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View ICR - OIRA Conclusion

OMB Control No: 0910-0458	ICR Reference No: 201701-0910-007
Status: Historical Active	Previous ICR Reference No: 201312-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations; Form FDA 3486 and Addendum 3486A
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: 02/17/2017
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/12/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	36 Months From Approved	02/28/2017
Responses	48,930	0	58,653
Time Burden (Hours)	93,854	0	112,499
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	48,930	58,653	-9,723
Annual Time Burden (Hours)	93,854	112,499	-18,645
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This information collection reflects an overall reduction we attribute to fewer respondents. We discuss this more fully in our supporting statement at Q15.