View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0815	ICR Reference No: 201903-0910-010
Status: Historical Active	Previous ICR Reference No: 201802-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: National Panel of Tobacco Consumer Studies
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: 02/28/2020
	Date Received in OIRA: 05/21/2019
Terms of Clearance: Approval is given consistent with the understanding that when communicating or publishing research outcomes associated with this clearance, CTP will present: a) the unweighted distribution of sociodemographic and geographic characteristics of the sample that responded to a given survey, and b) study results based on both weighted and unweighted data. Consistent with obligations under HHS and OMB’s Information Quality Guidelines, CTP will assess the quality of the information generated by collections conducted under this OMB Control Number for each regulatory or policy purpose under consideration. This three year clearance covers only survey replenishment and studies as currently described. Additional observational studies conducted under this control number will be submitted to OMB as revisions under the PRA.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2023	36 Months From Approved	02/29/2020
Responses	15,602	0	27,935
Time Burden (Hours)	3,340	0	4,435
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	15,602	27,935	-12,333
Annual Time Burden (Hours)	3,340	4,435	-1,095
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 is requesting an extension on the currently approved information collection request for remaining planned studies, panel maintenance and replenishment activities and non-substantive changes to update the estimated burden for an additional year of panel replenishment. The average annual burden hours will increase by 1,699 hours, from 4,435 to 6,134 hours.

Annual Cost to Federal Government: $3,265,966

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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