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View ICR - OIRA Conclusion

OMB Control No: 0910-0753	ICR Reference No: 202204-0910-007
Status: Historical Active	Previous ICR Reference No: 202009-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign
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 with change	Conclusion Date: 06/13/2022
	Date Received in OIRA: 04/07/2022
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	01/31/2023	01/31/2023
Responses	29,887	0	27,401
Time Burden (Hours)	10,462	0	8,894
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	29,887	27,401	2,486
Annual Time Burden (Hours)	10,462	8,894	1,568
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: FDA has added burden for the fifth follow up. This resulted in an increase of 2,486 responses and 1,568 hours. The new estimated burden for this collection is 10,462

Annual Cost to Federal Government: $12,641,919

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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

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