What We Do
With the passage of the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the FDA acquired the authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. To better inform FDA’s regulatory authorities, the NIH and FDA formed an interagency partnership to foster tobacco regulatory research, capitalizing on NIH’s infrastructure to support tobacco-related research and funding from FDA. Get more information about the FDA Center for Tobacco Products (FDA/CTP) research priorities.
NIDA-TRSP Office Roles
- Function as NIDA liaison with FDA/CTP and NIH-TRSP
- Manage internal coordinating committee comprised of each NIDA division to:
- Monitor NIH-TRSP activities and progress
- Provide administrative templates for NIDA staff
- Devise Standard Operating Procedures (SOPs)
- Help solicit nominations for IC Investigator-initiated funding requests in response to periodic NIH-TRSP-based requests
- Review Nicotine Research Cigarettes (NRC) requests, as necessary
- NRC page with procedures / schematic
- NIDA’s Drug Supply Program
- Organize NIDA-TRSP-related meetings
Current Funding Mechanisms
In collaboration with the FDA Center for Tobacco Products, NIH is increasing its portfolio to support the scientific needs of the Center. There are a number of funding opportunities, which are currently accepting applications. Investigator initiated applications may also be submitted for review. Refer to the Research Priorities page for topics relevant to FDA. Interested applicants should work with their NIH Program Officials or contact us at NIDATRSprogram@nida.nih.gov. For more information about current funding opportunities, please visit here.
Tobacco Centers of Regulatory Science (TCORS)
The TCORS program brings together scientists from across the country to aid in the development and evaluation of tobacco product regulations. Each TCORS application identifies a targeted research goal. Collectively, the TCORS sites increase knowledge across the full spectrum of basic and applied research on tobacco and addiction. The program also provides young investigators with training opportunities to ensure the development of the next generation of tobacco regulatory scientists.
Fourteen TCORS were funded in 2013 (TCORS 1.0) and in 2018, NIH and FDA renewed their commitment to the TCORS program and awarded a second cohort (TCORS 2.0) of Centers to nine institutions. NIDA programmatically manages several TCORS. The review of applications for TCORS 3.0 is underway. More information on TCORS is available here.
Grant Process:
Grant Schematic for R Funding Mechanisms
Legend:
CSR: Center for Scientific Review
IRG: Internal Review Group
PI: Principal Investigator
R Funding Mechanism (Stepwise Process)
- Principal Investigator initiates research idea and develops application.
- Principal Investigator submits application to NIH during applicable funding cycle.
- Applications compliant with NIH policies are assigned for review by the Division of Receipt and Referral in the Center of Scientific Review (CSR).
- CSR assigns application to an NIDA and a Scientific Review Group (SRG).
- Approved proposals are pre-reviewed for responsiveness to the RFA with officials from the FDA/CTP, NIH-TRSP, and NIDA Program for responsiveness and scientific merit.
- Proposals are reviewed by a CSR-based Internal Review Group (IRG)
- Proposals are evaluated based on priority score; FDA funding availability; and research priorities from the FDA Center for Tobacco Products.
- Proposals are reviewed during NIH Institute Council sessions for final approval by NIDA Institute Director.
- FDA/CTP makes funding recommendations. NIH-TRSP notifies NIDA staff of funding decisions and NIDA issues and sends Notice of Award (NoA) to applicant institution/organization.
- IC grants management staff conducts final administrative review and negotiates award.
- Research Institute (NIDA) receives and manages awards.
- Investigator conducts research.
FAQs on Grant Responsiveness:
Potential applicants should think about how the findings from the research they propose will inform a specific regulatory authority of FDA/CTP and fit within the FDA/CTP research priorities. For more information, please read the TRSP FAQs (PDF) or email NIDATRSprogram@nida.nih.gov with any questions concerning grant responsiveness.
Additional Resources:
- NIH TRSP webpage - http://prevention.nih.gov/tobacco-regulatory-research
- Ending the Tobacco Epidemic: A Tobacco Control Strategic Action Plan for the HHS - https://www.hhs.gov/sites/default/files/ash/initiatives/tobacco/tobaccostrategicplan2010.pdf (PDF, 2 MB)
- Ending the Tobacco Problem: A Blueprint for the Nation - https://www.nap.edu/catalog/11795/ending-the-tobacco-problem-a-blueprint-for-the-nation
- FDA Center for Tobacco Product’s Science and Research Page - https://www.fda.gov/tobacco-products/tobacco-science-research
- FDA Center for Tobacco Products Homepage - https://www.fda.gov/tobacco-products
- FDA Use of Investigational Tobacco Products Guidance - https://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm463953.pdf (PDF, 968KB)
Contact/Additional Information:
- All requests/questions should be sent to NIDATRSprogram@nida.nih.gov and addressed to one of the following NIDA TRSP team:
- Mary Kautz, Program Coordinator
- Lizette Nkongho, MPH, Scientific Program Manager
- Flair Lindsey, Program Analyst
- For media inquiries, please email the TRSP office to TRSP@mail.nih.gov