Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - Independent Clinical Trial Required) | RFA OD 20 010

Opportunity Information: Apply for RFA OD 20 010

The Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - Independent Clinical Trial Required) is an NIH grant opportunity aimed at building and sustaining a pipeline of promising early-career scientists who can become independent investigators in tobacco regulatory science. The central goal is to support research that can directly inform the development, implementation, and evaluation of regulations related to tobacco products, including how these products are manufactured, distributed, and marketed. In practical terms, the program is meant to help ensure that regulatory decisions affecting public health are backed by strong scientific evidence, while also strengthening the workforce of researchers trained to produce that evidence.

This funding mechanism uses the NIH K99/R00 "Pathway to Independence" structure, which is specifically designed to move a researcher from a mentored postdoctoral phase into an independent faculty-like role. The K99 phase supports a defined period of mentored research and career development while the applicant is still in a postdoctoral (or equivalent) position. The goal during this stage is to deepen the applicant's expertise, strengthen their publication and grantsmanship record, and position them competitively for an independent, tenure-track or equivalent appointment. Once the awardee secures an eligible independent position and meets the program's transition requirements, the grant shifts into the R00 phase, which provides independent research support. That second phase is meant to function as a launchpad for a self-directed research program that can compete successfully for future major NIH funding.

A key feature of this specific announcement is that an independent clinical trial is required, meaning the proposed work must include a clinical trial where the awardee will serve as the independent investigator responsible for designing and conducting the trial. This requirement signals that NIH expects applicants to propose research that involves human participants and tests an intervention or assesses outcomes in a manner consistent with NIH's definition of a clinical trial. For applicants, this typically raises the bar for planning and feasibility, since clinical trials require careful attention to study design, ethical oversight, recruitment strategies, data and safety monitoring, and regulatory compliance. In the context of tobacco regulatory research, this could involve trials related to tobacco product use behavior, risk perceptions, cessation-related outcomes, responses to marketing or labeling, or other human-subject outcomes that are relevant to regulatory questions.

Eligibility for applicant organizations is broad and includes many types of U.S.-based 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 Native American tribal organizations that are not federally recognized. The opportunity is also open to public housing authorities and Indian housing authorities, nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in that classification), for-profit organizations other than small businesses, and small businesses. The announcement also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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. At the same time, it clearly restricts foreign involvement: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them in its Grants Policy Statement) are not allowed.

Administratively, this is a discretionary grant program offered by the National Institutes of Health, with the funding opportunity number RFA OD 20 010 and a CFDA listing of 93.077. The original posting date in the source information is February 7, 2020, and the original closing date listed is July 10, 2022. The purpose statement emphasizes workforce development and timely career transition: it is meant for outstanding postdoctoral researchers with a research doctorate and/or clinical doctorate who are ready to move beyond mentored training and establish independent research programs that can contribute to tobacco product regulation science.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - 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 2020-02-07.
• Applicants must submit their applications by 2022-07-10. (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 20 010

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: