Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R01 Clinical Trial Optional) | PA 18 038

Opportunity Information: Apply for PA 18 038

The grant opportunity "Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R01 Clinical Trial Optional)" (Funding Opportunity Number PA-18-038) is a National Institutes of Health (NIH) discretionary grant that supports research aimed at improving how pain medications are used in two populations where evidence is often limited and the stakes are high: children and pregnant women. The central focus is patient safety and measurable outcomes, with an emphasis on generating data that can guide clinicians, patients, and public health decision-makers toward safer and more effective pain management strategies in real-world settings.

The FOA has two main goals. First, it seeks to stimulate a broad range of studies, including preclinical, translational, clinical, and epidemiological research, to address persistent knowledge gaps about the safety of pain medications in pediatric and pregnancy contexts. That includes questions about appropriate dosing, short- and long-term risks, differences in metabolism and drug response due to developmental stage or pregnancy-related physiological changes, and the balance between untreated pain risks versus medication-related risks. Second, the announcement prioritizes the development or improvement of instruments and approaches that can reliably assess and evaluate outcomes related to pain medication treatment in mothers and children. In practice, that means creating better tools to track meaningful endpoints such as maternal health outcomes, fetal and neonatal outcomes, childhood development, adverse events, and functional or quality-of-life impacts tied to pain treatment decisions.

Because it is an R01 mechanism, the opportunity is designed for substantial, hypothesis-driven projects that can produce robust, publishable findings and potentially shift clinical practice. The "Clinical Trial Optional" designation means applicants may propose studies that include clinical trials, but a trial is not required; strong applications could also be observational studies, comparative safety analyses using existing datasets, pharmacoepidemiology, pragmatic clinical research, or translational work that improves how outcomes are measured and interpreted. The overall activity category is listed under Health, Income Security and Social Services, and it is associated with CFDA number 93.865.

Eligibility is intentionally broad to encourage participation from many types of organizations capable of contributing to this research area. 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; 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 (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other entities. The FOA explicitly highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations. This wide net reflects the public health importance of the topic and the need for diverse settings, populations, and expertise to address it.

Key administrative details in the source information include an original closing date of January 7, 2020, and a creation date of November 3, 2017. The award ceiling and expected number of awards are not specified in the provided listing, which is common for NIH FOAs where budgets are often determined by project scope, institute priorities, and standard NIH budget justification processes rather than a single fixed cap. Overall, the opportunity is structured to produce actionable evidence about which pain medications are safest, under what circumstances, and how clinicians and researchers should measure outcomes in children and pregnancy so that future guidance rests on stronger, more precise data.

• 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 (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): 93.865.
• 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.)
• 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 PA 18 038

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