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View ICR - OIRA Conclusion

OMB Control No: 0910-0206	ICR Reference No: 201509-0910-008
Status: Historical Active	Previous ICR Reference No: 201207-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Request for Samples and Protocols
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: 12/09/2015
	Date Received in OIRA: 09/24/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved	12/31/2015
Responses	6,217	0	6,827
Time Burden (Hours)	18,692	0	20,572
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	6,217	6,827	-610
Annual Time Burden (Hours)	18,692	20,572	-1,880
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 previous burden estimate was 20,572 hours. The current decrease to 18,692 hours (-1,880 hours) is mostly due to a decrease in the total annual responses under section 610.2 (~600 responses). The slight decrease in burden is attributed to the normal variation in the submission of samples and protocols to FDA.

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