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OMB Control No: 0910-0775	ICR Reference No: 202509-0910-002
Status: Received in OIRA	Previous ICR Reference No: 202410-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Establishing That a Tobacco Product Was Commercially Marketed in the United States As of February 15, 2007
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 09/30/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	500	1,000
Time Burden (Hours)	2,500	5,000
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	500	1,000	-500
Annual Time Burden (Hours)	2,500	5,000	-2,500
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: The burden adjustment is related to and overall decrease in the expected number of respondents. The number of hours per response has remained the same. As a result of this adjustment, we recorded a decrease to the currently approved burden. Our estimated burden for the information collection reflects an overall decrease of 2,500 hours and a corresponding decrease of 500 responses. The number of submissions FDA received to establish marketing as of February 15, 2007 has decreased and we have therefore revised the number of respondents to the information collection based on this data.

Annual Cost to Federal Government: $663,190

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