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Evaluating New Nicotine Standards for Cigarettes

Award Number: U54DA031659
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Evaluating New Nicotine Standards for Cigarettes - OVERALL PROJECT SUMMARY Combusted tobacco use continues to devastate public health in the United States and worldwide. The Tobacco Control Act provides the Food and Drug Administration with the authority to establish product standards for the nicotine content of combusted tobacco products. In this renewal application we address a critical question: What will be the impact of reducing nicotine in cigarettes in the context of alternative tobacco products? If reduced nicotine product standards render combusted tobacco products less reinforcing, smokers who choose not to quit using nicotine/tobacco completely will likely increase their use of non- combusted products. This shift from combusted to non-combusted products could greatly reduce toxicant exposure and reduce the harms associated with tobacco. Three Projects and 3 Cores are proposed. Project 1 (PI: Hatsukami) is a 12-week clinical trial that examines the use of very low nicotine content (VLNC) vs. normal nicotine content (NNC) cigarettes when smokers are provided vouchers to exchange for cigarettes in an experimental marketplace that contains a wide range of non-combusted products. Project 2 (PI: Donny) is a 7- week clinical trial comparing VLNC and NNC cigarettes when participants have access to electronic cigarettes that vary in nicotine concentration (high v. low) and available flavors (tobacco only v. tobacco and other flavors). Project 3 (PIs: Colby & Tidey) is a laboratory-based study that assessed the choice to smoke, vape, or abstain when adolescent smokers are provided cigarettes with VLNC v. NNC and e-cigarettes that vary in nicotine concentrations and flavors. The Cores will provide the infrastructure and resources to conduct these studies. The Administrative Core (Directors: Donny & Hatsukami) will ensure the implementation of appropriate procedures and protocols, the integration of methods, measures, and concepts, the communication and dissemination of information, the generation of new tobacco regulatory science through a pilot project program, and the training of new tobacco regulatory scientists. The Biomarkers Core (Director: Hecht) will provide analysis of biomarkers associated with exposure to nicotine and tobacco-related toxicants. The Biostatistics and Data Management Core (Director: Le) will assist in study design, integration and monitoring of data, data analysis, and, when appropriate, the development of novel ways to analyze data.


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: 2024 ( Subtotal = $0 )
2024	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	10	8/27/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	10	8/26/2024	NON-COMPETING CONTINUATION	$0
2024	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	10	3/1/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	10	3/28/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	10	5/4/2023	NON-COMPETING CONTINUATION	$0
2023	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	10	2/6/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $3,179,841 )
2022	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	10	3/8/2022	NON-COMPETING CONTINUATION	$2,857,780
2022	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	003	10	8/10/2022	NON-COMPETING CONTINUATION	$0
2022	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	10	4/15/2022	SUPPLEMENT FOR EXPANSION	$322,061
2022	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	9	2/11/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $3,179,841

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	9	3/16/2021	NON-COMPETING CONTINUATION	$0
2021	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	9	12/2/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $4,409,415 )
2020	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	9	3/6/2020	NON-COMPETING CONTINUATION	$4,409,415
														Subtotal = $4,409,415

Issue Date FY: 2019 ( Subtotal = $4,421,280 )
2019	2019	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	8	3/7/2019	NON-COMPETING CONTINUATION	$4,421,280
														Subtotal = $4,421,280

Issue Date FY: 2018 ( Subtotal = $4,513,522 )
2018	2018	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	7	4/5/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$4,513,522
2018	2018	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	006	7	5/17/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$4,237,256
2018	2018	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	003	7	4/30/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$4,513,522
2018	2018	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	7	3/15/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$4,513,522
2018	2017	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	009	6	5/18/2018	COMPETING CONTINUATION	-$765,641
2018	2017	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	010	6	5/22/2018	COMPETING CONTINUATION	$765,641
2018	2017	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	005	6	5/17/2018	COMPETING CONTINUATION	-$3,471,615
2018	2017	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	6	3/15/2018	COMPETING CONTINUATION	$0
2018	2017	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	007	6	5/18/2018	COMPETING CONTINUATION	-$765,641
2018	2015	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	004	5	5/17/2018	NON-COMPETING CONTINUATION	-$765,641
2018	2015	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	008	5	5/18/2018	NON-COMPETING CONTINUATION	$765,641
														Subtotal = $4,513,522

Issue Date FY: 2017 ( Subtotal = $3,471,615 )
2017	2017	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	003	6	7/17/2017	COMPETING CONTINUATION	$3,842,622
2017	2017	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	005	6	9/22/2017	COMPETING CONTINUATION	-$1,873
2017	2017	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	6	2/28/2017	COMPETING CONTINUATION	$3,471,615
2017	2015	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	5	2/28/2017	NON-COMPETING CONTINUATION	$0
2017	2015	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	5	7/17/2017	NON-COMPETING CONTINUATION	-$3,842,622
2017	2015	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	004	5	9/22/2017	NON-COMPETING CONTINUATION	$1,873
														Subtotal = $3,471,615

Issue Date FY: 2016 ( Subtotal = $0 )
2016	2015	UNIVERSITY OF PITTSBURGH	123 UNIVERSITY PLACE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	5	7/28/2016	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $12,546,088 )
2015	2015	UNIVERSITY OF PITTSBURGH	123 UNIVERSITY PLACE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	5	8/25/2015	NON-COMPETING CONTINUATION	$12,546,088
2015	2015	UNIVERSITY OF PITTSBURGH	123 UNIVERSITY PLACE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	5	8/28/2015	NON-COMPETING CONTINUATION	-$12,546,088
2015	2015	UNIVERSITY OF PITTSBURGH	123 UNIVERSITY PLACE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	5	9/1/2015	NON-COMPETING CONTINUATION	$12,546,088
														Subtotal = $12,546,088

Issue Date FY: 2014 ( Subtotal = $14,046,199 )
2014	2014	UNIVERSITY OF PITTSBURGH	123 UNIVERSITY PLACE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	4	8/8/2014	NON-COMPETING CONTINUATION	$14,046,199
														Subtotal = $14,046,199

Issue Date FY: 2013 ( Subtotal = $12,959,016 ) (Continued on the next page)
2013	2013	UNIVERSITY OF PITTSBURGH	123 UNIVERSITY PLACE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	3	9/3/2013	SUPPLEMENT FOR EXPANSION	$7,142,414
2013	2013	UNIVERSITY OF PITTSBURGH	123 UNIVERSITY PLACE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	3	7/31/2013	NON-COMPETING CONTINUATION	$2,744,244
Grand Total All Awards = $62,159,331

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Evaluating New Nicotine Standards for Cigarettes

Award Number: U54DA031659

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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