View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0771	ICR Reference No: 201406-0910-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Providing Waiver-Related Materials in Accordance with Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/21/2014
	Date Received in OIRA: 06/19/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved
Responses	254	0	0
Time Burden (Hours)	321	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	254	254
Annual Time Burden (Hours)	321	321
Annual Cost Burden (Dollars)	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: No

Burden Reduction Due to:

Short Statement: This is a new data collection.

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