Opportunity Information: Apply for PAR 11 301
Apply for PAR 11 301
- 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 Aug 11, 2011.
- Applicants must submit their applications by Sep 4, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public and State controlled institutions of higher education State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) County governments Small businesses Private institutions of higher education Independent school districts.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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.
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Opportunity Summary:
The Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R01) opportunity (Funding Opportunity Number PAR-11-301) is a National Institutes of Health (NIH) discretionary research grant that supports studies aimed at improving how medicines are formulated and delivered for children. The central focus is on the practical reality that children are not just "small adults" when it comes to taking medications. Different pediatric age groups (for example, infants, toddlers, school-aged children, and adolescents) have distinct physiological needs, dosing constraints, swallowing abilities, taste sensitivities, and caregiver administration challenges. This program is intended to fund research that addresses those differences by developing pediatric-appropriate drug formulations and by designing and evaluating drug delivery systems that are better suited to children.
A key theme of the announcement is acceptability and usability, not only laboratory feasibility. Projects are expected to consider whether a formulation can realistically be used in pediatric settings, including at home, in clinics, and in hospitals, and whether it can be administered accurately and consistently. That includes issues like palatability (taste and mouthfeel), dosing flexibility (being able to adjust doses across a wide range of body weights and developmental stages), stability (shelf life and storage requirements), and ease of administration for caregivers. Alongside formulation work, the FOA explicitly encourages development and testing of novel pediatric drug delivery systems, which can include new devices, administration routes, or dosage forms designed to improve safety, adherence, and dosing precision in children.
The award mechanism is an R01 research project grant, which is NIH's standard mechanism for investigator-initiated research and typically supports well-developed projects with defined aims. The overall activity category is Health, and the opportunity 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 scientific scope can align with child health and development as well as areas connected to communication disorders, depending on the specific application. Cost sharing or matching is not required, which generally lowers the barrier to entry for applicants that may not have non-federal funds to contribute.
Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants listed include federal and non-federal entities such as state governments, county and city/township governments, special district governments, public and state-controlled institutions of higher education, private institutions of higher education, independent school districts, and public housing authorities/Indian housing authorities. The announcement also allows a wide range of nonprofit and for-profit applicants, including nonprofits with 501(c)(3) status, nonprofits without 501(c)(3) status (other than institutions of higher education), and for-profit organizations other than small businesses, as well as small businesses themselves. It further clarifies that other eligible applicants can include U.S. territory or possession entities, regional organizations, foreign organizations (non-U.S. entities), faith-based or community-based organizations, and a number of mission-driven institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities (TCCUs). Tribal governments are also included, both federally recognized and other than federally recognized tribal governments, along with Native American tribal organizations.
From an administrative timeline standpoint, the opportunity was posted on August 11, 2011, with an original closing date of September 7, 2014. The record provided shows a current closing date of September 4, 2013, and an archive date of October 4, 2013, indicating that the announcement is no longer active and has been archived. The creation date in the record is September 4, 2013, which likely reflects when this particular listing entry was created or updated in the system rather than the original release of the FOA.
For applicants or researchers looking for the official details, the funding announcement link is provided through the NIH Grants Guide: http://grants.nih.gov/grants/guide/pa-files/PAR-11-301.html. For access problems or broken links, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV, which is intended for technical assistance with accessing the announcement rather than scientific or programmatic questions.
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled The Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R01).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PAR-11-301.
Which federal agency offers this grant?
This is a National Institutes of Health (NIH) discretionary research grant opportunity.
What type of grant mechanism is used?
The award mechanism is an R01 research project grant, NIH's standard mechanism for investigator-initiated research.
What is the main purpose of this funding opportunity?
It supports studies aimed at improving how medicines are formulated and delivered for children, based on the premise that children are not just "small adults" when it comes to taking medications.
What pediatric issues is the program trying to address?
The program targets practical pediatric differences such as age-related physiology, dosing constraints, swallowing abilities, taste sensitivities, and caregiver administration challenges across pediatric age groups (for example, infants, toddlers, school-aged children, and adolescents).
What kinds of research activities does this opportunity encourage?
It encourages research to develop pediatric-appropriate drug formulations and to design and evaluate drug delivery systems that are better suited to children.
Does the announcement emphasize real-world use, or just laboratory feasibility?
It emphasizes acceptability and usability, not only laboratory feasibility. Projects are expected to consider whether a formulation can realistically be used in pediatric settings such as the home, clinics, and hospitals.
What usability factors are specifically highlighted?
Examples called out include palatability (taste and mouthfeel), dosing flexibility (adjusting doses across a wide range of body weights and developmental stages), stability (shelf life and storage requirements), and ease of administration for caregivers, along with accurate and consistent administration.
Are novel pediatric drug delivery systems included in the scope?
Yes. The FOA explicitly encourages development and testing of novel pediatric drug delivery systems, which may include new devices, administration routes, or dosage forms designed to improve safety, adherence, and dosing precision in children.
What is the overall activity category for this opportunity?
The overall activity category is Health.
Which CFDA numbers are associated with this opportunity?
The opportunity is associated with CFDA 93.173 (Research Related to Deafness and Communication Disorders) and 93.865 (Child Health and Human Development Extramural Research).
What does it mean that multiple CFDA numbers are listed?
Based on the listing, it signals that the scientific scope may align with child health and development and may also align with areas connected to communication disorders, depending on the specific application.
Is cost sharing or matching required?
No. Cost sharing or matching is not required.
Who is eligible to apply?
Eligibility is described as broad and includes many types of domestic and non-domestic organizations, spanning government entities, higher education, nonprofits, and for-profits.
Are government entities eligible applicants?
Yes. Eligible applicants listed include federal and non-federal entities such as state governments, county governments, city/township governments, and special district governments.
Are colleges and universities eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.
Are nonprofits eligible, including those without 501(c)(3) status?
Yes. The listing includes nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status (other than institutions of higher education).
Are for-profit organizations eligible?
Yes. Eligible applicants include for-profit organizations other than small businesses, and small businesses are also listed as eligible.
Are foreign (non-U.S.) organizations eligible?
Yes. The eligible applicants list includes foreign organizations (non-U.S. entities).
Are faith-based or community-based organizations eligible?
Yes. The announcement states that eligible applicants can include faith-based or community-based organizations.
Are Tribal governments and Native American tribal organizations eligible?
Yes. The eligible applicants list includes tribal governments (both federally recognized and other than federally recognized) and Native American tribal organizations.
Are U.S. territories or regional organizations eligible?
Yes. The listing includes U.S. territory or possession entities and regional organizations.
Are mission-driven institutions like HBCUs and HSIs explicitly included?
Yes. The listing explicitly mentions institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities (TCCUs).
When was the opportunity posted?
The opportunity was posted on August 11, 2011.
What were the closing and archive dates shown in the record?
The record shows a current closing date of September 4, 2013 and an archive date of October 4, 2013.
Is this funding opportunity still active?
No. The record indicates it has been archived, meaning the announcement is no longer active.
Why does the record show different dates (original closing date vs. current closing date)?
The information provided notes an original closing date of September 7, 2014, while the record provided shows a current closing date of September 4, 2013 and an archive date of October 4, 2013. This indicates the listing entry reflects an archived status and includes system-specific dates for that record.
What does the creation date in the record mean?
The creation date shown is September 4, 2013, which likely reflects when the listing entry was created or updated in the system, rather than the original release date of the FOA.
Where can applicants find the official funding announcement text?
The official details are available in the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PAR-11-301.html
Who should be contacted if the NIH Grants Guide link is broken or there are access problems?
For access problems or broken links, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Is the listed contact intended for scientific or programmatic questions?
No. The provided contact is intended for technical assistance with accessing the announcement, not for scientific or programmatic questions.
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Applicants also applied for:
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|---|
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R03) Apply for PAR 11 302 Funding Number: PAR 11 302 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $50,000 |
| Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R21) Apply for PAR 11 303 Funding Number: PAR 11 303 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $150,000 |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems SBIR (R43) Apply for PAR 11 304 Funding Number: PAR 11 304 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $150,000 |
| 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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| 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 |
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