Opportunity Information: Apply for PAR 13 311
Apply for PAR 13 311
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Aug 5, 2013 and posted on Aug 5, 2013.
- Applicants must submit their applications by Aug 16, 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 $200,000.00 in funding.
- Eligible applicants include: Small businesses County governments Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Native American tribal governments (Federally recognized) Special district governments Public and State controlled institutions of higher education City or township governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The grant opportunity titled Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R21) (Funding Opportunity Number PAR 13 311) is a National Institutes of Health (NIH) discretionary grant program aimed at supporting early-stage, exploratory research that can directly move discoveries toward practical improvements in medication use for two populations that are often underrepresented in drug development and clinical research: children across different developmental stages and pregnant women, including the developing fetus. The FOA emphasizes translational and clinical work, including clinical trials, that helps explain how drugs work, why responses vary between individuals, and what drives safety concerns in these groups. The central idea is to generate actionable evidence that can improve dosing, reduce adverse effects, and guide safer and more effective therapeutic strategies tailored to pediatric and obstetric patients.
A key focus of the FOA is understanding the underlying mechanisms that shape drug action, response, and safety. In practical terms, that means research that can clarify how physiology changes across childhood development or during pregnancy affect pharmacokinetics and pharmacodynamics, how these changes translate into different clinical responses, and how risks to the mother and fetus can be identified and mitigated. The opportunity also supports research intended to improve the use of existing medications, such as optimizing dosing, identifying biomarkers or predictors of response or toxicity, refining therapeutic monitoring approaches, or developing strategies that make currently available drugs safer in real-world pediatric or obstetric care. In addition, it encourages work that can help enable the development of new therapies or new ways to apply existing therapies to meet emerging clinical needs in these special populations.
This FOA uses the R21 activity code, which typically supports exploratory, high-impact projects that may be at an earlier stage of development than larger, more definitive studies. The listed award ceiling for this opportunity is $200,000, and there is no cost sharing or matching requirement, which can make it more feasible for a wide range of institutions to propose innovative pilot studies, mechanistic translational projects, or carefully designed clinical investigations that generate foundational data for later, larger trials or follow-on funding. The activity category is Health, and the associated CFDA number is 93.865 (Child Health and Human Development Extramural Research), reflecting its alignment with NIH priorities around maternal and child health research.
Eligibility is broad and includes many types of applicants across the public, private, nonprofit, and academic sectors. Eligible applicants include small businesses and other for-profit organizations, nonprofits (including those with or without 501(c)(3) status), private and public institutions of higher education, and a variety of government entities such as state governments, county governments, city or township governments, special district governments, independent school districts, and public housing authorities or Indian housing authorities. The FOA also explicitly includes a wide set of mission- and community-focused institutions and organizations, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, and eligible federal agencies. Importantly, the opportunity allows participation from non-U.S. entities as well: foreign organizations and foreign institutions are eligible to apply, non-U.S. components of U.S. organizations are eligible, and foreign components (as defined in the NIH Grants Policy Statement) are allowed. Tribal governments are included as eligible applicants, both federally recognized tribal governments and other tribal organizations.
From an administrative standpoint, the FOA was posted and created on August 5, 2013. The original and current closing date listed is August 16, 2016, with an archive date of September 16, 2016, meaning the opportunity is historically documented and no longer active for new submissions under those dates. The sponsoring agency is the National Institutes of Health, and the full announcement was made available through the NIH Grants Guide at the link provided: http://grants.nih.gov/grants/guide/pa-files/PAR-13-311.html (spacing in the source appears inconsistent, but the standard NIH format uses hyphens in the FOA number). For access or technical issues related to the electronic announcement, the contact provided is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Overall, this FOA is designed to catalyze translational and clinical research that addresses real gaps in evidence about medication use in pediatric and pregnant populations, with the practical goal of improving safety, optimizing effectiveness, and enabling more tailored therapies. It prioritizes work that connects mechanistic understanding to clinical decision-making, including studies and trials that can inform better dosing, better risk prediction, and better therapeutic strategies for children at different developmental stages and for pregnant women and the fetus.
Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R21).
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR-13-311 (often written with hyphens in NIH format).
Which federal agency sponsors this program?
The sponsoring agency is the National Institutes of Health (NIH).
What type of grant mechanism is used?
This FOA uses the R21 activity code, which is typically intended for early-stage, exploratory, potentially high-impact research, including pilot studies and projects that generate foundational data for later work.
What is the main purpose of this FOA?
The purpose is to support translational and clinical research (including clinical trials) that moves discoveries toward practical improvements in medication use for two underrepresented populations in drug development and clinical research: children across developmental stages and pregnant women (including the developing fetus).
What kinds of populations does the FOA focus on?
The FOA focuses on (1) pediatric patients across different developmental stages and (2) pregnant women, including consideration of maternal and fetal safety and outcomes.
What research areas are emphasized?
The FOA emphasizes translational and clinical work that helps explain:
- How drugs work in pediatric and obstetric populations
- Why responses vary between individuals
- What drives safety concerns for children, pregnant women, and the fetus
Are clinical trials allowed under this opportunity?
Yes. The FOA explicitly includes clinical work, including clinical trials, as part of its scope.
What is meant by "translational" research in this FOA?
Based on the FOA description, translational research refers to work that connects mechanistic understanding (how physiology and biology affect drug behavior and response) to clinical decision-making and real-world improvements such as dosing, monitoring, safety, and therapeutic strategy.
What scientific topics are specifically highlighted?
Key highlighted topics include understanding mechanisms that shape:
- Pharmacokinetics (PK) and pharmacodynamics (PD) in children and during pregnancy
- How physiologic changes across development or during pregnancy influence drug action
- How these changes translate into different clinical responses
- How maternal and fetal risks can be identified and mitigated
Does the FOA support research to improve how existing medications are used?
Yes. The FOA supports research intended to improve the use of existing medications, such as:
- Optimizing dosing
- Identifying biomarkers or predictors of response or toxicity
- Refining therapeutic monitoring approaches
- Developing strategies to make currently available drugs safer in real-world care
Does the FOA also encourage work related to new therapies?
Yes. It encourages research that can help enable the development of new therapies or new ways to apply existing therapies to meet emerging clinical needs in pediatric and obstetric populations.
What is the practical outcome this FOA is trying to achieve?
The FOA aims to generate actionable evidence that can improve:
- Dosing for children and pregnant patients
- Safety by reducing adverse effects
- Risk prediction and mitigation for mother and fetus
- Tailored therapeutic strategies specific to developmental stage and pregnancy
What is the award ceiling for this opportunity?
The listed award ceiling is $200,000.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
What is the activity category associated with this opportunity?
The activity category is Health.
What is the CFDA number for this program?
The associated CFDA number is 93.865, listed as Child Health and Human Development Extramural Research.
Who is eligible to apply?
Eligibility is broad and includes applicants from the public, private, nonprofit, and academic sectors. Eligible applicants include:
- Small businesses and other for-profit organizations
- Nonprofits (including those with or without 501(c)(3) status)
- Private and public institutions of higher education
- Government entities such as state, county, and city/township governments
- Special district governments, independent school districts, and public housing authorities (including Indian housing authorities)
- Tribal governments (federally recognized) and other tribal organizations
- Other eligible entities noted in the FOA, including eligible federal agencies
Are minority-serving and community-based institutions included as eligible applicants?
Yes. The FOA explicitly includes a wide set of mission- and community-focused institutions and organizations, including:
- Historically Black Colleges and Universities (HBCUs)
- Hispanic-serving institutions
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
- Faith-based or community-based organizations
Can foreign organizations apply?
Yes. The FOA states that foreign organizations and foreign institutions are eligible. It also allows non-U.S. components of U.S. organizations to apply and permits foreign components as defined by the NIH Grants Policy Statement.
When was this FOA posted?
The FOA was posted/created on August 5, 2013.
What was the closing date for this FOA?
The listed closing date is August 16, 2016.
Is this funding opportunity still active?
No. The opportunity is historically documented with an archive date of September 16, 2016, indicating it is no longer active for new submissions under those dates.
Where can the full FOA announcement be found?
The full announcement is available through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-311.html
Who is the contact for technical issues related to the electronic announcement?
The contact listed for access or technical issues is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
What kinds of projects are a good fit for the R21 approach described here?
Based on the FOA description, a good fit includes exploratory, early-stage translational or clinical projects that aim to produce actionable evidence for pediatric and obstetric medication use, such as mechanistic studies tied to clinical questions, pilot clinical investigations, or carefully designed clinical trials aligned with the FOA goals.
What is the overarching theme of the FOA?
The overarching theme is improving medication use for children and pregnant patients by linking mechanistic insights to real-world clinical decisions, with the aim of improving safety, effectiveness, and individualized therapy.
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Previous opportunity: Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R03)
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| Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R01) Apply for PAR 13 325 Funding Number: PAR 13 325 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R21) Apply for PAR 13 326 Funding Number: PAR 13 326 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R03) Apply for PAR 13 344 Funding Number: PAR 13 344 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $50,000 |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R43) Apply for PAR 13 345 Funding Number: PAR 13 345 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 13 346 Funding Number: PAR 13 346 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| 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 |
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| 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 |
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| 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 |
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