[National Institutes of Health](https://www.nih.gov)

October 4, 2024 (final deadline; early expiration)

Up to $500,000 direct costs/year, max 5 years; typically 6 awards, total program up to $4M/year.

Supports research to generate scientific data informing FDA regulation of tobacco products to protect public health.

This opportunity expires October 7, 2024; no applications accepted after October 4, 2024.

--- ## Description This funding opportunity supports biomedical and behavioral research that provides scientific data to inform the regulation of tobacco products, with the goal of protecting public health. Projects must address research priorities relevant to the regulatory authority of the FDA Center for Tobacco Products (CTP). The program is administered by NIH using funds from the FDA CTP and the Family Smoking Prevention and Tobacco Control Act. Research funded under this opportunity is expected to generate findings directly relevant to the FDA’s regulation of the manufacture, distribution, and marketing of tobacco products. Both clinical trial and non-clinical trial R01 applications are accepted. **Note:** This opportunity expires early—no applications will be accepted after October 4, 2024. --- ## Due Dates - **Final Application Deadline:** October 4, 2024 (5:00 PM local time of applicant organization) - **Letter of Intent:** 60 days prior to the application due date (encouraged, not required) - **No late applications will be accepted.** - **Expiration:** October 7, 2024 (see [NOT-OD-25-001](https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-001.html)) --- ## Funding Amount - **Direct Costs:** Up to $500,000 per year - **Project Period:** Up to 5 years - **Estimated Number of Awards:** Up to 6 R01s per cycle - **Total Program Funding:** Up to $4 million per year (subject to availability) - **No cost sharing or matching required.** --- ## Eligibility Eligible applicants include: - Public and private institutions of higher education (including HBCUs, Hispanic-serving, Tribal, and other minority-serving institutions) - Nonprofits with or without 501(c)(3) status (other than institutions of higher education) - For-profit organizations (including small businesses) - State, county, city, township, and special district governments - Native American tribal governments and organizations (federally recognized and other) - Independent school districts - Public housing authorities/Indian housing authorities - Faith-based and community-based organizations - Regional organizations - U.S. territories and possessions - Non-domestic (non-U.S.) entities (foreign organizations) and foreign components of U.S. organizations **Individuals** with the skills, knowledge, and resources necessary to carry out the proposed research are encouraged to apply. Multiple applications from the same organization are allowed if scientifically distinct. --- ## Application Process - **Application Mechanism:** R01 Research Project Grant (Clinical Trial Optional) - **Submission:** Applications must be submitted electronically via [Grants.gov](https://www.grants.gov/search-results-detail/347922) or NIH ASSIST. - **Required Registrations:** SAM, eRA Commons, Grants.gov (can take 6+ weeks; start early) - **Application Guide:** Follow the [SF424 (R&R) Application Guide](https://grants.nih.gov/grants/guide/url_redirect.php?id=82400) and the specific instructions in the [NOFO](https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-23-017.html). - **Letter of Intent:** Email to TRSP@nih.gov (see full NOFO for details) - **Page Limits:** As specified in the [NIH Table of Page Limits](https://grants.nih.gov/grants/forms_page_limits.htm) - **Data Management and Sharing Plan:** Required for all applications generating scientific data. --- ## Research Scope Projects must address research priorities within the regulatory authority of the FDA CTP, including but not limited to: - Product composition and design - Toxicity and health effects (short- and long-term) - Addiction and abuse liability - Knowledge, attitudes, perceptions, and behaviors related to tobacco use - Communication strategies about tobacco product risks - Marketing influences and impact analysis of regulatory actions **Non-responsive topics** (will not be reviewed) include: - Mechanistic studies not linked to regulatory outcomes - Studies of early-generation ENDS products’ acute effects - Studies of graphic health warnings for cigarette packages - Studies of health care provider knowledge/attitudes - Studies outside FDA CTP’s regulatory authority Applicants are strongly encouraged to consult with NIH scientific contacts to confirm responsiveness. --- ## Additional Information - **Clinical Trials:** Both clinical trial and non-clinical trial R01s are accepted. - **Data Harmonization:** Use of standard measures (e.g., PhenX Toolkit) is encouraged. - **Tobacco Industry Funding:** Applicants with tobacco industry funding or relationships should review NIH/FDA guidance ([see details](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)). - **Foreign Institutions:** Eligible and encouraged to apply; must follow NIH foreign institution policies. - **Reporting:** Annual and mid-period progress reports required; see NOFO for details. --- ## External Links - [NIH Funder Home Page](https://www.nih.gov) - [Full Funding Opportunity Announcement (NOFO)](https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-23-017.html) - [Grants.gov Opportunity Listing](https://www.grants.gov/search-results-detail/347922) - [NIH Application Guide (SF424 R&R)](https://grants.nih.gov/grants/how-to-apply-application-guide/forms-h/research-forms-h.pdf) - [FDA Center for Tobacco Products](https://www.fda.gov/tobacco-products) - [PhenX Toolkit for Tobacco Regulatory Research](https://www.phenxtoolkit.org/) - [NIH Data Management and Sharing Policy](https://sharing.nih.gov/data-management-and-sharing-policy/about-data-management-sharing-policy/data-management-and-sharing-policy-overview) --- ## Contact Information | Area | Contact | Email | Phone | |------|---------|-------|-------| | General Grants Info | NIH Grants Information | grantsinfo@nih.gov | 301-480-7075 | | Scientific/Research Contacts | Rachel Grana Mayne, PhD, MPH (NCI) | Rachel.Mayne@nih.gov | 240-276-5899 | | | Lisa Postow, PhD (NHLBI) | Lisa.Postow@nih.gov | 301-435-0202 | | | Mary Kautz, PhD (NIDA) | NIDATRSprogram@nida.nih.gov | 301-443-3206 | | | Fred Tyson, PhD (NIEHS) | Fred.Tyson@nih.gov | 984-287-3334 | | Peer Review | Center for Scientific Review | FOAReviewContact@csr.nih.gov | | | Grants Management | Crystal Wolfrey (NCI) | Crystal.Wolfrey@nih.gov | 240-276-6277 | | | Judy Sint (NHLBI) | Judy.Sint@nih.gov | 301-480-1307 | | | Amy Bucheimer (NIDA) | Amy.Bucheimer@nih.gov | 301-827-6694 | | | Michelle Victalino (NIEHS) | Michelle.Victalino@nih.gov | 984-287-3336 | ---

Tobacco Regulatory Science (R01 Clinical Trial Optional)

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