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OMB Control No: 0910-0877	ICR Reference No: 202511-0910-001
Status: Received in OIRA	Previous ICR Reference No: 202208-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Required Warnings for Cigarette Packages and Advertisements
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: 05/22/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	05/31/2026
Responses	102	178
Time Burden (Hours)	3,381	11,367
Cost Burden (Dollars)	0	0

Authorizing Statute(s): US Code: 21 USC 387e(g) Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 387c Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 387i Name of Law: Federal Food, Drug, and Cosmetic Act
   PL: Pub.L. 111 - 31 123 Name of Law: Tobacco Control Act
   US Code: 21 USC 371 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 374 Name of Law: Federal Food, Drug, and Cosmetic Act

Citations for New Statutory Requirements: None

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	102	178	-76
Annual Time Burden (Hours)	3,381	11,367	-7,986
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: Since the last OMB approval, FDA has adjusted its burden estimates based on updated data on submission activity. Our estimated burden for the information collection reflects an overall decrease of 7,986 hours and a corresponding decrease of 76 responses. The estimated number of respondents and total burden hours have decreased, reflecting fewer submissions in recent years.

Annual Cost to Federal Government: $669,820

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. No

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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