Opportunity Information: Apply for PAR 11 304
Apply for PAR 11 304
- 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 SBIR (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 93.853 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 $150,000.00 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, or it must be a for profit business concern that is at least 51 percent owned and controlled by another for profit business concern that is at least 51 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 Development of Appropriate Pediatric Formulations and Drug Delivery Systems SBIR (R43) opportunity (Funding Opportunity Number PAR-11-304) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Phase I grant program designed to push forward practical, age-appropriate medicines for children. The focus is on research and early development work that solves common real-world problems in pediatric therapeutics, especially the fact that many drugs are originally designed for adults and then adapted for children in ways that can be inconvenient, inaccurate, unsafe, or simply unacceptable for young patients. This announcement supports projects aimed at creating better pediatric formulations across different pediatric age groups and also promotes the development and evaluation of new or improved drug delivery systems specifically suited to pediatric use.
The core purpose is to complement and speed up pediatric product development rather than replace what private industry is already doing. In other words, NIH is trying to help fill gaps where the market may not naturally invest enough time or money, such as specialized dosage forms for infants, toddlers, and younger children, or delivery approaches that improve dosing accuracy and adherence. This can include formulation work that makes medicines easier to swallow, better tasting, safer to measure, more stable, or more appropriate for different developmental stages. It can also include innovative delivery technologies that make it easier to give medication correctly and consistently in real pediatric settings.
This FOA is categorized as discretionary funding, and the funding instrument is a grant. The activity area is listed under Health, Income Security, and Social Services, with CFDA listings that indicate relevance across multiple NIH research domains, including child health and human development (93.865), neurosciences and neurological disorders (93.853), and research related to deafness and communication disorders (93.173). Cost sharing or matching is not required, which means applicants are not expected to contribute a set percentage of non-federal funds as a condition of the award.
Eligibility is limited to United States small business concerns (SBCs) that meet standard SBIR size and ownership rules. To qualify, the applicant organization must be for-profit, have a place of business in the United States, and operate primarily in the United States (or otherwise make a significant contribution to the U.S. economy through taxes or U.S.-based labor and materials). The business must be structured as an allowable legal entity (such as an LLC, corporation, partnership, sole proprietorship, or similar), and it must be at least 51% owned and controlled by U.S. citizens or permanent resident aliens (with additional specific rules for joint ventures). The company, including affiliates, must have no more than 500 employees, and applicants are expected to follow the detailed eligibility guidance in the SF424 (R&R) SBIR/STTR Application Guide and the applicable SBA regulations (including 13 C.F.R. Part 121 on size and affiliation).
From a timing and administrative standpoint, the opportunity was originally posted on August 11, 2011, and later reflects administrative dates including a creation date of September 6, 2013. The listed award ceiling is $150,000, consistent with typical SBIR Phase I budget expectations for feasibility and proof-of-concept work. The record shows an original closing date of September 7, 2014, but also lists a current closing date of September 6, 2013, and an archive date of October 6, 2013, which together suggest the listing is historical and may have been revised or archived in the federal posting system. Anyone pursuing this topic today would typically look for the most current NIH pediatric formulation and drug delivery FOAs or successor announcements.
The sponsoring agency is NIH, and the full announcement and details were provided through the NIH Grants Guide, with an additional information link pointing to the FOA page. For technical issues accessing the announcement, the contact listed is the NIH Office of Extramural Research (OER) Webmaster via the provided email addresses.
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "The Development of Appropriate Pediatric Formulations and Drug Delivery Systems SBIR (R43)." It is identified by Funding Opportunity Number (FON) PAR-11-304.
Which agency is sponsoring this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What type of funding is this?
This is discretionary funding using a grant funding instrument under the NIH Small Business Innovation Research (SBIR) program.
What SBIR phase and activity code does this opportunity support?
This is an SBIR Phase I opportunity using activity code R43, which is typically intended for early feasibility and proof-of-concept work.
What is the main goal of PAR-11-304?
The goal is to push forward practical, age-appropriate medicines for children by supporting research and early development work that addresses real-world problems in pediatric therapeutics, especially where drugs designed for adults are later adapted for children in ways that can be inconvenient, inaccurate, unsafe, or unacceptable.
What kinds of projects does this FOA aim to support?
The announcement supports projects aimed at creating improved pediatric formulations across different pediatric age groups and promoting the development and evaluation of new or improved drug delivery systems specifically suited to pediatric use.
Why is NIH supporting pediatric formulations and delivery systems through SBIR?
The stated purpose is to complement and accelerate pediatric product development rather than replace what private industry is already doing, helping fill gaps where the market may not naturally invest enough time or money (for example, specialized dosage forms or delivery approaches for infants, toddlers, and younger children).
What pediatric challenges is the FOA trying to address?
The FOA highlights common problems such as medicines being designed for adults and then adapted for children in ways that may lead to inconvenient administration, inaccurate dosing, safety concerns, or poor acceptability for young patients.
What improvements to pediatric formulations are described as relevant in this announcement?
Examples described include making medicines easier to swallow, improving taste, making dosing safer and easier to measure, improving stability, and ensuring the dosage form is appropriate for different developmental stages.
What kinds of drug delivery innovations are in scope?
The announcement includes innovative delivery technologies and new or improved drug delivery systems that make it easier to administer medication correctly and consistently in real pediatric settings.
Is this funding intended to replace private sector pediatric product development?
No. The FOA states that the intent is to complement and speed up development, not to replace private industry efforts.
What broad activity area is this opportunity listed under?
The activity area is listed under Health, Income Security, and Social Services.
Which CFDA program areas are referenced?
The listing references CFDA areas that include child health and human development (93.865), neurosciences and neurological disorders (93.853), and research related to deafness and communication disorders (93.173), indicating relevance across multiple NIH research domains.
Who is eligible to apply?
Eligibility is limited to U.S. small business concerns (SBCs) that meet SBIR size and ownership requirements.
Does the applicant organization have to be for-profit?
Yes. The applicant must be a for-profit small business concern.
Does the business need to be located in the United States?
Yes. The business must have a place of business in the United States and must operate primarily in the United States, or otherwise make a significant contribution to the U.S. economy through taxes or U.S.-based labor and materials.
What types of legal entities can apply?
The business must be structured as an allowable legal entity, such as an LLC, corporation, partnership, sole proprietorship, or a similar entity type.
What are the ownership and control requirements?
The small business must be at least 51% owned and controlled by U.S. citizens or permanent resident aliens, with additional specific rules applying to joint ventures.
Is there an employee size limit for eligibility?
Yes. The company, including affiliates, must have no more than 500 employees.
Which regulations and guidance are referenced for determining eligibility?
Applicants are expected to follow the detailed eligibility guidance in the SF424 (R&R) SBIR/STTR Application Guide and applicable SBA regulations, including 13 C.F.R. Part 121 on size and affiliation.
Is cost sharing or matching required?
No. Cost sharing or matching is not required for this opportunity.
What is the maximum award amount listed?
The listed award ceiling is $150,000, consistent with typical SBIR Phase I budget expectations.
When was this opportunity originally posted?
The opportunity was originally posted on August 11, 2011.
Why do the dates in the listing look inconsistent?
The record includes multiple administrative dates (including a creation date of September 6, 2013), an original closing date of September 7, 2014, a current closing date of September 6, 2013, and an archive date of October 6, 2013. Together, these suggest the listing is historical and may have been revised or archived in the federal posting system.
Is PAR-11-304 likely to be an active opportunity today?
Based on the archive date and the mixed closing dates shown, the listing appears historical. The information provided indicates that anyone pursuing this topic today would typically look for the most current NIH pediatric formulation and drug delivery funding opportunities or successor announcements.
Where were the full announcement details published?
The full announcement and details were provided through the NIH Grants Guide, with an additional link pointing to the FOA page.
Who should be contacted for technical issues accessing the announcement?
For technical issues accessing the announcement, the listed contact is the NIH Office of Extramural Research (OER) Webmaster via the provided email addresses.
Browse more opportunities from the same category: Health Income Security and Social Services
Next opportunity: Development of Appropriate Pediatric Formulations and Drug Delivery Systems STTR (R41)
Previous opportunity: Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R21)
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 11 304) also looked into and applied for these:
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|---|
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems STTR (R41) Apply for PAR 11 305 Funding Number: PAR 11 305 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $100,000 |
| Biomarkers Bridging Pediatric and Adult Therapeutics (R03) Apply for PAR 11 323 Funding Number: PAR 11 323 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $50,000 |
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| Improving Adherence to Treatment Regimens for HIV Positive Adolescents and Young Adults (R01) Apply for RFA HD 12 206 Funding Number: RFA HD 12 206 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $400,000 |
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| Advanced Neural Prosthetics Research and Development (U01) Apply for PAR 12 053 Funding Number: PAR 12 053 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $1,000,000 |
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| Leadership Group for a Clinical Research Network on HIV/AIDS and HIV associated Infections in Pediatric and Maternal Populations (UM1) Apply for RFA AI 12 001 Funding Number: RFA AI 12 001 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Leadership Group for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV associated Infections in Adults (UM1) Apply for RFA AI 12 004 Funding Number: RFA AI 12 004 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Leadership Group for a Clinical Research Network on Microbicides to Prevent HIV Infection (UM1) Apply for RFA AI 12 008 Funding Number: RFA AI 12 008 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Biomedical and Behavioral Research Innovations to Ensure Equity (BRITE) in Maternal and Child Health (R15) Apply for PAR 12 093 Funding Number: PAR 12 093 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Academic Community Partnership Conference Series (R13) Apply for PAR 12 102 Funding Number: PAR 12 102 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $30,000 |
| Child Health Research Career Development Award (CHRCDA) Program K12 Apply for RFA HD 13 011 Funding Number: RFA HD 13 011 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $400,000 |
| Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (U24) Apply for PAS 12 165 Funding Number: PAS 12 165 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (U10) Apply for PAS 12 168 Funding Number: PAS 12 168 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Advanced Tools and Technologies for Cerebrospinal Fluid Shunts SBIR (R43/R44) Apply for PA 12 189 Funding Number: PA 12 189 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Advanced Tools and Technologies for Cerebrospinal Fluid Shunts STTR (R41/R42) Apply for PA 12 190 Funding Number: PA 12 190 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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