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View ICR - OIRA Conclusion

OMB Control No: 0910-0670	ICR Reference No: 201007-0910-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance for Industry Hypertension Indication: Drug labeling for Cardiovascular Outcome Claims
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: Approved without change	Conclusion Date: 10/18/2010
	Date Received in OIRA: 07/26/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2013	36 Months From Approved
Responses	71	0	0
Time Burden (Hours)	14	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	71	71
Annual Time Burden (Hours)	14	14
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The final guidance document contains provisions that are subject to the PRA. The guidance will assist applicants when developing labeling for outcome claims for drugs.

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