Opportunity Information: Apply for PAR 16 274

  • The HHS-NIH11 in the education, health sector is offering a public funding opportunity titled "Serious Adverse Drug Reaction Research (R21)" 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.)
  • 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).
Apply for PAR 16 274

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Opportunity Summary:

The Serious Adverse Drug Reaction Research (R21) opportunity (Funding Opportunity Number PAR 16 274) is a discretionary grant program from the U.S. Department of Health and Human Services, National Institutes of Health (HHS-NIH11). It is designed to fund exploratory, early-stage research that pushes forward what is known about serious adverse drug reactions, including how and why they occur, who is at greatest risk, how they can be detected earlier, and what strategies might prevent or reduce harm. The announcement explicitly welcomes applications across the full spectrum of research approaches, which generally means it is open to a wide range of scientific methods and disciplines as long as the work meaningfully advances knowledge in serious adverse drug reactions.

This is an R21 funding mechanism, which typically supports high-impact, innovative projects that may be at an earlier or more conceptual stage than larger, longer-term research grants. The intent is often to encourage novel ideas, pilot studies, feasibility work, new analytical methods, and other projects that can generate strong preliminary evidence or open up new directions for subsequent research. For this specific opportunity, the focus is squarely on serious adverse drug reactions, which commonly refers to harmful and clinically significant reactions to medications that may result in outcomes such as hospitalization, disability, life-threatening events, congenital anomalies, or death. Projects can be grounded in clinical, translational, epidemiologic, informatics, pharmacologic, or mechanistic research, depending on the investigator's goals and the data or systems they plan to use.

Funding under this announcement is capped at an award ceiling of $200,000. While the source listing does not specify the number of expected awards, the program sits within NIH and is associated with multiple CFDA numbers (93.172, 93.307, 93.393, 93.394, 93.395, 93.399, 93.846, 93.853, 93.855, 93.856), which reflects that NIH institutes and centers with different missions may participate or provide funds depending on the scientific scope of a given application. In practice, that can be relevant for applicants because it signals broad NIH interest and the possibility that projects may align with more than one NIH component, particularly when adverse drug reaction research overlaps areas like general medical sciences, heart/lung/blood, cancer, allergy/infectious disease, child health, or other domains.

Eligibility is broad and includes most major organizational types that commonly apply for federal research funding. 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 both with and without 501(c)(3) status (excluding higher education institutions where applicable); for-profit organizations other than small businesses; small businesses; and additional eligible entities as described in the announcement's eligibility text. This broad eligibility structure is meant to support participation from academic research centers, health systems, nonprofits, government-affiliated research groups, and industry or commercial entities with relevant capabilities, recognizing that serious adverse drug reaction research often benefits from real-world data access, clinical networks, pharmacovigilance expertise, and cross-sector collaboration.

The opportunity was created and posted on May 19, 2016, with a listed application closing date of September 7, 2019 (both original and current closing dates shown as the same). In other words, this specific posting reflects a defined submission window that has already passed, but it still provides a clear picture of NIH's interest in funding focused research on serious adverse drug reactions under an exploratory R21 mechanism, and similar or successor announcements may exist with updated dates or scopes.

At its core, the grant aims to strengthen the evidence base around serious medication-related harms. Competitive projects under a program like this typically emphasize rigorous definitions of adverse drug reactions, thoughtful methods for identifying and validating events (for example, through clinical adjudication, electronic health record phenotyping, claims-based algorithms, spontaneous reporting databases, or laboratory and genomic assays), and a clear plan for how results will improve detection, understanding, prediction, or prevention of severe drug-related outcomes. The overall message of the announcement is that NIH is seeking innovative, well-justified studies that meaningfully advance the science of serious adverse drug reactions, regardless of whether the work is basic, clinical, computational, or population-focused, as long as it addresses the central public health problem of severe medication harm.

Frequently Asked Questions (FAQs): Serious Adverse Drug Reaction Research (R21) - PAR 16 274

What is the Serious Adverse Drug Reaction Research (R21) opportunity?

It is a discretionary grant program from the U.S. Department of Health and Human Services, National Institutes of Health (HHS-NIH11) focused on exploratory, early-stage research that advances what is known about serious adverse drug reactions.

What is the Funding Opportunity Number?

The Funding Opportunity Number is PAR 16 274.

What type of grant mechanism is this?

This opportunity uses the NIH R21 mechanism, which typically supports high-impact, innovative projects that are exploratory or early-stage in nature.

What is the main purpose of this R21 program?

The program is designed to push forward understanding of serious adverse drug reactions, including how and why they occur, who is at greatest risk, how they can be detected earlier, and what strategies might prevent or reduce harm.

What kinds of research topics are encouraged under this announcement?

Research topics include (but are not limited to) mechanisms of serious adverse drug reactions, risk factors and susceptibility, earlier detection approaches, and prevention or harm-reduction strategies that address clinically significant medication-related harms.

How does the announcement describe the range of acceptable research approaches?

The announcement explicitly welcomes applications across the full spectrum of research approaches, meaning a wide range of scientific methods and disciplines may be appropriate as long as the project meaningfully advances knowledge about serious adverse drug reactions.

What research areas or disciplines can be relevant for a project under this opportunity?

Projects may be grounded in clinical, translational, epidemiologic, informatics, pharmacologic, or mechanistic research, depending on the investigator's goals and the data or systems they plan to use.

What does "serious adverse drug reaction" mean in the context of this opportunity?

It generally refers to harmful and clinically significant reactions to medications that may result in outcomes such as hospitalization, disability, life-threatening events, congenital anomalies, or death.

What kinds of project types are commonly aligned with the R21 intent?

R21 projects often include novel ideas, pilot studies, feasibility work, development of new analytical methods, and other early-stage efforts that can generate preliminary evidence or open new directions for later research.

What is the maximum award amount under this announcement?

Funding is capped at an award ceiling of $200,000.

Does the opportunity specify how many awards will be made?

The provided information does not specify the number of expected awards.

Which federal agency and component are associated with this opportunity?

The opportunity is associated with the U.S. Department of Health and Human Services and the National Institutes of Health (NIH), listed as HHS-NIH11.

What CFDA 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, 93.856.

Why are multiple CFDA numbers listed for this opportunity?

The listing of multiple CFDA numbers reflects that NIH institutes and centers with different missions may participate or provide funds depending on the scientific scope of an application, signaling broad NIH interest in serious adverse drug reaction research.

What types of organizations are eligible to apply?

Eligibility is broad and includes: 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 and without 501(c)(3) status (excluding higher education institutions where applicable); for-profit organizations other than small businesses; small businesses; and additional eligible entities as described in the announcement's eligibility text.

Are academic institutions eligible to apply?

Yes. 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. Eligible government applicants include state, county, and city or township governments, as well as special district governments and independent school districts.

Are tribal governments and tribal organizations eligible to apply?

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

Are nonprofit organizations eligible to apply?

Yes. Nonprofits with and without 501(c)(3) status are listed as eligible (excluding higher education institutions where applicable).

Are for-profit organizations eligible to apply?

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 included in the eligibility list.

When was this opportunity posted?

The opportunity was created and posted on May 19, 2016.

What was the application closing date for this opportunity?

The listed application closing date was September 7, 2019 (shown as both the original and current closing date).

Is this funding opportunity still open based on the dates provided?

No. Based on the provided application closing date (September 7, 2019), the defined submission window has already passed.

If the closing date has passed, is the topic still relevant for NIH funding?

The information indicates this posting reflects NIH interest in funding focused research on serious adverse drug reactions under an exploratory R21 mechanism, and similar or successor announcements may exist with updated dates or scopes.

What characteristics are implied to be important for competitive projects?

Competitive projects typically emphasize rigorous definitions of adverse drug reactions, thoughtful methods for identifying and validating events, and a clear plan for how results will improve detection, understanding, prediction, or prevention of severe drug-related outcomes.

What examples of identifying or validating adverse drug reaction events are mentioned?

Examples mentioned include clinical adjudication, electronic health record phenotyping, claims-based algorithms, spontaneous reporting databases, and laboratory and genomic assays.

Does the opportunity allow both basic and applied research?

Yes. The announcement indicates NIH is seeking innovative, well-justified studies regardless of whether the work is basic, clinical, computational, or population-focused, as long as it addresses serious adverse drug reactions.

What is the overall public health problem this opportunity targets?

The opportunity targets severe medication harm by strengthening the evidence base around serious medication-related adverse outcomes and supporting research that improves detection, understanding, prediction, or prevention.

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