View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0693	ICR Reference No: 201407-0910-012
Status: Historical Active	Previous ICR Reference No: 201108-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/21/2014
	Date Received in OIRA: 07/25/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved	08/31/2014
Responses	124	0	94
Time Burden (Hours)	2,004	0	1,524
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	124	94	30
Annual Time Burden (Hours)	2,004	1,524	480
Annual Cost Burden (Dollars)	0	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 burden has increased from 1,524 to 2,004 as a result of updated data on submission under this information collection request.

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