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View ICR - OIRA Conclusion

OMB Control No: 0910-0616	ICR Reference No: 201412-0910-013
Status: Historical Active	Previous ICR Reference No: 201109-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
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 with change	Conclusion Date: 02/09/2015
	Date Received in OIRA: 12/30/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2018	36 Months From Approved	02/28/2015
Responses	20,712	0	19,353
Time Burden (Hours)	7,119	0	6,881
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	20,712	19,353	1,359
Annual Time Burden (Hours)	7,119	6,881	238
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 increase in burden reflects a change in the overall number of research and marketing applications/submissions received by FDA since the previous estimate.

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