Key Dates

Related Announcements

• June 29, 2023 - Research Supplements to Promote Diversity in Health-Related Research (Parent Admin Supp - Clinical Trial Not Allowed).  See NOFO PA-23-189

Issued by

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Purpose

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 FDA’s 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 NIH’s 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.

• Product Composition and Design Understanding the chemical constituents in tobacco products and the methods for measuring them across products with diverse characteristics*
• Toxicity Understanding how tobacco products and changes to tobacco product characteristics* affect their potential to cause morbidity and mortality in users and nonusers through secondary exposure; including animal (in vivo) and cell culture (in vitro) models, as well as novel alternative toxicology approaches that test the toxicity of tobacco smoke (other than cigarette), aerosols, or specific constituents in tobacco and the tobacco product.
• Addiction Understanding the effect of tobacco product characteristics* on addiction and abuse liability across populations.
• Health Effects Understanding the short- and long-term health effects of tobacco products (excluding conventional cigarettes) with priority on longitudinal data. Areas of interest include cardiovascular, cancer, neurological (e.g., seizures), oral, reproductive, and respiratory health effects (including inflammation and lung disorders (e.g., asthma, COPD).
• Behavior Understanding the knowledge, attitudes, perceptions, and behaviors related to tobacco product use and the impact of tobacco product characteristics* on behaviors across populations, as appropriate.
• Communications Understanding how to effectively communicate to the public regarding nicotine and the health effects of tobacco products through media campaigns and digital media.
• Marketing Influences Understanding the impact of marketing on susceptibility to and initiation of using tobacco products (both classes of products and products within classes) and transitions between experimentation, initiation, regular use, product switching, dual use, and cessation-related behaviors among different populations. Topics may include marketing such as advertising, digital media, and promotions.
• Impact Analysis Understanding the potential or actual impact of FDA regulatory actions.

*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:

• Data Harmonization for Tobacco Regulatory Research via the PhenX Toolkit: NIH and FDA encourage investigators conducting human-subjects studies to incorporate measures from the PhenX Toolkit (www.phenxtoolkit.org), including measures from the Tobacco Regulatory Research Collections. The PhenX Toolkit provides standard measures for inclusion in human subjects research to enable sharing, comparing, and combining of data and results.
• Tobacco Industry Funding of Applicants: The FDA CTP has adopted the following guidance regarding tobacco industry funding of applicants responding to this supplement. The National Advisory Council on Drug Abuse (NACDA) has set forth points with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA’s credibility and reputation within the scientific community. This includes any consulting relationships (paid or unpaid) with the tobacco industry or organizations supported in whole or in part by this industry. Please see (https://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding-tobacco-industry-funding-nida) for details. While this guidance was originally issued for NIDA applicants, it is relevant for all applications submitted under this supplement.
• Recommended Guidelines for the Administration of Drugs to Human Subjects: NACDA also recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA’s Web site at https://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

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.

• For Institute and Center (IC) Application Due Date(s) and additional information, applicants should refer to the Table of IC-Specific Information, Requirements and Staff Contacts. Applicants are strongly encouraged to contact the identified IC staff listed below before submission of an application.
• Requests may be for up to 3 years of support.
• Applications that are non-responsive and proposing work outside of FDA-CTP’s regulatory authority will not be reviewed.
• Applicants are requested to state in the first sentence of the Research Strategy this specific Notice number (NOT-OD-24-074) and the title of the parent grant to facilitate processing of the supplement application.
• The parent award must be active and the proposed budget period of the supplement must be within the parent project period. It must also be within the scope of the parent award.
• For internal tracking purposes, applicants are requested to send an email to the TRSP mailbox (TRSP@nih.gov) and the identified Scientific/Research Contact listed below when a supplement application is submitted. Please include the PD/PI name and Notice Number (NOT-OD-24-074) in the subject line of this email.
• Applications submitted after May 15, 2024, will not be considered for this notice. IC-specific application due dates prior to May 15, 2024, supersede this date.

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 grant’s 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.

Inquiries

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: Rachel.Mayne@nih.gov

Lisa Postow, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0202
Email: Lisa.Postow@nih.gov

Mary Kautz, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-3206
Email: NIDATRSprogram@nida.nih.gov

Fred Tyson, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3334
Email: Fred.Tyson@nih.gov 

Tobacco Regulatory Science Program (TRSP)
Email: TRSP@nih.gov

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