Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R21 Clinical Trial Optional) | PAR 18 214

Opportunity Information: Apply for PAR 18 214

The National Institutes of Health (NIH) funding opportunity titled "Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R21 Clinical Trial Optional)" (Funding Opportunity Number: PAR-18-214) supports early-stage, exploratory research aimed at improving how medications are used and developed for two groups that are often underrepresented in drug studies: children across different developmental stages and women during pregnancy and lactation. The main emphasis is on translational and clinically oriented work that can clarify how drugs work in these populations, why responses differ, and what drives adverse effects. Because the FOA is "clinical trial optional," applicants can propose projects that include a clinical trial, but a trial is not required if the research question can be addressed through other translational, mechanistic, or clinical approaches.

At its core, this opportunity is about building practical evidence that can lead to safer and more effective therapies for pediatric and obstetric patients. NIH is looking for studies that deepen understanding of drug action, variability in response, and safety signals in the context of development (for infants, children, and adolescents) and in the unique physiology of pregnancy and breastfeeding. The expectation is that successful projects will generate strong preliminary data, test a novel hypothesis, or open up a new line of investigation that can be expanded later into larger confirmatory studies or later-phase clinical trials. Typical "fit" for an R21 mechanism is work that is innovative and potentially high-impact but still at an earlier stage where smaller, focused support can move the science forward.

The research scope is broad as long as it aligns with pediatric or obstetric pharmacology and therapeutics. Competitive applications would generally aim to explain underlying mechanisms of drug response and toxicity (for example, developmental changes in drug metabolism or transport, pregnancy-related physiologic changes affecting exposure, or lactation-related transfer into breast milk), improve dosing and safety strategies, or support better use of existing therapies through more tailored approaches. Projects may involve translational studies bridging laboratory findings with patient-level observations, clinical pharmacology work, model-informed approaches, biomarker development, pharmacogenomic contributors to response, or carefully designed clinical studies in these special populations. The FOA also supports research that can inform the development of new therapies or improve the safety profile and real-world use of drugs that are already on the market but lack adequate evidence in children, pregnant patients, or lactating individuals.

Administratively, this is a discretionary grant under the NIH umbrella, listed under CFDA numbers 93.173 and 93.865, and uses the R21 funding instrument. The R21 mechanism is typically used for exploratory/developmental research, meaning the project should be sharply defined with clear aims that can be accomplished within a limited budget and timeframe. The source data lists an award ceiling of $200,000, indicating an upper bound on the amount available under the announcement. The opportunity was originally posted on 2017-11-28, and the source data notes an original closing date of 2020-08-07, which is important for historical reference; in practice, applicants should verify current availability, reissues, or active receipt dates if considering submission now.

Eligibility is intentionally broad to encourage participation from a wide range of institutions and communities. 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 (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other qualifying organizations. The FOA explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; regional organizations; U.S. territories or possessions; and even non-domestic (non-U.S.) entities/foreign organizations. That breadth signals NIH interest in encouraging diverse research settings and populations, which is particularly relevant when studying medication safety and effectiveness in groups where evidence gaps are common.

In practical terms, the FOA is designed to seed projects that can change clinical thinking about how to dose, monitor, and select therapies for children and for pregnant or breastfeeding patients. The strongest proposals are typically those that identify a clear clinical need, explain why current knowledge is insufficient for these populations, and outline a feasible translational plan that can produce interpretable results within an R21-sized project. The overarching theme is better, safer, more personalized pharmacotherapy for pediatric and obstetric care, supported by mechanistic insight and clinically meaningful evidence rather than extrapolation from adult, non-pregnant populations.

• 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 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.865.
• This funding opportunity was created on 2017-11-28.
• Applicants must submit their applications by 2020-08-07. (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: 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 18 214

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