Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R03 Clinical Trial Optional) | PA 18 044

Opportunity Information: Apply for PA 18 044

The Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R03 Clinical Trial Optional) opportunity (PA-18-044) is a National Institutes of Health (NIH) discretionary grant program designed to strengthen the evidence base around how pain medications are used, how safe they are, and what outcomes they produce in two groups that are often underrepresented in medication research: children and pregnant women. The funding announcement emphasizes both generating new scientific data and improving the tools researchers use to measure meaningful outcomes for mothers and children. In practical terms, NIH is seeking small, focused projects that can quickly address specific knowledge gaps, pilot new approaches, or produce foundational data that can support larger future studies.

The program has two main aims. First, it encourages preclinical, translational, clinical, and epidemiological research that examines pain medication use in children and/or pregnant women, with a strong focus on clarifying safety in real-world or clinically relevant contexts. This can include questions like which medications are being used, at what doses, under what circumstances, and what short- and long-term effects are observed. The goal is to reduce uncertainty in clinical decision-making for these populations, where providers must often balance the risks of undertreated pain against the potential risks of medication exposure.

Second, the FOA places special weight on developing, refining, or validating instruments and approaches that can better assess maternal and child outcomes related to pain medication treatments. This includes methods for measuring outcomes that matter clinically and developmentally, such as birth outcomes, neonatal adaptation, child growth and neurodevelopment, maternal functioning, and other health indicators that could be affected by analgesic exposure during pregnancy or by pediatric pain treatment. This part of the opportunity recognizes that progress is limited not only by missing data, but also by inconsistent or inadequate outcome measurement across studies, and it aims to improve how outcomes are evaluated so future research is more comparable and actionable.

The award mechanism is the NIH R03 (small grant), and the announcement notes that clinical trials are optional, meaning applicants may propose a study that includes a clinical trial, but it is not required. R03 grants are generally used for targeted projects with a limited scope, such as feasibility studies, secondary analyses of existing datasets, pilot testing of measurement tools, exploratory clinical or translational work, or small-scale epidemiologic investigations that can be completed efficiently and inform broader research efforts.

Key administrative details from the source information include that the opportunity is categorized under Health, Income Security and Social Services, with CFDA number 93.865. The agency is the National Institutes of Health, and the funding instrument type is a grant. The listed award ceiling is $50,000. The original closing date shown is January 7, 2020, and the creation date for the posting is November 3, 2017. (Applicants should always confirm whether an opportunity is still active or has been reissued under a newer announcement, since NIH programs are often renewed or replaced.)

Eligibility is broad and intentionally inclusive, spanning many types of organizations that can contribute to research on medication safety and outcomes. 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; Native American tribal organizations that are not federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those specific nonprofit categories); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant categories 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), eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations). This breadth reflects the reality that answering safety and outcomes questions often requires diverse partnerships, access to specialized populations, and multiple research settings.

Overall, this grant opportunity is aimed at improving the quality and consistency of evidence about pain medication exposure and effects in children and pregnant women, while also strengthening the measurement tools needed to track outcomes for mothers and children. It supports smaller, well-defined studies that can clarify safety signals, improve outcome assessment, and lay groundwork for larger, definitive research that can better guide clinicians and patients.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R03 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
• This funding opportunity was created on 2017-11-03.
• Applicants must submit their applications by 2020-01-07. (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 $50,000.00 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.

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