Opportunity Information: Apply for PAR 18 845

The grant opportunity titled "Electronic Nicotine Delivery Systems (ENDS): Basic Mechanisms of Health Effects (R01 - Clinical Trial Not Allowed)" (Funding Opportunity Number PAR-18-845) is a discretionary NIH research grant designed to fund basic, mechanistic studies on how aerosols produced by electronic nicotine delivery systems affect biological systems. The central focus is on understanding what ENDS aerosols do to human-relevant cells, tissues, and organs, both under normal conditions and in the context of disease states. In practical terms, the program is aimed at foundational science: identifying biological pathways, cellular responses, tissue-level changes, and organ-specific mechanisms that are triggered or altered by exposure to ENDS aerosols or their constituents. Because it is an R01 mechanism, the opportunity is geared toward well-developed, hypothesis-driven projects that can support a sustained, multi-year line of investigation rather than short pilot work.

A key feature of this announcement is that clinical trials are not allowed. That means applicants are expected to stay within the boundaries of basic or preclinical research rather than testing interventions or outcomes in a way that meets the definition of a clinical trial. Typical approaches under this kind of announcement would include in vitro studies using human or animal cells, ex vivo models, organoids, tissue explants, and in vivo animal models, as well as advanced analytical and toxicological methods that can clarify dose-response relationships and mechanisms of action. The emphasis on "basic mechanisms" signals that descriptive studies are generally less competitive unless they clearly connect to mechanistic questions, such as identifying causal pathways, biomarkers linked to exposure, or specific constituents that drive harmful or adaptive responses.

The sponsoring agency is the National Institutes of Health, and the program is associated with multiple CFDA numbers (93.113, 93.121, 93.279, 93.399), reflecting that the topic spans more than one NIH institute or center mission area. The funding instrument is a grant, and the activity categories listed include education, environment, and health, which aligns with the cross-cutting nature of ENDS research: aerosol exposures intersect environmental exposure science and toxicology, while outcomes and mechanisms relate to respiratory, cardiovascular, immune, neurological, and other health domains. The source information lists an original closing date of June 15, 2021 and a creation date of June 29, 2018. No award ceiling or expected number of awards is specified in the provided data, which usually means budgets and award counts may depend on NIH institute participation, application volume, and available appropriations in a given cycle.

Eligibility is broad and includes most common U.S. applicant types: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The announcement also explicitly highlights additional eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). Taken together, this indicates NIH is encouraging a wide range of research performers and perspectives, including institutions serving underrepresented populations and organizations located outside the continental U.S., to contribute to the evidence base on ENDS aerosol health effects.

Overall, this opportunity is best understood as NIH support for rigorous laboratory and mechanistic research that can clarify how ENDS aerosol exposure translates into biological changes relevant to human health and disease. The scientific payoff NIH is seeking is the kind of foundational understanding that can later inform risk assessment, regulatory science, product standards, and future applied or clinical research, without directly conducting clinical trials under this particular funding announcement.

  • The National Institutes of Health in the education, environment, health sector is offering a public funding opportunity titled "Electronic Nicotine Delivery Systems (ENDS): Basic Mechanisms of Health Effects (R01 - Clinical Trial Not Allowed)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.279, 93.399.
  • This funding opportunity was created on 2018-06-29.
  • Applicants must submit their applications by 2021-06-15. (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.
Apply for PAR 18 845

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Frequently Asked Questions (FAQs)

What is the title and funding opportunity number for this grant?

The opportunity is titled "Electronic Nicotine Delivery Systems (ENDS): Basic Mechanisms of Health Effects (R01 - Clinical Trial Not Allowed)" and the Funding Opportunity Number is PAR-18-845.

What type of research is this grant meant to support?

This announcement supports basic, mechanistic research focused on how aerosols produced by electronic nicotine delivery systems (ENDS) affect biological systems. The emphasis is on identifying and explaining biological pathways and mechanisms (for example, cellular responses, tissue-level changes, organ-specific effects, and dose-response relationships) triggered by ENDS aerosol exposure or specific aerosol constituents.

What is the central scientific focus of the program?

The central focus is understanding what ENDS aerosols do to human-relevant cells, tissues, and organs. This includes studying effects under normal conditions and in the context of disease states, with an emphasis on mechanistic explanations rather than purely descriptive observations.

Which funding mechanism is used, and what does that imply about project scope?

The activity mechanism is an NIH R01 research project grant. In practical terms, this points to well-developed, hypothesis-driven projects designed to support a sustained, multi-year line of investigation rather than short pilot or exploratory work.

Are clinical trials allowed under this funding opportunity?

No. Clinical trials are not allowed. Applications are expected to remain within basic or preclinical research boundaries and not include work that meets the definition of a clinical trial.

If clinical trials are not allowed, what kinds of study approaches fit this announcement?

Approaches consistent with this announcement include basic and preclinical strategies such as in vitro studies (using human or animal cells), ex vivo models, organoids, tissue explants, in vivo animal models, and advanced analytical/toxicological methods aimed at clarifying mechanisms of action and dose-response relationships related to ENDS aerosols or their constituents.

Is the program primarily interested in descriptive studies?

The emphasis on "basic mechanisms" suggests that purely descriptive studies are generally less competitive unless they clearly connect observations to mechanistic questions. Examples of mechanistic connections described in the opportunity include identifying causal pathways, biomarkers linked to exposure, or specific constituents that drive harmful or adaptive responses.

What does the grant focus on: ENDS devices, nicotine, or the aerosol exposure?

The stated focus is on aerosols produced by ENDS and how those aerosols (or their constituents) affect biological systems. The announcement frames the research question around aerosol exposure and downstream biological mechanisms.

Who is the sponsoring agency?

The sponsoring agency is the National Institutes of Health (NIH).

Does this opportunity involve more than one NIH institute or center?

Yes. The opportunity is associated with multiple CFDA numbers (93.113, 93.121, 93.279, 93.399), which indicates the topic spans more than one NIH institute or center mission area.

What is the funding instrument for this opportunity?

The funding instrument is a grant.

What activity categories are associated with this announcement?

The listed activity categories are education, environment, and health, reflecting the cross-cutting nature of ENDS aerosol research across exposure science, toxicology, and health-related biological mechanisms.

What health domains or biological systems are relevant to this opportunity?

The opportunity describes outcomes and mechanisms that can relate to respiratory, cardiovascular, immune, neurological, and other health domains, consistent with the broad biological reach of aerosol exposures.

Who is eligible to apply?

Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities.

Are organizations serving underrepresented populations explicitly encouraged or included?

Yes. The announcement explicitly highlights additional eligible applicants including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs). It also includes faith-based or community-based organizations.

Can federal agencies apply?

Yes. Eligible applicants explicitly include eligible federal agencies.

Can U.S. territories or possessions apply?

Yes. The eligibility list explicitly includes U.S. territories or possessions.

Are foreign (non-U.S.) organizations eligible to apply?

Yes. The opportunity indicates that non-U.S. entities (foreign organizations) are eligible.

Is there a stated award ceiling or a stated expected number of awards?

No award ceiling or expected number of awards is specified in the provided information. This typically means actual budgets and award counts may vary based on NIH institute participation, application volume, and available appropriations in a given cycle.

What dates are provided for this opportunity?

The provided information lists a creation date of June 29, 2018 and an original closing date of June 15, 2021.

What is NIH ultimately trying to achieve through this program?

The program aims to build foundational, mechanistic understanding of how ENDS aerosol exposure translates into biological changes relevant to human health and disease. The intended scientific payoff is knowledge that can later inform risk assessment, regulatory science, product standards, and future applied or clinical research, without conducting clinical trials under this particular announcement.

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Funding Number: PA 19 053
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NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) Apply for PA 19 054

Funding Number: PA 19 054
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NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed) Apply for PA 19 052

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NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required) Apply for PA 19 091

Funding Number: PA 19 091
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NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required) Apply for PA 19 092

Funding Number: PA 19 092
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Funding Number: PA 19 121
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