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View ICR - OIRA Conclusion

OMB Control No: 0910-0753	ICR Reference No: 201907-0910-024
Status: Historical Active	Previous ICR Reference No: 201902-0910-009
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: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/16/2020
	Date Received in OIRA: 09/12/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	36 Months From Approved	01/31/2020
Responses	25,707	0	123,390
Time Burden (Hours)	7,327	0	25,713
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	25,707	123,390	-97,683
Annual Time Burden (Hours)	7,327	25,713	-18,386
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 has revised the burden due to the decision to complete data collection for the Media Tracking Survey. Therefore, the estimated burden hours for the 1) Screener and Consent Process, 2) Parent Baseline Questionnaire, 3) Media Tracking Screener, and 4) three waves of Media Tracking Questionnaires are no longer needed or requested. In addition, we have completed the baseline and first wave of follow-up data collection for Cohort 2 of the General Market campaign evaluation. The associated burden for those activities has been removed for this extension. This resulted in a decrease of 97,683 responses and 18,386 hours (from the currently approved 123,390 responses and 25,713 hours). The remaining burden to complete the final rounds of data collection is estimated to be 25,707 respondents/annual responses and 7,327 hours.

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? Uncollected

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

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