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: 0910-0641	ICR Reference No: 201207-0910-011
Status: Historical Inactive	Previous ICR Reference No: 201207-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance for Industry on Labeling for Products Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Act: Questions and Answers
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 10/15/2012
	Date Received in OIRA: 07/27/2012
Terms of Clearance: In accordance with the terms of 5 CFR 1320, this information collection is improperly submitted. Previous terms of clearance require FDA to accurately classify the burden related to third party disclosure. The Agency does not appear to have done so. We also note that the underlying Guidance document should be uploaded as part of the collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2012	36 Months From Approved	10/31/2012
Responses	100,000	0	100,000
Time Burden (Hours)	400,000	0	400,000
Cost Burden (Dollars)	0	0	0

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