Opportunity Information: Apply for RFA OD 18 008
The Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - Independent Clinical Trial Required) is an NIH grant opportunity intended to build and sustain a pipeline of early-career scientists whose work directly supports tobacco product regulation. The central goal is to develop a strong cohort of promising investigators who can produce evidence that helps inform and evaluate regulations related to how tobacco products are manufactured, distributed, and marketed. In practical terms, the award is meant to accelerate the career transition of outstanding postdoctoral researchers from a mentored training environment into stable, independent faculty-style research positions, ideally reaching research independence earlier than the typical timeline. A key feature of this specific announcement is that an independent clinical trial is required, signaling that the proposed research must include a clinical trial component that aligns with NIH definitions and expectations.
Mechanically, this opportunity follows the classic K99/R00 structure: an initial mentored phase (K99) supporting a postdoctoral or equivalent candidate while they complete targeted training and build a publication and preliminary data foundation, followed by an independent phase (R00) that activates once the awardee secures an independent research position and meets NIH transition requirements. The overall intent is career development plus a clear pathway to independence, not simply project funding. The research scope is anchored in tobacco regulatory science, meaning the funded studies should generate findings that are useful for regulatory decision-making around tobacco products, including evidence about product characteristics, consumer behavior, marketing impacts, distribution patterns, and other factors that regulators may consider when developing, implementing, or evaluating policy.
The sponsoring agency is the National Institutes of Health (NIH), and the opportunity is listed as a discretionary grant program in the health category with CFDA number 93.077. The funding opportunity title is "Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - Independent Clinical Trial Required)," and the funding opportunity number is RFA-OD-18-008. The posting was created on 2018-05-15, and the original closing date shown is 2019-11-08. The listing does not provide an award ceiling or expected number of awards in the provided source data, which typically means applicants would need to consult the full announcement and NIH budget guidance for caps, allowable costs, and typical award sizes.
Eligibility is broad across U.S.-based organizations and includes many common NIH applicant types: 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; public housing authorities and Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits with and without 501(c)(3) status (excluding higher education institutions where that distinction is relevant); for-profit organizations other than small businesses; and small businesses. The announcement also explicitly calls out additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Indian/Native American tribal governments other than federally recognized entities, regional organizations, Tribally Controlled Colleges and Universities (TCCUs), and U.S. territories or possessions. These inclusions signal an intent to encourage participation from a wide range of institutions, including those serving groups historically underrepresented in biomedical research.
At the same time, the opportunity draws a firm line on 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 to apply, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed. In other words, applicants must be U.S.-based organizations without foreign components in the proposed project structure, which can affect planning for international collaborations, study sites, or subcontracting arrangements.
Overall, this K99/R00 opportunity is best understood as a career-launching mechanism for tobacco regulatory scientists: it is designed to support a mentored postdoctoral period that strategically prepares an investigator for independence, followed by a funded jump into an independent role where they can continue producing policy-relevant tobacco research with increasing autonomy and competitiveness for future NIH or other independent research support.Apply for RFA OD 18 008
- 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 2018-05-15.
- Applicants must submit their applications by 2019-11-08. (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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FAQs: Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - Independent Clinical Trial Required)
What is this funding opportunity?
This is an NIH Pathway to Independence Award focused on tobacco regulatory research. The official title is "Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - Independent Clinical Trial Required)," and the funding opportunity number is RFA-OD-18-008.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What is the main purpose of this K99/R00 award?
The purpose is to build and sustain a pipeline of early-career scientists whose research directly supports tobacco product regulation. It is meant to help outstanding postdoctoral (or equivalent) researchers move from a mentored training environment into stable, independent faculty-style research positions, ideally reaching independence earlier than the typical career timeline.
Is this award primarily career development or project funding?
Based on the description provided, it is primarily a career development mechanism with a structured pathway to independence. While it supports research, the central intent is to accelerate the transition to research independence rather than to function as stand-alone project funding.
What does "K99/R00" mean in practical terms?
The opportunity follows a two-phase structure: (1) an initial mentored phase (K99) supporting a postdoctoral or equivalent candidate for targeted training and early research progress, and (2) an independent phase (R00) that activates after the awardee secures an independent research position and meets NIH transition requirements.
What is expected during the K99 (mentored) phase?
The K99 phase is described as a mentored training period where the investigator completes targeted training and builds a foundation that typically includes publications and preliminary data, positioning them to transition into an independent role.
When does the R00 (independent) phase start?
The R00 phase is designed to begin once the awardee secures an independent research position and meets NIH transition requirements. The provided information does not list specific requirements, but it does state that NIH transition requirements must be met for R00 activation.
What research area does this opportunity support?
The research scope is anchored in tobacco regulatory science. Funded studies should generate findings useful for regulatory decision-making about tobacco products, including how products are manufactured, distributed, and marketed, and how consumers respond to products and related marketing and availability.
What kinds of topics are considered relevant to tobacco regulatory decision-making under this opportunity?
The description highlights regulatory-relevant evidence such as product characteristics, consumer behavior, marketing impacts, distribution patterns, and other factors regulators may use when developing, implementing, or evaluating policy.
Does this funding opportunity require a clinical trial?
Yes. A key feature explicitly stated is "Independent Clinical Trial Required," meaning the proposed research must include an independent clinical trial component that aligns with NIH definitions and expectations.
What does "Independent Clinical Trial Required" imply for applicants?
It indicates that the proposed research must include a clinical trial component and that it must meet NIH definitions and expectations for an independent clinical trial. The provided information does not include operational details (such as specific trial design rules), but it clearly signals that a clinical trial is not optional for this announcement.
Who is this award intended for?
It is intended for early-career scientists, specifically outstanding postdoctoral researchers (or equivalent) who are ready to transition from mentored training into an independent research position.
What is the broader goal for awardees by the end of the program?
The program aims to produce a strong cohort of investigators capable of generating evidence that informs and evaluates tobacco-related regulations, while also establishing themselves in stable, independent research roles with increasing autonomy and competitiveness for future funding.
What is the CFDA number and what category is this opportunity listed under?
The CFDA number is 93.077, and it is listed as a discretionary grant program in the health category.
What is the funding opportunity number?
The funding opportunity number is RFA-OD-18-008.
When was this opportunity posted and what closing date is shown?
The posting was created on 2018-05-15, and the original closing date shown is 2019-11-08.
Is there an award ceiling or a stated expected number of awards?
Not in the information provided. The source data described does not include an award ceiling or the expected number of awards, which typically means applicants would need to consult the full announcement and NIH budget guidance for limits, allowable costs, and typical award sizes.
What types of U.S. organizations are eligible to apply?
Eligibility is broad and includes U.S.-based organizations such as 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; public housing authorities and Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses.
Are institutions that serve historically underrepresented groups explicitly included as eligible?
Yes. The announcement explicitly lists eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and other similar categories, signaling an intent to encourage broad participation.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly mentioned among the additional eligible applicant categories.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are explicitly included among the eligible applicant categories.
Are foreign (non-U.S.) institutions allowed to apply?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply.
Can a U.S. organization apply if it includes a non-domestic component?
No. The information provided states that non-domestic components of U.S. organizations are not eligible to apply.
Are foreign components allowed in the proposed project (for example, foreign sites or foreign subcontracting)?
No. The description states that foreign components (as defined by the NIH Grants Policy Statement) are not allowed. This can affect plans involving international collaborations, study sites, or subcontracting arrangements.
What is the practical takeaway regarding international collaboration?
The opportunity draws a firm line against foreign involvement: applicants must be U.S.-based organizations and cannot include foreign components. Any planning that relies on international study sites or foreign components would not fit the stated eligibility restrictions.
What type of evidence is NIH aiming to support through this program?
The program is aimed at producing evidence that helps inform and evaluate tobacco product regulations, including evidence relevant to manufacturing, distribution, marketing, and consumer behavior as they relate to regulatory decision-making.
What is the overall "pathway to independence" being supported?
The pathway is structured as a mentored postdoctoral period (K99) with targeted training and foundation-building, followed by support in an independent role (R00) where the investigator continues policy-relevant tobacco research with greater autonomy.
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