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: 0910-0716	ICR Reference No: 201203-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Potential Tobacco Product Violations Reporting Form
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/30/2012
	Date Received in OIRA: 03/12/2012
Terms of Clearance: In accordance with the terms of 5 CFR 1320, OMB approves this information collection request for a period of two years. OMB understands that telephone call screeners will request exactly the same information that is collected through the equivalent paper form. Before seeking reapproval of this collection, FDA should submit a formal telephone script as a non-substantive change to this collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2014	36 Months From Approved
Responses	1,000	0	0
Time Burden (Hours)	250	0	0
Cost Burden (Dollars)	5	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	1,000	1,000
Annual Time Burden (Hours)	250	250
Annual Cost Burden (Dollars)	5	5

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: This is a new information collection. FDA's estimate of 250 hours to submit the information by phone, Internet form, paper form, by mail, smartphone application, or e-mail is based on the previous rate of reporting for FDA's cigarette flavor ban, reports received from the FDA's toll-free telephone number and e-mail address, and FDA experience. FDA expects the rate of calls and reporting for potential tobacco product violations to remain constant over the next three years.

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