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View ICR - OIRA Conclusion

OMB Control No: 0910-0788	ICR Reference No: 201808-0910-001
Status: Historical Active	Previous ICR Reference No: 201803-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Evaluation of the Food and Drug Administration's 'Fresh Empire' Multicultural Youth Tobacco Prevention Campaign.
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/03/2018
	Date Received in OIRA: 08/02/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	36 Months From Approved
Responses	107,743	0	0
Time Burden (Hours)	15,135	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	107,743	32,638	75,105
Annual Time Burden (Hours)	15,135	4,813	10,322
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: FDA requests OMB approval to extend the evaluation of FDA’s multicultural youth tobacco public education campaign and to add two additional waves of data collection. Continued evaluation is necessary in order to determine the campaign’s impact on outcomes of interest. Adding the two waves increases the target number of completed campaign questionnaires for all respondents to 107,743, an increase of 32,638 responses, and the annualized response burden to 15,135, an increase of 4,813 hours.

Annual Cost to Federal Government: $8,996,243

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? Uncollected

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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