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: 200904-0910-009
Status: Historical Inactive	Previous ICR Reference No:
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: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Preapproved	Conclusion Date: 07/24/2009
	Date Received in OIRA: 04/17/2009
Terms of Clearance: This ICR is preapproved, consistent with changes to the classification of burden as "third party disclosures." FDA is reminded to accurately classify burdens in future submissions.

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

ICR Summary of Burden

	Total Request	Change Due to New Statute
Annual Number of Responses	100,000	100,000
Annual Time Burden (Hours)	400,000	400,000
Annual Cost Burden (Dollars)	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: This is a new collection.

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