Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R21 Clinical Trial Optional) | PAR 23 131

Opportunity Information: Apply for PAR 23 131

The National Institutes of Health (NIH) funding opportunity PAR 23-131, titled "Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R21 Clinical Trial Optional)," supports early-stage, exploratory research aimed at improving how medications are developed, evaluated, and used in pregnant people, lactating people, and children. The FOA is centered on translational work, meaning projects should be positioned to move discoveries toward practical clinical or public health impact, even if they are still in a proof-of-concept phase. Clinical trials are allowed but not required, which gives applicants flexibility to propose studies that range from preclinical translational research to human studies, as long as the work is tightly aligned with maternal and pediatric pharmacology and therapeutics.

The program is designed around three main scientific priorities. First, it seeks to advance precision medicine for pregnancy, lactation, and pediatrics by encouraging development of new tools, models, and technologies that can directly improve clinical decision-making or health outcomes. In practice, this can include innovative approaches to predicting drug exposure and response, better ways to measure relevant biomarkers, improved modeling of maternal-fetal or maternal-infant drug transfer, and technologies that help tailor dosing to an individual’s physiology. Second, the FOA emphasizes mechanistic understanding of drug action in these populations, including how normal development (pediatric ontogeny) changes drug absorption, distribution, metabolism, and elimination, as well as how pregnancy and lactation introduce dynamic physiological changes that can alter drug behavior and therapeutic response. Third, the FOA encourages discovery and development of new therapeutics, and also places clear value on improving the use of existing drugs, including drug repurposing, with the goal of making medication use safer and more effective for pregnant and lactating people, fetuses, neonates, and children.

A key theme running through the announcement is that these populations are often understudied in drug development and clinical pharmacology, despite having unique and rapidly changing biology. By supporting projects that generate actionable evidence, the FOA aims to close gaps that affect dosing, safety, efficacy, and real-world therapeutic outcomes. The scope explicitly includes fetuses, neonates, and children across developmental stages, and it also notes inclusion of individuals with disabilities, signaling interest in research that improves precision therapeutics across a broad range of patient needs and circumstances.

This opportunity uses the NIH R21 mechanism, which is generally intended for exploratory, high-impact, and potentially higher-risk projects that can open new directions or provide strong preliminary data for later, larger studies. The listed award ceiling is $225,000. The opportunity category is discretionary, the funding instrument is a grant, and the activity categories span education, health, income security, and social services, reflecting the broad NIH mission and the downstream societal impact of better therapeutics in maternal and pediatric care.

Eligibility is broad and includes many types of U.S. organizations and several non-U.S. entities. Eligible applicants include state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as stated); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant types 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), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and foreign (non-U.S.) organizations and regional organizations. This wide eligibility is consistent with the translational focus and the need for multidisciplinary teams, clinical networks, and community partnerships to address medication challenges in pregnancy, lactation, and childhood.

The original closing date listed for the FOA is 2026-05-07, and the opportunity was created on 2023-03-01. The CFDA numbers associated with the announcement are 93.279, 93.313, 93.855, and 93.865, indicating alignment with NIH programs that support pharmacology, therapeutics, and related biomedical research areas. Overall, PAR 23-131 is aimed at accelerating better, more individualized, and safer medication strategies for maternal and pediatric populations by funding translational approaches that produce clinically meaningful tools, mechanistic insight, and therapeutic advances.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Translational Research in Maternal and Pediatric 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): 93.279, 93.313, 93.855, 93.865.
• This funding opportunity was created on 2023-03-01.
• Applicants must submit their applications by 2026-05-07. (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 $225,000.00 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 23 131

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