testing of novel pediatric drug delivery systems, including devices or delivery platforms that can improve adherence, reduce dosing errors, and make treatment less invasive or less burdensome.
Why does this program emphasize that children are not simply "small adults"?
The program highlights that pediatric patients often need different excipients, dosage strengths, routes of administration, and delivery approaches compared to adults, in order to ensure medicines are safe, acceptable, and effective for developing bodies across pediatric age groups.
Is NIH trying to replace private-sector product development through this program?
No. The stated intent is not for NIH to compete with private-sector product development, but to complement it by accelerating progress in areas where market forces may not prioritize pediatric needs. The SBIR mechanism is described as helping to de-risk early R&D so promising solutions can advance toward later-stage development and adoption.
What is the maximum award amount listed for this Phase I (R43) opportunity?
The listed award ceiling is $150,000.
Is cost sharing or matching funds required?
No. The opportunity states that it does not require cost sharing or matching funds.
Who is eligible to apply?
Eligibility is limited to small businesses that meet SBIR requirements. The applicant organization must be U.S.-based (domestic).
Are foreign (non-U.S.) entities eligible to apply?
No. The announcement specifies that non-U.S. (foreign) entities are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible?
No. The announcement indicates that non-U.S. components of U.S. organizations are also not eligible.
Does the opportunity allow any foreign involvement at all?
It notes that foreign components, as defined under the NIH Grants Policy Statement, may be allowed. This suggests a domestic U.S. applicant might include certain foreign elements under NIH rules, but the applicant organization itself must be domestic and meet SBIR small business eligibility requirements.
What is the Funding Opportunity Number (FON) for this solicitation?
The Funding Opportunity Number is PAR-13-345.
When was this opportunity posted?
The posted/created date listed is September 6, 2013.
Is this funding opportunity still open?
No. The closing date shown is September 7, 2016, and the archive date is October 8, 2016, indicating that this specific announcement is no longer active.
What are the CFDA numbers associated with this opportunity?
The opportunity is associated with CFDA 93.865 (Child Health and Human Development Extramural Research) and also references 93.173 (Research Related to Deafness and Communication Disorders) and 93.350 (National Center for Advancing Translational Sciences).
Where can applicants find the full official announcement text?
The archived NIH Grants Guide listing is provided at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-345.html.
Who should be contacted for technical issues accessing or linking to the announcement?
Technical issues are directed to the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
What is the activity category and grant type described for this opportunity?
It is described as a discretionary grant with a health-focused activity category, using the SBIR Phase I (R43) mechanism.
What kinds of pediatric constraints does the solicitation mention for delivery innovation?
The description highlights constraints such as the need for small volumes for neonates, non-swallow alternatives, and the challenges of controlled release or targeted delivery in developing bodies.
What is the overall goal of the funded work described in this opportunity?
The overall goal is to address long-standing gaps in pediatric therapeutics by supporting feasible, early-stage innovations in pediatric formulations and delivery systems that can realistically move toward translation and broader use.
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