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View ICR - OIRA Conclusion

OMB Control No: 0910-0557	ICR Reference No: 201404-0910-013
Status: Historical Active	Previous ICR Reference No: 201102-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry - Pharmacogenomic Data 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 without change	Conclusion Date: 07/03/2014
	Date Received in OIRA: 05/08/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	36 Months From Approved	07/31/2014
Responses	4	0	7
Time Burden (Hours)	200	0	350
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	4	7	-3
Annual Time Burden (Hours)	200	350	-150
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Based on our experience with the submission of voluntary genomic data submissions under this guidance over the past few years, the number of annual responses has been reduced from 7 to 4 because of reduced submissions. There are no other changes or adjustments.

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