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.Apply for PA 18 038
- 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.
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Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R01 Clinical Trial Optional)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PA-18-038.
Which agency is offering this grant?
This is a National Institutes of Health (NIH) discretionary grant opportunity.
What is the main purpose of this funding opportunity?
The purpose is to support research that improves how pain medications are used in children and pregnant women by generating stronger evidence on patient safety and measurable outcomes that can inform clinicians, patients, and public health decision-makers.
Why does this FOA focus specifically on children and pregnant women?
The FOA targets these populations because evidence about pain medication safety and outcomes is often limited, and the clinical and public health stakes can be high for mothers, fetuses, newborns, and children.
What are the two main goals of the FOA?
First, it aims to stimulate a broad range of studies (including preclinical, translational, clinical, and epidemiological research) to address knowledge gaps about the safety of pain medications in pediatric and pregnancy contexts. Second, it prioritizes developing or improving instruments and approaches to reliably assess outcomes related to pain medication treatment in mothers and children.
What kinds of research does the FOA encourage?
The FOA encourages a broad range of research, including preclinical, translational, clinical, and epidemiological studies, as well as observational studies, comparative safety analyses using existing datasets, pharmacoepidemiology, pragmatic clinical research, and work that improves how outcomes are measured and interpreted.
Are clinical trials required under this FOA?
No. The FOA is designated "Clinical Trial Optional," meaning applicants may propose studies that include clinical trials, but a clinical trial is not required.
What does "R01" mean in this context?
R01 indicates the funding mechanism is intended for substantial, hypothesis-driven research projects that can produce robust, publishable findings and potentially influence clinical practice.
What kinds of knowledge gaps is the FOA trying to address?
Examples described include appropriate dosing; short- and long-term risks; differences in metabolism and drug response due to developmental stage or pregnancy-related physiological changes; and how to balance the risks of untreated pain against medication-related risks.
What types of outcomes does the FOA emphasize measuring?
The FOA emphasizes measurable endpoints such as maternal health outcomes, fetal and neonatal outcomes, childhood development, adverse events, and functional or quality-of-life impacts related to pain treatment decisions.
What does the FOA mean by improving "instruments and approaches" for outcomes?
It refers to creating or improving tools and methods that can reliably track and evaluate outcomes associated with pain medication treatment in mothers and children, so results are more consistent, meaningful, and useful for decision-making.
Is this opportunity limited to one research method or study design?
No. The FOA explicitly seeks a broad range of studies and notes multiple possible approaches, including studies using existing datasets and pragmatic real-world research, not only traditional interventional trials.
Who is eligible to apply?
Eligibility is broad and includes: 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.
Are U.S. territories or possessions eligible to apply?
Yes. The FOA highlights eligibility for U.S. territories or possessions.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA indicates that non-U.S. (foreign) organizations are eligible.
Are tribal entities eligible?
Yes. Eligible applicants include federally recognized Native American tribal governments and tribal organizations that are not federally recognized.
Are minority-serving institutions specifically mentioned as eligible?
Yes. 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), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. The FOA explicitly highlights faith-based or community-based organizations among the eligible groups.
Are federal agencies eligible to apply?
Yes. The FOA highlights eligible federal agencies.
What is the CFDA number associated with this opportunity?
The associated CFDA number is 93.865.
What is the activity category listed for this grant?
The overall activity category is listed under Health, Income Security and Social Services.
What was the original closing date provided in the listing?
The original closing date listed is January 7, 2020.
What is the creation date for this FOA listing?
The creation date provided is November 3, 2017.
Is there a stated award ceiling?
No award ceiling is specified in the provided listing.
Is the expected number of awards provided?
No. The expected number of awards is not specified in the provided listing.
Why might award ceilings and number of awards be unspecified for an NIH FOA?
The listing notes this 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.
What kind of impact is this FOA aiming to have?
It 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 is based on stronger, more precise data.
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| Advancing the Science of Multipurpose Technology for the Prevention of HIV and Unintended Pregnancy (R43/R44) Apply for RFA HD 18 033 Funding Number: RFA HD 18 033 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
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| Advancing the Science of Multipurpose Technology for the Prevention of HIV and Unintended Pregnancy (R43/R44) Apply for RFA HD 18 102 Funding Number: RFA HD 18 102 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
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