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View ICR - OIRA Conclusion

OMB Control No: 0910-0670	ICR Reference No: 201309-0910-001
Status: Historical Active	Previous ICR Reference No: 201007-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: 20420
Title: Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
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: 12/02/2013
	Date Received in OIRA: 09/10/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2016	36 Months From Approved	11/30/2013
Responses	21	0	71
Time Burden (Hours)	410	0	14
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	21	71	-50
Annual Time Burden (Hours)	410	14	396
Annual Cost Burden (Dollars)	0	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: The requested burden hours for the 2010 ICR was 290 hours. ROCIS erroneously approved the total hours as 14 so the current total burden hours shows as 14 in ICRAS/ROCIS. Therefore, although ICRAS/ROCIS shows an increase in burden (from 14 to 410) the actual increase in burden is 290 to 410 (a difference of 120 hours) which results from an adjustment based on a review of the data we received on this ICR over the past few years.

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