Electronic Nicotine Delivery Systems (ENDS): Basic Mechanisms of Health Effects (R21 - Clinical Trial Not Allowed) | PAR 17 475

Opportunity Information: Apply for PAR 17 475

The National Institutes of Health (NIH) funding opportunity titled "Electronic Nicotine Delivery Systems (ENDS): Basic Mechanisms of Health Effects (R21 - Clinical Trial Not Allowed)" (Funding Opportunity Number PAR-17-475) is a discretionary grant program designed to support early-stage, exploratory basic research on how aerosols produced by electronic nicotine delivery systems affect the body. The central focus is mechanistic work that helps clarify what ENDS aerosols do to normal biological function and to disease-related processes, particularly at the level of human-relevant cells, tissues, and organs. The intent is to build foundational knowledge about biological pathways and responses triggered by ENDS exposure, rather than to fund clinical trials or clinical intervention studies.

This opportunity uses the NIH R21 mechanism, which is commonly aimed at novel, higher-risk ideas and proof-of-concept studies. The award ceiling listed is $200,000, reflecting the small, exploratory nature of R21 projects. While the summary information does not list the exact project period or the number of awards expected, the R21 format generally supports targeted projects that can generate preliminary data or establish feasibility for larger follow-on studies. Importantly, the announcement explicitly states "Clinical Trial Not Allowed," meaning applicants must keep the scope in the realm of basic or preclinical research and avoid study designs that meet NIH's definition of a clinical trial (for example, prospectively assigning human participants to an intervention to measure health outcomes).

From a scientific standpoint, the program is aimed at understanding how ENDS aerosols influence biological systems that matter for health and disease. That can include studying direct cellular toxicity, inflammation, oxidative stress, immune effects, vascular and cardiopulmonary responses, or other mechanistic endpoints in relevant models. The emphasis on "normal and disease states" signals interest both in baseline physiology (how healthy systems respond) and in how ENDS exposure may worsen, trigger, or interact with pathological processes. Although the wording highlights relevance to human cells, tissues, and organs, the basic-mechanisms framing implies the work can be done using laboratory approaches that are appropriate for mechanistic research, such as cell culture systems, tissue models, organotypic cultures, or other non-clinical experimental platforms, as long as the project stays within NIH rules for a non-clinical-trial R21.

Eligibility is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants include state, county, city or township, 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; public housing authorities and Indian housing authorities; Native American tribal organizations that are not federally recognized; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education, since IHEs are already separately listed); for-profit organizations other than small businesses; small businesses; and other unspecified eligible entities. The announcement also explicitly calls out a range of institution types as eligible or welcomed, 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, regional organizations, eligible federal agencies, and U.S. territories or possessions. In practical terms, NIH is signaling that a wide variety of organizations with the capacity to conduct rigorous basic biomedical research can apply.

At the same time, there are clear restrictions related to foreign involvement. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined in the NIH Grants Policy Statement) are not allowed. In plain language, the applicant organization must be U.S.-based, the work cannot be routed through a foreign institutional applicant, and the project cannot include a formal foreign component under NIH policy.

Administratively, the opportunity is categorized under Education, Environment, and Health funding activity areas, and it is associated with CFDA numbers 93.113, 93.121, 93.279, and 93.396, which correspond to NIH program authorities tied to the relevant institutes and centers that participate in the announcement. The posting lists an original closing date of June 29, 2018, and a creation date of September 7, 2017, indicating when the opportunity was made available and when applications were originally due. Overall, the program’s purpose is straightforward: fund targeted, mechanistic, non-clinical-trial research that can explain, at a basic biological level, how ENDS aerosols affect human-relevant biological systems and disease processes, thereby strengthening the scientific evidence base needed to understand potential health impacts.

• 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 (R21 - 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, 93.396.
• This funding opportunity was created on 2017-09-07.
• Applicants must submit their applications by 2018-06-29. (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.

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