AppalTRUST Tobacco Regulatory Science Pilot Funding
The University of Kentucky Appalachian Tobacco Regulatory Science Team (AppalTRUST) Tobacco Center of Regulatory Science (TCORS) is pleased to announce a call for proposals for Tobacco Regulatory Science (TRS) Pilot Funding.
The goal is to support projects that align with the mission of AppalTRUST and inform tobacco regulatory policy. The overall mission of AppalTRUST is to investigate the impact of US Food and Drug Administration Center for Tobacco Products (FDA CTP) regulatory policies in rural communities, a priority and understudied population, through collaboration, education, and pioneering regulatory scientific research. Priority will be given to projects focusing on health disparities or advancing health equity.
Pilot Grant Application Form
Click below to submit a proposal. Priority will be given to projects focusing on health disparities or advancing health equity.
INTRODUCTION
Applications must be within the scope of current NIH TRSP and FDA CTP research priorities and fall within the FDA CTP’s regulatory authority over the manufacture, marketing, and distribution of tobacco products. Pilot study proposals will be vetted through the AppalTRUST Center and FDA for approval prior to funding.
The results from each funded project should provide preliminary data to support a grant application for external funding in tobacco regulatory science to be submitted within 12 months from the project pilot funding conclusion. In the pilot application, applicants are required to detail the external funding opportunity, the funding announcement number, and the funding application deadline they intend to pursue.
We are particularly interested in supporting post-doctoral, new, and early-stage investigators, as well as those new to tobacco regulatory science. The number of awards will depend on the availability of funds, total budget requests, and merit of the applications. The total annual budget for each pilot proposal is up to $20,000 for primary data collection and up to $8,000 for secondary data analysis for the project period. We anticipate funding a total of 2-4 projects in the 2024-2025 period of funding.
Timeline
Release Date: 08/15/2024
Application Deadline: 09/30/2024
Funding Decision 11/15/2024
Anticipated Funding Start Date: 12/01/2024
Project Duration: 9 months (ends Aug 31, 2025)
Eligibility
The principal investigator (PI) for each pilot project must be a full-time postdoctoral fellow or faculty member at the University of Kentucky. This program is open to full-time faculty members (all title series including regular, research, extension, lecturer, clinical, and special) and postdoctoral researchers at the University of Kentucky. To be eligible to apply for funding, applicants must apply to be an AppalTRUST Affiliate (link here).
For post-doctoral trainees, proposals must have a faculty co-I affiliated with the UK AppalTRUST. Post-doctoral mentors can apply to be an AppalTRUST Affiliate (link here).
Collaboration with existing AppalTRUST investigators is permitted but is not required. Affiliates from other universities and institutions participating with TCORS or conducting TRS research may collaborate with UK AppalTRUST investigators and participate in pilot research as co-investigators.
As this grant is funded by NIDA. NIDA provides researchers with additional considerations regarding applicants who also receive tobacco-industry funding. Based on your COI disclosures, AppalTRUST TCORS may ask for additional information regarding potential conflicts of interest.
Research Priorities
Proposals should address current National Institutes of Health (NIH) Tobacco Regulatory Science Program (TRSP) and US Food and Drug Administration Center for Tobacco Products (CTP) research priorities, with a specific focus on regulatory policies in rural communities, a priority and understudied population.
Responsiveness to FDA’s Center for Tobacco Products Regulatory Authority.
These FAQs (PDF) clarify research that is and is not within scope of the FDA’s Center for Tobacco Products (CTP) regulatory authority (see #3). Only research that is within the regulatory authority of the FDA CTP will be considered for funding. Note: For this mechanism you do not need to contact NIH staff to determine if pilot grant ideas are responsive to FDA CTP authority. If you have questions about whether your idea is responsive, please contact melinda.ickes@uky.edu to discuss your idea prior to submission.
In general, what areas of research are within the FDA CTP’s regulatory authority?
Research is encouraged in the following scientific domains:
• Chemistry and Engineering
• Toxicity
• Addiction
• Health effects
• Behavior
• Communications
• Marketing influences
• Impact analysis
In general, what areas of research are not within the FDA CTP’s regulatory authority?
The Family Smoking Prevention and Tobacco Control Act gives the FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by youth.
In general, the FDA CTP’s regulatory authorities do NOT extend to the following:
• Setting tax rates for tobacco products
• Regulating therapeutic products, such as those marketed to treat tobacco dependence (regulated by other parts of FDA)
• Setting clean indoor air policies
• Regulating tobacco growing
• Requiring the reduction of nicotine yields to zero
• Providing cessation services
• Banning all cigarettes, smokeless tobacco products, little cigars, other cigars, pipe tobacco, or roll-your-own tobacco products
• Changing the minimum age to purchase tobacco products
• Mechanistic studies (i.e., basic science of disease development) unless biomarkers of harm with predictive value for disease development associated with tobacco product use is an outcome
Application Process
Release Date: 08/15/2024
Application Deadline: 09/30/2024
Funding Decision 11/15/2024
Anticipated Funding Start Date: 12/01/2024
Project Duration: 9 months (ends Aug 31, 2025)
Applications must be submitted through the application portal (link). Please use the following format: single-spaced, at least 11-point Arial font, and adhere to 1/2-inch margins. The proposal documents should be compiled into one PDF to upload to the application portal. Proposal submission through OSPA or completion of an eIAF is not required.
Required Application Materials
Pilot Grant application form (link)
Lay abstract (300-word max) – provide a succinct overview of the proposal, including how the proposal is relevant to FDA’s tobacco regulatory authority, relevant to the overall theme of the UK AppalTRUST TCORS, or other TCORS sites or centers.
Body of application (6 page limit)
- Specific Aims (1 page)
- Briefly describe the research question(s) and significance of the proposed study
- Brief statement on how the project aligns with AppalTRUST’s mission and research priorities
- Brief statement on the relevance of the project to FDA/CTP’s tobacco regulatory authorities
- Research Plan (3-4 pages)
- Significance/Innovation: Describe how addressing the study aims will promote the translation of scientific knowledge that will impact tobacco regulatory science and impact public health. Describe how the aims, methods, etc. are innovative.
- Approach/Scientific Rigor and Reproducibility: Describe the activities that will be undertaken to address the study aims. Include a description of how scientific rigor and reproducibility will be ensured.
- Responsiveness to FDA/CTP Research Priorities.
- Investigators and Environment: Describe the qualifications of the investigative team, the role each team member will perform, and resources in the environment that will support the conduct of the study. Describe collaborations with UK AppalTRUST TCORS; and other TCORS sites or centers, as applicable.
- Dissemination and External Funding (½ page)
- Describe the plans for specific deliverables and outcomes beyond the pilot project, including dissemination plans and submissions for extramural funding (e.g., please include the names of the extramural funding opportunities and the date expected to apply for external funding). Examples include: presentations at TRS or TCORS events, presentations to the AppalTRUST Community Advisory Boards and other community dissemination outlets (e.g., UK CERH’s Appalachian Research Day), grant submissions, manuscript submissions, and/or the development of a new interdisciplinary team for future grant submissions.
Appendices (not included in the 5-page limit).
- Timeline: Must include a timeline with 3, 6, 9, and 12-month goals/targets achievements. References (no page limit)
- NIH or NSF style biosketch for each investigator (5-page limit per investigator)
- Clearly outline each investigator’s role on the project. Please check here for instructions on formatting an NIH biosketch. Please check here for instructions on formatting an NSF biosketch.
- Combine all biosketches into one PDF.
- Budget and budget justification (1-2 pages)
- Provide a detailed justification for each budget item or category.
- Allowable expenses include: staff, student, post-doc effort/salary; travel costs associated with data collection or recruitment; participant payments; supplies or materials to support the research.
- Non-allowable expenses include faculty salary, tuition, computers, and indirect costs.
- Pilot funds cannot replace current post-doctoral TCORS salary support. Please note that this only pertains to fully funded post-docs on the AppalTRUST or other TCORS.
- No-cost extensions are not permitted
- Note: The review committee will make budgetary recommendations that may impact the final award amount.
- Budgets do not need to be submitted through OSPA
- Letter(s) of support (optional)
- If applicable include letters of support from collaborators (e.g., community partners, consultants, data, or facilities access needed to complete the project)
- Post-docs should include a letter of support from their mentor.
- Institutional Review Board (if applicable)
- Should any component of the research require the use of human subjects, please indicate whether Institutional Research Board (IRB) approval is pending or approved.
- New (or a modification of) human subjects approval from NIDA is required before pilot project recruitment can commence. In addition, if a pilot project involves new activities with existing human subjects that are not covered under an existing IRB approval for studies currently in AppalTRUST/the UK TCORS, additional IRB approval will be needed before engaging in human subjects research. Additional details will be provided to those receiving funding.
Reporting Requirements
Recipients are expected to be responsive to ongoing contact from AppalTRUST to assess progress and outcomes from the award. Awardees are also required to present their findings at an AppalTRUST sponsored event upon request.
All publications, presentations, and other creative activities resulting from this award must include the following acknowledgment: “Research reported in this publication was supported by grant number U54DA05825601 from the NIH and FDA Center for Tobacco Products (CTP). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration.”
Awardees will submit a one-page 4-month progress report (due by March 30) describing progress on the project, barriers to progress, new feasibility concerns or major changes to the project, continued investigator commitment, and any products from the project.
Annual progress reports will be accompanied by a meeting with Career Enhancement Core Leads to discuss progress, challenges, and next steps. A final report that is one (1) page in length is due two weeks after project/funding completion (September 15, 2025). It must detail the tangible results, e.g., the status of external grant submission, citations from publications, presentations, community dissemination activities as appropriate, and next steps.
All pilot recipients will also receive a bi-annual reporting survey to detail external grant submissions, citations from publications, presentations, community dissemination activities as appropriate, and next steps.
Review Criteria
All proposals will first be screened to ensure they are responsive to FDA CTP research priorities. Those that are not responsive will not be fully reviewed. The AppalTRUST Pilot Review Committee will review responsive proposals based on the criteria outlined below. The review committee will also assess whether the proposed budget and timeline are appropriate for the scope and nature of the project and whether any human subjects considerations may affect study implementation.
As specified by NIH, research proposals selected for awards will need FDA approval before notifying awardees.
Each proposal will be evaluated based on the following criteria:
Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Significance: Does the project address an important issue or a critical barrier in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge and/or technical capability be improved? How will successful completion of the aims affect the concepts, methods, and technologies related to the manufacture, distribution, and marketing of tobacco products?
Innovation: (Does the application challenge and seek to shift current research in the field of tobacco regulatory science as it relates to the manufacture, distribution, and marketing of tobacco products? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, or instrumentation proposed? Will the outcomes of the project provide new information to further develop the knowledge base that informs the manufacture, distribution, and marketing of tobacco products in order to protect public health?
Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Investigator(s): (Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Evidence of future research and funding potential: Does the proposed research show unambiguous evidence of potential for future funding? Does the proposal adhere to the specific requirement regarding a clear explanation of the next steps toward external funding and provides details regarding an identified funding mechanism?
CONTACT
Please contact Melinda Ickes, PhD, lead of the AppalTRUST Career Enhancement Core (melinda.ickes@uky.edu) with any questions.