Evaluating the NIDA Standardized Research E-Cigarette in Risk Reduction and Related Studies (U01) | PAR 17 156

Opportunity Information: Apply for PAR 17 156

This funding opportunity, titled "Evaluating the NIDA Standardized Research E-Cigarette in Risk Reduction and Related Studies (U01)" (PAR 17-156), is a National Institutes of Health (NIH) discretionary grant offered as a cooperative agreement (U01). Its main goal is to speed up clinical research on whether electronic cigarettes (also called ENDS) can meaningfully reduce the harms linked to smoking combustible tobacco. The program is built around the use of a specific product, the newly developed NIDA Standard Research E-cigarette (SREC), which is intended to function as a consistent, research-grade reference e-cigarette. By requiring studies to use the same standardized device, the FOA aims to generate results that are easier to compare across studies and to create a benchmark that other e-cigarette products can be evaluated against.

The FOA is focused on clinical studies involving current tobacco smokers. Applicants are expected to design studies that examine both potential benefits and potential risks of switching from combustible cigarettes to the NIDA SREC. The research emphasis is on measuring effects across multiple domains, especially behavioral outcomes and biological or health-related biomarkers. In practice, this means proposed projects should not look at just one endpoint; they should gather a broader picture of how using the SREC affects indicators of exposure, harm, and behavior in smokers. The announcement explicitly highlights topics such as whether e-cigarettes can reduce the negative health impacts of conventional smoking and how the SREC influences craving and dependence, which signals interest in both harm reduction outcomes and addiction-related mechanisms that could affect continued use or cessation trajectories.

A central feature of this opportunity is its regulatory dependency. Funding is contingent on review by the FDA Center for Tobacco Products (CTP). Specifically, awards depend on CTP determining that the proposed studies fall under FDA regulatory jurisdiction. In addition, CTP must accept the use of the NIDA SREC in the study as an Investigational Tobacco Product (ITP), or determine that an ITP is not required for the proposed work. This requirement effectively means applicants need to be prepared for regulatory coordination and should build realistic timelines, compliance plans, and study procedures that can satisfy CTP expectations. It also underscores that the resulting evidence is meant to be relevant not only to scientific understanding but also to the broader regulatory and public health decision-making environment surrounding e-cigarettes.

The broader intended impact is twofold. First, NIH is aiming for these studies to quickly strengthen the evidence base on whether e-cigarettes, when evaluated through a standardized research product, actually reduce risk compared with combustible tobacco among people who currently smoke. Second, the FOA is designed to produce data that could be useful for public health policy discussions about e-cigarettes, including the evaluation of potential harm reduction claims, balancing of benefits and unintended consequences, and the interpretation of biomarker and behavioral findings in a way that can inform population-level considerations.

Eligibility is broad and includes many types of domestic organizations and some non-domestic entities. Eligible applicants include state, county, city, 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 and other tribal organizations; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other entities. The FOA also specifically calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, non-U.S. entities (foreign organizations), tribal governments that are not federally recognized, and U.S. territories or possessions. The assistance listing is associated with CFDA number 93.279. The opportunity was created on 2017-02-08, with an original closing date listed as 2019-04-24.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Evaluating the NIDA Standardized Research E-Cigarette in Risk Reduction and Related Studies (U01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2017-02-08.
• Applicants must submit their applications by 2019-04-24. (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 17 156

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