Opportunity Information: Apply for PAR 11 305
Apply for PAR 11 305
- 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 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Sep 6, 2013 and posted on Aug 11, 2011.
- Applicants must submit their applications by Sep 6, 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 $100,000.00 in funding.
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor 2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture 3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, , except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States and 4. Has, including its affiliates, not more than 500 employees. SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other or (b) a third party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R and R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
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Opportunity Summary:
The NIH grant opportunity titled "Development of Appropriate Pediatric Formulations and Drug Delivery Systems STTR (R41)" (Funding Opportunity Number PAR-11-305) is a discretionary, grant-based program under the Small Business Technology Transfer (STTR) mechanism. It is designed specifically to support early-stage, Phase I (R41) research by US small business concerns that are working in partnership with a research institution to tackle practical gaps in how medicines are formulated and delivered to children. The focus is on creating drug formulations that actually fit pediatric needs across different age groups, rather than simply adapting adult products in ways that may be unsafe, unpalatable, inaccurate in dosing, or otherwise unsuitable for infants, toddlers, children, and adolescents.
The core purpose of the announcement is to encourage R and D that results in age-appropriate pediatric formulations and also to promote the development and testing of novel pediatric drug delivery systems. In plain terms, the FOA is looking for technologies and approaches that make pediatric medicines easier to administer, more acceptable to children and caregivers, and more reliably dosed, while maintaining safety, stability, and effectiveness. This can include work on formulation strategies (for example, making a drug stable and bioavailable in a child-friendly dosage form) and delivery innovations (for example, devices or systems that improve how a medicine is administered in pediatric settings). A key theme is that pediatric populations are not just "small adults"; they have distinct physiological, developmental, and practical considerations that often require dedicated formulation and delivery solutions.
NIH also makes clear that the goal is not to duplicate or compete with what industry is already doing on its own. Instead, the program is meant to complement private sector activity and accelerate progress in areas where commercial incentives may be limited or where technical barriers slow down development. In that sense, the FOA is positioned as a catalyst: helping small businesses and their research partners generate proof-of-concept data, feasibility results, and early prototypes that can de-risk pediatric formulation and delivery innovations and move them toward later-stage development.
Eligibility is limited to US small business concerns (SBCs) meeting standard federal small business requirements at the time of award for Phase I and Phase II. The business must be for-profit, have a place of business in the United States, and operate primarily in the US or contribute significantly to the US economy through taxes or use of American labor and materials. It must be at least 51 percent owned and controlled by US citizens or permanent resident aliens, and it must have no more than 500 employees including affiliates. The FOA references the regulatory framework in 13 C.F.R. Part 121 and points applicants to the SF424 (R and R) SBIR/STTR Application Guide for the full set of detailed eligibility and application rules. Because this is an STTR opportunity, applicants should also expect the standard STTR requirement of meaningful collaboration between the small business and a nonprofit research institution, though the summary text primarily highlights the small business eligibility criteria.
The opportunity is administered by the National Institutes of Health and is associated with multiple CFDA program areas, including 93.173 (Research Related to Deafness and Communication Disorders), 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), and 93.865 (Child Health and Human Development Extramural Research). That mix signals that proposed projects may align with a range of child health and disorder-focused research areas, as long as they directly address pediatric formulation and/or drug delivery system needs. The funding instrument is a grant, and there is no cost sharing or matching requirement, which reduces financial barriers for small companies pursuing feasibility-stage R and D.
From an administrative standpoint, the FOA was posted on August 11, 2011. The record lists an award ceiling of $100,000 (noting that budgets in NIH small business programs can also be shaped by specific FOA limits and the applicant's well-justified needs, but the ceiling shown here reflects the opportunity record). The original closing date is shown as September 7, 2014, while the record also indicates a current closing date of September 6, 2013 and an archive date of October 6, 2013, which suggests the listing was ultimately archived and is no longer accepting applications. The full announcement was hosted through the NIH Grants Guide at http://grants.nih.gov/grants/guide/pa-files/PAR-11-305.html, and the contact provided for access or linking problems is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Overall, PAR-11-305 is essentially a targeted STTR Phase I funding pathway meant to help US small businesses, working with research partners, generate early evidence and prototypes for pediatric-ready drug formulations and delivery systems. The emphasis is on practical, development-oriented research that closes real-world gaps in pediatric medication administration and product design, with the broader intention of speeding up the availability of safer, more effective, and more usable medicines for children across developmental stages.
Frequently Asked Questions (FAQs)
What is the official title and funding opportunity number for this NIH program?
The opportunity is titled "Development of Appropriate Pediatric Formulations and Drug Delivery Systems STTR (R41)" and the Funding Opportunity Number (FON) is PAR-11-305.
What type of funding mechanism is PAR-11-305?
It is a discretionary, grant-based program offered under the NIH Small Business Technology Transfer (STTR) mechanism. The announcement is specifically for Phase I (R41) research.
What is the main purpose of this grant opportunity?
The core purpose is to encourage research and development that produces age-appropriate pediatric drug formulations and to promote the development and testing of novel pediatric drug delivery systems. The intent is to address real gaps in how medicines are formulated and delivered to children across different age groups.
What kinds of problems is NIH trying to solve with this FOA?
This FOA targets practical pediatric medication challenges that can arise when adult products are simply adapted for children in ways that may be unsafe, unpalatable, inaccurate in dosing, unstable, or otherwise unsuitable for infants, toddlers, children, and adolescents.
Who is the intended applicant for this opportunity?
The intended applicants are U.S. small business concerns (SBCs) conducting early-stage R&D in partnership with a research institution, consistent with STTR expectations for meaningful collaboration.
Is this opportunity only for Phase I (R41), or does it include Phase II?
Based on the information provided, this opportunity is designed specifically to support early-stage, Phase I (R41) research.
What does "pediatric populations are not just small adults" mean in the context of this FOA?
It means children have distinct physiological, developmental, and practical considerations that often require dedicated formulation and delivery solutions, rather than simply scaling down adult medicines.
What types of projects or technologies does this FOA encourage?
It encourages technologies and approaches that make pediatric medicines easier to administer, more acceptable to children and caregivers, and more reliably dosed, while maintaining safety, stability, and effectiveness. This includes formulation strategies and delivery innovations, including systems or devices that improve administration in pediatric settings.
Does NIH want applicants to compete directly with existing industry development programs?
No. NIH states the goal is not to duplicate or compete with what industry is already doing independently. The program is meant to complement private-sector activity and accelerate progress where commercial incentives may be limited or technical barriers slow development.
What stage of development is this funding intended to support?
It is intended to support feasibility-stage work such as proof-of-concept data, feasibility results, and early prototypes that can de-risk pediatric formulation and delivery innovations and move them toward later-stage development.
Who is eligible to apply?
Eligibility is limited to U.S. small business concerns meeting standard federal small business requirements at the time of award. The small business must be for-profit, have a place of business in the United States, and operate primarily in the U.S. (or contribute significantly to the U.S. economy through taxes or use of American labor and materials).
Are there ownership and control requirements for the small business?
Yes. The business must be at least 51 percent owned and controlled by U.S. citizens or permanent resident aliens.
Is there an employee size limit?
Yes. The small business must have no more than 500 employees, including affiliates.
Where are the detailed eligibility and application rules defined?
The FOA references 13 C.F.R. Part 121 and directs applicants to the SF424 (R&R) SBIR/STTR Application Guide for detailed eligibility and application requirements.
Is collaboration with a research institution required?
Because this is an STTR opportunity, applicants should expect the standard STTR requirement for meaningful collaboration between the small business and a nonprofit research institution. The summary emphasizes SBC eligibility while noting the STTR partnership expectation.
Which agency administers this opportunity?
The opportunity is administered by the National Institutes of Health (NIH).
Which CFDA program areas are associated with this opportunity?
The opportunity is associated with multiple CFDA program areas, including 93.173 (Research Related to Deafness and Communication Disorders), 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), and 93.865 (Child Health and Human Development Extramural Research).
Do projects have to fit within a particular disease area?
The associated CFDA areas suggest projects may align with a range of child health and disorder-focused research areas, as long as the project directly addresses pediatric formulation and/or drug delivery system needs.
What is the funding instrument?
The funding instrument is a grant.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
What is the listed award ceiling?
The record lists an award ceiling of $100,000. It also notes that NIH small business budgets may be shaped by FOA-specific limits and an applicant's well-justified needs, but the ceiling shown in the record is $100,000.
When was this FOA posted?
The FOA was posted on August 11, 2011.
What were the closing dates shown for this opportunity?
The record shows an original closing date of September 7, 2014, and also indicates a current closing date of September 6, 2013.
Is this opportunity still accepting applications?
The record indicates an archive date of October 6, 2013, which suggests the listing was archived and is no longer accepting applications.
Where can the full announcement be found?
The full announcement was hosted through the NIH Grants Guide at http://grants.nih.gov/grants/guide/pa-files/PAR-11-305.html.
Who should be contacted for access or linking problems with the announcement?
The contact listed for access or linking problems is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
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