Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent Clinical Trial Not Allowed) | RFA OD 22 023

Opportunity Information: Apply for RFA OD 22 023

The Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent Clinical Trial Not Allowed) is a National Institutes of Health (NIH) career development grant designed to help early-stage investigators build the skills, publication record, and mentoring relationships needed to become independent researchers in tobacco regulatory science. The award is structured to provide substantial protected time for research and career development over a sustained period of three, four, or five years, allowing the recipient to pursue an intensive, supervised training plan while conducting a focused research project. The central goal is to cultivate research independence by combining mentored research, formal training, and professional development activities that collectively position the awardee to compete successfully for future independent funding.

The research supported under this K01 must directly inform the development, implementation, or evaluation of regulations related to tobacco product manufacturing, distribution, and marketing. In practice, this means applicants need to propose biomedical, behavioral, or social science research that aligns with the regulatory mission and priorities of the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The opportunity is explicitly tied to the FDA's tobacco regulatory authority as established by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31, so proposals are expected to be grounded in real regulatory questions, evidence needs, and policy-relevant outcomes rather than purely exploratory or non-regulatory tobacco research. As indicated by the mechanism label, independent clinical trials are not allowed under this funding opportunity.

This is a discretionary grant opportunity (Funding Instrument: Grant) in the health funding activity category, listed under CFDA number 93.077. The funding opportunity number is RFA-OD-22-023, and the opportunity was created on 2022-11-10. The original closing date provided is 2025-03-12. While the source information includes a field for an award ceiling and expected awards, those values are not specified in the provided text, so applicants would need to consult the full funding announcement for budget limits, allowable costs, and anticipated award counts.

Eligibility is broad across many U.S.-based organization types. 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other eligible entities as defined in the announcement. The opportunity also highlights inclusion of organizations such as 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, and U.S. territories or possessions, reflecting an intent to encourage participation from a wide range of institutions and communities engaged in tobacco regulatory research.

At the same time, the opportunity places clear restrictions on foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations 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 short, the work and organizational structures supported by this K01 must remain fully domestic under NIH policy for this specific announcement.

Overall, this K01 is best understood as a mentored pathway award for investigators who want dedicated time and structured guidance to develop into independent scientists producing evidence that the FDA Center for Tobacco Products can use in regulating tobacco products, particularly in areas connected to product manufacturing, distribution, and marketing, while operating within the constraint that independent clinical trials are not permitted.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent 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): 93.077.
• This funding opportunity was created on 2022-11-10.
• Applicants must submit their applications by 2025-03-12. (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 RFA OD 22 023

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