Evaluating the NIDA Standardized Research E-Cigarette in Risk Reduction and Related Studies (U01 Clinical Trial Optional) | PAR 18 220

Opportunity Information: Apply for PAR 18 220

This funding opportunity, PAR 18-220, is a National Institutes of Health (NIH) cooperative agreement (U01, clinical trial optional) designed to speed up research on whether electronic cigarettes (also called ENDS) can meaningfully reduce harm for people who currently smoke combustible cigarettes. The central idea is to move beyond studies that use many different commercial vaping products by requiring investigators to use a single, newly developed research device: the NIDA Standard Research E-Cigarette (SREC). By standardizing the product, NIDA aims to make results easier to interpret across studies and to create a benchmark that other e-cigarettes can be compared against in future research and regulatory discussions.

The FOA focuses on clinical studies in current tobacco smokers that evaluate both potential benefits and potential risks of switching to, or using, the NIDA SREC. Proposed projects are expected to look at multiple outcomes rather than a single endpoint. This includes behavioral measures (such as patterns of use, product appeal, or compensatory behavior), dependence-related outcomes (including craving, withdrawal relief, nicotine exposure, and indicators of addiction potential), and health-related biomarkers. The intent is to build a clearer picture of whether using a standardized e-cigarette product can reduce exposure to harmful constituents found in combustible tobacco smoke and whether any exposure reductions translate into improvements in biologically relevant markers tied to disease risk.

A key feature of this announcement is that the work sits at the intersection of research and tobacco regulation. Funding is explicitly contingent on review by the FDA Center for Tobacco Products (CTP). Before an award can move forward, CTP must determine whether the proposed study falls under its regulatory jurisdiction. In addition, CTP must either accept the NIDA SREC for use as an Investigational Tobacco Product (ITP) in the proposed study or decide that an ITP submission is not required. In practical terms, applicants need to anticipate regulatory coordination as part of the study planning, because the ability to use the SREC in human research under the FOA depends on FDA CTP decisions.

The broader public health purpose is twofold. First, the FOA aims to rapidly increase scientifically credible evidence about the harm reduction potential of e-cigarettes for people who already smoke, including the possibility that e-cigarettes may lower the negative health impacts associated with continued combustible tobacco use. Second, by generating rigorous, standardized data using the SREC, the funded projects are expected to produce findings that can inform tobacco control and e-cigarette policy, including risk communication and regulatory decision-making. The emphasis on multiple biomarkers and behavioral endpoints reflects the reality that harm reduction is not only about toxicant exposure, but also about how products affect dependence, dual use, and the likelihood of sustained switching away from cigarettes.

Administratively, this is a discretionary grant mechanism under a cooperative agreement structure, which typically means there is substantial scientific or programmatic involvement from the funding institute compared to a standard research project grant. The activity area is listed under education and health, with CFDA number 93.279. The original closing date shown for this opportunity was April 24, 2019, and the record indicates it was created on November 28, 2017. While an award ceiling and expected number of awards are not specified in the provided text, the intent is clearly to support clinical studies capable of producing policy-relevant evidence in a relatively timely way.

Eligibility is broad and includes many types of organizations and governmental entities. Eligible applicants include state, county, city or township governments, special district governments, independent school districts, and public housing authorities; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) as well as small businesses; and other categories. The FOA also explicitly highlights additional eligible groups such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISI institutions, tribally controlled colleges and universities, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and even non-U.S. entities (foreign organizations). This wide eligibility reflects an interest in drawing on diverse research settings and populations to strengthen the evidence base around standardized e-cigarette research and harm reduction for smokers.

• 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 Clinical Trial Optional)" 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 2017-11-28.
• 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 18 220

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