View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0454	ICR Reference No: 201609-0910-002
Status: Historical Active	Previous ICR Reference No: 201309-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway
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: 11/08/2016
	Date Received in OIRA: 10/05/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2019	36 Months From Approved	11/30/2016
Responses	38	0	156
Time Burden (Hours)	3	0	12
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	38	156	-118
Annual Time Burden (Hours)	3	12	-9
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: There was a decrease in the total number of responses due to annual variation in the number of notices received. This resulted in an annual burden decrease of 118 responses and 9 hours.

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