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View ICR - OIRA Conclusion

OMB Control No: 0910-0880	ICR Reference No: 202003-0910-009
Status: Historical Active	Previous ICR Reference No: 201905-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products and Tobacco Smoke
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: 03/27/2020
	Date Received in OIRA: 03/16/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	11/30/2022	11/30/2022
Responses	22,950	0	9,700
Time Burden (Hours)	2,550	0	1,760
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	22,950	9,700	13,250
Annual Time Burden (Hours)	2,550	1,760	790
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: No

Burden Reduction Due to:

Short Statement: Updated burden estimates to reflect that more respondents may need to be screened in order to reach the desired sample size and that it may not be possible to close recruitment the exact moment that the total 4,500 completes are obtained.

Annual Cost to Federal Government: $208,998

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. 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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