Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R21 Clinical Trial Optional) | PA 18 043

Opportunity Information: Apply for PA 18 043

The Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R21 Clinical Trial Optional) grant opportunity (PA-18-043) is a National Institutes of Health (NIH) discretionary grant designed to strengthen the evidence base around how pain medications are used, how safe they are, and what outcomes they produce in two populations that are often underrepresented in research: children and pregnant women. The FOA focuses on addressing real-world knowledge gaps that make it difficult for clinicians and patients to weigh benefits and risks when treating pain during pregnancy or across pediatric age ranges. In addition to generating new biomedical and public health evidence, the announcement places strong emphasis on improving how outcomes are measured, encouraging the creation or refinement of tools that can better capture both maternal and child impacts of pain treatment.

The scientific scope is intentionally broad, supporting preclinical, translational, clinical, and epidemiological studies. That means projects could range from mechanistic or animal-model work that clarifies how specific analgesics might affect development, to translational studies that connect biological signals with clinical outcomes, to patient-focused clinical research, and to large-scale observational or database studies that examine prescribing patterns, safety signals, comparative risks, and longer-term outcomes. A key theme is the evaluation of pain medications as they are actually used in practice, including potential short- and long-term consequences for pregnant individuals and their offspring, as well as for children receiving these drugs at different developmental stages. Because the FOA is labeled "Clinical Trial Optional," applicants may propose studies that include a clinical trial if appropriate, but a trial is not required; well-justified non-trial clinical research and epidemiology are clearly within the intended scope.

A second major priority is measurement development: creating, validating, or improving instruments and approaches to assess outcomes of pain medication treatment in pregnancy and childhood. This could include tools for tracking maternal outcomes (such as obstetric complications, functional status, mental health, pain control, or medication-related adverse events) and child outcomes (such as neonatal adaptation, growth, neurodevelopment, behavioral outcomes, or other developmental endpoints). The goal is not only to study safety and effectiveness, but also to make outcome measurement more reliable, sensitive, and clinically meaningful so future studies and clinical decision-making can be better informed.

The award mechanism is the NIH R21, which is typically used for exploratory and developmental projects that can generate early, high-value data, establish feasibility, or produce proof-of-concept findings that lead to larger studies. The listed award ceiling is $200,000, reflecting a small-to-midsize research budget appropriate for pilot work, targeted analyses, methodological development, or focused clinical or translational studies. The FOA falls under the Health, Income Security and Social Services activity category and is associated with CFDA number 93.865. The original closing date shown in the source data is January 7, 2020, and the opportunity was created on November 3, 2017, which indicates that applicants would need to verify whether the announcement remains active, has been reissued, or has updated receipt dates through NIH and Grants.gov.

Eligibility is expansive and includes many organization types across the public, private, nonprofit, and academic sectors. Eligible applicants include state, county, city or 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other categories. The FOA explicitly highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, regional organizations, and non-U.S. entities (foreign organizations). This broad eligibility signals an intent to draw on diverse research settings and populations, including community-based contexts and geographically or culturally specific health systems.

Overall, this opportunity is aimed at producing practical, decision-relevant evidence about pain medication exposure and outcomes in pregnancy and pediatrics, while simultaneously improving the measurement infrastructure needed to evaluate maternal and child effects. Competitive applications would typically be expected to clearly define the pain medication(s) or classes of interest, articulate the specific knowledge gap being addressed, justify the study design for these special populations, and explain how outcomes will be assessed in ways that are rigorous and meaningful for both clinical care and public health.

• 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 (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): 93.865.
• 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 $200,000.00 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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