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View ICR - OIRA Conclusion

OMB Control No: 0910-0877	ICR Reference No: 202107-0910-012
Status: Historical Active	Previous ICR Reference No: 202102-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Required Warnings for Cigarette Packages and Advertisements
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/18/2021
	Date Received in OIRA: 07/13/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2023	04/30/2023	04/30/2023
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 387i Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 387c 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
   US Code: 21 USC 387e(g) Name of Law: Federal Food, Drug, and Cosmetic Act

Citations for New Statutory Requirements: None

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	178	178
Annual Time Burden (Hours)	11,367	11,367
Annual Cost Burden (Dollars)	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: This is a new data collection.

Annual Cost to Federal Government: $1,740,000

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: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

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