Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional) | PAR 20 300

Opportunity Information: Apply for PAR 20 300

The grant opportunity titled Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional), funding opportunity number PAR-20-300, is a National Institutes of Health (NIH) discretionary grant mechanism designed to strengthen the evidence base for medication and therapeutic use in pregnancy, lactation, and childhood. It supports R01-level projects, meaning it is aimed at substantial, hypothesis-driven research programs that can generate meaningful advances in knowledge and, when appropriate, move findings closer to clinical use. As indicated by the “Clinical Trial Optional” designation, applicants may propose studies that include a clinical trial, but a clinical trial is not required; strong basic and translational proposals are also within scope.

The central purpose of the FOA is to encourage basic, translational, and clinical research that improves drug safety and efficacy for pregnant women, lactating women, neonates, and children, with an emphasis on precision therapeutics. The announcement frames this goal through three major research directions: first, advancing understanding of the underlying mechanisms of drug action, which can include pharmacologic pathways, developmental pharmacology, maternal-fetal physiology, placental transfer, lactation-related exposure, age-dependent metabolism, and other biological factors that shape drug response and toxicity. Second, it encourages discovery and development of novel therapeutics, which can span early-stage target identification, preclinical development, formulation strategies appropriate for maternal or pediatric populations, and translational work that supports moving a candidate toward human study. Third, it supports research that improves the use of existing drugs, including optimizing dosing, improving safety monitoring, clarifying benefit-risk tradeoffs in under-studied populations, and drug repurposing efforts aimed at safer or more effective treatment in maternal and pediatric settings.

A key theme of the FOA is that maternal and pediatric populations are often therapeutically underserved because drug development and post-marketing evidence frequently rely on adult, non-pregnant populations, leaving gaps in dosing, safety, and effectiveness information for pregnancy, lactation, neonates, and children. This funding opportunity is intended to close those gaps by supporting research that can directly inform clinical decision-making and support precision approaches, meaning therapies and dosing strategies tailored to relevant biological and developmental factors rather than relying on one-size-fits-all extrapolations from adult data.

Eligibility for this opportunity is broad and includes many types of domestic institutions and organizations, reflecting a goal of expanding participation and encouraging diverse research environments. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); public housing authorities/Indian housing authorities; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized tribal governments; for-profit organizations other than small businesses; and small businesses. In addition, the FOA explicitly highlights other eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also lists eligible agencies of the federal government, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations), indicating that international participation is allowable when consistent with NIH policy and the goals of the announcement.

From an administrative standpoint, the opportunity is categorized under Health, Income Security and Social Services and references CFDA numbers 93.313 and 93.865, which correspond to NIH assistance listings associated with particular NIH institutes and program areas. The FOA record shows an original closing date of 2023-04-11 and a creation date of 2020-09-11. While the listing does not specify an award ceiling or the expected number of awards, the use of the R01 mechanism typically implies competitively reviewed applications with budgets and project periods justified by the proposed scope of work and aligned with NIH policies and institute-specific guidelines.

Overall, PAR-20-300 is aimed at generating actionable, high-quality evidence and therapeutic innovation for populations where medication decisions are often made with limited data. Competitive projects under this FOA would be expected to clearly connect mechanistic insights or translational findings to practical improvements in therapeutic selection, dosing, safety, or efficacy for pregnant and lactating women and for pediatric patients from the neonatal period through childhood, ultimately supporting better, more individualized care.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.313, 93.865.
• This funding opportunity was created on 2020-09-11.
• Applicants must submit their applications by 2023-04-11. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

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