Opportunity Information: Apply for PA 16 311
Apply for PA 16 311
- The HHS-NIH11 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)" 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 Jun 07, 2016 and posted on Jun 07, 2016.
- Applicants must submit their applications by Jan 07, 2020. (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 (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R01) funding opportunity (PA-16-311) is a National Institutes of Health (NIH) research grant announcement intended to improve what is known about the safety and real-world outcomes of pain medication use in two populations that are routinely underrepresented in medication research: children and pregnant women. The central goal is to support rigorous studies that close critical evidence gaps about how pain medicines affect mothers, fetuses, infants, and children, and to strengthen the tools researchers and clinicians use to measure those effects. In practice, the program is looking for projects that can produce clearer guidance on benefits versus risks, appropriate dosing and exposure considerations, and short- and long-term outcomes associated with pain treatments in these special populations.
This opportunity emphasizes a broad research pipeline. It encourages preclinical studies (such as mechanistic work and developmental toxicology concepts where appropriate), translational research that bridges laboratory findings to clinical questions, clinical research in relevant patient populations, and epidemiological studies that can use existing data sources or prospectively collected information to detect safety signals and characterize outcomes. A key theme is that many pain medications are used in pediatric care and during pregnancy despite limited definitive evidence on safety, optimal use, or downstream developmental and maternal effects. The FOA is positioned to support studies that address those gaps with methods that fit the question, whether that means controlled clinical investigations, comparative effectiveness approaches, pragmatic designs, pregnancy exposure registries, database studies, or carefully designed observational cohorts.
A second major focus is measurement development: creating or improving instruments, approaches, and analytic methods to assess and evaluate maternal and child outcomes of pain medication treatments. That can include developing validated outcome measures, standardizing definitions and endpoints, improving how exposure is captured (dose, timing, duration, trimester-specific exposure, concomitant medications), and building approaches for tracking clinically meaningful outcomes over time. Examples of outcomes of interest implied by the scope include maternal outcomes (pain control, function, adverse drug reactions, complications related to pregnancy or delivery) and child outcomes (birth outcomes, neonatal adaptation, neurodevelopmental trajectories, growth, and other longer-term health indicators). The emphasis on instruments and approaches reflects a recognition that even when data exist, inconsistent measurement can limit what can be concluded; better measurement can make studies more comparable and findings more actionable.
The funding mechanism is an R01 research project grant, which is NIH's standard mechanism for investigator-initiated, hypothesis-driven research. The opportunity is categorized as discretionary federal assistance and falls under the Health, Income Security and Social Services activity category, with CFDA numbers 93.865 listed. The sponsoring agency is within the U.S. Department of Health and Human Services, National Institutes of Health (HHS-NIH). The announcement was posted on June 7, 2016, and the listed closing date for the referenced cycle is January 7, 2020.
Eligibility is broad and includes many types of U.S.-based organizations that commonly apply to NIH: 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those categories as specified); for-profit organizations other than small businesses; and small businesses. The announcement also notes an "Others" category with additional eligibility clarification referenced in the full text, signaling that NIH may allow additional applicant types depending on specifics.
Overall, this FOA supports research that can directly inform safer, more evidence-based pain management for children and pregnant women by (1) generating stronger scientific evidence on safety and outcomes across preclinical to population-level research and (2) improving the practical measurement tools needed to evaluate maternal and pediatric outcomes consistently and credibly.
Frequently Asked Questions (FAQs)
What is the name of this NIH funding opportunity?
The opportunity is titled "The Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R01)" and is identified as PA-16-311.
What is the main goal of PA-16-311?
The central goal is to improve what is known about the safety and real-world outcomes of pain medication use in two groups that are often underrepresented in medication research: children and pregnant women. The program aims to support rigorous studies that close critical evidence gaps about how pain medicines affect mothers, fetuses, infants, and children, and to strengthen the tools used to measure those effects.
Which populations are specifically prioritized by this FOA?
This FOA prioritizes research focused on children and pregnant women, including outcomes relevant to mothers, fetuses, infants, and children.
What kinds of research does this FOA encourage?
The FOA emphasizes a broad research pipeline and encourages preclinical studies, translational research, clinical research in relevant patient populations, and epidemiological studies. It also supports projects designed to detect safety signals and characterize outcomes using existing data sources or prospectively collected data.
Does the FOA support both preclinical and human research?
Yes. The scope explicitly encourages preclinical work (including mechanistic and developmental toxicology concepts where appropriate), translational research that bridges lab findings to clinical questions, clinical research, and population-level epidemiological studies.
What types of study designs are mentioned as fitting the program scope?
Examples of approaches described as fitting the question include controlled clinical investigations, comparative effectiveness approaches, pragmatic designs, pregnancy exposure registries, database studies, and carefully designed observational cohorts.
What problem or gap is this funding opportunity trying to address?
A key theme is that many pain medications are used in pediatric care and during pregnancy despite limited definitive evidence on safety, optimal use, dosing and exposure considerations, or downstream developmental and maternal effects. This FOA is positioned to support research that addresses those evidence gaps.
What does the FOA mean by "real-world outcomes"?
Based on the description, "real-world outcomes" refers to outcomes observed in practical clinical use and population settings, including short- and long-term maternal and child outcomes associated with pain treatments, as characterized through clinical studies, observational cohorts, registries, and epidemiological/database analyses.
What is meant by improving guidance on benefits versus risks?
The FOA is looking for projects that can produce clearer guidance on how to weigh benefits and risks of pain medications for children and pregnant women, including appropriate dosing and exposure considerations and both short- and long-term outcomes.
Is measurement development part of the program?
Yes. A major focus is measurement development, including creating or improving instruments, approaches, and analytic methods to assess and evaluate maternal and child outcomes of pain medication treatments.
What kinds of measurement improvements are included in scope?
The FOA highlights developing validated outcome measures, standardizing definitions and endpoints, improving how exposure is captured (such as dose, timing, duration, trimester-specific exposure, and concomitant medications), and building approaches for tracking clinically meaningful outcomes over time.
What maternal outcomes are implied to be of interest?
Examples implied by the scope include maternal outcomes such as pain control, function, adverse drug reactions, and complications related to pregnancy or delivery.
What child outcomes are implied to be of interest?
Examples implied by the scope include birth outcomes, neonatal adaptation, neurodevelopmental trajectories, growth, and other longer-term health indicators.
Why does the FOA emphasize standardizing definitions and endpoints?
The description notes that even when data exist, inconsistent measurement can limit what can be concluded. Better measurement can make studies more comparable across settings and make findings more actionable for research and clinical decision-making.
What is the funding mechanism for this opportunity?
This opportunity uses the NIH R01 research project grant mechanism, described as NIH's standard mechanism for investigator-initiated, hypothesis-driven research.
Which federal agency sponsors this funding opportunity?
The sponsoring agency is within the U.S. Department of Health and Human Services, National Institutes of Health (HHS-NIH).
How is this opportunity categorized in federal assistance terms?
It is categorized as discretionary federal assistance and falls under the Health, Income Security and Social Services activity category.
What CFDA number is associated with this opportunity?
The CFDA number listed is 93.865.
When was this announcement posted?
The announcement was posted on June 7, 2016.
What is the listed closing date for the referenced cycle?
The listed closing date for the referenced cycle is January 7, 2020.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organization types commonly eligible for NIH grants, including 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those categories as specified); for-profit organizations other than small businesses; and small businesses.
Does the FOA mention any additional eligibility category beyond the listed organization types?
Yes. The announcement notes an "Others" category with additional eligibility clarification referenced in the full text, indicating NIH may allow additional applicant types depending on specifics.
Is this program limited to one discipline or research stage?
No. The program description emphasizes a broad pipeline from preclinical and translational research through clinical and epidemiological studies, along with measurement development work.
What is the overall intended impact of projects funded under this FOA?
The FOA is intended to support research that can directly inform safer, more evidence-based pain management for children and pregnant women by generating stronger evidence on safety and outcomes and improving the measurement tools needed to evaluate maternal and pediatric outcomes consistently and credibly.
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