Opportunity Information: Apply for PA 16 312
Apply for PA 16 312
- 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 (R21)" 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.)
- 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 (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 (R21) opportunity (Funding Opportunity Number PA-16-312) is a National Institutes of Health (NIH) discretionary grant program administered under HHS-NIH. It supports exploratory and developmental research using the NIH R21 mechanism, with the overall aim of strengthening the evidence base for how pain medications are used, how safe they are, and what outcomes they produce in two populations that are routinely underrepresented in traditional drug development and post-market evidence generation: children and pregnant women.
The FOA focuses on two closely related goals. First, it encourages a wide span of research, including preclinical, translational, clinical, and epidemiological studies, specifically targeted at filling knowledge gaps about the safe use of pain medications in pediatric patients or during pregnancy. This includes generating data that can clarify benefits and risks, dosing and exposure considerations, short- and long-term safety signals, and factors that may change how these drugs work or how adverse effects emerge in these groups. Second, the FOA emphasizes the need for better tools to measure what actually happens to mothers and children when pain medications are used, funding the development of instruments, methods, or analytic approaches that can more effectively assess, track, and evaluate maternal and child outcomes tied to pain treatment. In practice, this can include outcome measures suited to developmental stages, pregnancy-specific physiologic changes, and the complex timing of exposures and outcomes.
The program’s scope is intentionally broad in terms of study type and discipline. It allows for laboratory-based work that informs mechanisms of toxicity or altered drug response, translational efforts that bridge preclinical findings to patient-focused questions, clinical investigations that examine safety and outcomes in real-world or controlled settings, and epidemiological analyses that use population data to detect associations, risks, and patterns of use. The unifying theme is improving the quality of evidence that clinicians, patients, and policymakers can use when making decisions about pain treatment for children and pregnant women, where standard adult data often do not translate cleanly.
In addition to generating new safety and outcomes evidence, the FOA places explicit value on measurement development. That means applicants can propose creating or refining outcome assessment tools, endpoints, or methodologies that better capture relevant maternal outcomes (such as pregnancy-related complications or functional outcomes) and child outcomes (including neonatal effects, early development, longer-term neurodevelopmental or health trajectories, and other clinically meaningful endpoints). It also supports approaches that improve how outcomes are evaluated in studies where randomized trials may be difficult, such as advanced observational designs, improved exposure classification, or methods to reduce bias and confounding when using real-world data.
Eligibility is broad and includes multiple types of domestic organizations and governmental entities. Eligible applicants include state, county, and 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 institutions of higher education in those categories as specified); for-profit organizations other than small businesses; and small businesses. The listing also notes an “Others†category with reference to additional eligibility text in the full announcement, indicating NIH’s typical flexibility when justified by the program’s aims.
From an administrative standpoint, the opportunity is categorized under Health, Income Security and Social Services and is associated with CFDA numbers 93.865. The posted and creation dates are June 7, 2016, and the listed closing date for the referenced cycle is January 7, 2020. The award ceiling shown is $200,000, reflecting the program’s use of the R21 mechanism to fund focused, early-stage, or high-impact exploratory work designed to produce actionable preliminary data, validate a novel measurement approach, or establish feasibility for larger future studies.
Overall, this FOA is designed for investigators who can address concrete evidence gaps in pediatric and pregnancy-related pain pharmacotherapy, either by generating new safety and outcome data or by improving the tools and methods used to measure those outcomes. The emphasis is on practical, decision-relevant knowledge: understanding risks and benefits in these special populations and ensuring that maternal and child outcomes of pain medication treatment can be assessed in a rigorous, consistent, and clinically meaningful way.
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled The Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R21).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PA-16-312.
Which agency offers and administers this program?
This is a National Institutes of Health (NIH) discretionary grant program administered under HHS-NIH.
What type of grant mechanism does this FOA use?
This FOA uses the NIH R21 mechanism, which supports exploratory and developmental research.
What is the overall purpose of this FOA?
The overall aim is to strengthen the evidence base on how pain medications are used, how safe they are, and what outcomes they produce in two routinely underrepresented populations: children and pregnant women.
Which populations are the focus of the research?
The FOA focuses on pediatric patients (children) and pregnant women, specifically because these groups are often underrepresented in traditional drug development and post-market evidence generation.
What are the two main goals emphasized in the FOA?
The FOA emphasizes two closely related goals:
- Fill knowledge gaps about safe use of pain medications in children or during pregnancy (including benefits/risks, dosing/exposure, safety signals, and factors affecting drug response or adverse effects).
- Improve how outcomes are measured by supporting development of instruments, methods, or analytic approaches that better assess and track maternal and child outcomes related to pain treatment.
What kinds of research studies are encouraged?
The scope is broad and includes preclinical, translational, clinical, and epidemiological studies, as long as they address evidence gaps in safety and outcomes or improve outcome measurement for these populations.
Does the FOA support laboratory-based (preclinical) research?
Yes. The FOA allows for laboratory-based work that informs mechanisms of toxicity or altered drug response related to pain medications in children or pregnant women.
Does the FOA support translational research?
Yes. It supports translational efforts that bridge preclinical findings to patient-focused questions about safety and outcomes.
Does the FOA support clinical research?
Yes. It supports clinical investigations that examine safety and outcomes in real-world settings or in more controlled settings.
Does the FOA support epidemiological research using population data?
Yes. The FOA supports epidemiological analyses that use population data to detect associations, risks, and patterns of pain medication use.
What kinds of evidence gaps is this FOA trying to address?
The FOA is designed to address gaps such as:
- Clarifying benefits and risks of pain medications in children and pregnancy
- Understanding dosing and exposure considerations
- Identifying short- and long-term safety signals
- Determining factors that change drug response or how adverse effects emerge in these groups
What does the FOA mean by “measurement development�
Measurement development refers to creating or refining outcome assessment tools, endpoints, instruments, or methodologies that more effectively capture and evaluate maternal and child outcomes associated with pain medication use.
What kinds of maternal outcomes are mentioned as relevant?
Examples mentioned include pregnancy-related complications and functional outcomes tied to pain treatment.
What kinds of child outcomes are mentioned as relevant?
Examples mentioned include:
- Neonatal effects
- Early development
- Longer-term neurodevelopmental or broader health trajectories
- Other clinically meaningful endpoints
Why does the FOA emphasize developmental stage and pregnancy-specific considerations?
Because outcome measures may need to account for developmental stages, pregnancy-specific physiologic changes, and the timing of exposures and outcomes, which can be complex in pediatric and pregnancy research.
Does the FOA recognize challenges with randomized trials in these populations?
Yes. It explicitly supports approaches that improve evaluation of outcomes when randomized trials may be difficult, including advanced observational designs, improved exposure classification, and methods to reduce bias and confounding when using real-world data.
What is the unifying theme across different study types?
The unifying theme is improving evidence that clinicians, patients, and policymakers can use for decisions about pain treatment in children and pregnant women, where adult data often do not translate cleanly.
Who is eligible to apply?
Eligibility is broad and includes multiple types of domestic organizations and governmental entities, including:
- State governments
- County governments
- 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
- Other Native American tribal organizations
- Public housing authorities/Indian housing authorities
- Nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those categories as specified)
- For-profit organizations other than small businesses
- Small businesses
- Others (as referenced in additional eligibility text in the full announcement)
Is the program limited only to nonprofits or universities?
No. The eligibility list includes a wide range of entities, including governmental organizations, nonprofits, higher education institutions, for-profit organizations (other than small businesses), and small businesses.
What category is this opportunity listed under?
The opportunity is categorized under Health, Income Security and Social Services.
What CFDA number is associated with this opportunity?
The associated CFDA number is 93.865.
What is the award ceiling listed for this FOA?
The award ceiling shown is $200,000.
What does the $200,000 award ceiling reflect about the type of projects expected?
It reflects the R21 emphasis on focused, early-stage, or high-impact exploratory work, such as generating actionable preliminary data, validating a novel measurement approach, or establishing feasibility for larger future studies.
When was this FOA posted and created?
The posted and creation dates are listed as June 7, 2016.
What was the closing date listed for the referenced cycle?
The listed closing date for the referenced cycle is January 7, 2020.
What kinds of applicant projects fit this FOA best?
Projects fit best when they address concrete evidence gaps in pediatric or pregnancy-related pain pharmacotherapy by either:
- Generating new evidence on safety and outcomes of pain medication use in children or pregnant women, and/or
- Improving tools and methods used to measure maternal and child outcomes related to pain treatment
What is the practical impact this FOA aims to achieve?
The FOA emphasizes practical, decision-relevant knowledge: improving understanding of risks and benefits in these special populations and ensuring outcomes can be assessed in a rigorous, consistent, and clinically meaningful way.
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