Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent Clinical Trial Required) | RFA OD 22 024

Opportunity Information: Apply for RFA OD 22 024

The Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent Clinical Trial Required) is a National Institutes of Health (NIH) career development grant designed to help early-stage researchers build the skills, publication record, and mentoring relationships needed to become independent investigators in tobacco regulatory science. The award provides substantial protected time for a focused, supervised career development plan lasting three, four, or five years. The central idea is to pair an intensive research project with structured mentoring and training so the awardee can progress toward research independence while producing evidence that directly supports tobacco product regulation.

This opportunity is specifically tied to the regulatory mission of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. In practical terms, proposed research needs to align with FDA CTP priorities and produce findings that can inform how tobacco products are manufactured, distributed, and marketed, as well as how regulations are developed, implemented, and evaluated. The scope is intentionally broad across biomedical, behavioral, and social science research, but it must remain anchored to tobacco regulatory decision-making rather than general tobacco control topics that are not clearly linked to FDA authority.

A key feature of this particular K01 is that an independent clinical trial is required, meaning the research plan is expected to include a clinical trial component for which the candidate will be responsible as the trial’s lead investigator. Applicants should anticipate that this requirement will shape the design, oversight, compliance planning, and mentoring team composition, since the application must convincingly demonstrate the candidate’s ability to conduct the trial while receiving appropriate supervision and training.

Eligibility spans a wide range of U.S.-based organizations, reflecting that the award is meant to be accessible across many institutional settings. Eligible applicants include 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 Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

At the same time, the opportunity places firm limits on foreign involvement. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed. In effect, the project and its major operational elements must be U.S.-based without foreign components.

Administratively, the funding opportunity is listed as RFA OD 22 024, categorized as a discretionary grant in the health funding activity area (CFDA 93.077), and administered by NIH. The original closing date provided is March 12, 2025. While an award ceiling and expected number of awards are not specified in the provided listing, applicants typically should plan around NIH K award norms: a multi-year mentored period with an emphasis on protected time, a strong mentoring team, and a clear pathway to independence that culminates in future independent research funding applications.

Overall, this K01 is best understood as a mentored launching platform for researchers whose work can directly strengthen the scientific basis for FDA tobacco product regulation, combining a defined regulatory-relevant research agenda with formal training and mentorship over several years, and requiring leadership of an independent clinical trial as part of the proposed career development trajectory.

• 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 Required)" 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 22 024

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