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. For more information about the FDA Center for Tobacco Products (FDA/CTP) research priorities, please visit here.
NIDA-TRSP Office Roles:
- NIDA liaison with FDA/CTP and NIH-TRSP
Internal coordinating committee comprised of each NIDA division will:
Monitor NIH-TRSP activities and progress through the development of:
- Provide administrative templates for NIDA staff
- Devise Standard Operating Procedures (SOPs)
- Help solicit nominations 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 (http://www.cpdd.vcu.edu/Pages/NDSP.html)
- Monitor NIH-TRSP activities and progress through the development of:
- Organize NIDA-TRSP-related meetings
Current Funding Mechanisms:
In FY2014, NIDA supported 41 TRSP-related grant awards for an estimated total of $41,593,754. Of these 41 awards, there are three supplements totaling $5,177,534 and 38 research program grants (RPGs) totaling $36,416,220.
Tobacco Centers of Regulatory Science (TCORS):
The TCORS program brings together investigators from across the country to aid in the development and evaluation of tobacco product regulations. Each TCORS application identified a targeted research goal. Taken together, the TCORS sites will 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, made up of scientists with a broad range of expertise (e.g., epidemiology, economics, toxicology, addictions, and marketing) were funded in September 2013. NIDA will programmatically manage five of the 14 funded TCORS. More information about each of these fourteen TCORS is found here.
Grant Schematic for R Funding Mechanisms
*NOTE: This is the earliest date that the investigator can conduct research. Please note dates relating to funding are subject to change at the discretion of the Administrative staff.
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. (Note: For the RPGs, there are three funding cycles. These dates include January 15, 2014; June 17 2014; and January 15, 2015).
- 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. (Note: For the RPGs, these dates include mid-Feb 2014; mid- July 2014; and mid-February 2015).
- Proposals are reviewed by a CSR-based Internal Review Group (IRG) (Note: For the RPGs, these dates include July 2014; October 2014; and July 2015).
- Proposals are evaluated based on priority score; FDA funding availability; and research priorities from the FDA Center for Tobacco Products. (Note: For the RPGs, these dates include early August 2014; November 2014; and early August 2015).
- Proposals are reviewed during NIH Institute Council sessions for final approval by NIDA Institute Director. (Note: For the RPGs, these approximate dates are August 2014; January 2015; and August 2015).
- FDA/CTP makes funding decisions. 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. (Note: For the RPGs, the earliest date that principal investigator can conduct research is October 2014; April 2014; and October 2015).
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.
- NIH TRSP webpage - http://prevention.nih.gov/tobacco/resources.aspx
- Ending the Tobacco Epidemic: A Tobacco Control Strategic Action Plan for the HHS - http://www.hhs.gov/ash/initiatives/tobacco/tobaccostrategicplan2010.pdf (PDF, 2.3MB)
- Ending the Tobacco Problem: A Blueprint for the Nation - http://www.iom.edu/Reports/2007/Ending-the-Tobacco-Problem-A-Blueprint-for-the-Nation.aspx
- Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes - http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/UCM361598.pdf (PDF, 1.7MB)
- FDA Center for Tobacco Products Office of Compliance - http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm
Sign up for email updates from the TRSP at NIH!
For media inquiries, please email the TRSP office: TRSP@mail.nih.gov