Opportunity Information: Apply for PAR 16 275
Apply for PAR 16 275
- The HHS-NIH11 in the education, health sector is offering a public funding opportunity titled "Serious Adverse Drug Reaction Research (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172, 93.307, 93.393, 93.394, 93.395, 93.399, 93.846, 93.853, 93.855, 93.856,.
- This funding opportunity was created on May 19, 2016 and posted on May 19, 2016.
- Applicants must submit their applications by Sep 07, 2019. (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 Serious Adverse Drug Reaction Research (R01) funding opportunity (PAR-16-275) is a discretionary grant program from the U.S. Department of Health and Human Services, National Institutes of Health (HHS-NIH11). It supports investigator-initiated research projects using the NIH R01 mechanism, with the overall goal of advancing scientific knowledge about serious adverse drug reactions. The intent is broad: proposals can span the full spectrum of research, meaning applicants may pursue basic, translational, clinical, epidemiologic, data science, implementation, or other approaches as long as the work meaningfully improves understanding of serious harms associated with medication use and helps move the field forward.
A key feature of this announcement is its openness to many types of research questions and study designs. Rather than limiting applicants to a narrow topic area, it encourages a wide range of projects that could clarify mechanisms of serious adverse reactions, identify risk factors and vulnerable populations, improve methods for detecting and predicting these events, or develop strategies to prevent, mitigate, or better manage severe drug-related harm. In practice, this could include studying why certain patients experience severe toxicity, how genetics or co-morbidities influence risk, how drug-drug interactions contribute to serious outcomes, or how real-world clinical data can be leveraged to detect rare but dangerous reactions earlier.
Eligibility is expansive and includes many organizational types across the public, private, academic, nonprofit, and tribal sectors. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled colleges and universities; private institutions of higher education; federally recognized tribal governments and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and 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 as described in the announcement’s additional eligibility information. This broad eligibility reflects the reality that impactful adverse drug reaction research can be conducted in many settings, including academic medical centers, health systems, public health agencies, research institutes, and industry-affiliated research organizations.
The funding activity is categorized under education and health, and it is associated with multiple CFDA (Catalog of Federal Domestic Assistance) program numbers: 93.172, 93.307, 93.393, 93.394, 93.395, 93.399, 93.846, 93.853, 93.855, 93.856. The opportunity was created and posted on May 19, 2016. The listed original and current closing date was September 7, 2019. The source information does not specify an award ceiling or the expected number of awards, indicating that those details were either not provided in the excerpt or were determined through NIH’s standard R01 budgeting and peer-review processes rather than a fixed cap.
Overall, this FOA is designed for teams aiming to produce rigorous, publishable, and actionable evidence that improves medication safety. Competitive applications would typically be expected to define a clear serious adverse drug reaction problem, justify its public health impact, use strong and appropriate methods, and show how the results could improve understanding, prediction, prevention, or clinical management of severe drug-related harm.
Frequently Asked Questions (FAQs)
What is the Serious Adverse Drug Reaction Research (R01) funding opportunity?
This opportunity, titled "Serious Adverse Drug Reaction Research (R01)" (PAR-16-275), is a discretionary grant program from the U.S. Department of Health and Human Services, National Institutes of Health (HHS-NIH11). It supports investigator-initiated research projects using the NIH R01 mechanism to advance scientific knowledge about serious adverse drug reactions.
What is the main goal of this funding opportunity?
The overall goal is to advance scientific understanding of serious harms associated with medication use and to move the field of medication safety forward through rigorous research.
What does "investigator-initiated" mean in this context?
It means applicants propose their own research questions, hypotheses, and study approaches (rather than responding to a narrowly defined research topic), as long as the work meaningfully improves understanding of serious adverse drug reactions.
What grant mechanism is used for this program?
This funding opportunity uses the NIH R01 mechanism.
What kinds of research are supported?
The announcement is intentionally broad and can support projects across the full spectrum of research, including basic, translational, clinical, epidemiologic, data science, implementation, or other approaches, provided the project improves understanding of serious adverse drug reactions.
How broad is the scope of eligible research questions and study designs?
The scope is described as open to many types of research questions and study designs. Rather than restricting applicants to a narrow topic area, it encourages a wide range of projects that advance knowledge about serious adverse drug reactions and severe medication-related harms.
What are examples of topics that could be a fit for this FOA?
Examples mentioned include research that clarifies mechanisms of serious adverse reactions, identifies risk factors and vulnerable populations, improves methods for detecting and predicting these events, or develops strategies to prevent, mitigate, or better manage severe drug-related harm.
Does the FOA allow genetics- or comorbidity-related research on adverse reactions?
Yes. The description explicitly notes that projects could examine why certain patients experience severe toxicity and how genetics or co-morbidities influence risk.
Are drug-drug interactions within scope?
Yes. The description includes drug-drug interactions as an example of a factor that could contribute to serious outcomes and could be studied under this FOA.
Can projects use real-world clinical data to study adverse drug reactions?
Yes. The description notes that research could leverage real-world clinical data to detect rare but dangerous reactions earlier, which implies real-world data approaches are within scope.
Is implementation-focused research allowed?
Yes. Implementation approaches are listed among the types of research that may be supported, as long as the work improves understanding or management of serious adverse drug reactions.
Who is eligible to apply?
Eligibility is expansive and includes many organizational types across public, private, academic, nonprofit, and tribal sectors, as described in the announcement.
Are state and local governments eligible applicants?
Yes. Eligible applicants include state governments, county governments, city/township governments, and special district governments.
Are educational institutions eligible to apply?
Yes. Eligible applicants include independent school districts, public and state-controlled colleges and universities, and private institutions of higher education.
Are tribal entities eligible?
Yes. Eligible applicants include federally recognized tribal governments and other Native American tribal organizations.
Are nonprofits eligible?
Yes. Eligible applicants include nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status, with the stated exception that the nonprofit categories referenced exclude institutions of higher education within those nonprofit categories.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed as eligible.
Are public housing authorities eligible to apply?
Yes. Public housing authorities/Indian housing authorities are listed among eligible applicants.
What is the funding activity category for this opportunity?
The funding activity is categorized under education and health.
Which federal agency is offering this funding opportunity?
The opportunity is offered by the U.S. Department of Health and Human Services, National Institutes of Health (HHS-NIH11).
What CFDA program numbers are associated with this opportunity?
The opportunity is associated with multiple CFDA numbers: 93.172, 93.307, 93.393, 93.394, 93.395, 93.399, 93.846, 93.853, 93.855, and 93.856.
When was this opportunity created and posted?
The opportunity was created and posted on May 19, 2016.
What was the closing date for this opportunity?
The listed original and current closing date was September 7, 2019.
Is an award ceiling provided?
No award ceiling is specified in the provided information. The excerpt indicates that this detail was not provided there or may have been determined through NIH R01 budgeting and peer-review processes rather than a fixed cap.
Is the expected number of awards provided?
No. The provided information does not specify the expected number of awards.
What types of organizations might realistically conduct this research?
The description notes that impactful serious adverse drug reaction research can be conducted in many settings, including academic medical centers, health systems, public health agencies, research institutes, and industry-affiliated research organizations.
What does the FOA emphasize about competitiveness or application quality?
Competitive applications would typically be expected to define a clear serious adverse drug reaction problem, justify its public health impact, use strong and appropriate methods, and explain how results could improve understanding, prediction, prevention, or clinical management of severe drug-related harm.
What outcomes is this FOA trying to drive?
The FOA is designed to support teams producing rigorous, publishable, and actionable evidence that improves medication safety by improving understanding and management of serious adverse drug reactions.
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