Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R01 Clinical Trial Optional) | PAR 18 215

Opportunity Information: Apply for PAR 18 215

The National Institutes of Health (NIH) funding opportunity titled "Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R01 Clinical Trial Optional)" (Funding Opportunity Number PAR-18-215) supports research projects that push drug therapy for children and for pregnant or lactating women toward safer, more effective, and more individualized care. The FOA is centered on translational and clinical research, meaning it is meant to bridge the gap between basic discoveries and real-world medical use, and it explicitly allows clinical trials but does not require them. The core scientific emphasis is on improving what clinicians and researchers know about how drugs work (mechanisms of action), how different patients respond (variability in response), and how to better predict and prevent harm (safety), especially in groups that have historically had less direct evidence to guide dosing and treatment decisions.

A major goal of this opportunity is to generate evidence that can improve the use of medications already being prescribed to pediatric and obstetric patients. That includes refining dosing approaches, understanding developmental and physiologic factors that change how drugs are absorbed, distributed, metabolized, and eliminated, and clarifying how those factors influence both benefits and side effects. In pediatrics, the FOA is aimed at addressing the reality that infants, children, and adolescents are not just "small adults"; drug handling and drug targets can shift dramatically across developmental stages, and those shifts can change both efficacy and toxicity. In obstetrics, the FOA is designed to improve medication decision-making during pregnancy and lactation, when changes in maternal physiology can alter drug exposure and when there can be unique considerations for the fetus, newborn, and breastfeeding infant. Overall, the program is intended to strengthen the scientific foundation for choosing the right drug, at the right dose, for the right patient, at the right time, in these special populations.

The scope also includes helping enable the development of new therapies, or safer and more tailored ways to use existing therapies, to meet emerging clinical needs. In practice, that can encompass research that identifies why certain subgroups of children or pregnant/lactating women respond differently, explores biomarkers or other predictors of response or adverse events, and develops strategies that support individualized or precision therapeutics. Because the FOA welcomes translational work, projects can range from mechanistic studies linked to clinical outcomes to applied clinical pharmacology research that directly informs prescribing. Since clinical trials are optional, investigators can propose anything from observational and modeling work through interventional studies, as long as the project advances understanding of drug action, response, and safety in the targeted populations.

This opportunity uses the NIH R01 mechanism, which is the standard grant program for health research projects and typically supports well-developed, hypothesis-driven studies or a cohesive body of work led by an independent investigator team. The funding instrument type is a grant, and the activity category is listed under Health, Income Security and Social Services. The CFDA numbers associated with the FOA are 93.173 and 93.865, which correspond to NIH assistance listings relevant to the participating NIH institutes and programs.

Eligibility is broad and includes many types of applicants across the public, private, nonprofit, and academic sectors. Eligible applicants listed 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; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with 501(c)(3) status as well as nonprofits without 501(c)(3) status (in both cases, other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other applicant types. The FOA also explicitly notes additional eligible applicant categories, including 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); eligible federal agencies; faith-based or community-based organizations; Indian/Native American tribal governments other than federally recognized; regional organizations; non-domestic (non-U.S.) entities (foreign organizations); and U.S. territories or possessions. This wide eligibility reflects an intent to encourage participation from diverse institutions and communities, including those that may be well-positioned to study or serve pediatric and obstetric populations.

Key administrative details from the source data include an original closing date of 2020-08-07 and a creation date of 2017-11-28. The award ceiling and expected number of awards are not specified in the provided listing, which generally means applicants would need to consult the full NIH FOA text and any institute-specific guidance for budget expectations, paylines, or anticipated award counts. In summary, PAR-18-215 is an NIH R01 opportunity aimed at producing practical, clinically relevant knowledge that improves drug therapy for children across development and for women during pregnancy and lactation, with an emphasis on mechanisms, response variability, and safety, and with the flexibility to include clinical trials when they are the best way to answer the research question.

• 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 (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): 93.173, 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.)
• 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 18 215

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