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: 0910-0673	ICR Reference No: 201503-0910-003
Status: Historical Active	Previous ICR Reference No: 201405-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
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: 03/16/2015
	Date Received in OIRA: 03/06/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	08/31/2015	08/31/2015
Responses	300	0	1,000
Time Burden (Hours)	38,075	0	360,000
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	300	1,000	-700
Annual Time Burden (Hours)	38,075	360,000	-321,925
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The Food and Drug Administration is submitting this nonmaterial/non-substantive change request to reduce the burden based on new guidance document recommendations which will reduce the time for a manufacturer to submit a Substantial Equivalence (SE) report.

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