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OMB Control No: 0910-0731	ICR Reference No: 202509-0910-001
Status: Received in OIRA	Previous ICR Reference No: 202410-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 09/19/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	20	65
Time Burden (Hours)	600	1,820
Cost Burden (Dollars)	0	0

Abstract: This ICR is for a guidance intended to assist tobacco manufacturers, importers, researchers, and investigators, and their representatives who seek meetings with staff of FDA’s Center for Tobacco Products (CTP). This guidance does not pertain to other types of meetings or meeting requests with CTP staff. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) offers several pathways to obtain an order from FDA to authorize the marketing of a new tobacco product before it may be introduced or delivered into interstate commerce. To provide assistance with these pathways to market products, FDA will meet with tobacco product manufacturers, importers, researchers, and investigators (or their representatives) where appropriate. This guidance is intended to assist persons who seek guidance relating to their research to inform the regulation of tobacco products or to support the development or marketing of tobacco products. This guidance describes two collections of information: (1) The submission of a meeting request containing certain information and (2) the submission of a meeting information package in advance of the meeting. The purpose of the meeting information package is to provide Agency staff the opportunity to adequately prepare for the meeting, including the review of relevant data concerning the product. In the Agency’s experience, reviewing such information is critical to achieving a productive meeting. For information that was previously submitted in a meeting request, the information package should provide updated information that reflects the most current and accurate information available.

Authorizing Statute(s): PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 27636	06/27/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 45227	09/19/2025
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	20	65	-45
Annual Time Burden (Hours)	600	1,820	-1,220
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Based on the combined impacts of program changes and adjustments describes above, FDA’s estimated burden for the entire information collection reflects an overall annual decrease of 1,220 hours and 90 respondents (45 fewer respondents submitting meeting requests, and 45 fewer respondents submitting metting information packages). The total burden hours for the collection have been reduced from 1,820 hours to 600 total hours. FDA’s estimated cost burden to the respondents has increased from $53,437.20 to $92,274 due to a re-assessment of staff occupational employment categories needed to create and review meeting requests and packages.

Annual Cost to Federal Government: $265,276

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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