April 1, 2024
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
This Notice of Information is to notify Program Director(s)/Principal Investigator(s) who are conducting tobacco regulatory research that funds are available for administrative supplements to enhance the tobacco regulatory research workforce by recruiting, mentoring, and supporting high school, undergraduate and graduate/clinical students, post baccalaureate and post-Masters individuals, postdoctoral researchers (including health professionals), and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research. This supplement opportunity is also available to support PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability to continue to work on the research project. The Research Supplements to Promote Diversity in Health-Related Research are designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. However, applicants are permitted to propose engagement in a research experience in a clinical trial led by a mentor or co-mentor.
The activities proposed in the supplement application must fall within the scope of the parent grant and the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) and support the research training and professional development of the supplement candidate.
Awards under this supplement will be administered by NIH using funds made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from these awards are expected to generate findings and data that are directly relevant in informing the FDAs regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. More information about the FDA CTP is available at: https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp .
Please note that consistent with NIH practice and applicable law, funded programs may not use the race, ethnicity, or sex of prospective program participants or faculty as an eligibility or selection criteria. The race, ethnicity, or sex of candidates will not be considered by NIH in the application review process or when making funding decisions.
Background
Since 2009, FDA has regulated cigarettes, smokeless, and roll-your-own tobacco. FDA finalized a rule, effective August 8, 2016, to regulate all tobacco products including electronic nicotine delivery systems or ENDS (e.g., vapes, vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigarettes or e-cigs), and e-pipes), cigars, pipe tobacco, gels, hookah (waterpipe) tobacco, and future tobacco products. Tobacco products are subject to provisions outlined in the FD&C Act. FDA also has the authority to develop tobacco product standards, when appropriate for the protection of public health.
A full description of the FSPTCA can be found at: https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-prevention-and-tobacco-control-act-table-contents .
Notice of NIHs Interest in Diversity
NIH has a strong interest in the diversity of the NIH-funded research enterprise (see NIH notice NOT-OD-20-031 and NOT-OD-22-019) and encourages institutions to engage in recruitment activities with prospective individuals from groups identified as underrepresented in the biomedical, clinical, behavioral, and social sciences to foster their participation in the scientific research enterprise. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.
All research conducted through the supplement must fall within CTP regulatory authority with aims related to the following scientific domains. Detailed scientific domains may be viewed on the TRSP website.
*The term characteristic encompasses materials, ingredients (including additives, nicotine formulations, and flavors), design, composition, heating source, and other features of a tobacco product, including harmful and potentially harmful constituents. Product characteristics can be incorporated into all the above topics.
Projects must propose research aims that are within the regulatory authority of FDA CTP and the scientific interest areas identified in this Notice in order to be considered responsive to this Notice. As such, investigators are strongly encouraged to discuss whether their application is responsive to this Notice with a Scientific/Research Contact listed below before submission of their application.
SPECIAL CONSIDERATIONS
Applicants should keep the following special considerations in mind as they prepare their applications:
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity.
PA-23-189 - Research Supplements to Promote Diversity in Health-Related Research (Parent Admin Supp - Clinical Trial Not Allowed)
All instructions in the SF424 (R&R) Application Guide must be followed.
Review Process/ Information
NIH ICs, the NIH Tobacco Regulatory Science Program (TRSP), and CTP will conduct administrative reviews of all applications.
Reporting
In addition to an annual progress report, submitted as required in the parent grants research performance progress report (RPPR), a Mid-Period Progress Report (MPPR) will be due every six (6) months following the project start date. Electronic copies should be sent to the Grants Management Specialist listed on the Notice of Grant Award. The MPPR will use the Non-Competing Continuation Progress Report; PHS 2590, and the scientific summary should be a maximum of two (2) pages.
Potential applicants are strongly encouraged to contact the identified appropriate Scientific/Research Contact.
Scientific/Research Contact(s)
Rachel Grana Mayne, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-5899
Email: [email protected]
Lisa Postow, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0202
Email: [email protected]
Mary Kautz, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-3206
Email: [email protected]
Fred Tyson, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3334
Email: [email protected]
Tobacco Regulatory Science Program (TRSP)
Email: [email protected]
For Specific IC Information pertaining to PA-23-189 Research Supplements to Promote Diversity Health-Related Research (Parent Admin Supp - Clinical Trial Not Allowed):
See Table of IC-Specific Information, Requirements and Staff Contacts
Peer Review Contact(s)
Not Applicable