View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0877	ICR Reference No: 202208-0910-010
Status: Active	Previous ICR Reference No: 202107-0910-012
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/24/2023
	Date Received in OIRA: 04/21/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2026	36 Months From Approved	05/31/2023
Responses	178	0	178
Time Burden (Hours)	11,367	0	11,367
Cost Burden (Dollars)	0	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

Annual Cost to Federal Government: $587,525

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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