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University of Vermont Tobacco Center of Regulatory Science

Award Number: U54DA036114
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2013
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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University of Vermont Tobacco Center of Regulatory Science - The overarching goal of this application is to renew the University of Vermont Tobacco Center of Regulatory Science (UVM TCORS). This multidisciplinary center is located at UVM but leverages close collaborations with Brown University, Johns Hopkins University, University of Pittsburgh, and University of Minnesota. The UVM TCORS focuses on a crosscutting integrative theme (vulnerable populations) and two of the scientific domains (addiction, behavior) of the Food and Drug Administration Center for Tobacco Products (FDA CTP). Building programmatically on research in the current funding period, we propose to focus our primary studies on three vulnerable populations, socioeconomically disadvantaged women of reproductive age/pregnant, individuals with comorbid opioid use disorders, and individuals with comorbid affective disorders. Each of these populations is at increased risk for tobacco use, dependence, and tobacco-related adverse health outcomes. Despite their increased risk, these populations are often excluded from tobacco regulatory studies, leaving a significant knowledge gap. The overall goal of the UVM TCORS is to provide FDA CTP with sound scientific evidence on the impacts of tobacco products in vulnerable populations, a topic that is critically important to FDA CTP effectively executing its tobacco regulatory responsibilities. Regarding specific regulatory priorities, we will continue to focus on reduced nicotine standards in combusted tobacco products. We have designed our studies in vulnerable populations to align with those conducted in healthier populations by the University of Pittsburgh/University of Minnesota TCORS. The primary trials proposed in this application will examine the extent to which the availability and appeal of alternative non-combusted sources of nicotine (i.e., e-cigarettes) may moderate the impact of reduced nicotine standards on reducing cigarette smoking. That topic will be investigated in each of the primary vulnerable populations of interest using common protocols to the extent possible, and also protocols that facilitate comparisons with studies in healthier populations as noted above. We propose to continue our Administrative and Career Enhancement Cores. The Administrative Core supported completion of three multisite studies, with three others underway, during the past 4 years, along with numerous pilot/developmental studies. Cumulatively, those projects resulted in 58 publications in peer- reviewed journals and many more presentations at national scientific meetings. We are proposing a plan to effectively recruit and implement pilot and rapid-response studies. We propose to continue a highly effective predoctoral and postdoctoral mentoring program comprising 10 fellow slots that have been continuously filled during the current funding period. We will continue contributing to FDA CTP conferences and other scholarly initiatives, and plan to continue leading the Vulnerable Populations TCORS Workgroup and to participate in others. Overall, UVM TCORS is well positioned to be a valuable asset to FDA CTP and others with interests in tobacco regulatory science especially as it applies to vulnerable populations.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = -$445 )
2026	2022	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT STREET	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	10	3/3/2026	NON-COMPETING CONTINUATION	-$445
														Subtotal = -$445

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2022	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT STREET	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	10	12/9/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT STREET	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	10	8/9/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT STREET	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	10	7/19/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $3,882,006 )
2022	2022	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	10	8/26/2022	NON-COMPETING CONTINUATION	$3,882,006
2022	2021	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	9	4/21/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $3,882,006

Issue Date FY: 2021 ( Subtotal = $3,892,998 )
2021	2021	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	9	9/17/2021	NON-COMPETING CONTINUATION	$0
2021	2021	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	9	8/30/2021	NON-COMPETING CONTINUATION	$3,892,998
2021	2020	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	8	7/22/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $3,892,998

Issue Date FY: 2020 ( Subtotal = $5,618,361 )
2020	2020	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	005	8	8/25/2020	NON-COMPETING CONTINUATION	$3,904,096
2020	2019	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	003	7	6/19/2020	NON-COMPETING CONTINUATION	$0
2020	2018	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	6	5/14/2020	COMPETING CONTINUATION	$1,713,820
2020	2018	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	004	6	7/23/2020	COMPETING CONTINUATION	$445
2020	2018	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	6	5/15/2020	COMPETING CONTINUATION	$0
2020	2018	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	6	1/31/2020	COMPETING CONTINUATION	$0
														Subtotal = $5,618,361

Issue Date FY: 2019 ( Subtotal = $3,922,576 )
2019	2019	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	003	7	8/8/2019	NON-COMPETING CONTINUATION	$3,922,576
2019	2018	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	6	10/24/2018	COMPETING CONTINUATION	$0
2019	2018	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	6	10/23/2018	COMPETING CONTINUATION	$0
2019	2018	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	6	5/13/2019	COMPETING CONTINUATION	$0
														Subtotal = $3,922,576

Issue Date FY: 2018 ( Subtotal = $3,779,709 )
2018	2018	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	6	8/31/2018	COMPETING CONTINUATION	$3,779,709
														Subtotal = $3,779,709

Grand Total All Awards = $21,095,205

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University of Vermont Tobacco Center of Regulatory Science

Award Number: U54DA036114

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2013

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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