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View ICR - OIRA Conclusion

OMB Control No: 0910-0340	ICR Reference No: 201312-0910-009
Status: Historical Active	Previous ICR Reference No: 201008-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: 21080
Title: Over-the-Counter Human Drugs; Labeling Requirements
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/27/2014
	Date Received in OIRA: 12/20/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	36 Months From Approved	01/31/2014
Responses	961	0	5,650
Time Burden (Hours)	11,523	0	14,303
Cost Burden (Dollars)	2,100,000	0	3,663,000

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	961	5,650	-4,689
Annual Time Burden (Hours)	11,523	14,303	-2,780
Annual Cost Burden (Dollars)	2,100,000	3,663,000	-1,563,000

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: The previous burden estimate in 2011 was 14,303 hours. The decrease in burden to 11,523 (-2,780) hours is mostly attributed to a decrease in the number of manufacturers of sunscreen drug products and a corresponding decrease in the number of total annual burden for manufacturers of new products marketed under NDA, ANDAs, or OTC drug monographs used for the estimates under section 201.66(c) and (d). In addition, the respondents of sunscreen drug products has decreased from the estimate in 2011 from 400 to 20. Conversely, the hours per response increased from 9500 to 720.

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