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Workshop series to identify, discuss, and develop recommendations for the optimal generation and use of in vitro assay data for tobacco product regulation.

Award Number: R13FD007386
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2021
PERIOD OF PERFORMANCE END DATE: 10/31/2022

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Workshop series to identify, discuss, and develop recommendations for the optimal generation and use of in vitro assay data for tobacco product regulation. - Project Summary/Abstract Research priorities for the Center for Tobacco Products (CTP) include “toxicological assays (in vivo and in vitro) to compare toxicity across different types of tobacco products within the same class, including electronic nicotine delivery systems (ENDS), cigars, waterpipes, and smokeless tobacco.” Although CTP regulatory guidance documents include genotoxicity and other in vitro assays in the types of toxicity information required for submissions, there is no standardized guidance or regulatory approved methods for the evaluation of various tobacco products, including ENDS. Therefore, the Institute for In Vitro Sciences (IIVS), a 501(c)(3) nonprofit organization, has organized a Workshop Series to identify, discuss and develop recommendations for the best scientific/technical approaches for generating and interpreting in vitro assay data for comparing toxicity within and across tobacco product classes. Designed as true working meetings, expert stakeholders will discuss and develop recommendations that will then be published. The initial focus of the series has been on the regulatory genetic toxicology assays (Ames test, in vitro mammalian assays for cytogenetic damage and gene mutation). Going forward there will be an increasing emphasis on human disease models. These workshops provide a unique opportunity for multiple stakeholders to share their expertise and will provide published resources that regulatory agencies, academic laboratories, and industry may use as they address the public health issues related to the use of tobacco products. Some of workshop reports may serve as authoritative publications that can be referenced for optimal methodologies and data interpretation. So far, the workshops have identified important issues for using in vitro assays for evaluating tobacco products, and have focused on several of CTP’s high-priority topics. Multiple working groups have been established to collect background information, to hold discussions between workshops, to draft manuscripts, and to develop recommendations that are presented and discussed during the workshops. Consensus statements have resulted from these workshops. Two manuscripts have been published and two are in preparation. For upcoming workshops additional background documents are in preparation by working groups. Methods for generating aerosols for in vitro cell exposure and quantitative approaches to comparing toxicity potency will be the focus of a virtual workshop in April 2021. Workshops for October 2021 and April 2022 are now planned. Working groups are discussing and preparing background manuscripts with a focus on ENDS products and, in addition, (1) methods for dosimetry, (2) recommendations for the Ames test, and (3) recommendations for the mouse lymphoma gene mutation assay. Also included will be approaches for evaluating both general toxicity and disease-causing potential of tobacco products using 3-D respiratory models,


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: 2023 ( Subtotal = -$49,859 )
2023	2021	INSTITUTE FOR INVITRO SCIENCES INC	30 W WATKINS MILL RD	GAITHERSBURG	MD	20878	MONTGOMERY	USA	Food and Drug Administration Research	000	1	7/17/2023	NEW	-$49,859
														Subtotal = -$49,859

Issue Date FY: 2021 ( Subtotal = $49,859 )
2021	2021	INSTITUTE FOR IN VITRO SCIENCES	30 W WATKINS MILL RD STE 100	GAITHERSBURG	MD	20878	MONTGOMERY	USA	Food and Drug Administration Research	000	1	6/25/2021	NEW	$49,859
														Subtotal = $49,859

Grand Total All Awards = $0

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Workshop series to identify, discuss, and develop recommendations for the optimal generation and use of in vitro assay data for tobacco product regulation.

Award Number: R13FD007386

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2021

PERIOD OF PERFORMANCE END DATE: 10/31/2022

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