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.Apply for RFA OD 22 023
- 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.
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Frequently Asked Questions (FAQs)
What is the Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01)?
It is an NIH career development grant designed to support early-stage investigators as they build the skills, publication record, and mentoring relationships needed to become independent researchers in tobacco regulatory science. The award combines mentored research, formal training, and professional development activities with substantial protected time to support career development and a focused research project.
What is the main goal of this K01 award?
The central goal is to cultivate research independence. The award is structured to position recipients to compete successfully for future independent funding by providing sustained mentored training, career development, and time to produce policy-relevant research outputs.
How long can the K01 project period be?
The award can provide support over a sustained period of three, four, or five years.
What type of funding instrument is this opportunity?
This is a discretionary grant opportunity (Funding Instrument: Grant) in the health funding activity category.
What is the focus area of the research supported by this K01?
The research must directly inform the development, implementation, or evaluation of regulations related to tobacco product manufacturing, distribution, and marketing. The proposed work should address real regulatory questions and evidence needs relevant to tobacco regulation, rather than purely exploratory or non-regulatory tobacco research.
Does the research need to align with a specific agency mission?
Yes. Proposed research is expected to align with the regulatory mission and priorities of the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP).
What law or authority is this opportunity tied to?
The opportunity is explicitly tied to the FDA's tobacco regulatory authority established by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31.
Are independent clinical trials allowed under this K01?
No. Independent clinical trials are not allowed under this funding opportunity (K01 - Independent Clinical Trial Not Allowed).
What kinds of scientific disciplines can be proposed?
Applicants may propose biomedical, behavioral, or social science research, as long as the work directly supports tobacco regulatory science needs tied to regulation of tobacco product manufacturing, distribution, and marketing.
Is this award intended for mentored or independent researchers?
This is a mentored pathway award. It is designed for investigators who need dedicated time and structured guidance to develop into independent scientists in tobacco regulatory research.
What is meant by "protected time" in this announcement?
The award is structured to provide substantial protected time for research and career development across the multi-year project period, supporting an intensive, supervised training plan alongside a focused research project.
What is the CFDA number for this opportunity?
The CFDA number listed is 93.077.
What is the funding opportunity number (FOA number)?
The funding opportunity number is RFA-OD-22-023.
When was this opportunity created?
The opportunity was created on 2022-11-10.
What is the original closing date listed for this opportunity?
The original closing date provided is 2025-03-12.
Is the award ceiling (maximum budget) provided in the information here?
No. The source information indicates fields for an award ceiling and expected awards, but those values are not specified in the provided text. Applicants would need to consult the full funding announcement for budget limits and allowable costs.
Is the expected number of awards provided?
No. The provided text notes that expected awards are not specified and directs applicants to the full funding announcement for anticipated award counts.
Who is eligible to apply (in general)?
Eligibility is broad across many U.S.-based organization types, including various levels of government, institutions of higher education (public and private), nonprofit organizations (with and without 501(c)(3) status, excluding institutions of higher education in those nonprofit categories), for-profit organizations (including small businesses and other than small businesses), tribal entities, public housing authorities/Indian housing authorities, and other eligible entities as defined in the announcement.
Are U.S. state and local governments eligible applicants?
Yes. Eligible applicants include state, county, city or township, and special district governments.
Are institutions of higher education eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.
Are tribal governments and tribal organizations eligible?
Yes. Eligible applicants include federally recognized Native American tribal governments and other Native American tribal organizations.
Are nonprofits eligible?
Yes. Nonprofits with and without 501(c)(3) status are listed as eligible (excluding institutions of higher education in those nonprofit categories).
Are for-profit organizations and small businesses eligible?
Yes. The eligibility list includes for-profit organizations other than small businesses as well as small businesses.
Are independent school districts eligible applicants?
Yes. Independent school districts are included in the eligibility list.
Are U.S. territories or possessions included as eligible entities?
Yes. The opportunity highlights U.S. territories or possessions among the organizations and communities encouraged to participate.
Does the announcement encourage participation from specific institution types?
Yes. It highlights a range of organizations such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, and regional organizations.
Are foreign (non-U.S.) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply.
Can a U.S. organization include a non-domestic component in the proposed project?
No. Non-domestic components of U.S. organizations are not eligible under this announcement.
Are foreign components allowed under NIH policy for this specific opportunity?
No. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed for this specific announcement.
What is the overall purpose of this K01 in the context of tobacco regulation?
It is intended to support a mentored pathway for investigators to generate 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 under the restriction that independent clinical trials are not permitted.
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