View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0693	ICR Reference No: 201503-0910-011
Status: Historical Active	Previous ICR Reference No: 201407-0910-012
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/18/2015
	Date Received in OIRA: 03/26/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	08/31/2017	08/31/2017
Responses	124	0	124
Time Burden (Hours)	2,004	0	2,004
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	124	124
Annual Time Burden (Hours)	2,004	2,004
Annual Cost Burden (Dollars)	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 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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