Opportunity Information: Apply for PA 16 313

  • 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 (R03)" 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 $50,000.00 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 (R03) funding opportunity (PA-16-313) is a National Institutes of Health (NIH) discretionary grant program under the U.S. Department of Health and Human Services (HHS). It supports small, targeted research projects focused on improving what is known about the safety of pain medications when used by two populations that are often underrepresented in research: children and pregnant women. The core intent is to generate practical evidence that can close key knowledge gaps about benefits, risks, and real-world outcomes associated with pain medication exposure in these groups, where typical adult-focused data may not translate well.

The FOA emphasizes research across the full spectrum of biomedical and population science, including preclinical, translational, clinical, and epidemiological studies. Projects are expected to address unanswered questions about safe use, such as dosing considerations, developmental or pregnancy-related physiology that affects drug response, short- and long-term adverse effects, and differences in outcomes based on timing of exposure (for example, by trimester in pregnancy or by developmental stage in childhood). The program is also explicitly interested in work that strengthens the ability to measure outcomes by developing or refining instruments, tools, or approaches that can better capture and evaluate maternal and child results of pain medication treatments. In practice, that can include improved outcome measures, validated assessment tools, better data collection strategies, or analytic approaches that help clarify causal links between medication exposure and health outcomes.

This opportunity uses the NIH R03 mechanism, which is designed for smaller-scale, short-duration studies, pilots, secondary analyses, feasibility projects, or discrete method-development efforts that can be completed with limited resources. The listed award ceiling is $50,000, reinforcing that the program is geared toward focused projects that can produce actionable findings or lay the groundwork for larger follow-on research rather than large multi-site trials.

Eligible applicants are broad and include many types of organizations that conduct health research or support research infrastructure. This includes state, county, city, 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 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 nonprofit categories as specified); for-profit organizations other than small businesses; small businesses; and other applicants as allowed under the NIH eligibility guidance referenced in the FOA.

Administrative details from the source indicate the FOA was created and posted on June 7, 2016, with a closing date of January 7, 2020. The activity falls under the Health, Income Security and Social Services category and references CFDA numbers 93.865. Overall, the opportunity is aimed at producing clearer safety evidence and better outcome measurement methods for pain medication use in children and pregnant women, with the broader goal of improving clinical decision-making and protecting maternal and child health.

Frequently Asked Questions (FAQs)

What is the title and number of this funding opportunity?

The opportunity is titled "The Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R03)" and is identified as PA-16-313.

Which federal agency is offering this grant?

This is a National Institutes of Health (NIH) discretionary grant program under the U.S. Department of Health and Human Services (HHS).

What is the main purpose of this FOA?

The main purpose is to support small, targeted research projects that improve what is known about the safety of pain medications when used by children and pregnant women, two populations that are often underrepresented in research.

Why does the FOA focus on children and pregnant women?

The FOA emphasizes these groups because typical adult-focused data may not translate well to children or to pregnancy, and there are key knowledge gaps about benefits, risks, and real-world outcomes for pain medication exposure in these populations.

What types of research are encouraged under this opportunity?

The FOA emphasizes research across the full spectrum of biomedical and population science, including preclinical, translational, clinical, and epidemiological studies.

What kinds of questions or topics should projects address?

Projects are expected to address unanswered questions about safe use of pain medications, such as dosing considerations, developmental or pregnancy-related physiology that affects drug response, short- and long-term adverse effects, and differences in outcomes based on timing of exposure (for example, by trimester in pregnancy or by developmental stage in childhood).

Does the FOA support work on measuring outcomes, not just studying medications?

Yes. The program is explicitly interested in strengthening the ability to measure outcomes by developing or refining instruments, tools, or approaches that better capture and evaluate maternal and child results of pain medication treatments.

What are examples of outcome-measurement work that fit this FOA?

Examples mentioned include improved outcome measures, validated assessment tools, better data collection strategies, and analytic approaches that help clarify causal links between medication exposure and health outcomes.

What grant mechanism does this opportunity use?

This opportunity uses the NIH R03 mechanism.

What does the R03 mechanism imply about the size and scope of projects?

The R03 mechanism is designed for smaller-scale, short-duration studies such as pilots, secondary analyses, feasibility projects, or discrete method-development efforts that can be completed with limited resources.

What is the listed award ceiling?

The listed award ceiling is $50,000.

Is this intended to fund large multi-site clinical trials?

No. Based on the R03 mechanism and the $50,000 award ceiling, the program is geared toward focused projects that can produce actionable findings or lay groundwork for larger follow-on research, rather than large multi-site trials.

Who is eligible to apply?

Eligible applicants are broad and include: state, county, city, 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 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 nonprofit categories as specified); for-profit organizations other than small businesses; small businesses; and other applicants as allowed under NIH eligibility guidance referenced in the FOA.

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized Native American tribal governments and other tribal organizations are listed as eligible applicants.

Are small businesses eligible?

Yes. Small businesses are included in the eligible applicant types.

Are for-profit organizations eligible?

Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed separately as eligible.

Are universities and colleges eligible to apply?

Yes. Both public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible applicants.

Are government entities eligible to apply?

Yes. State, county, city, and special district governments are eligible, and independent school districts are also listed as eligible.

When was this FOA created and posted?

Administrative details indicate it was created and posted on June 7, 2016.

What was the closing date for this funding opportunity?

The closing date listed is January 7, 2020.

What category does this opportunity fall under?

The activity falls under the Health, Income Security and Social Services category.

What CFDA number is associated with this opportunity?

The FOA references CFDA number 93.865.

What broader impact is this FOA aiming for?

The broader goal is to produce clearer safety evidence and better outcome measurement methods for pain medication use in children and pregnant women, improving clinical decision-making and protecting maternal and child health.

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