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View ICR - OIRA Conclusion

OMB Control No: 0910-0670	ICR Reference No: 201610-0910-011
Status: Historical Active	Previous ICR Reference No: 201309-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: GFI: 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: 01/23/2017
	Date Received in OIRA: 11/08/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2020	36 Months From Approved	01/31/2017
Responses	2	0	21
Time Burden (Hours)	30	0	410
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	2	21	-19
Annual Time Burden (Hours)	30	410	-380
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 information collection reflects fewer respondents. This is explained more fully at Q15 of the agency's supporting statement.

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