Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional) | PAR 23 130

Frequently Asked Questions (FAQs)

What is the official title and funding opportunity number for this NIH grant?

The opportunity is titled "Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (Clinical Trial Optional)" and the funding opportunity number is PAR-23-130. The grant mechanism is an NIH R01.

What type of grant mechanism is this, and what does that imply for the project?

This is an R01 research project grant. Based on the information provided, the expectation is that applicants propose a well-developed, hypothesis-driven program of research capable of producing meaningful advances, rather than only early-stage exploratory work.

What is the overall purpose of PAR-23-130?

The program supports translational and clinical research to improve how medications are developed, evaluated, and used in pregnant persons, lactating persons, fetuses, neonates, and children. A central goal is to make drug therapy safer, more effective, and more individualized for these populations.

Which patient populations are specifically emphasized in this funding opportunity?

The FOA emphasizes pregnant persons, lactating persons, fetuses, neonates, and children (from newborns through adolescence). It also highlights the importance of accounting for childhood development and includes an emphasis on children with disabilities in the context of precision therapeutics.

Is the focus purely clinical, or can it include translational and mechanistic work?

The scope is described as translational and clinically oriented, meaning the work should connect mechanistic insights and model development to real-world therapeutic decisions and outcomes. The FOA also supports non-trial translational work such as model development, validation studies, and mechanistic investigations.

Are clinical trials required under this FOA?

No. Clinical trials are optional. Applicants may propose studies involving human participants and interventional designs when scientifically justified, but the FOA also supports projects that are not structured as clinical trials.

What is meant by "precision therapeutics" in the context of this opportunity?

Precision therapeutics here refers to moving beyond one-size-fits-all dosing and treatment decisions by generating evidence, tools, and technologies that better account for the unique biology of pregnancy, lactation, and childhood development. The aim is to better predict drug exposure and response so therapy can be safer, more effective, and more individualized.

What are the major scientific aims highlighted in the FOA?

The FOA highlights three broad aims: (1) advancing precision medicine by developing or improving tools, models, and enabling technologies that can directly influence clinical care or health outcomes; (2) deepening understanding of drug action mechanisms in the context of pediatric ontogeny and the changing physiology of pregnancy and lactation; and (3) discovering and developing novel therapeutics and improving the use of existing drugs (including repurposing) to achieve safer and more effective medication options for maternal and pediatric populations.

What kinds of tools, models, or enabling technologies does the FOA suggest are relevant?

Examples described include new experimental or computational models, novel biomarkers, innovative sampling strategies, improved pharmacometric approaches, and other technologies that help clinicians predict drug exposure and response more accurately in pregnancy or across pediatric age ranges.

What does the FOA mean by pediatric ontogeny, and why does it matter here?

Pediatric ontogeny refers to how maturation affects drug absorption, distribution, metabolism, and elimination across development. The FOA encourages studies that clarify how these developmental changes influence drug behavior and how that should inform dosing, safety monitoring, or therapeutic targets in pediatric patients.

How does the FOA frame the role of pregnancy and lactation physiology in drug research?

The FOA emphasizes that pregnancy and lactation involve rapidly changing physiology that can alter how drugs behave. It encourages research that explains differences in drug behavior across stages (for example, early versus late pregnancy) and translates those insights into dosing and safety decisions.

Does the opportunity support repurposing existing drugs?

Yes. The FOA explicitly includes efforts to improve the use of existing drugs, including repurposing, with the goal of achieving safer and more effective medication options for pregnant and lactating persons and pediatric populations.

What is the program trying to improve in real-world care?

Based on the description, the program prioritizes closing evidence gaps that affect medication use in maternal and pediatric populations, including better dosing, improved safety profiles, clearer mechanistic understanding of variability in drug response, and more reliable individualized therapeutic strategies.

Who is eligible to apply (in general terms)?

Eligibility is broad. It includes many organization types commonly eligible for NIH grants, including government entities, higher education institutions (public and private), nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), and other entities listed in the FOA.

Are state, county, or local government entities eligible applicants?

Yes. The eligible applicants listed include state governments, county governments, local governments, and special district governments.

Are colleges and universities eligible to apply?

Yes. Eligible applicants include public and state-controlled institutions of higher education as well as private institutions of higher education. The FOA also calls out multiple categories of minority-serving and tribally controlled institutions as eligible.

Can nonprofit organizations apply even if they do not have 501(c)(3) status?

Yes. The eligibility information states that nonprofit organizations are eligible whether or not they have 501(c)(3) status.

Are for-profit organizations and small businesses eligible?

Yes. For-profit organizations (other than small businesses) and small businesses are both included in the eligible applicant list.

Are tribal governments and tribal organizations eligible?

Yes. The eligibility list includes federally recognized Native American tribal governments and Native American tribal organizations that are not federally recognized tribal governments. It also mentions tribal governments other than federally recognized tribes.

Can non-U.S. (foreign) organizations apply?

Yes. The FOA explicitly lists non-U.S. entities (foreign organizations) as eligible applicants based on the information provided.

Are U.S. territories or possessions eligible to apply?

Yes. U.S. territories or possessions are included among the explicitly listed eligible applicants.

Are faith-based or community-based organizations eligible?

Yes. The eligibility list explicitly includes faith-based or community-based organizations.

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are included in the eligibility list provided.

What activity category is associated with this opportunity?

The opportunity is described as a discretionary grant program in the Health, Income Security and Social Services activity category.

Which CFDA numbers are associated with this grant opportunity?

The opportunity is associated with multiple CFDA numbers: 93.242, 93.313, 93.855, and 93.865.

When was this opportunity created, and what is the listed closing date?

The opportunity was created on March 1, 2023. The listed original closing date is May 7, 2026, indicating a multi-year window for submissions aligned with NIH submission cycles and FOA instructions.

Is there a stated award ceiling or a specified expected number of awards?

No. The provided information states that the award ceiling and expected number of awards are not specified, which is noted as common for NIH FOAs where budgets are guided by project scope, institute policies, and standard R01 expectations rather than a single fixed cap.

Does the FOA prioritize projects that directly influence clinical care?

Yes. A stated emphasis is on creating or improving tools, models, and enabling technologies that can directly influence clinical care or health outcomes, and on connecting translational findings to therapeutic decisions and outcomes.

What kinds of research questions does the FOA encourage about differences across life stages?

The FOA encourages research clarifying why a drug may behave differently in a fetus versus a neonate, or in early pregnancy versus late pregnancy, and how those differences should translate into dosing strategies, safety monitoring, or therapeutic targets.