Opportunity Information: Apply for PAR 17 188

The Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R03) grant opportunity (Funding Opportunity Number PAR-17-188) is a National Institutes of Health (NIH) discretionary grant designed to support small, focused projects that can quickly move the field forward in how medications are understood and used in two high-need groups: children across different stages of development and women who are pregnant or breastfeeding. The heart of the announcement is translational and clinical work, including clinical trials, that improves what clinicians and researchers know about how drugs work (mechanisms of action), how patients respond (including variability in response), and how safe medications are in these populations. The overall intent is practical and patient-centered: make currently used drugs safer and more effective for pediatric and obstetric patients, and speed progress toward new drugs or safer, better-tailored use of existing drugs to meet emerging clinical needs.

A central theme of this FOA is that children are not simply small adults, and pregnancy and lactation create physiologic conditions that can significantly change drug exposure and effects. For pediatrics, developmental stage matters because absorption, distribution, metabolism, and elimination can shift dramatically from newborns to infants, children, and adolescents. For obstetrics, pregnancy-related changes in blood volume, kidney filtration, liver enzyme activity, and placental transfer can alter both maternal drug levels and fetal exposure, while lactation raises additional questions about medication transfer into breast milk and potential effects on nursing infants. Projects supported under this announcement are meant to address these kinds of real-world gaps in evidence that often lead to off-label use, uncertain dosing, or incomplete safety profiles in clinical practice.

The FOA sits in the Health, Income Security and Social Services activity category and is associated with CFDA number 93.865. It uses the NIH R03 mechanism, which is typically structured for short-term, limited-scope studies that can generate strong preliminary data, test a targeted hypothesis, or evaluate feasibility in a way that positions a research team for larger future studies. The source data lists an award ceiling of $50,000, signaling that applications should be tightly scoped with clear, achievable aims, efficient study designs, and a direct line of sight to meaningful clinical or translational impact.

Eligibility is broad and includes many types of U.S. organizations and governments. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). That emphasis signals an interest in encouraging diverse institutional participation and broadening the settings and communities represented in pediatric and obstetric pharmacology research.

In practical terms, a competitive project under this FOA would be expected to focus on questions that can change or inform care, such as clarifying a dosing strategy for a pediatric age band, identifying biomarkers or predictors of drug response or toxicity, characterizing pharmacokinetics or pharmacodynamics in pregnancy, evaluating medication safety signals in lactation, or testing an intervention that improves how therapies are tailored for these populations. Because the announcement explicitly welcomes clinical trials, applicants can propose prospective interventional studies when justified, though the R03 scale implies that trials should be pilot in nature or otherwise limited and sharply focused. The translational emphasis also supports studies that bridge laboratory or mechanistic findings with clinical application, for example by linking developmental biology or pregnancy physiology to observed differences in drug exposure and clinical outcomes.

The opportunity was created on March 3, 2017, with an original closing date listed as July 3, 2020, in the provided source data. While the date indicates this particular listing is historical, the summary elements remain useful for understanding the purpose, scope, and the kinds of applicants and projects NIH aimed to attract: targeted, high-value studies that reduce uncertainty in medication use for children and for pregnant or breastfeeding women, ultimately improving safety, effectiveness, and individualized therapy where the evidence base has traditionally been limited.

  • 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 (R03)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
  • This funding opportunity was created on 2017-03-03.
  • Applicants must submit their applications by 2020-07-03. (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 $50,000.00 in funding.
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
Apply for PAR 17 188

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Frequently Asked Questions (FAQs)

What is the Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R03) opportunity?

This opportunity (Funding Opportunity Number PAR-17-188) is a National Institutes of Health (NIH) discretionary grant that supports small, focused research projects intended to quickly advance how medications are understood and used in two high-need patient groups: children (across developmental stages) and women who are pregnant or breastfeeding.

What is the main purpose of this FOA?

The core purpose is to generate practical, patient-centered evidence that makes currently used drugs safer and more effective for pediatric and obstetric patients, and to speed progress toward new drugs or improved, better-tailored use of existing therapies to meet emerging clinical needs.

What kinds of research does this FOA prioritize?

The announcement emphasizes translational and clinical research, including clinical trials, that improves understanding of:

  • How drugs work (mechanisms of action)
  • How patients respond, including variability in response
  • Medication safety in children and in pregnant or breastfeeding women

Does this FOA allow clinical trials?

Yes. The FOA explicitly welcomes clinical trials. However, because this uses the NIH R03 mechanism, proposed trials are expected to be limited in scope (for example, pilot or sharply focused studies) and designed to be feasible within the small, targeted nature of an R03.

Why does the FOA emphasize that children are not simply small adults?

The FOA highlights that drug absorption, distribution, metabolism, and elimination can change dramatically as children grow (from newborns to infants, children, and adolescents). These developmental differences can affect drug exposure, response, and safety, which is why age- and stage-specific evidence is often needed.

Why does pregnancy change how medications work?

Pregnancy can significantly alter drug exposure and effects due to physiologic changes such as increased blood volume, changes in kidney filtration, changes in liver enzyme activity, and placental transfer. These factors can affect maternal drug levels and fetal exposure.

How does lactation factor into medication safety and effectiveness?

Lactation introduces questions about how medications transfer into breast milk and what effects, if any, they may have on nursing infants. Projects may address these evidence gaps to improve real-world decision-making for breastfeeding patients.

What types of real-world clinical gaps is this FOA trying to address?

This FOA is designed to reduce common areas of uncertainty that can lead to off-label use, unclear dosing, or incomplete safety profiles in practice. It targets gaps in evidence about medication exposure, response, and safety in pediatric and obstetric populations.

What grant mechanism is used for this opportunity?

This FOA uses the NIH R03 mechanism, which is typically intended for short-term, limited-scope studies that can test a targeted hypothesis, evaluate feasibility, or generate strong preliminary data that positions a team for larger future studies.

What is the funding level or award ceiling indicated in the source data?

The provided source data lists an award ceiling of $50,000. This suggests applications should be tightly scoped, with clear and achievable aims, efficient study designs, and a direct line of sight to meaningful translational or clinical impact.

What is the activity category and CFDA number associated with this FOA?

The FOA is listed under the Health, Income Security and Social Services activity category and is associated with CFDA number 93.865.

Who is eligible to apply?

Eligibility is broad. The FOA includes many types of U.S. organizations and governments, including:

  • State, county, city, township, and special district governments
  • Independent school districts
  • Public and state-controlled institutions of higher education
  • Private institutions of higher education
  • Federally recognized Native American tribal governments
  • Tribal organizations that are not federally recognized
  • Public housing authorities and Indian housing authorities
  • Nonprofits with and without 501(c)(3) status (as long as they are not institutions of higher education)
  • For-profit organizations other than small businesses
  • Small businesses

Are any additional applicant categories explicitly highlighted?

Yes. The FOA explicitly highlights additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations).

Does the FOA allow applications from non-U.S. organizations?

Yes. The FOA indicates that non-U.S. entities (foreign organizations) are included among eligible applicants.

What kinds of project topics might be a good fit based on the FOA description?

Based on the description provided, examples of competitive project focuses include:

  • Clarifying dosing strategies for a defined pediatric age band
  • Identifying biomarkers or predictors of drug response or toxicity
  • Characterizing pharmacokinetics (PK) or pharmacodynamics (PD) during pregnancy
  • Evaluating medication safety signals during lactation
  • Testing an intervention that improves how therapies are tailored for pediatric or obstetric patients

What does "translational" mean in the context of this FOA?

In this FOA, translational work refers to studies that bridge mechanistic or laboratory insights with clinical application. Examples include linking developmental biology or pregnancy physiology to observed differences in drug exposure, response, and clinical outcomes.

How narrowly should a project be scoped for an R03 under this FOA?

The R03 structure and the listed award ceiling suggest a narrow, efficient project with tightly defined aims. The intent is to support studies that are achievable in the short term and that generate high-value outputs (such as preliminary data, feasibility findings, or targeted evidence) that can meaningfully inform care or justify future larger studies.

When was this opportunity created, and what is the closing date in the provided data?

The opportunity was created on March 3, 2017. The provided source data lists an original closing date of July 3, 2020.

Is this FOA still open based on the dates provided?

The source data indicates a closing date of July 3, 2020, which suggests this particular listing is historical. The description remains useful for understanding the intended purpose, scope, eligible applicants, and the types of projects NIH aimed to support under this announcement.

What is the overall intended impact of projects funded through this FOA?

The intended impact is to reduce uncertainty and improve individualized therapy in pediatric and obstetric care by strengthening evidence on drug action, variability in response, and safety. Ultimately, the goal is safer and more effective medication use for children and for pregnant or breastfeeding women.

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Apply for PAR 17 188

 

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